Peginterferon Alfa-2b

Peginterferon alfa-2b is a prescription medication used to prevent malignant melanoma (a kind of skin cancer) from coming back after it has been removed by surgery. It is also used to treat chronic hepatitis C. Peginterferon alfa-2b belongs to a group of drugs called interferons. Peginterferon alfa-2b treats hepatitis by activating the immune system to attack the hepatitis virus but the way it treats malignant melanoma is unknown.

Peginterferon alfa-2b 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 ribavirin to treat chronic (lasting a long time) hepatitis C infection in people 3 years and older with stable liver problems.
• alone, sometimes to treat adults who have chronic (lasting a long time) hepatitis C infection with stable liver problems and who can not take ribavirin.
• alone to prevent malignant melanoma (a kind of skin cancer) from coming back after it has been removed by surgery. Peginterferon alfa-2b should be started within 84 days of surgery to remove lymph nodes containing cancer.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Malignant Melanoma treatment (Sylatron formulation)

• 6 mcg/kg/week subcutaneously for 8 doses followed by 3 mcg/kg/week subcutaneously for up to 5 years

Chronic Hepatitis C treatment (PegIntron formulation)

• Adults dose: 1.5 mcg/kg/week
• Pediatric dose: 60 mcg/m2/week

Peginterferon alfa-2b can cause serious side effects that:

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

Tell your healthcare provider right away if you have any of the symptoms listed below while taking peginterferon alfa-2b. If symptoms get worse, or become severe and continue, your healthcare provider may tell you to stop taking peginterferon alfa-2b permanently. In many, but not all people, these symptoms go away after they stop taking peginterferon alfa-2b.

• 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

• low blood pressure
• fast heart rate or abnormal heart beat
• trouble breathing or chest pain
• heart attacks or heart muscle problems (cardiomyopathy)

• 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 peginterferon alfa-2b with ribavirin if you are pregnant or planning to get pregnant or breastfeeding.

While taking peginterferon alfa-2b, you should see a healthcare provider regularly for check-ups and blood tests to make sure that your treatment is working, and to check for side effects.

Do not take peginterferon alfa-2b:

• if you have had a serious allergic reaction to another alpha interferon or to any of the ingredients in peginterferon alfa-2b. Ask your healthcare provider if you are not sure.
• 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 breastfeeding.

Talk to your healthcare provider before taking peginterferon alfa-2b if you have any of these conditions.

Peginterferon alfa-2b may cause serious side effects including:

• See "Drug Precautions".
• Serious eye problems. Peginterferon alfa-2b may cause eye problems that may lead to vision loss or blindness. You should have an eye exam before you start taking peginterferon alfa-2b. If you have eye problems or have had them in the past, you may need eye exams while you are taking peginterferon alfa-2b. Tell your healthcare provider or eye doctor right away if you have any vision changes while taking peginterferon alfa-2b.
• Blood problems. Peginterferon alfa-2b 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.

• 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 peginterferon alfa-2b, talk to your healthcare provider before you take peginterferon alfa-2b. If you develop high blood sugar or diabetes while taking peginterferon alfa-2b, your healthcare provider may tell you to stop peginterferon alfa-2b 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 peginterferon alfa-2b.
• Nerve problems. People who take peginterferon alfa-2b 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 healthcare provider if you have any of these symptoms.
• Dental and gum problems.

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

The most common side effects of peginterferon alfa-2b include:

• Flu-like symptoms. Symptoms may include: headache, muscle aches, tiredness, and fever. Some of these symptoms may be decreased by injecting your peginterferon alfa-2b dose at bedtime. Talk to your healthcare provider about which over-the-counter medicines you can take to help prevent or decrease some of these symptoms.
• Tiredness. Many people become very tired during treatment with peginterferon alfa-2b.
• Appetite problems. Nausea, loss of appetite, and weight loss can happen with peginterferon alfa-2b.
• Skin reactions. Redness, swelling, and itching are common at the site of injection.
• Hair thinning.

Tell your healthcare 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 peginterferon alfa-2b. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• aldesleukin (Proleukin)
• fluoxetine (Prozac, Sarafem, Symbyax)
• methadone (Dolophine, Methadose)
• pegloticase (Krystexxa)
• ribavirin (Copegus, Rebetol, Ribasphere, Virazole)
• telbivudine (Tyzeka)
• theophylline 
• zidovudine (Retrovir, in Combivir, Trizivir)

This is not a complete list of peginterferon alfa-2b drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if peginterferon alfa-2b will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you should use peginterferon alfa-2b or breastfeed. You should not do both.

It is not known if peginterferon alfa-2b will harm your unborn baby. You should use effective birth control during treatment with peginterferon alfa-2b.

Expect to get "flu-like" symptoms when taking peginterferon alfa-2b. To help reduce flu-like symptoms:

• Follow your healthcare provider's instructions about taking acetaminophen before future doses of peginterferon alfa-2b.
• Inject peginterferon alfa-2b at bedtime to help reduce flu-like symptoms.

Your healthcare provider should do regular blood tests before you start peginterferon alfa-2b, and during treatment to see how well the treatment is working and to check you for side effects.