(ribavirin, USP) TABLETS
200 mg, 400 mg, and 600 mg
Rx Only
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, USP) in combination with peginterferon alfa-2a is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A).
JUST TWO RIBASPHERE (RIBAVIRIN, USP) TABLETS A DAY MAY LEAD TO GREATER PATIENT COMPLIANCE.
- Up to 66% fewer tablets than Copegus®
- Each tablet is bioequivalent to comparable multi-tablet does of Copegus®
- Simpler dosing
- Cost effective
IMPORTANT SAFETY INFORMATION
- RIBASPHERE (ribavirin, USP) must not be used alone because ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection. The safety and efficacy of ribavirin have only been established when used together with peginterferon alfa-2a, recombinant.
- Patients must be informed that ribavirin may cause birth defects and/or death of the exposed fetus. RIBASPHERE (ribavirin, USP) therapy must not be used by women who are pregnant or by men whose female partners are pregnant. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients taking RIBASPHERE (ribavirin, USP) therapy and for 6 months posttherapy. RIBASPHERE (ribavirin, USP) Tablets therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Patients must perform a pregnancy test monthly during therapy and for 6 months posttherapy.
- RIBASPHERE can cause a dangerous drop in your red blood cell count. RIBASPHERE can cause anemia, which is a decrease in the number of red blood cells. This can be dangerous, especially if you have heart or breathing problems. This may cause a worsening of heart (cardiovascular) or circulatory problems. Some patients may get chest pain and rarely, a heart attack. Patients with a history of heart disease have the highest chance of this. Tell your healthcare provider, before taking RIBASPHERE if you have or have ever had any heart or breathing problems. Your healthcare provider should check your red blood cell count before you start treatment with RIBASPHERE and often during the first 4 weeks of treatment. Your red blood cell count may be done more often if you have any heart or breathing problems.
- There are significant adverse events caused by ribavirin/peginterferon alfa-2a therapy, including severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, pulmonary dysfunction, pancreatitis, and diabetes. The PEGASYS package insert and MEDICATION GUIDE should be reviewed in their entirety prior to initiation of combination treatment for additional safety information.
HOW SUPPLIED
RIBASPHERE (ribavirin, USP) is available as tablets for oral administration.
They are packaged as follows:
200 mg Bottles of 168
200 mg Bottles of 500
400 mg Bottles of 56
400 mg Bottles of 500
600 mg Bottles of 56
600 mg Bottles of 250
Please download the PACKAGE INSERT for complete prescribing information.
If you would like additional information, please contact us at 1-800-405-8506