ropeginterferon alfa 2b (Rx)

Brand and Other Names:Besremi, ropeginterferon alfa-2b-njft
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 500mcg/mL (single-dose prefilled syringe)

Polycythemia Vera

Indicated for treatment of polycythemia vera

Not currently on hydroxyurea

  • Initial dose: 100 mcg SC q2Weeks
  • Increase dose by 50 mcg q2Weeks (not to exceed 500 mcg/dose) until hematological parameters are stabilized (hematocrit [Hct] <45%, platelets [Plt] <400x 109/L, leukocytes <10x 109/L)

Transitioning from hydroxyurea

  • Initial dose: 50 mcg SC q2Weeks in combination with hydroxyurea
  • Increase dose by 50 mcg q2Weeks (not to exceed 500 mcg/dose) until hematological parameters are stabilized (HCT <45%, Plt <400 x 109/L, leukocytes <10 x 109/L)
  • Weeks 3-12: Gradually taper off hydroxyurea by reducing total biweekly dose by 20-40% q2Weeks
  • Week 13: Discontinue hydroxyurea

Dosage Modifications

Liver enzyme elevations

  • >5x to ≤20x ULN
    • Decrease dose by 50 mcg; if no improvement, continue decreasing at biweekly intervals until ALT/AST <3x ULN if baseline was normal; 3x baseline if baseline was abnormal, and gamma-glutamyl transferase (GGT) recovers to <2.5x ULN if baseline was normal; or 2.5x baseline if baseline was abnormal
    • If interrupted dose is 50 mcg, hold treatment until recovery
  • >20x ULN
  • Interrupt treatment until ALT/AST <3x ULN if baseline was normal or 1.5x baseline if baseline was abnormal, and GGT <2.5x ULN if baseline was normal or 2x baseline if baseline was abnormal
  • Consider permanent discontinuation if toxicity persists after 4 dose modifications

Elevated liver enzymes with elevated bilirubin, or other evidence of hepatic decompensation

  • Any increase above baseline: Interrupt treatment until recovery; restart at 50 mcg lower than interrupted dose
  • If interrupted dose is 50 mcg, hold treatment until recovery
  • Consider permanent discontinuation if toxicity persists after 4 dose modifications

Cytopenia

  • Non-life-threatening
    • Defined as hemoglobin (Hgb) <8 g/dL, platelet (PLT) count ≥25,000 to <50,000/mm3, or WBC ≥1,000 to <2,000/mm3
    • Decrease dose by 50 mcg; if toxicity does not improve, continue decreasing at biweekly intervals until recovery of Hgb >10 g/dL, Plt count >75,000/mm3, and WBC >3,000/mm3
    • If interrupted dose is 50 mcg, hold treatment until recovery
  • Life-threatening
    • Defined as Hgb levels are life threatening, or urgent intervention needed, PLT count <25,000/mm3, or WBC <1,000/mm3
    • Interrupt treatment until recovery of Hgb >10 g/dL, PLT count >75,000/mm3, and WBC >3,000/mm3
    • Consider permanent discontinuation if toxicity persists after 4 dose modifications

Depression

  • Mild, without suicidal ideation: Consider psychiatric consultation if persistent (>8 weeks)
  • Moderate, without suicidal ideation: Consider dose reduction and psychiatric consultation
  • Severe, or any severity with suicidal ideation: Discontinue therapy, recommend psychiatric consultation

Renal impairment

  • eGFR ≥30 mL/min: No dose adjustment necessary
  • eGFR <30 mL/min: Avoid use

Hepatic impairment

  • Mild (Child-Pugh A): No dose adjustment necessary
  • Moderate-to-severe (Child-Pugh B or C): Contraindicated

Dosing Considerations

Maintain 2-week dosing interval at which hematological stability is achieved for at least 1 year

After achievement of hematological stability for at least 1 year on a stable dose, dosing interval may be expanded to every 4 weeks

Monitor parameters

  • Verify pregnancy in females of reproductive potential before initiating
  • Perform complete blood cell (CBC) counts regularly, every 2 weeks during titration or dosage modification, and every 3-6 months during maintenance (once optimal dose is established)
  • Monitor CBC more frequently if clinically indicated
  • Phlebotomy as rescue treatment to normalize blood hyperviscosity may be necessary during titration

