peginterferon alfa 2a (Rx)

Brand and Other Names:Pegasys, Pegasys ProClick
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

vial

  • 180mcg/mL (single-dose)

prefilled syringe

  • 180mcg/0.5mL (single-dose)

Chronic Hepatitis C

Indicated as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs for treatment of adults with chronic hepatitis C (CHC) with compensated liver disease

180 mcg SC once weekly

Treatment duration (CHC)

  • Refer to prescribing information of the other HCV antiviral drugs for the recommended dosage of the other HCV antiviral drugs and duration of the entire treatment regimen
  • Genotype 1 in combination with ribavirin or alone: Discontinue treatment if at least a 210 reduction from baseline in HCV RNA has not been demonstrated by 12 weeks or if undetectable HCV RNA has not been achieved after 24 weeks
  • Genotypes 1, 4: 48 weeks if PEG-INF-alfa-2a and ribavirin are used without other HCV antiviral drugs
  • Genotypes 2, 3: 24 weeks if PEG-INF-alfa-2a and ribavirin are used without other HCV antiviral drugs
  • Genotypes 5, 6: Insufficient data to recommend use
  • PEG-INF-alfa-2a monotherapy: 48 weeks
  • HIV coinfection: 48 weeks if PEG-INF-alfa-2a and ribavirin are used without other HCV antiviral drugs (regardless of HCV genotype)

Chronic Hepatitis

Indicated for treatment of adults with HBeAg-positive and HBeAg-negative chronic hepatitis B infection who have compensated liver disease and evidence of viral replication and liver inflammation

180 mcg SC once weekly for 48 weeks

Dosage Modifications

Neutropenia

  • ANC <750 cells/mm3: Reduce to 135 mcg SC once weekly
  • ANC <500 cells/mm3: Discontinue treatment until ANC values return to >1000 cells/mm3 and then reinstitute at 90 mcg SC once weekly; monitor ANC

Thrombocytopenia

  • Platelet <50,000 cells/mm3: Reduce to 90 mcg SC once weekly
  • Platelets <25,000 cells/mm3: Discontinue treatment

Increased ALT

  • If ALT increases are progressive despite dose reduction or accompanied by increased bilirubin or evidence of hepatic decompensation, discontinue treatment immediately
  • Chronic hepatitis C: If ALT increases above baseline values, reduce to 135 mcg/week and perform more frequent monitoring of liver function; after dosage reduction or withholding, resume therapy after ALT flares subside
  • Chronic hepatitis B (ALT >5x ULN): Monitor LFTs more frequently; consider reducing the dosage to 135 mcg/week or temporarily discontinuing treatment; after dosage reduction or withholding, resume therapy after ALT flares subside
  • Consider discontinuing in adults with persistent, severe hepatitis B flares (ALT >10x ULN)

Depression

  • Mild
    • No dosage change; evaluate once weekly by visit and/or phone
    • Depression severity remains stable after 8 weeks: Continue weekly visit schedule
    • Depression severity improves after 8 weeks: Resume normal visit schedule
    • Depression severity improves after 8 weeks: Discontinue or reduce dosage to 135 mcg or 90 mcg once weekly and consider psychiatric consult
  • Moderate
    • Reduce dosage to 135 mcg or 90 mcg once weekly; evaluate once weekly (office visit at least every other week)
    • Depression severity remains stable after 8 weeks: Continue reduce dosing; consider psychiatric consultation
    • If symptoms improve and are stable for 4 weeks, may resume normal visit schedule; continue reduced dosage or return to normal dosage
    • Depression severity improves after 8 weeks: Discontinue permanently and obtain immediate psychiatric consult
  • Severe
    • Discontinue permanently; obtain immediate psychiatric consult
    • Depression management after 8 weeks: Psychiatric therapy necessary

Renal impairment

  • CrCl 30-50 mL/min: 180 mcg once weekly
  • CrCl <30 mL/min (including patients on hemodialysis)
    • 135 mcg once weekly
    • If severe adverse reactions or laboratory abnormalities develop, reduce dose to 90 mcg once weekly until adverse reactions abate
    • If intolerance persists after dosage adjustment, discontinued treatment

Hepatic impairment

  • CHC patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons,
  • During treatment, closely monitor patients’ clinical status and hepatic and discontinue treatment immediately if decompensation (Child-Pugh score ≥6) is observed

