Bedaquiline dosage and administration

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Bedaquiline
SIRTURO® FDA Package Insert
Description
Clinical Pharmacology
Indications and Usage
Microbiology
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

Dosage and Administration

SIRTURO should only be used in combination with at least 3 other drugs to which the patient's MDR-TB isolate has been shown to be susceptible in vitro. If in vitro testing results are unavailable, treatment may be initiated with SIRTURO in combination with at least 4 other drugs to which the patient's MDR-TB isolate is likely to be susceptible. Throughout treatment with, and following the last intake of SIRTURO, patients should continue to take their companion drugs as directed. The recommended dosage of SIRTURO is:

  • Weeks 1–2: 400 mg (4 tablets of 100 mg) once daily with food
  • Weeks 3–24: 200 mg (2 tablets of 100 mg) 3 times per week with food (with at least 48 hours between doses) for a total dose of 600 mg per week.

The total duration of treatment with SIRTURO is 24 weeks. The SIRTURO tablet should be swallowed whole with water. Patients should avoid alcohol use while on treatment.

Missed doses

Patients should be advised of the need to take SIRTURO as prescribed. Compliance with the full course of therapy must be emphasized. If a dose is missed during the first 2 weeks of treatment, patients should not make up the missed dose but should continue the usual dosing schedule. From Week 3 onwards, if a 200 mg dose is missed, patients should take the missed dose as soon as possible, and then resume the 3 times a week regimen.[1]

References

  1. "SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]". Retrieved 23 December 2013.

Adapted from the FDA Package Insert.