Safety and efficacy not established

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Interactions

Interaction Checker

and ropeginterferon alfa 2b

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              Serious - Use Alternative (175)

              • abemaciclib

                ropeginterferon alfa 2b, abemaciclib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • acalabrutinib

                ropeginterferon alfa 2b, acalabrutinib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • albendazole

                ropeginterferon alfa 2b, albendazole. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • aldesleukin

                ropeginterferon alfa 2b, aldesleukin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • alemtuzumab

                ropeginterferon alfa 2b, alemtuzumab. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • allopurinol

                ropeginterferon alfa 2b, allopurinol. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • altretamine

                ropeginterferon alfa 2b, altretamine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • arsenic trioxide

                ropeginterferon alfa 2b, arsenic trioxide. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • azacitidine

                ropeginterferon alfa 2b, azacitidine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • belinostat

                ropeginterferon alfa 2b, belinostat. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • bendamustine

                ropeginterferon alfa 2b, bendamustine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • bevacizumab

                ropeginterferon alfa 2b, bevacizumab. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • bexarotene

                ropeginterferon alfa 2b, bexarotene. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • blinatumomab

                ropeginterferon alfa 2b, blinatumomab. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • bortezomib

                ropeginterferon alfa 2b, bortezomib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • bosutinib

                ropeginterferon alfa 2b, bosutinib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppressionMyelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • busulfan

                ropeginterferon alfa 2b, busulfan. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • cabazitaxel

                ropeginterferon alfa 2b, cabazitaxel. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • capecitabine

                ropeginterferon alfa 2b, capecitabine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • carbamazepine

                ropeginterferon alfa 2b, carbamazepine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • carboplatin

                ropeginterferon alfa 2b, carboplatin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • carfilzomib

                ropeginterferon alfa 2b, carfilzomib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • carmustine

                ropeginterferon alfa 2b, carmustine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • chlorambucil

                ropeginterferon alfa 2b, chlorambucil. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • chloramphenicol

                ropeginterferon alfa 2b, chloramphenicol. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • cidofovir

                ropeginterferon alfa 2b, cidofovir. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • cisplatin

                ropeginterferon alfa 2b, cisplatin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • cladribine

                ropeginterferon alfa 2b, cladribine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • clofarabine

                ropeginterferon alfa 2b, clofarabine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • clozapine

                ropeginterferon alfa 2b, clozapine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • colchicine

                ropeginterferon alfa 2b, colchicine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • cyclophosphamide

                ropeginterferon alfa 2b, cyclophosphamide. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • cytarabine

                ropeginterferon alfa 2b, cytarabine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • dacarbazine

                ropeginterferon alfa 2b, dacarbazine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • dactinomycin

                ropeginterferon alfa 2b, dactinomycin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • dasatinib

                ropeginterferon alfa 2b, dasatinib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • daunorubicin

                ropeginterferon alfa 2b, daunorubicin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • decitabine

                ropeginterferon alfa 2b, decitabine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • desflurane

                ropeginterferon alfa 2b and desflurane both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • desvenlafaxine

                ropeginterferon alfa 2b and desvenlafaxine both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • deutetrabenazine

                ropeginterferon alfa 2b and deutetrabenazine both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • dexchlorpheniramine

                ropeginterferon alfa 2b and dexchlorpheniramine both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • dexmedetomidine

                ropeginterferon alfa 2b and dexmedetomidine both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • dexrazoxane

                ropeginterferon alfa 2b, dexrazoxane. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • dichloralphenazone

                ropeginterferon alfa 2b and dichloralphenazone both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • dichlorphenamide

                ropeginterferon alfa 2b and dichlorphenamide both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • difelikefalin

                ropeginterferon alfa 2b and difelikefalin both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • difenoxin hcl

                ropeginterferon alfa 2b and difenoxin hcl both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • dinutuximab

                ropeginterferon alfa 2b, dinutuximab. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • diphenoxylate hcl

                ropeginterferon alfa 2b and diphenoxylate hcl both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • docetaxel

                ropeginterferon alfa 2b, docetaxel. Either increases levels of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • doxorubicin

                ropeginterferon alfa 2b, doxorubicin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • doxorubicin liposomal

                ropeginterferon alfa 2b, doxorubicin liposomal. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • dronabinol

                ropeginterferon alfa 2b and dronabinol both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • droperidol