Dosing Considerations

Preform pregnancy screening for females of childbearing potential

CHC

  • PEG-INF-alfa-2a alone or in combination with ribavirin without additional HCV antiviral drugs is not recommended for treatment of patients with CHC who previously failed therapy with an interferon-alfa
  • Not recommended for treatment of patients with CHC who have had solid organ transplantation

Chronic Myelogenous Leukemia (Orphan)

Orphan indication sponsor

Hoffman-La Roche Inc; 340 Kingsland St; Nutley, NJ 07110-1199

Renal Cell Carcinoma (Orphan)

Orphan indication sponsor

Hoffman-La Roche Inc; 340 Kingsland St; Nutley, NJ 07110-1199

Dosage Forms & Strengths

vial

  • 180mcg/mL (single-dose)

prefilled syringe

  • 180mcg/0.5mL (single-dose)

Chronic Hepatitis C

Indicated in combination with ribavirin for treatment of chronic hepatitis C (CHC) in children aged ≥5 yr with CHC and compensated liver disease

<5 years: Safety and efficacy not established

≥5 years H4

  • 180 mcg/1.73 m2 SC qWeek with daily ribavirin  
  • Treatment duration
    • Genotypes 2, 3: 24 weeks
    • Genotypes 1, 4: 48 weeks
    • Patients who initiate treatment prior to their 18th birthday should maintain the recommended pediatric dosage (not the adult dosage) through the completion of therapy
    • Refer to ribavirin prescribing information for dose and duration

Chronic Hepatitis B

Indicated for treatment of HBeAg-positive CHB in non-cirrhotic children aged ≥3 years with evidence of viral replication and elevations in ALT

180 mcg/1.73 m2 x BSA (maximum dose: 180 mcg) SC qWeek for 48 weeks

Dosage Modifications

Neutropenia (CHC)

  • ANC 750-999 cells/mm^3
    • Week 1-2: Immediately decrease dose to 135 mcg/1.73 m2 x BSA
  • Week 3-48: No modification
  • ANC 500-749 cells/mm^3
    • Week 1-2: Delay or hold treatment until >750 cells/mm3 then resume dose at 135 mcg/1.73 m2 x BSA; assess 3x/week to verify ANC >750 cells/mm3
    • Week 3-48: Immediately decrease dose to 135 mcg/1.73 m2 x BSA
  • ANC 250-499 cells/mm^3
    • Week 1-2: Delay or hold treatment until >750 cells/mm3 then resume dose at 90 mcg/1.73 m2 x BSA
    • Week 3-48: 135 mcg/1.73 m2 x BSA
  • ANC <250 cells/mm^3 (or febrile neutropenia)
    • Discontinue treatment

Neutropenia (CHB)

  • ANC 750-999 cells/mm3: No dosage modification
  • ANC 500-749 cells/mm3: Immediately decrease dose to 135 mcg/1.73 m2 x BSA
  • ANC 250-499 cells/mm3: Interrupt dosing until ANC ≥1000 cells/mm3, then resume dose with 90 mcg/1.73 m2 x BSA and monitor
  • ANC <250 cells/mm3 (or febrile neutropenia): Discontinue treatment

Thrombocytopenia

  • Platelets 25,000 to <50,000 cells/mm3: Decrease dose to 90 mcg/1.73 m2 x BSA SC once weekly
  • Platelets ≤25,000 cells/mm3: Discontinue treatment

Increased ALT

  • Persistent or increasing elevations ALT ≥5 to <10x ULN
    • CHC: Decrease dose to 135 mcg/1.73 m2 x BSA; monitor weekly, reduce dosage further if necessary until stable or ALT level decreases
    • CHB: Decrease dose to 135 mcg/1.73 m2 x BSA; monitor weekly to ensure ALT is stable or decreasing
  • Persistent ALT ≥10x ULN: Discontinue treatment

