RIBASPHERE (ribavirin, USP) Capsules 200 mg

Hepatitis C is a viral infection of the liver. It’s often chronic, and can lead to cirrhosis and liver cancer. It’s difficult to treat, and harder to cure. Diagnosis is based on the antibodies your body produces in response to hepatitis C infection, liver biopsy, and/or a PCR test that directly measures the hep C viral activity in your blood. You can be a carrier, or have a persistent infection. When to treat and the best way to treat hepatitis C is not yet known.

Who should get tested for hepatitis C?

  • persons who ever injected illegal drugs, including those who injected once or a few times many years ago
  • persons who were treated for clotting problems with a blood product made before 1987 when more advanced methods for manufacturing the products were developed
  • persons who were notified that they received blood from a donor who later tested positive for hepatitis C
  • persons who received a blood transfusion or solid organ transplant before July 1992 when better testing of blood donors became available
  • long-term hemodialysis patients
  • persons who have signs or symptoms of liver disease (e.g., abnormal liver enzyme tests)
  • healthcare workers after exposures (e.g., needle sticks or splashes to the eye ) to HCV-positive blood on the job
  • children born to HCV-positive women

RIBASPHERE (Ribavirin capsules) are indicated in combination with INTRON A (interferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients 18 years of age and older with compensated liver disease previously untreated with alpha interferon and in patients 18 years of age and older who have relapsed following alpha interferon therapy.

The safety and efficacy of RIBASPHERE (Ribavirin capsules) with interferons other than INTRON A or PEG-INTRON products have not been established.

HOW SUPPLIED
RIBASPHERE (Ribavirin capsules), 200 mg are packaged in HDPE bottles with child-resistant closures containing 180 capsules.

 

IMPORTANT SAFETY INFORMATION:
The most serious possible side effects of RIBASPHERE (Ribavirin capsules) are:

  • Harm to unborn children. RIBASPHERE (Ribavirin capsules) may cause birth defects or death of an unborn child.
  • Anemia. Anemia is a reduction in the number of red blood cells you have which can be dangerous, especially if you have heart or breathing problems. Tell your health care provider right away if you feel tired, have chest pain or shortness of breath. These may be signs of low red blood cell counts.

Tell your provider right away if you have any of the following symptoms. They may be signs of a serious side effect:

  • trouble breathing
  • hives or swelling
  • chest pain
  • severe stomach or low back pain
  • bloody diarrhea or bloody stools (bowel movements). These may appear black and tarry.
  • bruising
  • other bleeding

The most common side effects of RIBASPHERE (Ribavirin capsules) are:

  • feeling tired
  • nausea and appetite loss
  • rash and itching
  • cough

This summary does not include all possible side effects of ribavirin therapy. Talk to your health care provider, if you do not feel well while taking ribavirin. Your health care provider can give you more information about managing your side effects.

Please download the PACKAGE INSERT for complete prescribing information.

If you would like additional information, please contact us at 1-800-405-8506

 

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