                ropeginterferon alfa 2b and droperidol both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • duloxetine

                ropeginterferon alfa 2b and duloxetine both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • efavirenz

                ropeginterferon alfa 2b and efavirenz both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • entacapone

                ropeginterferon alfa 2b and entacapone both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • epirubicin

                ropeginterferon alfa 2b, epirubicin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • eribulin

                ropeginterferon alfa 2b, eribulin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • escitalopram

                ropeginterferon alfa 2b, escitalopram. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • estramustine

                ropeginterferon alfa 2b, estramustine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • ethosuximide

                ropeginterferon alfa 2b and ethosuximide both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • ethotoin

                ropeginterferon alfa 2b and ethotoin both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • etoposide

                ropeginterferon alfa 2b, etoposide. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • everolimus

                ropeginterferon alfa 2b, everolimus. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • flibanserin

                ropeginterferon alfa 2b and flibanserin both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • floxuridine

                ropeginterferon alfa 2b, floxuridine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • flucytosine

                ropeginterferon alfa 2b, flucytosine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • fludarabine

                ropeginterferon alfa 2b, fludarabine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • fluorouracil

                ropeginterferon alfa 2b, fluorouracil. Either increases levels of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • fosphenytoin

                ropeginterferon alfa 2b and fosphenytoin both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • gabapentin

                ropeginterferon alfa 2b and gabapentin both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • gabapentin enacarbil

                ropeginterferon alfa 2b and gabapentin enacarbil both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • ganciclovir

                ropeginterferon alfa 2b, ganciclovir. Either increases levels of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • guanfacine

                ropeginterferon alfa 2b and guanfacine both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • haloperidol

                ropeginterferon alfa 2b, haloperidol. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • hydroxyurea

                ropeginterferon alfa 2b, hydroxyurea. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • ibritumomab tiuxetan

                ropeginterferon alfa 2b, ibritumomab tiuxetan. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • ibrutinib

                ropeginterferon alfa 2b, ibrutinib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • idarubicin

                ropeginterferon alfa 2b, idarubicin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • ifosfamide

                ropeginterferon alfa 2b, ifosfamide. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • imatinib

                ropeginterferon alfa 2b, imatinib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • interferon alfa 2b

                ropeginterferon alfa 2b, interferon alfa 2b. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • interferon beta 1a

                ropeginterferon alfa 2b, interferon beta 1a. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • interferon beta 1b

                ropeginterferon alfa 2b, interferon beta 1b. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • interferon gamma 1b

                ropeginterferon alfa 2b, interferon gamma 1b. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • irinotecan

                ropeginterferon alfa 2b, irinotecan. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • isoflurane

                ropeginterferon alfa 2b and isoflurane both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • ixabepilone

                ropeginterferon alfa 2b, ixabepilone. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • ketamine

                ropeginterferon alfa 2b and ketamine both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • lenalidomide

                ropeginterferon alfa 2b, lenalidomide. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • levetiracetam

                ropeginterferon alfa 2b, levetiracetam. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • linezolid

                ropeginterferon alfa 2b, linezolid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • lithium

                ropeginterferon alfa 2b and lithium both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • lomustine

                ropeginterferon alfa 2b, lomustine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • maprotiline

                ropeginterferon alfa 2b and maprotiline both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • mebendazole

                ropeginterferon alfa 2b, mebendazole. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • mechlorethamine

                ropeginterferon alfa 2b, mechlorethamine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • meclizine

                ropeginterferon alfa 2b and meclizine both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • melphalan

                ropeginterferon alfa 2b, melphalan. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • mercaptopurine

                ropeginterferon alfa 2b, mercaptopurine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • methadone

                ropeginterferon alfa 2b and methadone both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • methimazole

                ropeginterferon alfa 2b, methimazole. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • methohexital

                ropeginterferon alfa 2b and methohexital both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • methotrexate

                ropeginterferon alfa 2b, methotrexate. Either increases levels of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • methsuximide

                ropeginterferon alfa 2b and methsuximide both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • metyrosine

                ropeginterferon alfa 2b and metyrosine both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • mirtazapine

                ropeginterferon alfa 2b and mirtazapine both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • mitomycin

                ropeginterferon alfa 2b, mitomycin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • mitoxantrone

                ropeginterferon alfa 2b, mitoxantrone. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • morphine

