Generic Name: simeprevir
Other Market Name: Galexos (Canada); Sovriad (Japan)
Drug Class: NS3/4A Protease Inhibitors (PIs)
Approval Status: Not available
Generic Version Available: No
Experimental Code: TMC435
Janssen voluntarily discontinued the manufacture of Olysio. As of May 25, 2018, Olysio is no longer available in the United States.
- Olysio was approved by the U.S. Food and Drug Administration for use by people living with hepatitis C on November 22, 2013.
- In clinical trials, an average of 93 percent of participants were cured with 12 weeks of Olysio plus Sovaldi.
Adult Dose: One tablet taken orally once daily with food. Usually prescribed with Sovaldi, so follow additional dosing instructions for that drug; if ribavirin is prescribed, follow additional dosing instructions for that drug.
Pediatric Dose: N/A
Dosing Info: Olysio is generally prescribed for 12 to 24 weeks, with or without ribavirin. Duration of treatment and the choice of additional drugs that are prescribed with Olysio are determined by genotype subtype, prior treatment experience and the presence of cirrhosis. For specific treatment recommendations, see Hepatitis C Treatment-Naive Recommendations or Hepatitis C Re-treatment Recommendations.
- The most common side effects associated with Olysio are rash (including a potentially serious photosensitivity reaction), pruritus and nausea.
- When taken with Sovaldi, fatigue, headache and nausea were the most common side effects. Taking ribavirin increases the type, frequency and intensity of side effects.
- Before taking this medication, tell your medical provider and pharmacist about any drugs, supplements and herbs you take, whether prescribed, over-the-counter or illicit.
- Patients taking amiodarone should not take Sovaldi, and thus Olysio when prescribed together; heart-related complications, including one death, have been reported by patients taking these medications together.
- Olysio may interact with drugs and herbs that are metabolized in the liver and intestines, such as milk thistle, phenytoin, rifampin and St. John’s wort. Additional drug-drug interactions may occur; these are listed in Olysio’s full prescribing information. Potential interactions are listed at hep-druginteractions.org.
- Warning: Patients who are coinfected with hepatitis B and C who take this medication may be at risk of hepatitis B virus (HBV) reactivation. Before taking this medication, be sure your doctor has tested you for evidence of current or prior hepatitis B virus infection. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in serious hepatitis flares, liver failure, and death.
- Pregnant women or those who are trying to become pregnant should not take Olysio if it is prescribed with ribavirin. Women of childbearing age and their male sexual partners must use two forms of birth control throughout treatment and for six months after treatment if ribavirin is prescribed.
- There are no adequate and well-controlled studies in pregnant women who have taken Olysio without ribavirin. Olysio should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
- The safety of breast feeding while taking Olysio has not been established.
For More Info: http://www.olysio.com/
Co-Pay Program Info: http://www.hepmag.com/basics/hepatitis-c-basics/paying-hepatitis-c-treatment
Patient Assistance Program Info: http://www.hepmag.com/basics/hepatitis-c-basics/paying-hepatitis-c-treatment
Last Reviewed: March 26, 2018