peginterferon alfa 2b (Rx)

Brand and Other Names:PEG Intron, PegIntron Redipen, more...Sylatron
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

prefilled pen/vial (PegIntron Redipen, PEG Intron)

  • 50mcg
  • 80mcg
  • 120mcg
  • 150mcg

injectable powder with diluent (Sylatron)

  • 296mcg/vial
  • 444mcg/vial
  • 888mcg/vial

Chronic Hepatitis C

Patients who are initiating therapy for HCV infection or who experienced relapse after prior PEG/RBV therapy, by HCV genotype (AASLD and IAS guidelines, April 2014)

Peginterferon is not recommended as monotherapy for any patient group

Genotypes 1, 4, 5, or 6

  • Peginterferon alfa 2b + ribavirin + sofosbuvir (preferred regimen)
  • 1.5 mcg/kg/Week SC; not to exceed 150 mcg/week, PLUS
  • Ribavirin PO 1000-1200 mg/day (based on body weight) plus sofosbuvir 400 mg PO qDay
  • Treat for 12 weeks (treatment-naive or relapsed); for nonresponders, may extend treatment of PEG/RBV to 24 weeks
  • Reduce ribavirin dose if CrCl ≤50 mL/min

Alternative regimens

  • Genotype 1: Simeprevir 150 mg/day x 12 weeks + PEG/RBV x 24 weeks
  • Genotype 3: Sofosbuvir + PEG/RBV x 12 weeks
  • Genotype 4: Simeprevir 150 mg/day x 12 weeks + PEG/RBV x 24-48 weeks
  • Genotypes 5 and 6: PEG/RBV x 48 weeks

Melanoma (Sylatron)

Indicated for melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy

6 mcg/kg/week SC for 8 doses, THEN  

3 mcg/kg/week SC for up to 5 years

Renal Impairment

Dose reductions of 25% and 50% are recommended in patients with moderate and severe renal impairment, respectively, receiving alpha interferons for chronic hepatitis C

CrCl 30-50 mL/min: Reduce 25%

CrCl 10-29 mL/min (including HD): 50%

The effect of varying degrees of renal impairment on the pharmacokinetics of peginterferon alfa-2b at the recommended doses of 3 mcg/kg or 6 mcg/kg for patients with melanoma has not been studied

Hepatic Impairment

Peginterferon alfa-2b has not been studied in patients with melanoma who have hepatic impairment; in patients treated for viral hepatitis, peginterferon alfa-2b treatment is contraindicated in those with moderate or severe hepatic impairment (Child-Pugh scores >6)

Discontinue Sylatron if hepatic decompensation (Child-Pugh scores >6) occurs during treatment

Orphan Designations

Thrombocythemia

Myelofibrosis

Dosage Forms & Strengths

prefilled pen/vial (PegIntron Redipen, PEG Intron)

  • 50mcg
  • 80mcg
  • 120mcg
  • 150mcg

Chronic Hepatitis C

<3 years: Safety and efficacy not established

3-17 years: 60 mcg/m² SC qWeek (+ ribavirin 15 mg/kg/day PO divided q12hr); administer on same day each week

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Interactions

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              Serious - Use Alternative (3)

              • deferiprone

                deferiprone, peginterferon alfa 2b. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.

              • pexidartinib

                peginterferon alfa 2b and pexidartinib both increase Other (see comment). Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.

              • pretomanid

                peginterferon alfa 2b, pretomanid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.

              Monitor Closely (72)

              • acalabrutinib

                acalabrutinib, peginterferon alfa 2b. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.

              • aldesleukin

                peginterferon alfa 2b increases toxicity of aldesleukin by unknown mechanism. Use Caution/Monitor. Interferons may enhance the adverse effects of aldesleukin including myocardial and renal toxicity.

              • amitriptyline

                peginterferon alfa 2b, amitriptyline. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • amoxapine

                peginterferon alfa 2b, amoxapine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • aripiprazole

                peginterferon alfa 2b, aripiprazole. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • atomoxetine

                peginterferon alfa 2b, atomoxetine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • bosentan

                peginterferon alfa 2b decreases levels of bosentan by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .

              • celecoxib

                peginterferon alfa 2b decreases levels of celecoxib by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered.

              • chlorpromazine

                peginterferon alfa 2b, chlorpromazine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • chlorpropamide

                peginterferon alfa 2b decreases levels of chlorpropamide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered.

              • clomipramine

                peginterferon alfa 2b, clomipramine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • codeine

                peginterferon alfa 2b, codeine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • dapsone

                peginterferon alfa 2b decreases levels of dapsone by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered.

              • desipramine

                peginterferon alfa 2b, desipramine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • dextromethorphan

                peginterferon alfa 2b, dextromethorphan. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • diclofenac

                peginterferon alfa 2b decreases levels of diclofenac by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .

              • doxepin

                peginterferon alfa 2b, doxepin. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • duloxetine

                peginterferon alfa 2b, duloxetine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • etravirine

                peginterferon alfa 2b decreases levels of etravirine by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .

              • flecainide

                peginterferon alfa 2b, flecainide. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • fluoxetine

                peginterferon alfa 2b, fluoxetine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • fluvastatin

                peginterferon alfa 2b decreases levels of fluvastatin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered.

              • fluvoxamine

                fluvoxamine, peginterferon alfa 2b. Other (see comment). Use Caution/Monitor. Comment: Therapeutic effect may be altered with coadministration of CYP2D6 substrates; peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • glimepiride

                peginterferon alfa 2b decreases levels of glimepiride by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .

              • glipizide

                peginterferon alfa 2b decreases levels of glipizide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .

              • glyburide

                peginterferon alfa 2b decreases levels of glyburide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .

              • haloperidol

                peginterferon alfa 2b, haloperidol. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • ibuprofen

                peginterferon alfa 2b decreases levels of ibuprofen by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered.

              • ibuprofen IV

                peginterferon alfa 2b decreases levels of ibuprofen IV by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered.

              • ifosfamide

                ifosfamide, peginterferon alfa 2b. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Ifosfamide may enhance the toxicities of myelosuppressive agents. Monitor for increased risk of myelosuppression.

              • imipramine

                peginterferon alfa 2b, imipramine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • indomethacin

                peginterferon alfa 2b decreases levels of indomethacin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered.

              • lamivudine

                peginterferon alfa 2b, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of liver decompensation.

              • losartan

                peginterferon alfa 2b decreases levels of losartan by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .

              • maprotiline

                peginterferon alfa 2b, maprotiline. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • methadone

                peginterferon alfa 2b will increase the level or effect of methadone by unknown mechanism. Use Caution/Monitor. Methadone levels may be elevated, increasing the pharmacologic effects and adverse reactions. Monitor patients for signs and symptoms of increased narcotic effects and adjust methadone dose as needed.

              • methamphetamine

                peginterferon alfa 2b, methamphetamine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • metoprolol

                peginterferon alfa 2b, metoprolol. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • mexiletine

                peginterferon alfa 2b, mexiletine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • mirtazapine

                peginterferon alfa 2b, mirtazapine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • montelukast

                peginterferon alfa 2b decreases levels of montelukast by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .

              • naproxen

                peginterferon alfa 2b decreases levels of naproxen by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered.

              • nateglinide

                peginterferon alfa 2b decreases levels of nateglinide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .

              • nortriptyline

                peginterferon alfa 2b, nortriptyline. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • palonosetron

                peginterferon alfa 2b, palonosetron. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • paroxetine

                peginterferon alfa 2b, paroxetine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • pegloticase

                pegloticase will decrease the level or effect of peginterferon alfa 2b by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknown

              • pegvaliase

                pegvaliase, peginterferon alfa 2b. Other (see comment). Use Caution/Monitor. Comment: The majority of patients treated with pegvaliase develop anti-polyethylene glycol (PEG) IgM and IgG antibodies. Risk of coadministration with different PEGylated products is unknown. There is a case report of anaphylaxis following a medroxyprogesterone acetate injectable suspension that contained PEG 3350. Carefully read all drug labels, including OTC drugs to check contents for PEG. Note: Unable to include an exhaustive product list for this interaction.