                ropeginterferon alfa 2b and morphine both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • nabilone

                ropeginterferon alfa 2b and nabilone both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • nefazodone

                ropeginterferon alfa 2b and nefazodone both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • nelarabine

                ropeginterferon alfa 2b, nelarabine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • nilotinib

                ropeginterferon alfa 2b, nilotinib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • nitrous oxide

                ropeginterferon alfa 2b and nitrous oxide both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • obinutuzumab

                ropeginterferon alfa 2b, obinutuzumab. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • olaparib

                ropeginterferon alfa 2b, olaparib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • opium tincture

                ropeginterferon alfa 2b and opium tincture both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • oxaliplatin

                ropeginterferon alfa 2b, oxaliplatin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • oxybutynin

                ropeginterferon alfa 2b and oxybutynin both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • paclitaxel

                ropeginterferon alfa 2b, paclitaxel. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • palbociclib

                ropeginterferon alfa 2b, palbociclib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • pazopanib

                ropeginterferon alfa 2b, pazopanib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • peginterferon alfa 2a

                ropeginterferon alfa 2b, peginterferon alfa 2a. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • pemetrexed

                ropeginterferon alfa 2b, pemetrexed. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • pentostatin

                ropeginterferon alfa 2b, pentostatin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • perampanel

                ropeginterferon alfa 2b and perampanel both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • pheniramine

                ropeginterferon alfa 2b and pheniramine both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • phenobarbital

                ropeginterferon alfa 2b and phenobarbital both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • phenytoin

                ropeginterferon alfa 2b and phenytoin both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • ponatinib

                ropeginterferon alfa 2b, ponatinib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • primaquine

                ropeginterferon alfa 2b, primaquine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • primidone

                ropeginterferon alfa 2b and primidone both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • procarbazine

                ropeginterferon alfa 2b, procarbazine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • propofol

                ropeginterferon alfa 2b and propofol both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • propylthiouracil

                ropeginterferon alfa 2b, propylthiouracil. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • pyrimethamine

                ropeginterferon alfa 2b, pyrimethamine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • rituximab

                ropeginterferon alfa 2b, rituximab. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • ruxolitinib

                ropeginterferon alfa 2b, ruxolitinib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • scopolamine

                ropeginterferon alfa 2b and scopolamine both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • sevoflurane

                ropeginterferon alfa 2b and sevoflurane both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • sirolimus

                ropeginterferon alfa 2b, sirolimus. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • sodium oxybate

                ropeginterferon alfa 2b and sodium oxybate both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • sorafenib

                ropeginterferon alfa 2b, sorafenib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • streptozocin

                ropeginterferon alfa 2b, streptozocin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • sulfasalazine

                ropeginterferon alfa 2b, sulfasalazine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • sunitinib

                ropeginterferon alfa 2b, sunitinib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • tacrolimus

                ropeginterferon alfa 2b, tacrolimus. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • tedizolid

                ropeginterferon alfa 2b, tedizolid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • temazepam

                ropeginterferon alfa 2b and temazepam both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • temozolomide

                ropeginterferon alfa 2b, temozolomide. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • teniposide

                ropeginterferon alfa 2b, teniposide. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • tetrabenazine

                ropeginterferon alfa 2b and tetrabenazine both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • thalidomide

                ropeginterferon alfa 2b, thalidomide. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • theophylline

                ropeginterferon alfa 2b and theophylline both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • thioguanine

                ropeginterferon alfa 2b, thioguanine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • thiotepa

                ropeginterferon alfa 2b, thiotepa. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • tizanidine

                ropeginterferon alfa 2b and tizanidine both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • tofacitinib

                ropeginterferon alfa 2b, tofacitinib. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • tolcapone

                ropeginterferon alfa 2b and tolcapone both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • topotecan

                ropeginterferon alfa 2b, topotecan. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • tositumomab

                ropeginterferon alfa 2b, tositumomab. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • trabectedin

                ropeginterferon alfa 2b, trabectedin. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • trastuzumab

                ropeginterferon alfa 2b, trastuzumab. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • trimethobenzamide

                ropeginterferon alfa 2b and trimethobenzamide both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • valerian

                ropeginterferon alfa 2b and valerian both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • vilazodone

                ropeginterferon alfa 2b and vilazodone both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • vinblastine

                ropeginterferon alfa 2b, vinblastine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • vincristine

                ropeginterferon alfa 2b, vincristine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • vinorelbine

                ropeginterferon alfa 2b, vinorelbine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • vorinostat

                ropeginterferon alfa 2b, vorinostat. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              • ziconotide

                ropeginterferon alfa 2b and ziconotide both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              • zidovudine

                ropeginterferon alfa 2b, zidovudine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

