Rebetol

Rebetol is a prescription medication used to treat hepatitis C infection in adults and children over 3 years old. Rebetol belongs to a group of antiviral drugs called nucleoside analogues, which stop the spread of hepatitis C virus in the body.

This medication comes in capsule and liquid forms and is usually taken twice a day, with food. Swallow Rebetol capsules whole.

Common side effects of Rebetol include flu-like symptoms, mood changes, and decreased appetite.

Rebetol is a prescription medicine used with either interferon alfa-2b (Intron A) or peginterferon alfa-2b (PegIntron) to treat chronic (lasting a long time) hepatitis C infection in people 3 years and older with liver disease.

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

• Merck Sharp & Dohme Corp.

Rebetol may cause serious side effects, including:

See "Drug Precautions".

• Swelling and irritation of your pancreas (pancreatitis). You may have stomach pain, nausea, vomiting, or diarrhea.
• Serious breathing problems. Difficulty breathing may be a sign of a serious lung infection (pneumonia) that can lead to death.
• Serious eye problems that may lead to vision loss or blindness.
• Dental problems. Your mouth may be very dry, which can lead to problems with your teeth and gums.
• Severe depression
• Suicidal thoughts and attempts. Adults and children who take Rebetol, especially teenagers, are more likely to have suicidal thoughts or attempt to hurt themselves while taking. Call your healthcare provider right away or go to the nearest hospital emergency room if you have new or worse depression or thoughts about suicide or dying.
• Severe blood disorders. An increased risk when used in combination with pegylated alpha interferons and azathioprine
• Weight loss and slowed growth in children

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

The most common side effects of Rebetol include:

• flu-like symptoms - feeling tired, headache, shaking along with high temperature (fever), nausea, and muscle aches.
• mood changes, feeling irritable.

The most common side effects of Rebetol in children include:

• a decrease in the blood cells that fight infection (neutropenia).
• a decrease in appetite.
• stomach pain and vomiting.

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

These are not all the possible side effects of Rebetol. 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 healthcare provider about all the medicines you take, including prescription medicines, vitamins, and herbal supplements. Rebetol may affect the way other medicines work.

Especially tell your healthcare provider if you take didanosine (Videx) or azathioprine (Imuran and Azasan).

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

1. Do Not take Rebetol alone to treat chronic hepatitis C infection. Rebetol should be used in combination with either interferon alfa-2b (Intron A) or peginterferon alfa-2b (PegIntron) to treat chronic hepatitis C infection.
2. Rebetol may cause a significant drop in your red blood cell count and cause anemia in some cases. Anemia has been associated with worsening of heart problems, and in rare cases can cause a heart attack and death. Tell your healthcare provider if you have ever had any heart problems. Rebetol may not be right for you. Seek medical attention right away if you experience chest pain.
3. Rebetol may cause birth defects or the death of your unborn baby. Do not take Rebetol if you or your sexual partner is pregnant or plan to be come pregnant. Do not become pregnant within 6 months after discontinuing Rebetol therapy. You must use 2 forms of birth control when you take Rebetol and for the 6 months after treatment.
   • Females must have a pregnancy test before starting Rebetol, every month while taking Rebetol, and every month for the 6 months after the last dose of Rebetol.
   • If you or your female sexual partner becomes pregnant while taking Rebetol or within 6 months after you stop taking Rebetol, tell your healthcare provider right away. You or your healthcare provider should contact the pregnancy registry by calling 1-800-593-2214. The Rebetol pregnancy registry collects information about what happens to mothers and their babies if the mother takes Rebetol while she is pregnant.

Do not take Rebetol if you have:

• or ever had serious allergic reactions to the ingredients in Rebetol.
• certain types of hepatitis (autoimmune hepatitis).
• certain blood disorders (hemoglobinopathies).
• severe kidney disease.
• take didanosine (Videx).

Talk to your healthcare provider before taking Rebetol if you have any of these conditions.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Rebetol, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take Rebetol, tell your healthcare provider if you have or ever had:

• treatment for hepatitis C that did not work for you.
• breathing problems. Rebetol may cause or worsen breathing problems you already have.
• vision problems. Rebetol may cause eye problems or worsen eye problems you already have. You should have an eye exam before you start treatment with Rebetol.
• certain blood disorders such as anemia (low red blood cell count).
• high blood pressure, heart problems, or have had a heart attack. Your healthcare provider should check your blood and heart before you start treatment with Rebetol.
• thyroid problems
• liver problems other than hepatitis C infection
• human immunodeficiency virus (HIV) or any immunity problems
• mental health problems, including depression or thoughts of suicide
• kidney problems
• an organ transplant
• diabetes. Rebetol may make your diabetes worse or harder to treat.
• any other medical condition
• are breastfeeding. It is not known if Rebetol passes into your breast milk. You and your healthcare provider should decide if you will take Rebetol or breast feed.

Tell your healthcare provider about all the medicines you take, including prescription medicines, vitamins, and herbal supplements. Rebetol may affect the way other medicines work.

Tell your doctor if you are pregnant or plan to become pregnant. The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Rebetol falls into category X.

Rebetol may cause birth defects or the death of your unborn baby. Do not take Rebetol if you or your sexual partner is pregnant or plan to be come pregnant. Do not become pregnant within 6 months after discontinuing Rebetol therapy. You must use 2 forms of birth control when you take Rebetol and for the 6 months after treatment.

• Females must have a pregnancy test before starting Rebetol, every month while taking Rebetol, and every month for the 6 months after the last dose of Rebetol.
• If you or your female sexual partner becomes pregnant while taking Rebetol, tell your healthcare provider right away. You or your healthcare provider should contact the Rebetol pregnancy registry by calling 1-800-593-2214. The Rebetol pregnancy registry collects information about what happens to mothers and their babies if the mother takes Rebetol while she is pregnant.

Tell your healthcare provider if you are breastfeeding. It is not known if Rebetol passes into your breast milk. You and your healthcare provider should decide if you will take Rebetol or breastfeed.

• Take Rebetol exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Rebetol to take and when to take it.
• Take Rebetol with food.
• Take Rebetol capsules whole. Do not open, break, or crush Rebetol capsules before swallowing. If you cannot swallow Rebetol capsules whole, tell your healthcare provider.
• If you miss a dose of Rebetol, take the missed dose as soon as possible during the same day. Do not double the next dose. If you have questions about what to do, call your healthcare provider.
• If you take too much Rebetol, call your healthcare provider or Poison Control Center at 1-800-222-1222, or go to the nearest hospital emergency room right away.

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

Rebetol capsules and solution are typically given as 800 mg -1400 mg per day in two divided doses.

If you take too much Rebetol, call your healthcare provider or Poison Control Center at 1-800-222-1222, or go to the nearest hospital emergency room right away.

• Store Rebetol capsules between 59°F to 86°F (15°C to 30°C).
• Store Rebetol oral solution between 59°F to 86°F (15°C to 30°C) or in the refrigerator between 36°F to 46°F (2°C to 8°C).

Keep Rebetol and all medicines out of the reach of children.

WARNING: RISK OF SERIOUS DISORDERS AND REBETOL-ASSOCIATED EFFECTS

• Rebetol monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication.
• The primary toxicity of Rebetol is hemolytic anemia. The anemia associated with Rebetol therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with Rebetol.
• Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to Rebetol. In addition, Rebetol has a multiple-dose half-life of 12 days, and so it may persist in nonplasma compartments for as long as 6 months. Therefore, Rebetol therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking Rebetol therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month post treatment follow-up period