Depression

  • Mild
    • No dosage change; evaluate once weekly by visit and/or phone
    • Depression severity remains stable after 8 weeks: Continue weekly visit schedule
    • Depression severity improves after 8 weeks: Resume normal visit schedule
    • Depression severity improves after 8 weeks: Discontinue or reduce dosage to 135 or 90 mcg/1.73 m2 once weekly and consider psychiatric consult
  • Moderate
    • Reduce dosage to 135 or 90 mcg/1.73 m2 once weekly; evaluate once weekly (office visit at least every other week)
    • Depression severity remains stable after 8 weeks: Continue reduce dosing; consider psychiatric consultation
    • If symptoms improve and are stable for 4 weeks, may resume normal visit schedule; continue reduced dosage or return to normal dosage
    • Depression severity improves after 8 weeks: Discontinue permanently and obtain immediate psychiatric consult
  • Severe
    • Discontinue permanently; obtain immediate psychiatric consult
    • Depression management after 8 weeks: Psychiatric therapy necessary

Renal impairment

  • Dosage recommendations for pediatric patients with renal impairment are not available

Hepatic impairment

  • CHC patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons,
  • During treatment, closely monitor patients’ clinical status and hepatic and discontinue treatment immediately if decompensation (Child-Pugh score ≥6) is observed

Dosing Considerations

Preform pregnancy screening for females of childbearing potential

CHC

  • PEG-INF-alfa-2a alone or in combination with ribavirin without additional HCV antiviral drugs is not recommended for treatment of patients with CHC who previously failed therapy with an interferon-alfa
  • Not recommended for treatment of patients with CHC who have had solid organ transplantation
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Interactions

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            Adverse Effects

            >10%

            CHC (adults)

            • Fatigue/asthenia (56%)
            • Headache (54%)
            • Pyrexia (37%)
            • Myalgia (37%)
            • Rigors (35%)
            • Arthralgia (28%)
            • Nausea/vomiting (24%)
            • Alopecia (23%)
            • Injection site reaction (22%)
            • Neutropenia (21%)
            • Irritability/anxiety/nervousness (19%)
            • Insomnia (19%)
            • Depression (18%)
            • Anorexia (17%)
            • Diarrhea (16%)
            • Dizziness (16%)
            • Abdominal pain (15%)
            • Pruritus (12%)
            • Pain (11%)

            CHC (pediatrics)

            • Influenza like illness (91%)
            • Headache (51%)
            • Gastrointestinal disorder (49%)
            • Injection site reaction (44%)
            • Musculoskeletal pain (35%)
            • Fatigue (25%)
            • Irritability (24%)
            • Rash (15%)
            • Pruritus (11%)
            • Decreased appetite (11%)

            CHB

            • Fatigue/asthenia (65%)
            • Headache (43%)
            • Pyrexia (41%)
            • Myalgia (40%)
            • Irritability/anxiety/nervousness (33%)
            • Insomnia (30%)
            • Alopecia (28%)
            • Neutropenia (27%)
            • Nausea/vomiting (25%)
            • Rigors (25%)
            • Anorexia (24%)
            • Injection site reaction (23%)
            • Arthralgia (22%)
            • Depression (20%)
            • Pruritus (19%)
            • Dermatitis (16%)
            • Lymphopenia (14%)
            • Dizziness (14%)
            • Dyspnea (13%)
            • Overall resistance mechanism disorders (12%)
            • Anemia (11%)
            • Diarrhea (11%)

            1-10%

            CHC (adults)

            • Overall resistance mechanism disorder (10%)
            • Back pain (9%)
            • Concentration impairment (8%)
            • Dermatitis (8%)
            • Dry mouth (6%)
            • Sweating increased (6%)
            • Memory impairment (6%)
            • Thrombocytopenia (5%)
            • Memory impairment (5%)
            • Rash (5%)
            • Decreased weight (4%)
            • Dyspnea (4%)
            • Cough (4%)
            • Dry skin (4%)
            • Vision blurred (4%)
            • Hypothyroidism (3%)
            • Lymphopenia (3%)
            • Mood alteration (3%)
            • Anemia (2%)
            • Eczema (1%)

            CHC (pediatrics)

            • Insomnia (9%)

            CHB

            • Pain (10%)
            • Concentration impairment (10%)
            • Dry skin (10%)
            • Cough (10%)
            • Decreased weight (10%)
            • Rash (8%)
            • Abdominal pain (8%)
            • Sweating increased (6%)
            • Dyspepsia (6%)
            • Vision blurred (5%)
            • Eczema (5%)
            • Mood alteration (5%)
            • Back pain (5%)
            • Thrombocytopenia (5%)
            • Dyspnea exertional (4%)
            • Dry mouth (4%)
            • Hypothyroidism (4%)

