What Is PEGINTRON?

PEGINTRON is a prescription medicine that is used:

• with ribavirin and an approved hepatitis C virus (HCV) protease inhibitor to treat chronic (lasting a long time) hepatitis C infection in adults with stable liver problems.
• with ribavirin to treat chronic hepatitis C infection in people 3 years and older with stable liver problems.
• alone, sometimes to treat adults who have chronic hepatitis C infection with stable liver problems and who can not take ribavirin.

People with hepatitis C have the virus in their blood and in their liver. PEGINTRON reduces the amount of virus in the body and helps the body's immune system fight the virus. Ribavirin is a drug that helps to fight the viral infection but does not work when used by itself to treat chronic hepatitis C.

It is not known if PEGINTRON use for longer than 1 year is safe and will work. It is not known if PEGINTRON use in children younger than 3 years old is safe and will work.

If you are taking PEGINTRON with ribavirin with or without an approved HCV protease inhibitor, also read the Medication Guides for those medicines.

Important Safety Information

What is the most important information I should know about PEGINTRON?

PEGINTRON can cause serious side effects that:

• may cause death, or
• may worsen certain serious diseases that you may already have.

Tell your health care provider right away if you have any of the symptoms listed below while taking PEGINTRON. If symptoms get worse or become severe and continue, your heath care provider may tell you to stop taking PEGINTRON permanently. In many, but not all people, these symptoms go away after they stop taking PEGINTRON.

• Mental health problems and suicide. PEGINTRON may cause you to develop mood or behavior problems that may get worse during treatment with PEGINTRON or after your last dose, including: irritability (getting upset easily), depression (feeling low, feeling bad about yourself, or feeling hopeless), aggressive behavior, thoughts of hurting yourself or others, or suicide. Former drug addicts may fall back into drug addiction or overdose.
• If you have these symptoms, your health care provider should carefully monitor you during treatment with PEGINTRON and for 6 months after your last dose.
• Heart problems. Some people who take PEGINTRON may get heart problems, including: low blood pressure, fast heart rate or abnormal heart beat, trouble breathing or chest pain, heart attacks or heart muscle problems (cardiomyopathy).
• Stroke or symptoms of a stroke. Symptoms may include: weakness, loss of coordination, and numbness.  Stroke or symptoms of a stroke may happen in people who have some risk factors or no known risk factors for a stroke.
• New or worsening autoimmune problems. Some people taking PEGINTRON develop autoimmune problems (a condition where the body's immune cells attack other cells or organs in the body), including rheumatoid arthritis, systemic lupus erythematosus, and psoriasis. In some people who already have an autoimmune problem, it may get worse during your treatment with PEGINTRON.
• Infections. Some people who take PEGINTRON^® (Peginterferon alfa-2b) may get an infection. Symptoms may include: fever, chills, bloody diarrhea, burning or pain with urination, urinating often, coughing up mucus (phlegm) that is discolored (for example, yellow or pink).
• Do not take PEGINTRON with ribavirin if you are pregnant or planning to get pregnant, or you are breastfeeding.

While taking PEGINTRON, you should see a health care provider regularly for check-ups and blood tests to make sure that your treatment is working, and to check for side effects.

Who should not take PEGINTRON?

Do not take PEGINTRON:

• if you have had a serious allergic reaction to another alpha interferon or to any of the ingredients in PEGINTRON.
• if you have certain types of hepatitis (autoimmune hepatitis).
• if you have certain other liver problems.
• with ribavirin if you are pregnant, planning to get pregnant, or are breastfeeding.

What should I tell my health care provider before taking PEGINTRON?

Before you take PEGINTRON, tell your health care provider if you:

• are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior.
• have or ever had any problems with your heart, including heart attack or high blood pressure.
• have any kind of autoimmune disease (where the body's immune system attacks the body's own cells), such as psoriasis, systemic lupus erythematosus or rheumatoid arthritis.
• have or ever had bleeding problems or a blood clot.
• have or ever had low blood cell counts.
• have ever been addicted to drugs or alcohol.
• have liver disease (other than hepatitis C infection).
• have or had lung disease such as chronic obstructive pulmonary disease (COPD).
• have thyroid problems.
• have diabetes.
• have colitis (inflammation of your intestine).
• have a condition that suppresses your immune system, such as cancer.
• have hepatitis B infection.
• have human immunodeficiency virus (HIV) infection.
• have kidney problems.
• have high blood triglyceride levels (fat in your blood).
• have an organ transplant and are taking medicine that keeps your body from rejecting your transplant (suppresses your immune system).
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if PEGINTRON will harm your unborn baby. You should use effective birth control during treatment with PEGINTRON. Talk to your health care provider about birth control choices for you during treatment with PEGINTRON. Tell your health care provider if you become pregnant during treatment with PEGINTRON.
• are breastfeeding or plan to breastfeed. It is not known if PEGINTRON passes into your breast milk. You and your health care provider should decide if you will use PEGINTRON or breastfeed.

Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. PEGINTRON and certain other medicines may affect each other and cause side effects. Especially tell your health care provider if you take the anti-hepatitis B medicine telbivudine (Tyzeka^®).

What are the possible side effects of PEGINTRON?

PEGINTRON may cause serious side effects including:

• Serious eye problems. PEGINTRON may cause eye problems that may lead to vision loss or blindness. You should have an eye exam before you start taking PEGINTRON. If you have eye problems or have had them in the past, you may need eye exams while you are taking PEGINTRON. Tell your health care provider or eye doctor right away if you have any vision changes while taking PEGINTRON.


• Blood problems. PEGINTRON can affect your bone marrow and cause low white blood cell and platelet counts. In some people, these blood counts may fall to dangerously low levels. If your blood counts become very low, you can get infections and problems with bleeding and bruising.


• Swelling of your pancreas (pancreatitis) or intestines (colitis). Symptoms may include:
• • severe stomach area (abdomen) pain
• • severe back pain
• • nausea and vomiting
• • bloody diarrhea
• • fever


• 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

You may need to have a chest X-ray or other tests if you develop fever, cough, shortness of breath, or other symptoms of a lung problem during treatment with PEGINTRON^® (Peginterferon alfa-2b).

• Severe liver problems, or worsening of liver problems, including liver failure and death.  Symptoms may include:
• • nausea
• • loss of appetite
• • tiredness
• • diarrhea
• • yellowing of your skin or the white part of your eyes
• • bleeding more easily than normal
• • swelling of your stomach area (abdomen)
• • confusion
• • sleepiness
• • you cannot be awakened (coma)


• Thyroid problems. Some people develop changes in their thyroid function. Symptoms of thyroid changes include:
• • problems concentrating
• • feeling cold or hot all of the time
• • weight changes
• • skin changes


• Blood sugar problems. Some people may develop high blood sugar or diabetes. If you have high blood sugar or diabetes that is not controlled before starting PEGINTRON, talk to your health care provider before you take PEGINTRON. If you develop high blood sugar or diabetes while taking PEGINTRON, your health care provider may tell you to stop PEGINTRON and prescribe a different medicine for you. Symptoms of high blood sugar or diabetes may include:
• • increased thirst
• • tiredness
• • urinating more often than normal
• • increased appetite
• • weight loss
• • your breath smells like fruit


• Serious allergic reactions and skin reactions. Symptoms may include:
• • itching
• • swelling of the face, eyes, lips, tongue, or throat
• • trouble breathing
• • anxiousness
• • chest pain
• • feeling faint
• • skin rash, hives, sores in your mouth, or your skin blisters and peels


• Growth problems in children. Weight loss and slowed growth are common in children during treatment with PEGINTRON.


• Nerve problems. People who take PEGINTRON or other alpha interferon products with telbivudine (Tyzeka^®) can develop nerve problems such as continuing numbness, tingling, or burning sensation in the arms or legs (peripheral neuropathy). Call your health care provider if you have any of these symptoms.


• Dental and gum problems.

Tell your health care provider right away if you have any of the symptoms listed above.

The most common side effects of PEGINTRON include flu-like symptoms, tiredness, appetite problems, skin reactions and hair thinning.

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

These are not all of the possible side effects of PEGINTRON. For more information, ask your health care provider or pharmacist.

Call your health care provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Read the Medication Guide and Instructions for Use before you start taking PEGINTRON, and each time you get a refill. There may be new information. The Medication Guide and Instructions for Use do not take the place of talking with your health care provider about your medical condition or your treatment.

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