              • perphenazine

                peginterferon alfa 2b, perphenazine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • phenytoin

                peginterferon alfa 2b decreases levels of phenytoin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .

              • promethazine

                peginterferon alfa 2b, promethazine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • propafenone

                peginterferon alfa 2b, propafenone. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • propranolol

                peginterferon alfa 2b, propranolol. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • protriptyline

                peginterferon alfa 2b, protriptyline. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • risperidone

                peginterferon alfa 2b, risperidone. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • ritonavir

                peginterferon alfa 2b, ritonavir. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate. The concomitant use of interferons and anti-retroviral protease inhibitors should be done with caution as both can cause hepatic damage. .

              • sertraline

                peginterferon alfa 2b, sertraline. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • tamoxifen

                peginterferon alfa 2b decreases levels of tamoxifen by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .

              • theophylline

                peginterferon alfa 2b increases levels of theophylline by unknown mechanism. Use Caution/Monitor. Alpha interferons may decrease the clearance of theophylline resulting in increased plasma concentrations.

              • thioridazine

                peginterferon alfa 2b, thioridazine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • timolol

                peginterferon alfa 2b, timolol. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • tolbutamide

                peginterferon alfa 2b decreases levels of tolbutamide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .

              • tolterodine

                peginterferon alfa 2b, tolterodine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • torsemide

                peginterferon alfa 2b decreases levels of torsemide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .

              • tramadol

                peginterferon alfa 2b, tramadol. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • trazodone

                peginterferon alfa 2b, trazodone. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • trimipramine

                peginterferon alfa 2b, trimipramine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • venlafaxine

                peginterferon alfa 2b, venlafaxine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

              • voriconazole

                peginterferon alfa 2b decreases levels of voriconazole by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .

              • warfarin

                peginterferon alfa 2b decreases levels of warfarin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .

              • zafirlukast

                peginterferon alfa 2b decreases levels of zafirlukast by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .

              • zidovudine

                peginterferon alfa 2b will increase the level or effect of zidovudine by Other (see comment). Use Caution/Monitor. Interferons may enhance adverse effects of zidovudine including increased myelosuppression.

              Minor (0)

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                Adverse Effects

                >10% (Hepatitis C Trials)

                Headache (56%)

                Fatigue (52%)

                Injection site inflammation/reaction (47%)

                Depression (16-29%)

                Anxiety/emotional lability/irritability (28%)

                Nausea (26%)

                Insomnia (23%)

                Alopecia (22%)

                Fever (22%)

                Anorexia (20%)

                Diarrhea (18%)

                Abdominal pain (15%)

                Dizziness (12%)

                Impaired concentration (5-12%)

                Pain (12%)

                Pruritus (12%)

                Dry skin (11%)

                Weight loss (11%)

                >10% (Melanoma Trials)

                Fatigue (94%)

                ALT or AST increased (77%)

                Pyrexia (75%)

                Headache (70%)

                Anorexia (69%)

                Myalgia (68%)

                Nausea (64%)

                Arthralgia (51%)

                Chills (63%)

                Injection site reactions (62%)

                Depression (59%)

                Dysgeusia (38%)

                Diarrhea (37%)

                Exfoliative rash (36%)

                Dizziness (35%)

                Alopecia (34%)

                Vomiting (26%)

                Olfactory nerve disorder (23%)

                Blood alkaline phosphatase increased (23%)

                Paraesthesia (21%)

                Weight loss (11%)

                1-10% (Hepatitis C Trials)

                Pharyngitis (10%)

                Transient increase in transaminases (10%)

                Malaise (8%)

                Dermatitis (7%)

                Sinusitis (7%)

                Vomiting (7%)

                Dyspepsia (6%)

                Flushing (6%)

                Hepatomegaly (6%)

                Rash (6%)