              Monitor Closely (29)

              • alfentanil

                ropeginterferon alfa 2b will increase the level or effect of alfentanil by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • amphotericin B cholesteryl sulfate

                ropeginterferon alfa 2b will increase the level or effect of amphotericin B cholesteryl sulfate by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • amphotericin B deoxycholate

                ropeginterferon alfa 2b will increase the level or effect of amphotericin B deoxycholate by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • amphotericin B liposomal

                ropeginterferon alfa 2b will increase the level or effect of amphotericin B liposomal by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • amphotericin B phospholipid complex

                ropeginterferon alfa 2b will increase the level or effect of amphotericin B phospholipid complex by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • clonidine

                ropeginterferon alfa 2b will increase the level or effect of clonidine by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • cyclosporine

                ropeginterferon alfa 2b will increase the level or effect of cyclosporine by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • dihydroergotamine

                ropeginterferon alfa 2b will increase the level or effect of dihydroergotamine by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • dihydroergotamine inhaled

                ropeginterferon alfa 2b will increase the level or effect of dihydroergotamine inhaled by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • disopyramide

                ropeginterferon alfa 2b will increase the level or effect of disopyramide by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • divalproex sodium

                ropeginterferon alfa 2b will increase the level or effect of divalproex sodium by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • ergotamine

                ropeginterferon alfa 2b will increase the level or effect of ergotamine by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • fentanyl

                ropeginterferon alfa 2b will increase the level or effect of fentanyl by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • fentanyl intranasal

                ropeginterferon alfa 2b will increase the level or effect of fentanyl intranasal by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • fentanyl iontophoretic transdermal system

                ropeginterferon alfa 2b will increase the level or effect of fentanyl iontophoretic transdermal system by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • fentanyl transdermal

                ropeginterferon alfa 2b will increase the level or effect of fentanyl transdermal by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • fentanyl transmucosal

                ropeginterferon alfa 2b will increase the level or effect of fentanyl transmucosal by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • isavuconazonium sulfate

                ropeginterferon alfa 2b and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • levothyroxine

                ropeginterferon alfa 2b will increase the level or effect of levothyroxine by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • midazolam

                ropeginterferon alfa 2b will increase the level or effect of midazolam by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • minoxidil

                ropeginterferon alfa 2b will increase the level or effect of minoxidil by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • pimozide

                ropeginterferon alfa 2b will increase the level or effect of pimozide by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • prazosin

                ropeginterferon alfa 2b will increase the level or effect of prazosin by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • quinidine

                ropeginterferon alfa 2b will increase the level or effect of quinidine by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • repaglinide

                ropeginterferon alfa 2b will increase the level or effect of repaglinide by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • thioridazine

                ropeginterferon alfa 2b will increase the level or effect of thioridazine by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • triazolam

                ropeginterferon alfa 2b will increase the level or effect of triazolam by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • valproic acid

                ropeginterferon alfa 2b will increase the level or effect of valproic acid by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              • warfarin

                ropeginterferon alfa 2b will increase the level or effect of warfarin by Other (see comment). Use Caution/Monitor. Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates. Therefore, monitor patients who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index from toxicities to such drugs.

              Minor (0)

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                Adverse Effects

                >10%

                Influenza-like illness (59%)

                Arthralgia (47%)

                Fatigue (47%)

                Pruritus (45%)

                Nasopharyngitis (43%)

                Musculoskeletal pain (41%)

                Headache (39%)

                Diarrhea (33%)

                Hyperhidrosis (29%)

                Nausea (28%)

                Upper respiratory tract infection (27%)

                Local administration site reactions (26%)

                Dizziness (22%)

                Abdominal pain (20%)

                Depression (20%)

                Sleep disorder (20%)

                Leukopenia (18%)

                Decreased appetite (18%)

                Alopecia (16%)

                Edema (16%)

                Hypertension (16%)

                Muscle spasms (16%)

