BETHESDA, MD 02 January 2013—
and Janssen Therapeutics on December 31 announced the approval of bedaquiline for the treatment of multidrug-resistant pulmonary tuberculosis.
Janssen will market bedaquiline as Sirturo. A company spokeswoman said Janssen expects bedaquiline to be commercially available in the second quarter of this year.
According to Janssen, 98 cases of multidrug-resistant tuberculosis were reported in the United States during 2011.
Bedaquiline's labeling (PDF) describes the medication as a diarylquinoline antimycobacterial drug that inhibits an enzyme necessary for energy production by Mycobacterium tuberculosis.
According to the labeling, bedaquiline is indicated as part of a combination regimen for the treatment of pulmonary tuberculosis in adults for whom no other treatment regimen is an option. Bedaquiline should be concomitantly administered with at least three additional drugs to which the patient's Mycobacterium tuberculosis infection is likely to be responsive on the basis of laboratory testing.
The drug is not indicated for the treatment of latent or extrapulmonary tuberculosis or for tuberculosis resulting from mycobacteria that are susceptible to first-line drugs. Little to no clinical data exist on the use of bedaquiline in patients who are coinfected with HIV.
The full 24-week regimen for bedaquiline is four 100-mg tablets taken once daily with food, through directly observed therapy, for two weeks, followed by two 100-mg tablets taken three times per week but at least 48 hours apart.
Bedaquiline tablets should be swallowed whole with water, and patients should avoid alcohol use during the treatment regimen.
The use of hepatotoxic drugs should also be avoided during bedaquiline therapy.
The labeling for bedaquiline includes a boxed warning about the increased risks of death and QT-interval prolongation that are associated with the drug's use. Patients should undergo electrocardiography before starting bedaquiline therapy and at least 2, 12, and 24 weeks into the regimen.
A medication guide that is part of the drug's labeling describes these risks and also emphasizes the need for patients to take all doses of bedaquiline as prescribed to improve the likelihood of clearing the infection.
In clinical trials, the most commonly reported adverse events associated with bedaquiline use were nausea, arthralgia, headache, blood-stained sputum, and chest pain.
Bedaquiline 100-mg tablets will be packaged in bottles of 188 tablets each. The drug should be dispensed in the original container and stored at controlled room temperature. If the tablets are repackaged, they should be stored in a tightly sealed light-resistant container with an expiration date of no more than three months.