RIBASPHERE- ribavirin capsule 
Kadmon Pharmaceuticals, LLC

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MEDICATION GUIDE

Ribasphere® (Rīb-a-sphere) (ribavirin capsules)

Rx Only

Read this Medication Guide before you start taking  Ribasphere® (ribavirin capsules), and each time you get a refill. 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.

What is the most important information I should know about Ribasphere (ribavirin capsules)?

  1. Do Not take Ribasphere (ribavirin capsules) alone to treat chronic hepatitis C infection. Ribasphere (ribavirin capsules) should be used in combination with either interferon alfa-2b (Intron A®1) or peginterferon alfa-2b (PegIntron®2) to treat chronic hepatitis C infection.
  2. Ribasphere (ribavirin capsules) 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. Ribasphere (ribavirin capsules) may not be right for you. Seek medical attention right away if you experience chest pain.
  3. Ribasphere (ribavirin capsules) may cause Birth Defects or Death of your unborn baby. Do Not Take Ribasphere (ribavirin capsules) if you or your sexual partner is pregnant or plan to become pregnant. Do Not become Pregnant within 6 months after discontinuing Ribasphere (ribavirin capsules) therapy. You must use 2 forms of birth control when you take Ribasphere (ribavirin capsules) and for the 6 months after treatment.

    ○   Females must have a pregnancy test before starting Ribasphere (ribavirin capsules), every month while taking Ribasphere (ribavirin capsules), and every month for the 6 months after the last dose of Ribasphere (ribavirin capsules).

    ○   If you or your female sexual partner becomes pregnant while taking Ribasphere (ribavirin capsules), 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 Ribasphere (ribavirin capsules) while she is pregnant.

What is Ribasphere (ribavirin capsules)?

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

It is not known if Ribasphere (ribavirin capsules) use for longer than one year is safe and will work.

It is not known if Ribasphere (ribavirin capsules) use in children younger than 3 years old is safe and will work.

Who should not take Ribasphere (ribavirin capsules)?

See “What is the most important information I should know about Ribasphere (ribavirin capsules)?”

Do not take Ribasphere (ribavirin capsules) if you have:

Talk to your healthcare provider before taking Ribasphere (ribavirin capsules) if you have any of these conditions.

What should I tell my healthcare provider before taking Ribasphere (ribavirin capsules)?

Before you take Ribasphere (ribavirin capsules), tell your healthcare provider if you have or ever had:

Tell your healthcare provider about all the medicines you take, including prescription medicines, vitamins, and herbal supplements. Ribasphere 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.

How should I take Ribasphere (ribavirin capsules)?

What are the possible side effects of Ribasphere (ribavirin capsules)?

Ribasphere (ribavirin capsules) may cause serious side effects, including:

See “What is the most important information I should know about Ribasphere (ribavirin capsules)?”

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

The most common side effects of Ribasphere (ribavirin capsules) include:

The most common side effects of Ribasphere (ribavirin capsules) in children include:

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 Ribasphere (ribavirin capsules). 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.

How should I store Ribasphere (ribavirin capsules)?

Store Ribasphere (ribavirin capsules) between 59˚F to 86˚F (15˚C to 30˚C).

Keep Ribasphere (ribavirin capsules) and all medicines out of the reach of children.

GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF RIBASPHERE (RIBAVIRIN CAPSULES).

It is not known if treatment with Ribasphere (ribavirin capsules) will cure hepatitis C virus infections or prevent cirrhosis, liver failure, or liver cancer that can be caused by hepatitis C virus infections. It is not known if taking Ribasphere (ribavirin capsules) will prevent you from infecting another person with the hepatitis C virus.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Ribasphere (ribavirin capsules) for a condition for which it was not prescribed. Do not give Ribasphere (ribavirin capsules) 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 Ribasphere (ribavirin capsules). If you would like more information, talk with your healthcare provider. You can ask your pharmacist or health care provider for information about Ribasphere (ribavirin capsules) that is written for health professionals.

What are the ingredients in Ribasphere (ribavirin capsules)?

Active ingredients: ribavirin

Ribasphere (ribavirin capsules)

Inactive ingredients: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, and povidone. The capsule shell consists of gelatin and titanium dioxide. The capsule is printed horizontally with "riba 200" on both the body and the cap of the capsule using edible green pharmaceutical ink which is made of Butyl Alcohol, NF, Yellow Iron Oxide, NF, dehydrated alcohol USP, FD&C Blue #2 Aluminum Lake, isopropyl alcohol USP, propylene glycol USP, Shellac, NF, strong ammonia solution, NF and titanium dioxide.

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

Manufactured by:

DSM PHARMACEUTICALS, INC.
Greenville, NC 27834, USA
for
Kadmon Pharmaceuticals, LLC
Warrendale, PA 15086, USA

Copyright© 2012 Kadmon Pharmaceuticals, LLC.

All rights reserved.

U.S. Patent No. 6,720,000

C001.00068-01/11
Issued: 09/12

1. INTRON A is a registered trademark of Schering Corporation

2. PegIntron is a registered trademark of Schering Corporation

3. VIDEX® is a registered trademark of Bristol-Myers Squibb Company.

4. Imuran® is a registered trademark of Prometheus Laboratories, Inc.

5. Azasan® is a registered trademark of AAI Properties, Inc.

Revised: 12/2013
 
Kadmon Pharmaceuticals, LLC