                Neutropenia (16%)

                Rash (16%)

                Transaminase elevations (16%)

                Urinary tract infection (16%)

                Thrombocytopenia (12%)

                Vertigo (12%)

                1-10%

                Atrial fibrillation (<10%)

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                Warnings

                Black Box Warnings

                Risk of serious disorders

                • Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders
                • Closely monitor patients with periodic clinical and laboratory evaluations
                • Withdraw therapy in patients with persistently severe or worsening signs or symptoms of these conditions; in many, but not all cases, these disorders resolve after stopping therapy

                Contraindications

                Presence or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt

                Hypersensitivity to interferons including interferon alfa-2b or any inactive ingredients

                Moderate or severe (Child-Pugh B or C) hepatic impairment

                History or presence of active serious or untreated autoimmune disease

                Immunosuppressed transplant recipients

                Cautions

                Endocrine toxicity has occurred; do not use in patients with active serious or untreated endocrine disorders associated with autoimmune disease; evaluate thyroid function in patients who develop symptoms suggestive of thyroid disease during therapy; discontinue in patients who develop endocrine disorders that cannot be adequately managed during treatment

                Cardiovascular toxicity (eg, cardiomyopathy, myocardial infarction, atrial fibrillation, coronary artery ischemia) reported; closely monitor for cardiovascular toxicity during therapy; avoid use with severe or unstable cardiovascular disease, (eg, uncontrolled hypertension, congestive heart failure (NYHA class ≥2), serious cardiac arrhythmia, significant coronary artery stenosis, unstable angina) or recent stroke or myocardial infarction

                Decreased peripheral blood counts have occurred; these toxicities may include thrombocytopenia (increasing the risk of bleeding), anemia, and leukopenia (increasing the risk of infection)

                Hypersensitivity reactions may occur; may include serious, acute hypersensitivity reactions (eg, urticaria, angioedema, bronchoconstriction, anaphylaxis); if such reactions occur, discontinue therapy and institute appropriate medical therapy immediately

                Pancreatitis reported; symptoms may include nausea, vomiting, upper abdominal pain, bloating, and fever; may experience elevated lipase, amylase, WBC, or altered renal/hepatic function; interrupt treatment in patients with possible pancreatitis and evaluate promptly; consider discontinuation with confirmed pancreatitis

                Fatal and serious ulcerative or hemorrhagic/ischemic colitis have occurred; symptoms may include abdominal pain, bloody diarrhea, and fever; discontinue if signs or symptoms develop; colitis may resolve within 1-3 weeks of stopping treatment

                Pulmonary toxicities may occur; toxicity may manifest as dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension, and sarcoidosis; discontinue if pulmonary infiltrates or pulmonary function impairment

                Ophthalmologic toxicity reported; advise patients to have eye examinations before and during treatment; evaluate eye symptoms promptly and discontinue if new or worsening eye disorders,especifically in those patients with a retinopathy-associated disease such as diabetes mellitus or hypertension

                Hyperlipidemia, hypertriglyceridemia, or dyslipidemia occurred; monitor serum triglycerides before treatment and intermittently during therapy and manage when elevated

                Hepatotoxicity may occur; these toxicities may include increases in serum ALT, AST, GGT and bilirubin; monitor liver enzymes and hepatic function at baseline and during treatment. Reduce dose or discontinue depending on severity; discontinue in patients who develop evidence of hepatic decompensation (eg, jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, variceal hemorrhage) during treatment

                Renal toxicity reported; monitor serum creatinine at baseline and during therapy; avoid use in patients with eGFR <30 mL/min; discontinue if severe renal impairment develops

                Dental and periodontal toxicity may occur; these toxicities may include dental and periodontal disorders; advise patients on good oral hygiene and to have regular dental examinations

                Dermatologic toxicities (eg, skin rash, pruritus, alopecia, erythema, psoriasis, xeroderma, dermatitis, acneiform hyperkeratosis, hyperhidrosis) reported; consider discontinuing if clinically significant dermatologic toxicity

                Advise patients to avoid driving or using machinery if they experience dizziness, somnolence, or hallucination