                Hypertonia (5%)

                Hypothyroidism (5%)

                Injection site pain (2%)

                Taste perversion

                Neutropenia

                Thrombocytopenia

                1-10% (Melanoma Trials)

                GGT increased (8%)

                Proteinuria (7%)

                Anemia (6%)

                Dyspnea (6%)

                Cough (5%)

                <1% (Hepatitis C Trials)

                Colitis

                Pancreatitis

                Autoimmune thrombocytopenia

                Blindess, thrombosis of retinal vein

                Aggressive behavior

                Depression

                Homicidal thoughts, suicidal thoughts, suicide

                Frequency Not Defined

                As with all proteins, there is a potential for immunogenicity

                Postmarketing reports

                Pulmonary fibrosis

                Bacterial infection including sepsis

                Hepatitis B virus reactivation in HCV/HBV co-infected patients

                Pericarditis

                Aphthous stomatitis

                Tongue pigmentation

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                Warnings

                Black Box Warnings

                Alfa interferons cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders

                The risk of serious depression, with suicidal ideation and completed suicides, and other serious neuropsychiatric disorders are increased with alpha interferons

                Discontinue drug if persistently severe or worsening signs or symptoms of the above conditions are present; disorders typically resolve after stopping therapy

                These disorders may not resolve after the drug is discontinued

                Monitored closely with periodic clinical and laboratory evaluations

                Combination therapy with ribavirin

                • Ribavirin may cause birth defects and/or fetal death
                • Extreme care must be taken to avoid pregnancy in women taking peginterferon alfa-2a and in female partners of men taking peginterferon alfa-2a
                • Ribavirin causes hemolytic anemia; associated anemia may result in worsening of cardiac disease
                • Because ribavirin is genotoxic and mutagenic, consider it a potential carcinogen

                Contraindications

                Hypersensitivity

                Autoimmune hepatitis

                Decompensated liver disease (Child-Pugh >6 [class B and C])

                Contraindications for combination therapy with ribavirin:

                • Pregnant women and men whose female partners are pregnant
                • Hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)
                • Creatinine clearance less than 50 mL/min

                Cautions

                May cause/aggravate fatal or life threatening autoimmune, ischemic, and infectious disorders

                Life-threatening or fatal neuropsychiatric events, including suicide, suicidal and homicidal ideation, depression, relapse of drug addiction/overdose, and aggressive behavior sometimes directed towards others reported in patients with and without a previous psychiatric disorder during therapy and follow-up; psychoses, hallucinations, bipolar disorders, and mania have been observed in patients receiving this therapy and should be used with caution in patients with a history of psychiatric disorders; report any symptoms of depression or suicidal ideation to healthcare provider

                Monitor and evaluate patients for signs and symptoms of depression and other psychiatric symptoms every 3 weeks during first 8 weeks of treatment and every 6 months thereafter; monitor patients during treatment and for at least 6 months after last dose; permanently discontinue therapy for suicidal or homicidal ideation, aggressive behavior towards others, or other severe or persistent psychiatric symptoms (see Black Box Warnings)

                Caution with hypothyroidism, hyperthyroidism, hyperglycemia, and diabetes mellitus that cannot be effectively treated by medication

                Cardiac adverse reactions occurred in 4% of patients during clinical trials; permanently discontinue with new onset ventricular arrhythmia or cardiovascular decompensation

                Risk of visual impairment and retinal disorders; discontinue if ophthalmologic problems develop

                Dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension, and sarcoidosis, some resulting in respiratory failure or patient deaths, may be induced or aggravated by therapy; recurrence of respiratory failure has been observed with interferon rechallenge; monitor

                Ischemic and hemorrhagic cerebrovascular events observed

                Development or exacerbation of autoimmune disorders (e.g., thyroiditis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, rheumatoid arthritis, interstitial nephritis, systemic lupus erythematosus, and psoriasis) observed; use with caution in patients with autoimmune disorders

