Indications for PEGASYS:
As part of a combination regimen, to treat adults with chronic hepatitis C (CHC) with compensated liver disease (monotherapy only indicated if there are contraindications or significant intolerance to other HCV antiviral drugs). In combination with ribavirin for the treatment of pediatrics ≥5yrs with CHC and compensated liver disease. HBeAg (+) or HBeAg (–) chronic hepatitis B (hep B), in adults with compensated liver disease and evidence of viral replication and liver inflammation. HBeAg (+) CHB, in non-cirrhotic pediatrics ≥3yrs with evidence of viral replication and elevations of serum ALT.
Limitations of Use:
Pegasys alone or in combination with ribavirin without additional HCV antiviral drugs is not recommended for patients who previously failed therapy with an interferon-alfa. Not recommended for CHC patients with solid organ transplantation.
SC inj into thigh or abdomen. If used in combination with other CHC antiviral drugs, refer to labeling of other antivirals for duration of entire treatment regimen. CHC (Genotypes 1, 4): 180mcg once weekly; if Pegasys and ribavirin used without other HCV antivirals, recommended duration is 48 weeks. CHC (Genotypes 2, 3): 180mcg once weekly; if Pegasys and ribavirin used without other HCV antivirals, recommended duration is 24 weeks. Monotherapy: 180mcg once weekly for 48 weeks. CHC with HIV co-infection: 180mcg once weekly; with other HCV antivirals, see labeling for treatment duration; in combination with ribavirin without other HCV antivirals: recommended duration is 48 weeks. Chronic hep B: 180mcg once weekly for 48 weeks. CrCl <30mL/min or ESRD on hemodialysis: 135mcg SC once weekly; may reduce to 90mcg once weekly if severe adverse reactions or lab abnormalities develop; if intolerance persists, discontinue. Reduce dose and/or discontinue if ALT increases progressively or with increased bilirubin, or if neutropenia, thrombocytopenia, or depression occurs; see full labeling.
CHC: <5yrs: not established. ≥5yrs: 180mcg/1.73m2 x BSA SC once weekly; max dose 180mcg; give in combination with ribavirin. HCV genotypes 2 or 3: treat for 24 weeks. Other HCV genotypes: treat for 48 weeks. Patients who initiate treatment before 18th birthday should maintain recommended pediatric dosage through therapy completion. CHB: <3yrs: not established. ≥3yrs: 180mcg/1.73m2 x BSA SC once weekly; max dose 180mcg. Treat for 48 weeks. Maintain pediatric dose through duration of therapy in those who turn 18yrs of age. Dose modifications: see full labeling.
Autoimmune hepatitis. Hepatic decompensation (Child-Pugh B and C) in cirrhotic patients or cirrhotic CHC patients coinfected with HIV. Neonates. Infants. Combination with ribavirin contraindicated in pregnancy and men with pregnant partners.
Risk of serious disorders.
May worsen neuropsychiatric, autoimmune, endocrine, ischemic, ophthalmic, pulmonary, or infectious disorders: monitor closely, discontinue if severe or persistently worsens. Cardiovascular or cerebrovascular disease. Renal impairment. Severe myelosuppression. Discontinue if severe hypersensitivity reactions, colitis or pancreatitis develops. Monitor CBC, thyroid, visual, renal, and hepatic function before and during therapy. Transplant recipients. CD4 cell count <100 cells/microliter. HBV with HCV or HIV co-infection. Elderly. Pregnancy; may have abortifacient effects; exclude status prior to initiation. Use effective contraception during therapy. Nursing mothers: not recommended.
May potentiate theophylline, methadone; monitor. Caution with NRTIs; monitor for toxicities. Monitor for worsening neutropenia and/or anemia with zidovudine. Peripheral neuropathy possible with concomitant telbivudine.
Fatigue/asthenia, pyrexia, myalgia, psychiatric/CNS effects (depression, irritability, suicidal ideation, headache, insomnia), alopecia, GI upset, decreased CD4, CD8 counts; cardiovascular, hepatic, hematologic (eg, decreased WBCs, platelets), respiratory, thyroid, visual abnormalities, infections, anorexia, ALT elevations; also in children: growth inhibition.
See Copegus entry in Antivirals section for information on ribavirin.
Vial single-use—1; Prefilled syringe—4 (w. supplies); Autoinjector—1, 4