                May cause fetal harm when administered to pregnant females

                Depression and suicide

                • Life-threatening or fatal neuropsychiatric reactions have occurred
                • These reactions may occur in patients with and without previous psychiatric illness
                • Other CNS effects, including suicidal ideation, attempted suicide, aggression, bipolar disorder, mania, and confusion have been observed with other interferon alfa products
                • Contraindicated with history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt
                • Closely monitor for any symptoms of psychiatric disorders and consider psychiatric consultation and treatment if such symptoms emerge
                • If psychiatric symptoms worsen, discontinue therapy

                Drug interaction overview

                • Drugs metabolized by CYP450
                  • Certain proinflammatory cytokines, including interferons, can suppress CYP450 enzymes resulting in increased exposures of some CYP substrates
                  • Monitor patients on ropeginterferon alfa who are receiving concomitant drugs that are CYP450 substrates with a narrow therapeutic index to inform if dosage modification for these concomitant drugs is necessary
                • Myelosuppressive agents
                  • Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression
                  • Myelosuppressive agents can produce additive myelosuppression
                • Narcotics, hypnotics, or sedatives
                  • Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity
                  • Narcotics, hypnotics, or sedatives can produce additive neuropsychiatric side effects
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                Pregnancy & Lactation

                Pregnancy

                Insufficient human data are available on use in pregnant females to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

                Animal studies assessing reproductive toxicity have not been conducted

                Based on mechanism of action and the role of interferon alfa in pregnancy and fetal development, fetal harm may occur and should be assumed to have abortifacient potential when administered to pregnant females

                Verify pregnancy in females of reproductive potential before initiating

                Disease-associated maternal and/or embryofetal risk

                • Untreated polycythemia vera during pregnancy is associated with adverse maternal outcomes such as thrombosis and hemorrhage
                • Adverse pregnancy outcomes associated with polycythemia vera include increased risk for miscarriage

                Contraception

                • Females of reproductive potential: Use effective contraception during treatment and for at least 8 weeks after final dose

                Infertility

                • Based on its mechanism of action, therapy can cause disruption of the menstrual cycle
                • No animal fertility studies have been conducted

                Lactation

                There are no data on presence in human or animal milk, effects on breastfed children, or effects on milk production

                Advise females not to breastfeed during treatment and for 8 weeks after final dose

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Long-acting pegylated interferon alfa-2b

                Alfa interferons bind to and activates the human type 1 interferon receptor; signal transduction is initially mediated by the Janus kinase-2 gene (JAK2); polycythemia vera is caused by a JAK2 V617F mutation, that permanently turns of signaling at affected cytokine receptors; this results in overproduction of RBCs by the bone marrow

                Absorption

                Steady-state reached by 2-5 days

                Peak plasma concentration: 4.4-31 ng/mL

                Minimal plasma concentration: 1.4-12 ng/mL

                AUC:1,011-7,809 ng·hr/mL

                Absorption rate: 0.12 day-1

                Distribution

                Vd: 4.8 L

                Elimination

                Half-life: 7 days

                Clearance 1.7-2.5 L/hr

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                Administration

                SC Administration

                SC administration only

                Proper training on storage, preparation, and administration technique should be provided

                If a patient or caregiver is not an appropriate candidate for any reason, then administer by a healthcare professional

                Remove prefilled syringe from refrigerator and allow it to reach room temperature of 15-25ºC (59-77ºF) for 15-30 min

                Visually inspect prefilled syringe for particulate matter and discoloration before administration (discard if solution is cloudy, discolored, contains particulate matter or if the syringe shows any sign of damage)

                Choose 1 of the following injection sites: Lower stomach (abdomen) area, at least 2 inches away from the belly button, or top of thighs

                Rotate injection site for each injection; do not inject into skin that is irritated, red, bruised, infected, or scarred

                Uncap needle and tap on the body of the syringe to move any air bubbles to the top; remove the excess air

                Depending on prescribed dose, the amount of dose in the syringe may need to be adjusted by discarding some of the medication

                Pinch the chosen injection site, insert needle at a 45- to 90-degree angle into pinched skin, then release pinched skin

                Inject by slowly pressing on the plunger all the way until it stops

                After all the liquid medicine is injected, remove the needle from the skin

                Discard used syringe with the needle still attached, into an FDA-cleared sharps disposal container; do not recap needle

                Storage

                Refrigerate at 2-8°C (36-46°F) in the original carton to protect from light

                Do not freeze

                Keep away from heat

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                Images

                No images available for this drug.
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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.