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INDICATIONS

What is PEGASYS?
PEGASYS® (peginterferon alfa-2a) is a prescription medication that is:

  • used alone or with COPEGUS® (ribavirin, USP) to treat adults and children 5 years and older who have chronic (lasting a long time) hepatitis C infection and certain types of liver problems, and have not taken alpha interferon
  • used if you have chronic hepatitis C, you should not take PEGASYS by itself unless you are not able to take COPEGUS
  • used to treat adults with chronic hepatitis B virus who show signs that the virus is damaging the liver

It is not known if PEGASYS is safe and will work in children under 5 years of age.

IMPORTANT SAFETY INFORMATION

PEGASYS, like other alpha interferons, may cause or make fatal or 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 many patients, but not all, these conditions get better after they stop taking PEGASYS (see the Medication Guide for more information and Warnings).

COPEGUS can cause birth defects and/or death to 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 (see the COPEGUS Medication Guide for more information and Warnings).

What is the most important information I should know about PEGASYS alone or in combination with COPEGUS?

  1. COPEGUS in combination with PEGASYS may cause birth defects or death of your unborn baby. Females must have pregnancy tests before, during and for 6 months after PEGASYS/COPEGUS combination therapy. During treatment and for 6 months after treatment, female and male patients must:
    • use 2 forms of birth control, one being a condom with spermicide.
    • inform their healthcare provider if pregnancy occurs while taking PEGASYS/COPEGUS or within 6 months after stopping PEGASYS/COPEGUS therapy. Patients or their healthcare provider should contact the Ribavirin Pregnancy Registry by calling 1-800-593-2214.
  2. Mental health problems and suicide. PEGASYS therapy may cause you to develop mood or behavioral problems, including:
    • irritability (getting upset easily)
    • depression (feeling low, feeling bad about yourself or feeling hopeless), and anxiety.
    • aggressive behavior
    • former drug addicts may fall back into drug addiction or overdose
    • thoughts of hurting yourself or others, or suicide
  3. Heart problems. Some people who take PEGASYS alone or in combination with COPEGUS may get heart problems, including:
    • high blood pressure
    • fast heart rate or abnormal heart beat
    • chest pain
    • heart attacks
  4. Stroke or symptoms of a stroke. Symptoms may include weakness, loss of coordination, and numbness.
  5. New or worsening autoimmune problems. Some people taking PEGASYS develop autoimmune problems (a condition where the body's immune cells attack other cells or organs in the body), such as rheumatoid arthritis, lupus, and psoriasis.
  6. Infections. Some people who take PEGASYS may get an infection. Symptoms may include:
    • fever
    • chills
    • burning and painful urination
    • urinating often
    • coughing up yellow or pink mucus (phlegm)

PEGASYS alone or in combination with COPEGUS can cause serious side effects. Some of these side effects may cause death. Tell your healthcare provider right away if you have any of these symptoms while taking PEGASYS.

Who should not take PEGASYS?
Do not take PEGASYS if you:

  • have certain other liver problems
  • have certain types of hepatitis caused by your immune system attacking your liver (autoimmune hepatitis)
  • have had a serious allergic reaction to another alpha interferon medicine or to any of the ingredients in PEGASYS. Symptoms of a serious allergic reaction to alpha interferon may include: itching, swelling of your face, tongue, throat, trouble breathing, feeling dizzy or faint, and chest pain

Do not take PEGASYS in combination with COPEGUS if you:

  • are pregnant, or planning to get pregnant during treatment or during the 6 months after treatment
  • are a male patient with a female sexual partner who is pregnant or plans to become pregnant at any time while you are being treated with COPEGUS or during the 6 months after your treatment has ended
  • have certain blood disorders such as thalassemia major or sickle-cell anemia
  • take didanosine (Videx® or Videx® EC)

Do not give PEGASYS to a baby under 1 year of age. PEGASYS contains benzyl alcohol, which can cause nervous system problems and other problems that can lead to death.

Before taking PEGASYS, tell your healthcare provider about all your medical conditions or problems, and if you are pregnant or breastfeeding, or plan to become pregnant or breast feed during treatment with PEGASYS.

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

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Especially tell your healthcare provider if you take:

  • the anti-hepatitis B medicine telbivudine (Tyzeka®)
  • theophylline (Theo-24®, Elixophyllin®, Uniphyl®, Theolair™). Your healthcare provider may need to monitor the amount of theophylline in your body and make changes to your theophylline dose.
  • any anti-HIV medicines
  • methadone hydrochloride (Methadose™, Dolophine® hydrochloride)
  • azathioprine (Azasan®, Imuran®)

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

  • If you are pregnant do not start taking or continue taking PEGASYS alone or in combination with COPEGUS. COPEGUS in combination with PEGASYS may cause birth defects or death of your unborn baby.
  • Avoid becoming pregnant while taking PEGASYS, alone or in combination with COPEGUS. PEGASYS, alone or in combination with COPEGUS, may harm your unborn child (death or serious birth defects) or cause you to lose your baby (miscarry).
  • Do not breast-feed your baby while on PEGASYS, alone or in combination with COPEGUS.
  • Drinking 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 are the possible side effects of PEGASYS?
PEGASYS can cause serious side effects including:

