Pegasys and Copegus Product Information
Safety Information
Contact Us
Site Map
Glossary
Search
PEGASYS® (Peginterferon alfa-2a) for Injection
  • About PEGASYS
  • Taking PEGASYS and COPEGUS
  • Treating Hepatitis C
  • Hepatitis C Basics
  • How do I know if I have Hepatitis C?
  • Living With Hepatitis C
  • PEGASYS for Healthcare Providers
Long term and short term success begins here
  • Understanding Hepatitis C
  • Natural History of Hepatitis C Infection
  • Evolution of Hepatitis C Treatment
  • Hepatitis C and Fibrosis
  • Hepatitis C and Cirrhosis
  • Hepatitis C and Liver Transplantation
  • Hepatitis C and HIV Coinfection
  • About PEGASYS
  • Efficacy for Patients With Chronic Hepatitis B
  • Safety and Tolerability
  • Patient Support
  • Resource Library
  • Healthcare Professional Tools

Pegassist Support

Because we know that the best treatment plan goes beyond medication.
Hepatitis C Support: PEGASSIST

Hepatitis C and Cirrhosis

Cirrhosis can lead to severe complications1

  • Major complications of cirrhosis include ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, portal hypertension, variceal bleeding, and hepatorenal syndrome

Complications of Cirrhosis

Today, the incidence of complications of cirrhosis from hepatitis C is increasing, a trend that is expected to continue for as many as 40 more years.2,3

  • Once complications of cirrhosis develop, survival rates are poor and liver transplantation is often the only treatment option

Projected prevalence of HCV-related cirrhosis and complications in the United States by 20202

  • HCV infections: 2.7 million
  • Cirrhosis: 0.86 million
  • Decompensated cirrhosis: 0.13 million
  • Hepatocellular carcinoma: 13,390
  • Liver-related deaths: 36,483

Advanced cirrhosis can affect major organs other than the liver

Extrahepatic manifestations of HCV infection4

  • Patients with chronic hepatitis C can present with extrahepatic manifestations or syndromes considered to be of immunologic origin, such as rheumatoid symptoms, keratoconjunctivitis sicca, lichen planus, glomerulonephritis, lymphoma, and essential mixed cryoglobulinemia
  • Chronic hepatitis C is also related to porphyria cutanea tarda
  • Psychological disorders including depression have been associated with HCV infection

Estimated disease progression from compensated cirrhosis5

  • Decompensation: 3.6% to 6.0% per year
  • Hepatocellular carcinoma: 1.4% to 3.3% per year
  • Death: 2.6% to 4.0% per year

Patients with decompensated cirrhosis* are at high risk of death5,6

  • 5-year survival rate is 50% in patients who do not receive a liver transplant

 

*Defined as biopsy-proven cirrhosis with biochemical deterioration (thrombocytopenia, hypoalbuminemia, hyperbilirubinemia, or coagulopathy) or clinical complications (ascites, spontaneous bacterial peritonitis, jaundice, encephalopathy, variceal hemorrhage, or renal dysfunction).

References:

  1. Feldman M et al, eds. Sleisenger and Fordtran’s Gastrointestinal and Liver Disease: Pathophysiology/Diagnosis/Management. 6th ed. Philadelphia, PA: WB Saunders; 1998.
  2. Davis GL. Chronic hepatitis C and liver transplantation. Rev Gastroenterol Disord. 2004;4(1):7-17.
  3. US Preventive Services Task Force. Screening for hepatitis C in adults. http://www.ahrq.gov/clinic/uspstf/uspshepc.htm.
  4. National Institutes of Health consensus statement on management of hepatitis C: 2002. NIH Consens State Sci Statements. 2002;19(3):1-46.
  5. Everson GT. Treatment of hepatitis C in patients who have decompensated cirrhosis. Clin Liver Dis. 2005;9(3):473-486.
  6. Fattovich G et al. Morbidity and mortality in compensated cirrhosis type C: a retrospective follow-up study of 384 patients. Gastroenterology. 1997;112(2):463-472.

INDICATIONS

PEGASYS, alone or in combination with COPEGUS, is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that is clinically stable (eg, antiretroviral therapy not required or receiving stable antiretroviral therapy).

PEGASYS is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation.

Boxed WARNINGS and additional IMPORTANT SAFETY INFORMATION

Alpha interferons, including PEGASYS® (Peginterferon alfa-2a), 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.

Use with Ribavirin. Ribavirin, including COPEGUS®, may cause birth defects and/or death of the fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen.

