COPEGUS- ribavirin tablet, film coated 
Genentech, Inc.

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MEDICATION GUIDE
COPEGUS® (Co-PEG-UHS)
(ribavirin)
Tablets

Read this Medication Guide carefully before you start taking COPEGUS and read the Medication Guide each time you get more COPEGUS. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Also read the Medication Guide for PEGASYS (peginterferon alfa-2a).

What is the most important information I should know about COPEGUS?

  1. You should not take COPEGUS alone to treat chronic hepatitis C infection. COPEGUS should be used with PEGASYS to treat chronic hepatitis C infection.
  2. COPEGUS may cause you to have a blood problem (hemolytic anemia) that can worsen any heart problems you have, and cause you to have a heart attack or die. Tell your healthcare provider if you have ever had any heart problems. COPEGUS may not be right for you. If you have chest pain while you take COPEGUS, get emergency medical attention right away.
  3. COPEGUS may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant, do not take COPEGUS. You or your sexual partner should not become pregnant while you take COPEGUS and for 6 months after treatment is over. You must use two 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 treated with COPEGUS, and every month for the 6 months after treatment with 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 Ribavirin Pregnancy Registry by calling 1-800-593-2214. The Ribavirin Pregnancy Registry collects information about what happens to mothers and their babies if the mother takes COPEGUS while she is pregnant.

What is COPEGUS?

COPEGUS is a prescription medicine used with another medicine called PEGASYS (peginterferon alfa-2a) to treat chronic (lasting a long time) hepatitis C infection in people 5 years and older whose liver still works normally, and who have not been treated before with a medicine called an interferon alpha. It is not known if COPEGUS is safe and will work in children under 5 years of age.

Who should not take COPEGUS?

See "What is the most important information I should know about COPEGUS?"

Do not take COPEGUS if you:

Talk to your healthcare provider before starting treatment with COPEGUS if you have any of these medical conditions.

What should I tell my healthcare provider before taking COPEGUS?

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

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Some medicines can cause serious side effects if taken while you also take COPEGUS. Some medicines may affect how COPEGUS works or COPEGUS may affect how your other medicines work.

Especially tell your healthcare provider if you take any medicines to treat HIV, including didanosine (Videx or Videx EC), or if you take azathioprine (Imuran or Azasan).

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

How should I take COPEGUS?

What should I avoid while taking COPEGUS?

What are the possible side effects of COPEGUS?

COPEGUS may cause serious side effects including:

See "What is the most important information I should know about COPEGUS?"

Call your healthcare provider or get medical help right away if you have any of the symptoms listed above. These may be signs of a serious side effect of COPEGUS treatment.

Common side effects of COPEGUS taken with PEGASYS include:

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

These are not all the possible side effects of COPEGUS treatment. 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.

You may also report side effects to Genentech at 1-888-835-2555.

How should I store COPEGUS?

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

General information about the safe and effective use of COPEGUS

It is not known if treatment with COPEGUS in combination with PEGASYS will prevent an infected person from spreading the hepatitis C virus to another person while on treatment.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use COPEGUS for a condition for which it was not prescribed. Do not give COPEGUS to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about COPEGUS. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about COPEGUS that is written for healthcare professionals.

What are the ingredients in COPEGUS?

Active Ingredient: ribavirin

Inactive Ingredients: The core of the tablet contains pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, cornstarch, and magnesium stearate. The coating of the tablet contains Chromatone-P or Opadry Pink (made by using hydroxypropyl methyl cellulose, talc, titanium dioxide, synthetic yellow iron oxide, and synthetic red iron oxide), ethyl cellulose (ECD-30), and triacetin.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

MG Revised: August 2011

COPEGUS and PEGASYS are trademarks of Hoffmann-La Roche Inc.

Distributed by:

Genentech USA, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990

PI Revised: February 2013

© 2013 Genentech, Inc. All rights reserved.

Revised: 02/2013
 
Genentech, Inc.