Bedaquiline fumarate

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Bedaquiline fumarate
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

Disclaimer

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Black Box Warning

WARNINGS:
See full prescribing information for complete Boxed Warning.
* An increased risk of death was seen in the SIRTURO® treatment group (9/79, 11.4%) compared to the placebo treatment group (2/81, 2.5%) in one placebo-controlled trial. Only use SIRTURO when an effective treatment regimen cannot otherwise be provided.
  • QT prolongation can occur with SIRTURO. Use with drugs that prolong the QT interval may cause additive QT prolongation.

Overview

Bedaquiline fumarate is an antitubercular that is FDA approved for the treatment of multidrug resistant tuberculosis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include chest pain, nausea, arthralgia, headache, hemoptysis, increased liver enzymes.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adults (≥ 18 years) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided. SIRTURO should be administered by directly observed therapy (DOT).
  • This indication is based on analysis of time to sputum culture conversion from two controlled Phase 2 trials in patients with pulmonary MDR-TB.

Limitations of Use:

  • The safety and efficacy of SIRTURO for the treatment of latent infection due to Mycobacterium tuberculosis have not been established. The safety and efficacy of SIRTURO for the treatment of drug-sensitive TB have not been established. In addition, there are no data on the treatment with SIRTURO of extra-pulmonary TB (e.g., central nervous system). The safety and efficacy of SIRTURO for the treatment of infections caused by non-tuberculous mycobacteria (NTM) have not been established. Therefore, use of SIRTURO in these settings is not recommended.

Dosage

  • 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.

DOSAGE FORMS AND STRENGTHS

  • 100 mg Tablet

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Bedaquiline fumarate in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Bedaquiline fumarate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Bedaquiline fumarate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Bedaquiline fumarate in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Bedaquiline fumarate in pediatric patients.

Contraindications

  • Condition1

Warnings

WARNINGS:
See full prescribing information for complete Boxed Warning.
* An increased risk of death was seen in the SIRTURO® treatment group (9/79, 11.4%) compared to the placebo treatment group (2/81, 2.5%) in one placebo-controlled trial. Only use SIRTURO when an effective treatment regimen cannot otherwise be provided.
  • QT prolongation can occur with SIRTURO. Use with drugs that prolong the QT interval may cause additive QT prolongation.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Bedaquiline fumarate in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Bedaquiline fumarate in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bedaquiline fumarate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Bedaquiline fumarate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Bedaquiline fumarate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Bedaquiline fumarate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Bedaquiline fumarate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Bedaquiline fumarate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Bedaquiline fumarate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Bedaquiline fumarate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Bedaquiline fumarate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Bedaquiline fumarate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Bedaquiline fumarate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Bedaquiline fumarate in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Bedaquiline fumarate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Bedaquiline fumarate in the drug label.

Pharmacology

There is limited information regarding Bedaquiline fumarate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Bedaquiline fumarate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Bedaquiline fumarate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Bedaquiline fumarate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Bedaquiline fumarate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Bedaquiline fumarate in the drug label.

How Supplied

Storage

There is limited information regarding Bedaquiline fumarate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Bedaquiline fumarate in the drug label.

Precautions with Alcohol

  • Alcohol-Bedaquiline fumarate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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