            <1%

            CHC

            • Dyspepsia (<1%)
            • Dyspnea exertional (<1%)

            Postmarketing Reports

            Blood and lymphatic system disorders: Pure red cell aplasia

            Ear and labyrinth disorders: Hearing impairment, hearing loss

            Gastrointestinal disorders: tongue pigmentation

            Immune system disorders: Liver graft rejection and renal graft rejection

            Infections and infestations: Limb abscess

            Metabolism and nutrition disorders: Dehydration

            Skin and subcutaneous tissue disorders: Serious skin reactions

            Neurological: Seizures

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            Warnings

            Risk of Serious Disorders

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

            Monitor closely with periodic clinical and laboratory evaluations

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

            Contraindications

            Known hypersensitivity reactions (eg, urticaria, angioedema, bronchoconstriction, anaphylaxis, or Stevens-Johnson syndrome)

            Autoimmune hepatitis

            Hepatic decompensation (Child-Pugh score >6 [class B and C]) in cirrhotic patients with or without HIV coinfection before treatment

            Use in neonates and infants

            Combination therapy with ribavirin is contraindicated in females who are pregnant and men whose female partners are pregnant

            Cautions

            Refer to prescribing information of the other HCV antiviral drugs, including ribavirin, for their warnings and precautions

            May cause birth defects and/or death of the exposed fetus; patients must avoid pregnancy (female patients or female partners of male patients) while taking PEG-INF-alfa-2a and ribavirin combination therapy

            Life-threatening or fatal neuropsychiatric reactions may manifest and include suicide, suicidal ideation, homicidal ideation, depression, relapse of drug addiction, and drug overdose; these reactions may occur with and without history of previous psychiatric illness

            Hypertension, supraventricular arrhythmias, chest pain, and myocardial infarction reported; caution with pre-existing cardiovascular disease

            Suppresses bone marrow function and may result in severe cytopenias; ribavirin may potentiate the neutropenia and lymphopenia induced by alpha interferons; rare occurrences of aplastic anemia observed

            Development or exacerbation of autoimmune disorders including myositis, hepatitis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis, interstitial nephritis, thyroiditis, and systemic lupus erythematosus reported

            May cause or aggravate endocrine disorders including hypothyroidism, hyperthyroidism, hyperglycemia, hypoglycemia, and diabetes mellitus

            Alpha interferons may induce or exacerbate ophthalmic disorders including decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots, optic neuritis, papilledema and serous retinal detachment

            Patients with CHC with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons

            Exacerbations of hepatitis during hepatitis B therapy are not uncommon and are characterized by transient and potentially severe increases in serum ALT

            Dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension and sarcoidosis, some resulting in respiratory failure and/or patient deaths, may be induced or aggravated by alpha interferons

            Serious and severe infections (bacterial, viral, or fungal), some fatal, have been reported during treatment with alpha interferons

            Ulcerative and hemorrhagic/ischemic colitis, sometimes fatal, have been observed within 12 weeks of starting alpha interferon treatment

            Pancreatitis, sometimes fatal, has occurred during alpha interferon and ribavirin treatment

            Severe acute hypersensitivity reactions (eg, urticaria, angioedema, bronchoconstriction, and anaphylaxis) observed

            Growth inhibition observed in children aged 5-17 years with CHC during combination therapy for up to 48 weeks with ribavirin, and also in children aged 3-17 years with CHB for up to 48 weeks during monotherapy

            Laboratory tests

            • Standard hematological and biochemical laboratory tests recommended for all patients
            • Preform pregnancy screening for females of childbearing potential
            • Administer electrocardiograms if pre-existing cardiac abnormalities exist before combination treatment with ribavirin
            • After initiation, perform hematological tests at 2 and 4 weeks and biochemical tests at 4 weeks
            • Perform additional testing periodically during therapy

