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Peginterferon Alfa 2a

    Brands

    DEA Class; Rx

    Common Brand Names; Pegasys, Pegasys ProClick

    • Hepatitis B/Hepatitis C Agents

    Covalent conjugate of recombinant interferon alfa-2a with PEG
    Used to treat chronic HCV infections in patients 5 years and older, and chronic HBV infections in patients 3 years and older
    Improved tolerability when compared with interferon alfa-2a

    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

    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

    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%)

    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

    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

    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

    Adults

    180 mcg/week subcutaneously.

    Geriatric

    180 mcg/week subcutaneously.

    Adolescents

    180 mcg/1.73 m2 x BSA subcutaneously once weekly, up to a maximum of 180 mcg weekly.

    Children

    5 years and older: 180 mcg/1.73 m2 x BSA subcutaneously once weekly, up to a maximum of 180 mcg weekly.
    3 to 4 years: 180 mcg/1.73 m2 x BSA subcutaneously once weekly, up to a maximum of 180 mcg weekly for chronic hepatitis B; safety and efficacy for hepatitis C have not been established.
    Younger than 3 years: Safety and efficacy have not been established.

    Infants

    Use not recommended.

    Neonates

    Use not recommended.

    Peginterferon alfa-2a

    vial

    • 180mcg/mL (single-dose)

    prefilled syringe

    • 180mcg/0.5mL (single-dose)