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Important Safety Information for the Patient

What is PEGASYS?

PEGASYS is a medicine used to treat some adults who have viral hepatitis C or hepatitis B who show signs of liver damage with no prior treatment with interferon. PEGASYS is also used in patients coinfected with hepatitis C and HIV. PEGASYS works to reduce the amount of virus in your blood, helping your body fight the virus.

Most Serious Side Effects for PEGASYS
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). Your doctor should monitor you during regular visits. If you show signs or symptoms of these conditions, your doctor may stop your medication. In most patients, these conditions get better after you stop taking PEGASYS (see medication guide for more information and warnings).

What is COPEGUS?

COPEGUS is a medicine that works by slowing down the growth of the virus. COPEGUS should be taken with PEGASYS to fight the Hepatitis C virus. COPEGUS can also be used in patients coinfected with hepatitis C and HIV. Do not take COPEGUS by itself.

Most Serious Side Effects for COPEGUS
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 your DNA and possibly cause cancer (see medication guide for more information and warnings).

Who should not take PEGASYS and COPEGUS?

Do not take PEGASYS alone or with COPEGUS if:

• You are younger than 18 years of age
• You are pregnant or your partner is pregnant
• You or your partner plans to get pregnant during therapy or within 6 months after treatment ends
• You are breastfeeding
• You have hepatitis caused by your immune system (autoimmune hepatitis)
• You have unstable or severe liver disease before or during treatment
• You are allergic to alpha interferons or any of the ingredients in PEGASYS and COPEGUS
• You have abnormal red blood cells (caused by conditions like sickle-cell anemia or thalassemia major)

What if I am pregnant or thinking about having a baby?

If you are a woman who could get pregnant, you must take pregnancy tests before, during and for 6 months after treatment ends to make sure you 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)
• Tell your doctor right away if you or your partner becomes pregnant. You or your doctor should also call the Ribavirin Pregnancy Registry at 1-800-593-2214

What should I avoid while taking PEGASYS, or PEGASYS with COPEGUS?

• If you are pregnant do not start taking or continue taking COPEGUS in combination with PEGASYS
• Avoid becoming pregnant while taking PEGASYS, alone or in combination with COPEGUS. PEGASYS, alone or in combination with COPEGUS, may harm your unborn child (such as death or serious birth defects) or cause you to lose your baby (ie, miscarry)
• Do not breastfeed your baby while on PEGASYS, alone or in combination with COPEGUS
• Do not drink alcohol, including beer, wine, and liquor. This may make your liver disease worse
• Taking other medicines. Take only medicines prescribed or approved by your healthcare provider. These include prescription and nonprescription medicines and herbal supplements

What medications should I tell my healthcare provider I am taking before starting therapy with PEGASYS and COPEGUS?

You should tell your healthcare provider about any medications, vitamins, supplements, or herbal medicines you are taking. Also tell your healthcare provider if you 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: Your healthcare provider may need to monitor the amount of theophylline in your body and make changes to your theophylline dose
• Any HIV medications: Some patients developed serious liver problems including death
• Didanosine: Do not take COPEGUS and didanosine
• Zidovudine: The combination of zidovudine and PEGASYS/COPEGUS can reduce the number of red and white blood cells in your body. Your healthcare provider will need to monitor your condition and possibly have you stop taking zidovudine
• Methadone: People taking methadone should be monitored by their healthcare provider for signs and symptoms of methadone toxicity
  

What are the most serious side effects of PEGASYS and COPEGUS?

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. Most blood counts may be reduced including white blood cell, red blood cell, platelets, hemoglobin, neutrophil, and lymphocyte counts.
• 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 for you and/or causing death
• Eye problems (blurred, loss of vision, and retinal detachment)
• Autoimmune problems (sarcoidosis, rheumatoid arthritis, systemic lupus erythematosus, psoriasis, and thyroid problems, such as hyperthyroidism and hypothyroidism)
• 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. If you have a rise in this blood test you may need to be watched more closely with additional blood tests. 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

What are the most common side effects of PEGASYS and COPEGUS?

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
  

Tell your doctor immediately if you think you or your partner may be pregnant or if any of these symptoms occur..

TYZEKA^® is a registered trademark of Novartis Pharmaceuticals Corporation.

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

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