            Drug interaction overview H4

            • Peginterferon alfa-2a is a weak CYP1A2 inhibitor
            • Theophylline
              • Once-weekly peginterferon alfa-2a treatment for 4 weeks in healthy subjects was associated with a 25% increase in theophylline AUC
              • If coadministered, monitor theophylline serum levels and consider appropriate dose adjustments
            • NRTIs
              • Hepatic decompensation (including fatalities) observed when patients coinfected with CHC/HIV received NRTIs
              • Closely monitor for treatment-associated toxicities when peginterferon alfa-2a/ribavirin combined with other HCV antiviral drugs and NRTIs
              • Refer to prescribing information for other HCV antiviral drugs and the respective NRTIs for guidance regarding toxicity management
              • Consider dose reduction or discontinuation of peginterferon alfa-2a, ribavirin, or both if worsening toxicities observed
            • Zidovudine
              • Coadministration may increase risk for developing severe neutropenia and/or anemia
              • Consider discontinuing zidovudine as medically appropriate
              • Consider dose reduction or discontinuation of peginterferon alfa-2a, ribavirin, or both if worsening clinical toxicities observed, including hepatic decompensation (eg, Child-Pugh >6)
            • Methadone
              • Coadministration increases methadone levels by 10-15% from baseline
              • Clinical significance unknown; monitor for potential methadone toxicity
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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled studies in pregnant women to inform of drug-associated risk

            Combination treatment with ribavirin is contraindicated in women who are pregnant and in the male partners of women who are pregnant; significant teratogenic and/or embryocidal effects demonstrated in all animal species exposed to ribavirin

            Animal data

            • Therapy can cause fetal harm and should be assumed to have abortifacient potential
            • Nonpegylated interferon alfa-2a treatment caused abortion when given to pregnant rhesus monkeys

            Pregnancy exposure registry

            • Monitors maternal and fetal outcomes of pregnancies of female patients and female partners of male patients exposed to ribavirin during pregnancy or who become pregnant within 6 months following discontinuation of ribavirin
            • Encourage healthcare providers and patients to report such cases by calling 1-800-593-2214

            Pregnancy testing

            • Treatment with ribavirin or with other HCV drug
              • Females of reproductive potential: Perform before initiation of treatment, monthly during treatment, and for at least 6 months following treatment
              • Males with female partners of reproductive potential: Perform before initiation of treatment, monthly during treatment, and for at least 6 months following treatment

            Contraception

            • Females of reproductive potential: Use effective contraception during therapy; when receiving combination therapy with ribavirin, use effective contraception during treatment and for at least 6 months after last dose

            Infertility

            • Based on its mechanism of action and studies in female monkeys, disruption of the menstrual cycle may occur
            • No female fertility study has been performed

            Lactation

            There is no information regarding drug presence in human milk, effects on breastfed infants, or on milk production

            The Centers for Disease Control and Prevention recommends that HIV-infected mothers not breastfeed their infants to avoid potential transmission of HIV; therefore, CHC- and CHB-infected mothers coinfected with HIV should not breastfeed their infants

            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

            Recombinant alfa-2a interferon w/ polyethylene glycol (PEG) side chain

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

            Absorption

            Peak plasma time: 72-96 hr

            Mean trough concentration at week 48: 16 ng/mL

            Steady-state reached by Week 5-8

            Metabolism

            Inhibits CYP1A2

            Elimination

            Clearance: 94 mL/hr

            Half-life: 160 hr (CHC)

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            Administration

            SC Administration

            Administer SC in the abdomen or thigh

            Visually inspect for particulate matter and discoloration before administration (do not use if particulate matter is visible or product is discolored)

            Avoid drinking alcohol

            Avoid driving or operating machinery if you become dizzy, confused, very sleepy, or tired during treatment

            180 mcg/mL vial

            • 180 mcg = 1 mL
            • 135 mcg = 0.75 mL
            • 90 mcg = 0.5 mL
            • Use 180 mcg/ml vial to prepare pediatric dose; dose should be drawn from 180 mcg/mL vial using a 1-mL tuberculin syringe

            180 mcg/mL prefilled syringe

            • 180 mcg = 0.5 mL
            • 135 mcg = 0.375 mL
            • 90 mcg = 0.25 mL

            Missed dose

            • Missed dose <2 days of scheduled dose: Administer as soon possible; take your next dose on next scheduled day
            • Missed dose ≥≥2 days: Advise patient to reach out to healthcare provider

            Storage

            Vials and prefilled syringes

            • Refrigerate at 36-46ºF (2-8ºC)
            • Do not leave out of the refrigerator for >24 hr
            • Do not freeze or shake
            • Protect from light
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            Formulary

            FormularyPatient Discounts

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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.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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