                Pancreatitis and ulcerative or hemorrhagic/iscemic colitis may occur

                Severe decreases in neutrophil or platelet counts reported

                May cause birth defects and fetal death: use extreme care to avoid pregnancy in female patients and female partners of male patients

                When administered in combination with ibavirin causes hemolytic anemia; associated anemia may result in worsening of cardiac disease

                Hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including peginterferon alpha 2b; cirrhotic CHC patients co-infected with HIV receiving highly active antiretroviral therapy (HAART) and alpha interferons with or without ribavirin appear to be at increased risk for development of hepatic decompensation compared to patients not receiving HAART; monitor clinical status and hepatic function during treatment and discontinue immediately if decompensation (Child-Pugh score greater than 6) observed

                Monitor closely patients with impaired renal function, for signs and symptoms of interferon toxicity, including increases in serum creatinine; adjust dose or discontinue therapy accordingly

                Serious, acute hypersensitivity reactions and cutaneous eruptions reported

                Dental/periodontal disorders reported with combination therapy

                Hypertriglyceridemia may result in pancreatitis (e.g., triglycerides greater than 1000 mg/dL)

                Weight loss and growth inhibition reported during combination therapy in pediatric patients

                Long-term growth inhibition (height) reported in some patients

                Peripheral neuropathy observed when used in combination with telbivudine

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                Pregnancy & Lactation

                Pregnancy

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

                Verify pregnancy status in females of reproductive potential prior to initiating treatment

                Drug may be used in combination with ribavirin; if administered with ribavirin, the information for ribavirin regarding pregnancy testing, contraception, and infertility also applies to this combination regimen; refer to ribavirin prescribing information for additional information

                Contraception

                • Treatment may cause embryo-fetal harm when administered to a pregnant woman; advise female patients of reproductive potential to use effective contraception during treatment and for at least 10 days after final dose

                Infertility

                • Based on animal fertility studies conducted in female cynomolgus monkeys, drug may impair human fertility; effects have been shown to be reversible

                Animal data

                • Based on findings from animal studies, treatment can cause embryo-fetal harm when administered to a pregnant woman; administration of nonpegylated interferon alfa-2b was abortifacient in rhesus monkeys at doses approximately 13 times higher than recommended dose of 6 mcg/kg/week; premature infant death was also observed

                Lactation

                There are no data on presence of peginterferon alfa-2b in human or animal milk, or on its effects on the breastfed infant, or milk production; nonpegylated interferon alfa 2-b is present in human milk at low levels; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for treatment and any potential adverse effects from treatment on breastfed infant or from underlying maternal condition

                Therapy may be used in combination with ribavirin; if drug is administered with ribavirin, breastfeeding is not recommended because of potential for serious adverse reactions from ribavirin in the breastfed infant

                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

                Immunomodulatory cytokine that enhances phagocytic activity of macrophages and cytotoxic activity of lymphocytes for target cells

                Absorption

                Half-life: 4.6 hr

                Peak plasma time: 15-44 hr

                Metabolism

                Conjugation with polyethylene glycol slows metabolism

                Elimination

                Half-life: 40 hr

                Excretion: Urine (30%)

                Pharmacogenomics

                A genetic variant near the gene encoding interferon-lambda-3 (IL28B rs12979860, a C to T change) is a strong predictor of response to peginterferon and ribavirin

                Sustained virologic response rates tended to be lower with the C/T and T/T genotypes compared to those with the C/C genotype, particularly among previously untreated subjects receiving 48 weeks of peginterferon and ribavirin

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                Administration

                SC Preparation (Sylatron)

                Reconstitute with 0.7 mL sterile water for injection

                Do not withdraw more than 0.5 mL of reconstituted solution from vial

                Resulting concentration following reconstitution

                • 296 mg/vial = 40 mcg/0.1 mL
                • 444 mg/vial = 60 mcg/0.1 mL
                • 888 mg/vial = 120 mcg/0.1 mL

                SC Administration

                Once weekly dosing: Administer on same day each week

                Rotate injection site

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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

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                • Compare formulary status to other drugs in the same class.
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                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.