CONTRAINDICATIONS

PEGASYS is contraindicated in patients with hypersensitivity to PEGASYS or any of its components, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment. PEGASYS is also contraindicated in hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment. PEGASYS is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurological and other complications in neonates and infants, which are sometimes fatal.

PEGASYS and COPEGUS therapy is additionally contraindicated in patients with a hypersensitivity to COPEGUS or any of its components, in women who are pregnant, men whose female partners are pregnant, and patients with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).

AVOIDING PREGNANCY

COPEGUS 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 two forms of effective contraception during treatment and during the 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time. If pregnancy should occur during treatment or during 6 months post-therapy, the patient must be advised of the significant teratogenic risk of COPEGUS therapy to the fetus. Healthcare providers and patients are strongly encouraged to immediately report any pregnancy in a patient or partner of a patient during treatment or during 6 months after treatment cessation to the Ribavirin Pregnancy Registry at 1-800-593-2214.

WARNINGS

Serious adverse events in hepatitis B and hepatitis C trials included neuropsychiatric disorders (homicidal ideation, suicidal ideation, suicide attempt, suicide, psychotic disorder and hallucinations), serious and severe bacterial infections (sepsis), bone marrow toxicity (cytopenia and rarely, aplastic anemia), cardiovascular disorders (hypertension, supraventricular arrhythmias and myocardial infarction), hypersensitivity (including anaphylaxis), endocrine disorders (including thyroid disorders and diabetes mellitus), autoimmune disorders (including idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, psoriasis, lupus, rheumatoid arthritis and interstitial nephritis), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension, and sarcoidosis), colitis (ulcerative and hemorrhagic/ischemic colitis), pancreatitis, ophthalmologic disorders (decrease or loss of vision, retinopathy including macular edema and retinal thrombosis/hemorrhages, optic neuritis and papilledema), and peripheral neuropathy (in combination with telbivudine).

Adverse reactions reported during post-approval use of PEGASYS therapy, with and without ribavirin, include dehydration, hearing impairment, hearing loss, serious skin reactions, including erythema multiforme major, infections (bacterial, viral and fungal), and serous retinal detachment, and pure red cell aplasia.

MOST COMMON ADVERSE EVENTS

The most common adverse events reported for PEGASYS and COPEGUS combination therapy observed in clinical trials were fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia (40%), irritability/anxiety/nervousness (33%), insomnia (30%), alopecia (28%), neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia (24%), injection-site reaction (23%), arthralgia (22%), depression (20%), pruritus (19%) and dermatitis (16%). The adverse event profile of coinfected patients treated with PEGASYS and COPEGUS was generally similar to that shown for monoinfected patients. Events occurring more frequently in coinfected patients were neutropenia (40%), anemia (14%), thrombocytopenia (8%), weight decrease (16%) and mood alteration (9%). In clinical trials of 48-week treatment duration, the adverse event profile of PEGASYS in chronic hepatitis B was similar to that seen in chronic hepatitis C PEGASYS monotherapy use, except for exacerbations of hepatitis. The most common adverse events reported for PEGASYS, observed in clinical studies, were pyrexia (54%), headache (27%), myalgia (26%), fatigue (24%), alopecia (18%) and anorexia (16%).

WARNINGS SPECIFIC TO HEPATITIS C PATIENTS

Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEGASYS. Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART. During treatment, patients’ clinical status and hepatic function should be closely monitored, and PEGASYS treatment should be immediately discontinued if decompensation (Child-Pugh score >6) is observed. Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alfa-based therapies, including PEGASYS. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and a causal relationship between interferon alfa-based therapies and these events is difficult to establish.

WARNINGS SPECIFIC TO HEPATITIS B PATIENTS

Exacerbations of hepatitis during hepatitis B therapy are not uncommon and are characterized by transient and potentially severe increases in serum ALT. Patients experiencing ALT flares should receive more frequent monitoring of liver function. PEGASYS dose reduction should be considered in patients experiencing transaminase flares. If ALT increases are progressive despite reduction of PEGASYS dose or are accompanied by increased bilirubin or evidence of hepatic decompensation, PEGASYS should be immediately discontinued.

Please see full Prescribing Information, including Boxed WARNINGS for additional Important
Safety Information.

Print this page



THIS SITE INTENDED FOR U.S. AUDIENCES ONLY

For more information about PEGASYS, contact your physician or other healthcare professional.

Photographs used for illustrative purposes.


© 2002-2010 Genentech USA, Inc. All rights reserved. Use and access of this site is subject to the terms and conditions as set out in our Legal Statement and Privacy Statement.
Genentech Logo