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Brand Name
Sirturo
Generic Name
Bedaquiline
View Brand Information FDA approval date: December 28, 2012
Classification: Diarylquinoline Antimycobacterial
Form: Tablet
What is Sirturo (Bedaquiline)?
SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients with pulmonary multi-drug resistant tuberculosis . Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided. This indication is approved under accelerated approval based on time to sputum culture conversion. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adult and pediatric patients with pulmonary multi-drug resistant tuberculosis . Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided. This indication is approved under accelerated approval based on time to sputum culture conversion. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Limitations of Use : Do not use SIRTURO for the treatment of latent, extra-pulmonary or drug-sensitive tuberculosis or for the treatment of infections caused by non-tuberculous mycobacteria . Safety and efficacy of SIRTURO in HIV-infected patients with MDR-TB have not been established, as clinical data are limited. Limitations of Use: Do not use SIRTURO for the treatment of: Latent infection due to Mycobacterium tuberculosis Drug-sensitive tuberculosis Extra-pulmonary tuberculosis Infections caused by non-tuberculous mycobacteria The safety and efficacy of SIRTURO in the treatment of HIV infected patients with MDR-TB have not been established as clinical data are limited.
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Brand Information
SIRTURO (Bedaquiline Fumarate)
WARNING: QTc PROLONGATION
QTc prolongation can occur with SIRTURO. Use with drugs that prolong the QTc interval may cause additive QTc prolongation. Monitor ECGs. Discontinue SIRTURO if significant ventricular arrhythmia or QTc interval greater than 500 ms develops
1INDICATIONS AND USAGE
SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (2 years and older and weighing at least 8 kg) with pulmonary tuberculosis (TB) due to
2DOSAGE FORMS AND STRENGTHS
- SIRTURO 20 mg tablet: uncoated, white to almost white oblong functionally scored tablet, with a score line on both sides, debossed with "2" and "0" on one side and plain on the other side.
- SIRTURO 100 mg tablet: uncoated, white to almost white round biconvex tablet with debossing of "T" over "207" on one side and "100" on the other side.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling:
- QTc Prolongation
- Mortality Imbalance in Clinical Trials
- Hepatotoxicity
- Drug Interactions
4.1Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Refer to the prescribing information of the drugs used in combination with SIRTURO for their respective adverse reactions.
5OVERDOSAGE
There is no experience with the treatment of acute overdose with SIRTURO. Take general measures to support basic vital functions including monitoring of vital signs and ECG (QTc interval) in case of deliberate or accidental overdose. It is advisable to contact a poison control center to obtain the latest recommendations for the management of an overdose. Since bedaquiline is highly protein-bound, dialysis is not likely to significantly remove bedaquiline from plasma.
6DESCRIPTION
SIRTURO
Bedaquiline fumarate is a white to almost white powder and is practically insoluble in aqueous media. The chemical name of bedaquiline fumarate is (1
SIRTURO 20 mg tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose 2910 5 mPa.s, polysorbate 20, purified water (removed during processing), silicified microcrystalline cellulose and sodium stearyl fumarate.
SIRTURO 100 mg tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose 2910 15 mPa.s, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, purified water (removed during processing).
7PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Medication Guide).
8PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label
NDC 59676-702-60
Sirturo
20 mg
ATTENTION: Dispense the enclosed
Each tablet contains 20 mg of bedaquiline
Rx only
Johnson
&Johnson
9PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
NDC 59676-701-01
Sirturo®
(bedaquiline) tablets
(bedaquiline) tablets
100 mg
Attention: Dispense the enclosed
Medication Guide to each patient.
Each tablet contains 100 mg of
bedaquiline (equivalent to
120.89 mg of bedaquiline fumarate).
Rx only
188 Tablets
188 Tablets
Johnson
&Johnson