Sirturo

Generic Name: bedaquiline
Date of Approval: December 28, 2012
Company: Janssen Research & Development, LLC

Treatment for: Multi-Drug Resistant Pulmonary Tuberculosis

FDA Approves Sirturo

The U.S. Food and Drug Administration has approved Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available.

Multi-drug resistant tuberculosis occurs whenMycobacterium tuberculosis becomes resistant to isonazid and rifampin, two powerful drugs most commonly used to treat tuberculosis. Sirturo is the first drug approved to treat multi-drug resistant tuberculosis and should be used in combination with other drugs used to treat tuberculosis. Sirturo works by inhibiting an enzyme needed by M. tuberculosis to replicate and spread throughout the body.

Sirturo Medication Guide

Read this Medication Guide before you start taking Sirturo and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Important information about Sirturo

Sirturo is an antibiotic prescription medicine used to treat multi-drug resistant tuberculosis (TB) of the lungs in people with limited treatment options. Multi-drug resistant tuberculosis is a serious disease that can result in death and for which there are few treatment choices. More people treated with Sirturo cleared TB from their sputum compared to people who did not receive Sirturo.

It is important to complete the full course of treatment with Sirturo and your other TB medicines and not skip doses. Skipping doses may decrease the effectiveness of the treatment and increase the likelihood that your TB disease will not be treatable by Sirturo or other medicines.

Sirturo can cause serious side effects.

In one clinical trial, more deaths were seen in people who were treated with Sirturo compared to people who did not receive Sirturo.
Heart rhythm problems can happen with Sirturo.
Talk with your healthcare provider about whether Sirturo is right for you.