  • blood problems. PEGASYS can affect your bone marrow and cause low red blood cell, low white blood cell, and platelet counts.
  • thyroid problems
  • blood sugar problems. Some people may develop high blood sugar or diabetes.
  • serious eye problems. PEGASYS may cause eye problems that may lead to vision loss or blindness.
  • serious liver problems, worsening of liver problems, including liver failure and death.
  • lung problems including:
    • trouble breathing
    • pneumonia
    • inflammation of lung tissue
    • new or worse high blood pressure of the lungs (pulmonary hypertension). This can be severe and may lead to death.
  • inflammation of your pancreas (pancreatitis)
  • inflammation of your intestines (colitis)
  • serious allergic reactions and skin reactions.
  • effect on growth in children
  • nerve problems. People who take PEGASYS or other alpha interferon products with telbivudine (Tyzeka®) for hepatitis B can develop nerve problems such as continuing numbness, tingling, or burning sensation in the arms or legs (peripheral neuropathy).

Tell your healthcare provider right away if you believe you may have any of the side effects listed above.

The most common, but less serious, side effects of PEGASYS include:

  • flu-like symptoms
  • tiredness and weakness
  • stomach problems
  • loss of appetite
  • skin reactions
  • hair thinning
  • trouble sleeping

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Please see PEGASYS full Prescribing Information and Medication Guide 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.

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INDICATIONS

What is PEGASYS?
PEGASYS® (peginterferon alfa-2a) is a prescription medication that is:

It is not known if PEGASYS is safe and will work in children under 5 years of age.

IMPORTANT SAFETY INFORMATION

PEGASYS, like other alpha interferons, may cause or make fatal or 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 many patients, but not all, these conditions get better after they stop taking PEGASYS (see the Medication Guide for more information and Warnings).

COPEGUS can cause birth defects and/or death to 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 (see the COPEGUS Medication Guide for more information and Warnings).

What is the most important information I should know about PEGASYS alone or in combination with COPEGUS?

  1. COPEGUS in combination with PEGASYS may cause birth defects or death of your unborn baby. Females must have pregnancy tests before, during and for 6 months after PEGASYS/COPEGUS combination therapy. During treatment and for 6 months after treatment, female and male patients must:
    • use 2 forms of birth control, one being a condom with spermicide.
    • inform their healthcare provider if pregnancy occurs while taking PEGASYS/COPEGUS or within 6 months after stopping PEGASYS/COPEGUS therapy. Patients or their healthcare provider should contact the Ribavirin Pregnancy Registry by calling 1-800-593-2214.
  2. Mental health problems and suicide. PEGASYS therapy may cause you to develop mood or behavioral problems, including:
    • irritability (getting upset easily)
    • depression (feeling low, feeling bad about yourself or feeling hopeless), and anxiety.
    • aggressive behavior
    • former drug addicts may fall back into drug addiction or overdose
    • thoughts of hurting yourself or others, or suicide
  3. Heart problems. Some people who take PEGASYS alone or in combination with COPEGUS may get heart problems, including:
    • high blood pressure
    • fast heart rate or abnormal heart beat
    • chest pain
    • heart attacks
  4. Stroke or symptoms of a stroke. Symptoms may include weakness, loss of coordination, and numbness.
  5. New or worsening autoimmune problems. Some people taking PEGASYS develop autoimmune problems (a condition where the body's immune cells attack other cells or organs in the body), such as rheumatoid arthritis, lupus, and psoriasis.
  6. Infections. Some people who take PEGASYS may get an infection. Symptoms may include:
    • fever
    • chills
    • burning and painful urination
    • urinating often
    • coughing up yellow or pink mucus (phlegm)

PEGASYS alone or in combination with COPEGUS can cause serious side effects. Some of these side effects may cause death. Tell your healthcare provider right away if you have any of these symptoms while taking PEGASYS.

Who should not take PEGASYS?
Do not take PEGASYS if you:

Do not take PEGASYS in combination with COPEGUS if you:

Do not give PEGASYS to a baby under 1 year of age. PEGASYS contains benzyl alcohol, which can cause nervous system problems and other problems that can lead to death.

Before taking PEGASYS, tell your healthcare provider about all your medical conditions or problems, and if you are pregnant or breastfeeding, or plan to become pregnant or breast feed during treatment with PEGASYS.

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

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Especially tell your healthcare provider if you take:

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

What are the possible side effects of PEGASYS?
PEGASYS can cause serious side effects including:

Tell your healthcare provider right away if you believe you may have any of the side effects listed above.

The most common, but less serious, side effects of PEGASYS include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Please see PEGASYS full Prescribing Information and Medication Guide 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.