Peginterferon Alfa-2A (1 brand name, 2 dosage forms, 1 route)
Available dosage forms: SYRINGE, VIAL.
Routes of administration: SUBCUTANEOUS.
Brand Names
- PEGASYS
Contraindications
PEGASYS is contraindicated in patients with: Known hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction, anaphylaxis, or Stevens-Johnson syndrome to alpha interferons, including PEGASYS, or any of its components. Autoimmune hepatitis Hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic patients before treatment Hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before treatment PEGASYS is contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurologic and other complications which are sometimes fatal in neonates and infants. When PEGASYS is used in combination with other HCV antiviral drugs, the contraindications applicable to those agents are applicable to combination therapies. PEGASYS combination treatment with ribavirin is contraindicated in women who are pregnant and men whose female partners are pregnant [See Warnings and Precautions (5.1)and Use in Specific Populations (8.1)]. Refer to the prescribing information of the other HCV antiviral drugs, including ribavirin, for a list of their contraindications.
Warnings and Precautions
Refer to the prescribing information of the other HCV antiviral drugs, including ribavirin, for their Warnings and Precautions.
Adverse Reactions
In clinical trials, a broad variety of serious adverse reactions were observed in 1,010 subjects who received PEGASYS at doses of 180 mcg for 48 weeks, alone or in combination with ribavirin [see Boxed Warningand Warnings and Precautions (5)] . The most common life-threatening or fatal events induced or aggravated by PEGASYS and ribavirin include depression, suicide, relapse of drug abuse/overdose, and bacterial infections, each occurring at a frequency of less than 1%. Hepatic decompensation occurred in 2% (10/574) of CHC/HIV subjects [see Warnings and Precautions (5.9)] .
Mechanism of Action
Pegylated recombinant human interferon alfa-2a is an inducer of the innate antiviral immune response [see Microbiology (12.4)] .
Overdosage
There is limited experience with overdosage. The maximum dose received by any patient was 7 times the intended dose of PEGASYS (180 mcg/day for 7 days). There were no serious reactions attributed to overdosages. Weekly doses of up to 630 mcg have been administered to patients with cancer. Dose-limiting toxicities were fatigue, elevated liver enzymes, neutropenia, and thrombocytopenia. There is no specific antidote for PEGASYS. Hemodialysis and peritoneal dialysis are not effective.