PEGASYS® (peginterferon alfa-2a), as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs, is indicated for the treatment of adults with chronic hepatitis C (CHC) with compensated liver disease. For information about the safe and effective use of other HCV antiviral drugs to be used in combination with PEGASYS, refer to their prescribing information. PEGASYS in combination with ribavirin is indicated for treatment of pediatric patients 5 years of age and older with CHC and compensated liver disease. PEGASYS monotherapy is only indicated for the treatment of patients with CHC with compensated liver disease if there are contraindications or significant intolerance to other HCV antiviral drugs.
Limitations of Use:
- PEGASYS 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
- PEGASYS is not recommended for treatment of patients with CHC who have had solid organ transplantation
PEGASYS is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B infection who have compensated liver disease and evidence of viral replication and liver inflammation.
Important Safety Information and BOXED WARNINGS
RISK of Serious Disorders
Alpha interferons, including PEGASYS, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy.
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 >6 [class B and C]) in cirrhotic patients before treatment; hepatic decompensation with Child-Pugh score ≥6 in cirrhotic CHC patients coinfected with HIV before treatment.
PEGASYS is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurologic and other complications in neonates and infants, which are sometimes fatal.
PEGASYS combination treatment with ribavirin is contraindicated in women who are pregnant and men whose female partners are pregnant.
Refer to the prescribing information of the other HCV antiviral drugs, including ribavirin, for their Warnings and Precautions.
WARNINGS AND PRECAUTIONS:
Pegasys Use with ribavirin:
- Pregnancy: Use with ribavirin may cause birth defects and/or death of the exposed fetus. Female patients and female partners of male patients must avoid pregnancy while taking PEGASYS and ribavirin combination therapy. Ribavirin therapy should not be started unless a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use 2 forms of effective contraception during treatment and for at least 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time
- Neuropsychiatric reactions; cardiovascular disorders; bone marrow suppression; pancytopenia (with concomitant use of azathioprine); autoimmune disorders; endocrine disorders; ophthalmologic disorders; cerebrovascular disorders; hepatic failure and hepatitis exacerbations; pulmonary disorders; infections; colitis; pancreatitis; hypersensitivity and serious skin reactions, including Stevens-Johnson syndrome; impact on growth in pediatric patients; peripheral neuropathy (in combination with telbivudine)
The most common life-threatening or fatal events induced or aggravated by PEGASYS and ribavirin include include depression, suicide, relapse of drug abuse/overdose, and bacterial infections, each occurring at a frequency of <1%. Hepatic decompensation occurred in 2% (10/574) of CHC/HIV subjects.
The most common serious adverse event for PEGASYS with or without ribavirin was bacterial infection (eg, sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia). Other serious adverse events occurred at a frequency of <1% and included: suicide, suicidal ideation, aggression, anxiety, drug abuse and drug overdose, angina, hepatic dysfunction, fatty liver, cholangitis, arrhythmia, diabetes mellitus, autoimmune phenomena (eg, hyperthyroidism, hypothyroidism, sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis), peripheral neuropathy, aplastic anemia, peptic ulcer, gastrointestinal bleeding, pancreatitis, colitis, corneal ulcer, pulmonary embolism, coma, myositis, cerebral hemorrhage, thrombotic thrombocytopenic purpura, psychotic disorder, and hallucination.
For hepatitis C subjects, the most commonly reported adverse reactions were psychiatric reactions, including depression, insomnia, irritability, anxiety, and flu-like symptoms such as fatigue, pyrexia, myalgia, headache, and rigors. Other common reactions were anorexia, nausea and vomiting, diarrhea, arthralgias, injection site reactions, alopecia, and pruritus.
The safety profile observed in pediatric subjects was similar to that seen in adults, the most prevalent adverse events were influenza-like illness, upper respiratory tract infection, headache, gastrointestinal disorder, skin disorder, and injection-site reaction. Most of the adverse events reported in the study were mild or moderate in severity. Severe adverse events (hyperglycemia and cholecystectomy) were reported in 2 subjects.
Chronic Hepatitis C with HIV Coinfection (Adult Patients):
The adverse event profile of HCV/HIV coinfected adult subjects treated with PEGASYS/ribavirin was generally similar to that shown for monoinfected patients. Events occurring more frequently in coinfected subjects were neutropenia, anemia, thrombocytopenia, weight decrease, and mood alteration.
Chronic Hepatitis B:
The most common or important serious adverse events, all of which occurred at a frequency of less than or equal to 1%, in the hepatitis B studies were infections (sepsis, appendicitis, tuberculosis, influenza), hepatitis B flares, and thrombotic thrombocytopenic purpura. The most commonly observed adverse reactions in patients treated with PEGASYS were pyrexia, headache, fatigue, myalgia, alopecia, and anorexia.
Report side effects to the FDA (800) FDA-1088 or www.FDA.gov/medwatch.
Report side effects to Genentech at (888) 835-2555.
Please see the PEGASYS full Prescribing Information for Boxed WARNINGS and additional Important Safety Information.
PEGASYS® and COPEGUS® are registered trademarks of Hoffmann-La Roche Inc. All other brands for listed products are trademarks or registered trademarks (as indicated) of their respective owners and are not trademarks of Genentech, Inc. or Hoffmann-La Roche Inc.