INDICATIONS

Copegus is an antiviral medication.

Copegus must be used together with an interferon alfa product (such as Pegasys, PegIntron, Sylatron, or Intron A) to treat chronic hepatitis C.

INSTRUCTIONS

Take exactly as prescribed by your doctor.

Ribavirin is not effective when used alone to treat hepatitis C. It must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C.

Take this medicine with food.

Use ribavirin regularly to get the most benefit.  Drink extra fluids while you are taking ribavirin to keep from getting dehydrated, especially during exercise or in hot weather.

DOSAGE

Please consult your doctor to prescribe the required dosage.

The daily dose of COPEGUS is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen.

STORAGE 

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

SAFETY INFORMATION

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

severe liver disease (especially cirrhosis);
autoimmune hepatitis;
a hemoglobin disorder such as anemia, thalassemia (Mediterranean anemia), or sickle-cell anemia;
if you are also taking didanosine (Videx); or
if you are pregnant woman, or a man whose female sexual partner is pregnant.

To make sure you can safely take ribavirin, tell your doctor if you have any of these other conditions:

kidney or liver disease (other than hepatitis C);
hepatitis B infection;
a blood cell disorder such as hemolytic anemia (a lack of red blood cells);
human immunodeficiency virus (HIV or AIDS);
diabetes;
a pancreas disorder;
sarcoidosis;
breathing problems;
a thyroid disorder;
new or worsening eye problems (such as retinopathy);
a history of heart disease, high blood pressure, or a heart attack;
a history of depression or suicide attempt;
a history of a liver, kidney, or other organ transplant; or
if you have ever received treatment for hepatitis C that did not work well.

This medication can cause birth defects or death in an unborn baby.

If you are a woman, do not take ribavirin if you are pregnant. You will need frequent pregnancy tests to make sure you are not pregnant while taking ribavirin.

If you are a man, do not take ribavirin if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin. 

Use at least two effective forms of birth control while either sexual partner is taking ribavirin, and for at least 6 months after treatment ends.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking ribavirin.

It is not known whether ribavirin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking ribavirin.

Ribavirin may affect growth in children.

SIDE EFFECTS

Stop using ribavirin and call your doctor at once if you have a serious side effect such as:

problems with your vision;
fever, chills, body aches, flu symptoms;
severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
stabbing chest pain, wheezing, feeling short of breath;
severe depression, hallucinations, thoughts of suicide or hurting yourself;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
pale or yellowed skin, dark colored urine, easy bruising or bleeding, confusion, or unusual weakness.

Less serious side effects may include:

headache;
muscle pain;
dry mouth;
nausea; vomiting, stomach pain, loss of appetite;
weight loss;
feeling tired or irritable;
anxiety, mood changes; or
pain, swelling, or irritation where the interferon injection was given.