Peginterferon alfa
PEGASYS
What it isPegylated interferon alfa driving an antiviral immune response; chronic hepatitis B and D.
Why this oneIt offers a finite treatment course with durable off-therapy response, which nucleos(t)ides do not.
What limits itFlu-like symptoms, depression and cytopenias make it poorly tolerated. Contraindicated in decompensated cirrhosis and autoimmune disease.
FDA label
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Chronic hepatitis C | adults | 180 mcg SC once weekly | 180 mcg weekly (with other HCV antivirals; monotherapy only if intolerant/contraindicated to others) | 180 mcg weekly |
| Chronic hepatitis C | pediatric ≥5 years | 180 mcg/1.73 m2 × BSA SC once weekly (with ribavirin) | 180 mcg/1.73 m2 × BSA weekly | 180 mcg/1.73 m2 × BSA weekly |
| Chronic hepatitis B (HBeAg-positive or -negative) | adults | 180 mcg SC once weekly | 180 mcg weekly | 180 mcg weekly for 48 weeks |
| Chronic hepatitis B (HBeAg-positive, non-cirrhotic) | pediatric ≥3 years | 180 mcg/1.73 m2 × BSA SC once weekly | 180 mcg/1.73 m2 × BSA weekly | 180 mcg/1.73 m2 × BSA weekly for 48 weeks |
Renal Reduce dose to 135 mcg weekly in ESRD on hemodialysis; dose modification for CrCl <30 mL/min and 30–50 mL/min.
Hepatic Discontinue immediately for hepatic decompensation (Child-Pugh ≥6) in cirrhotic patients.
Duration depends on indication, genotype, and combination regimen.
Instructions
- Administer by SC injection in the abdomen or thigh, once weekly.
- For CHC, use in combination with other HCV antiviral drugs (monotherapy only if others contraindicated/not tolerated).
- Dose-modify for neutropenia, thrombocytopenia, ALT elevation, and depression.
Contraindications
- Autoimmune hepatitis
- Hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic patients before treatment
- Hepatic decompensation (Child-Pugh score ≥6) in cirrhotic CHC patients coinfected with HIV before treatment
- Neonates and infants (product contains benzyl alcohol)
- In combination with ribavirin: women who are pregnant and men whose female partners are pregnant
Cautions
- Neuropsychiatric reactions
- Cardiovascular disorders
- Bone marrow suppression
- Autoimmune and endocrine disorders (thyroid, hyperglycemia)
- Ophthalmologic disorders
- Cerebrovascular disorders
- Hepatic decompensation / hepatitis exacerbation
- Pulmonary disorders
- Infections
- Colitis and pancreatitis
- Hypersensitivity and serious skin reactions (Stevens-Johnson syndrome)
- Growth impairment in pediatric patients
- Peripheral neuropathy with telbivudine
Adverse reactions
- Depression
- Fatigue
- Headache
- Pyrexia
- Myalgia
- Neutropenia
- Nausea/anorexia
- Injection site reactions
- Alopecia
- Irritability/insomnia
Pregnancy Can cause fetal harm and has abortifacient potential (animal data); with ribavirin, contraindicated due to teratogenicity/fetal death.
Lactation No information on presence in human milk; consider discontinuing nursing or drug.
⚠ BOXED WARNING
- Neuropsychiatric, autoimmune, ischemic and infectious disorders
Classes and tags
Clinical profile
Mechanism of action: Peginterferon alfa ballicule
