Copegus

Copegus is a prescription medication used to treat hepatitis C infection in adults and children over 5 years old. Copegus 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 tablet and is usually taken twice a day, with food.

Common side effects of Copegus include flu-like symptoms, nausea, and decreased appetite.

Copegus 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 5 years and older with liver disease.

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

• Genentech, Inc.

Copegus 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 Copegus, especially teenagers, are more likely to have suicidal thoughts or attempt to hurt themselves while taking Copegus. 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 Copegus 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 Copegus in children include:

• Flu-like symptoms.
• headache.
• 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 Copegus. 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. Copegus may affect the way other medicines work.

Especially tell your healthcare provider if you take didanosine (Videx), zidovudine (Retrovir) 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 Copegus alone to treat chronic hepatitis C infection. Copegus should be used in combination with either interferon alfa-2b (Intron A) or peginterferon alfa-2b (PegIntron) to treat chronic hepatitis C infection.
2. Copegus 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. Copegus may not be right for you. Seek medical attention right away if you experience chest pain.
3. Copegus may cause liver failure when taken with interferon. Your doctor should monitor your liver function while you are taking Copegus.
4. Copegus may cause severe skin reactions and should be discontinued if you suspect you are developing a skin reaction while taking Copegus.
5. Children treated with Copegus and interferon showed a delay in growth after 48 weeks
6. Copegus may cause birth defects or the death of your unborn baby. Do not take Copegus if you or your sexual partner is pregnant or plan to be come pregnant. Do not become pregnant within 6 months after discontinuing Copegus therapy. You must use 2 forms of birth control when you take ribavirin and for the 6 months after treatment.
   • Females must have a pregnancy test before starting Copegus, every month while taking Copegus, and every month for the 6 months after the last dose of Copegus.
   • If you or your female sexual partner becomes pregnant while taking Copegus or within 6 months after you stop taking Copegus, tell your healthcare provider right away. You or your healthcare provider should contact the Copegus pregnancy registry by calling 1-800-593-2214. The Copegus pregnancy registry collects information about what happens to mothers and their babies if the mother takes Copegus while she is pregnant.

Do not take Copegus if you have:

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

Talk to your healthcare provider before taking Copegus 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 Copegus, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• treatment for hepatitis C that did not work for you.
• breathing problems. Copegus may cause or worsen breathing problems you already have.
• vision problems. Copegus may cause eye problems or worsen eye problems you already have. You should have an eye exam before you start treatment with Copegus.
• 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 Copegus.
• 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. Copegus may make your diabetes worse or harder to treat.
• any other medical condition
• are breastfeeding. It is not known if Copegus passes into your breast milk. You and your healthcare provider should decide if you will take Copegus or breast feed.

Tell your healthcare provider about all the medicines you take, including prescription medicines, vitamins, and herbal supplements. Copegus 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 thepossible risks to an unborn baby when a medication is taken during pregnancy. Copegus falls into category X.

It has been shown that women taking Copegus during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women. Do not take Copegus if you or your sexual partner is pregnant or plan to be come pregnant. Do not become pregnant within 6 months after discontinuing Copegus therapy. You must use 2 forms of birth control when you take Copegus and for the 6 months after treatment.

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

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

• Take Copegus exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Copegus to take and when to take it.
• Take Copegus with food.
• If you miss a dose of Copegus, 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 Copegus, 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

The recommended dose of Copegus for hepatitis C is 800 mg to 1200 mg divided in two daily doses.

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

• Store Copegus tablets between 59°F to 86°F (15°C to 30°C).
• Keep Copegus and all medicines out of the reach of children.

WARNING: RISK OF SERIOUS DISORDERS AND COPEGUS-ASSOCIATED EFFECTS

• Copegus 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 Copegus is hemolytic anemia. The anemia associated with Copegus 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 Copegus.
• Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to Copegus. In addition, Copegus has a multiple-dose half-life of 12 days, and so it may persist in nonplasma compartments for as long as 6 months. Therefore, Copegus therapy is contraindicated in women who are pregnant and in the male partners of women who are Copegus. 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 Copegus therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month posttreatment follow-up period