Copegus

Copegus is an antiviral medicine used to treat chronic hepatitis C.

Copegus does not work when taken alone. It must be taken together with interferon alfa or peginterferon alfa.

Copegus may also be given to people who are taking other antiviral medicines for hepatitis C.

Copegus may be used for reasons not mentioned in this medication guide.

Copegus is not effective on its own and must be used with other medications to treat hepatitis C.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Copegus with food.

Swallow the capsule whole and do not crush, chew, break, or open it. Tell your doctor if you have trouble swallowing the capsule.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Drink extra fluids while you are taking Copegus to avoid dehydration.

Copegus can cause dry mouth, which could lead to tooth decay or gum disease. If you vomit while taking this medicine, rinse your mouth out with water to prevent damage to your teeth or gums. Be sure to have regular dental exams while you are taking this medication.

You will need frequent medical tests.

Store Copegus tablets or capsules at room temperature away from moisture, heat, and light.

Store Copegus liquid (oral solution) at room temperature or in the refrigerator.

You should not use Copegus if you have autoimmune hepatitis, moderate to severe kidney disease, a hemoglobin blood cell disorder, or if you take didanosine.

Copegus can harm an unborn baby if either the mother or the father is using Copegus. Do not use if you are pregnant, or if you are a man whose sex partner is pregnant. Both men and women should use effective birth control while taking this medicine and for at least 6 months after the last dose.

Copegus is not effective when used alone and must be used in combination with an interferon.

In rare cases, Copegus can cause fatal heart problems. Get emergency medical attention if you have chest pain.

You should not take Copegus if you are allergic to it, or if you have:

• a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia;
• autoimmune hepatitis;
• moderate to severe kidney disease;
• if you are also taking didanosine; or
• if you are pregnant, or if you are a man whose sex partner is pregnant.

When you take Copegus with other medications: There may be other reasons you should not take the combination treatment. Tell your doctor about all your medical conditions.

Tell your doctor if you have ever had:

• a blood cell disorder such as anemia (low red blood cells);
• heart problems, high blood pressure, or a heart attack;
• breathing problems;
• vision problems (you may need an eye exam before taking Copegus);
• diabetes;
• human immunodeficiency virus (HIV or AIDS) or a weak immune system;
• depression, mental illness, or thoughts of hurting yourself or others;
• a thyroid disorder;
• kidney disease;
• an organ transplant;
• liver problems other than hepatitis C; or
• treatment for hepatitis C that did not work well.

Both men and women taking Copegus should use effective birth control to prevent pregnancy. This medicine can cause birth defects, miscarriage, or death to an unborn baby if the mother or father is using this medicine.

• If you are a woman, do not take Copegus if you are pregnant. You will need to have a negative pregnancy test before taking this medicine. You will also need pregnancy tests during treatment and for 6 months after your last dose.
• If you are a man, do not take Copegus if your sex partner is pregnant.
• Both men and women should keep using effective birth control for at least 6 months after the last dose of Copegus.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking Copegus. Your name may be listed on a pregnancy registry to track the effects of Copegus on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Copegus is not approved for use by anyone younger than 3 years old. The tablets of this medicine are not approved for use by anyone younger than 5 years old.

Get emergency medical help if you notice signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Copegus can cause anemia. In rare cases, this may lead to life-threatening heart problems. Get emergency medical attention if you experience chest pain.

Copegus may lead to serious side effects. Call your doctor immediately if you have:

• problems with your vision;
• severe pain in your upper stomach that spreads to your back, nausea, vomiting, diarrhea;
• new or worsening cough, fever, sharp chest pain, wheezing, or feeling short of breath;
• severe depression, thoughts of suicide, or thoughts of hurting someone else;
• signs of serious anemia, such as pale or yellowed skin, dark urine, confusion, or weakness; or
• other signs of low blood cell counts, including fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, easy bruising, unusual bleeding, or feeling light-headed.

Copegus can impact growth in children. Inform your doctor if your child is not growing at a normal rate while taking this medicine.

Common side effects of Copegus may include:

• nausea, vomiting, loss of appetite;
• fever, chills, or shaking;
• low blood cell counts, anemia;
• feeling weak or tired;
• headache, muscle pain; or
• mood changes, feeling anxious or irritable.

This is not a complete list of side effects, and others may occur. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Take the missed dose on the same day you remember it. Skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Avoid drinking alcohol. It can make your liver problems worse.

Using Copegus will not prevent you from passing hepatitis C to other people. Follow your doctor's instructions about how to prevent passing the disease to another person.

Tell your doctor about all your other medicines, especially:

• azathioprine; or
• medicines to treat HIV or AIDS.

This list is not complete. Other drugs may affect Copegus, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.