Ribasphere® (ribavirin, USP) Tablets and Capsules

Please download the package insert (TABLETS or CAPSULES) for complete prescribing information.

Ribasphere (ribavirin, USP) is a form of ribavirin, an antiviral medication used in combination with other drugs for the treatment of chronic hepatitis C.

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.

INDICATION

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.

CONTRAINDICATIONS

Ribasphere (ribavirin, USP) is contraindicated in:

  • Patients with known hypersensitivity to Ribasphere (ribavirin, USP) or to any component of the tablet.
  • Women who are pregnant.
  • Men whose female partners are pregnant, plan to become pregnant, or are not using contraception.
  • Patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia).
  • In combination with didanosine. Reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials.

Ribasphere (ribavirin, USP) and peginterferon alfa-2a combination therapy is contraindicated in patients with:

  • Autoimmune hepatitis.
  • Hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment.
  • Hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment.

The peginterferon alfa-2a Package Insert should be reviewed in its entirety for additional safety information prior to initiation of combination treatment. For more information, please see the complete Ribasphere (ribavirin, USP) prescribing information (TABLETS or CAPSULES) and Medication Guide.

Packaging

  • Ribasphere (ribavirin, USP) capsules are packaged in 200 mg bottles.
  • Ribasphere (ribavirin, USP) tablets are packaged in 200 mg, 400 mg and 600 mg bottles.

Ribasphere (ribavirin, USP) tablets and capsules are distributed in child-resistant packaging and meet 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 the CPSIA of 2008.

RIBAVIRIN PREGNANCY REGISTRY

The Ribavirin Pregnancy Registry is a program to monitor pregnancy exposures to ribavirin. The development of the Registry was mandated by the FDA.

Although the Registry is voluntary, Kadmon encourages participation to support this overall public health initiative. If you have 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, Monday-Friday, 8:30 AM to 6 PM, EST
Fax: 1 800-800-1052
E-mail: registries@kendle.com