Ribasphere® RibaPak® (ribavirin, USP) Tablets
Please download the PACKAGE INSERT for complete prescribing information.
Ribavirin is an oral medication (taken by mouth) used to treat hepatitis C. Ribavirin is taken twice a day, and is often prescribed in combination with other medication. Ribasphere RibaPak Tablets are a unique brand of ribavirin available from Kadmon.
IMPORTANT SAFETY INFORMATION
Ribasphere (ribavirin, USP) monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication.
The primary clinical toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin.
Significant teratogenic and /or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple dose half-life of 12 days, and it may persist in non-plasma compartments for as long as 6 months. Ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of therapy in both female patients and in female partners of male patients who are taking ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month posttreatment follow-up period.
What makes Ribasphere RibaPak Tablets different?
Ribasphere RibaPak is a prepackaged set of ribavirin pills. Eack package provides 7 days of treatment divided into morning and evening doses. This packaging is designed to simplify treatment, make it easier to remember to take your medication, and also help you keep track of how many pills you’ve taken.
With the Ribasphere RibaPak, you take only 2 ribavirin pills each day. Other ribavirin formulations may require you to take up to 6 pills every day. Over the typical 24-week or 48-week treatment period, the Ribasphere RibaPak can greatly reduce your total number of ribavirin pills. Some people are able to reduce their ribavirin pill count by as much as 66%.
Stick with your treatment
Once you have started ribavirin treatment, following your prescribed dosing is very important. An analysis of the data from two medical studies revealed that people who took ribavirin more often (along with a pegylated interferon injection) had a better chance of achieving an SVR compared with people who missed many of their ribavirin doses.
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.
For Important Safety Information, please see the Patient Medication Guide and complete Prescribing Information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
Ribasphere RibaPak is distributed in child-resistant packaging and meets the requirements of the Consumer Product Safety Improvement Act (CPSIA) of 2008 and the Poison Prevention Packaging Act of 1970. View the list of Kadmon products sold in child-resistant packaging as required by CPSIA.
Ribavirin Pregnancy Registry
Because of a risk of birth defects, ribavirin should not be taken by women who are pregnant or who become pregnant during treatment. The Ribavirin Pregnancy Registry is a program that monitors pregnant women who are exposed to ribavirin. Please click here for more information about pregnancy risks associated with ribavirin treatment.
Although the Registry is voluntary, Kadmon encourages participation in this program to support this very important public health initiative.
If you have any questions, please contact the centralized registry at:
Ribavirin Pregnancy Registry
1011 Ashes Drive
Wilmington, NC 28405
http://www.ribavirinpregnancyregistry.com
Phone: 1 800-593-2214
Fax: 1 800-800-1052
E-mail: registries@kendle.com
Reference:
- Reddy KR, Shiffman ML, Morgan TR, et al. Impact of ribavirin dose reductions in hepatitis C virus genotype 1 patients completing peginterferon alfa-2a/ribavirin treatment. Clin Gastroenterol Hepatol. 2007;5:124-129.