Pegasys Full Prescribing Information and Medication Guide (505K/PDF)
Pegasys Medication Guide (260K/PDF)
Copegus Full Prescribing Information and Medication Guide (223K/PDF)
Copegus Medication Guide (97K/PDF)
Important Drug Warning Update to Pegasys and Copegus Package Inserts - Dear Healthcare Professional Letter (63K/PDF)

01-16-2009 Pegasys® 180µg/1mL Vials (peginterferon alpha-2a) Packaging Change (758K/PDF)

01-05-2009 Pegasys® Pre-filled Syringes Monthly Convenience Pack (peginterferon alpha-2a) Important Information (404K/PDF)

08-09-2006 Pegasys Packaging Change (221K/PDF)

Important Safety Information Pegasys (Peginterferon alfa-2a), like other alpha interferons, can cause fatal or make life-threatening problems worse (like mental, immune system, heart, liver, lung, intestinal and infections). Doctors should monitor patients during regular visits. If patients show signs or symptoms of these conditions, their doctor may stop their medication. In most patients, these conditions get better after they stop taking Pegasys (see the Medication Guide for more information and Warnings).

Copegus (Ribavirin, USP) can be extremely harmful and cause birth defects in an unborn baby. Female patients and the female partners of male patients should avoid getting pregnant. Ribavirin is known to cause anemia (low red blood cells), which can make heart disease worse. Also, ribavirin can harm DNA and possibly cause cancer (see the Medication Guide for more information and Warnings).

People should not take PEGASYS alone or with COPEGUS if:
They are younger than 18 years of age; they are pregnant or their partner is pregnant; they or their partner plans to get pregnant during therapy or within 6 months after treatment ends; they are breastfeeding; they have hepatitis caused by their immune system (autoimmune hepatitis); they have unstable or severe liver disease before or during treatment; they are allergic to alpha interferons or any of the ingredients in Pegasys and Copegus; they have abnormal red blood cells (caused by conditions like sickle-cell anemia or thalassemia major).

Women who could get pregnant must take pregnancy tests before, during and for 6 months after treatment ends to make sure they are not pregnant.

During treatment and for 6 months after treatment, female and male patients must use two forms of birth control (one being a condom with spermicide), and tell their doctor right away if they or their partner becomes pregnant. They or their doctor should also call the Ribavirin Pregnancy Registry at 1-800-593-2214.

Patients should tell their healthcare provider about any medications, vitamins, supplements, or herbal medicines they are taking. Patients must also tell healthcare provider if they are taking any of the following medicines:

• Telbivudine (Tyzeka®), a drug used to treat hepatitis B: People who take Pegasys with Tyzeka can have nerve problems (such as numbness and tingling)
• Theophylline: A patient's healthcare provider may need to monitor the amount of theophylline in the body and make changes to a patient's theophylline dose
• Any HIV medications: Some patients developed serious liver problems including death
• Didanosine: Patients must not take Copegus and didanosine
• Zidovudine: The combination of zidovudine and Pegasys/Copegus can reduce the number of red and white blood cells in the body. A patient's healthcare provider will need to monitor the patient's condition and possibly have them stop taking zidovudine
• Methadone: People taking methadone should be monitored by their healthcare provider for signs and symptoms of methadone toxicity
• Azathioprine: The combination of azathioprine and Pegasys/Copegus can reduce the number of red and white blood cells, and platelets in the body. A patient's healthcare provider will need to monitor the patient's complete blood counts more frequently, and possibly have them stop taking azathioprine and Pegasys/Copegus.

The most serious side effects of Pegasys and Copegus are:

• Mental health problems (such as depression, thoughts about suicide, suicide attempts and relapse of drug abuse or drug overdose, all of which can lead to death. Other problems include thoughts of homicide or hurting other people, irritability, anxiety, aggressiveness, bipolar disorders, mania, and hallucinations)
• Blood problems (like a drop in blood cells leading to increased risk for infections, bleeding and/or heart or circulatory problems). Low levels of red blood cells can cause death in patients taking Copegus.
• Other blood disorders
• Problems with pregnancy
• Lung problems (like trouble breathing, pneumonia, inflammation of lung tissue, and high lung blood pressure), sometimes requiring a machine to breathe and/or causing death
• Eye problems (blurred, loss of vision, and retinal detachment)
• Autoimmune problems (where the body's immune system attacks the body's own cells), such as psoriasis (as skin disease), systemic lupus erythematosus, rheumatoid arthritis
• Heart problems (including high or low blood pressure, chest pain, fast heart rate, and heart attacks) which can lead to death
• Stomach pain (stomach or corneal ulcers)
• Rash with fever or blisters
• Weakness, loss of coordination, numbness, and difficulty speaking due to stroke, including patients with no known risk for stroke
• Liver problems (rarely, liver function worsens) including an increased chance of liver failure in patients with cirrhosis. Patients with both the hepatitis C virus and HIV have an increased chance of liver failure during Pegasys treatment. Change in a blood test that measures liver inflammation occurs more often in patients with hepatitis B. Severe liver damage can lead to death
• Colitis (inflammation of the colon, which can cause abdominal pain, bloody diarrhea, and fever) which can lead to death
• Inflammation of the pancreas, muscles, and bile ducts which can lead to death
• Blood sugar problems such as high or low blood sugar and diabetes
• Bacterial, viral, fungal infections (such as in the blood, bones, heart, kidneys and lungs) which can lead to death

The most common side effects of Pegasys and Copegus are:

• Flu-like symptoms (including fever, chills, muscle aches, joint pain, headaches, tiredness)
• Upset stomach (like nausea, vomiting, taste changes, diarrhea)
• Skin problems (like rash, dry or itchy skin, or redness and swelling at injection site)
• Hair thinning or loss (temporary)
• Mental health problems (such as depression, difficulty sleeping, irritability, and anxiety)
• Anorexia or loss of appetite leading to weight loss
• Dehydration

For the full prescribing information for Pegasys and Copegus, including Boxed WARNINGS and Medication Guide, please visit www.pegasys.com.

 

Tyzeka® is a registered trademark of Novartis Pharmaceuticals Corporation.