Bedaquiline Fumarate (SIRTURO)

US NDC LINE: 59676-701

Trade Name: SIRTURO

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Janssen Products, LP

Presentation: TABLET

Strength: 20 mg/1

Storage and handling

BEDAQUILINE FUMARATE Diarylquinoline Antimycobacterial [EPC],Diarylquinolines [CS]

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  • WARNING: INCREASED MORTALITY and QT PROLONGATION
  • See full prescribing information for complete boxed warning.
  • Increased Mortality
  • QT Prolongation
  • No data
  • SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (MDR-TB). 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:
  • SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (MDR-TB). 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
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  • Administer SIRTURO by directly observed therapy (DOT). ()
  • Emphasize need for compliance with full course of therapy. ()
  • Prior to administration, obtain ECG, liver enzymes and electrolytes. Obtain susceptibility information for the background regimen against isolate if possible. ()
  • Only use SIRTURO in combination with at least 3 other drugs to which the patient's MDR-TB isolate has been shown to be susceptible . If testing results are unavailable, may initiate SIRTURO in combination with at least 4 other drugs to which patient's MDR-TB isolate is likely to be susceptible. ()
  • Recommended dosage in adult patients: 400 mg (4 of the 100 mg tablets OR 20 of the 20 mg tablets) once daily for 2 weeks followed by 200 mg (2 of the 100 mg tablets OR 10 of the 20 mg tablets) 3 times per week (with at least 48 hours between doses) for 22 weeks. ()
  • Recommended dosage in pediatric patients (5 years and older and weighing at least 15 kg) is based on body weight. ()
  • Take SIRTURO tablets with food. ()
  • See full prescribing information for the different methods of administration of SIRTURO 20 mg tablet and administration of the 100 mg tablet.
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  • Tablets: 20 mg, functionally scored ()
  • Tablets: 100 mg ()
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  • QT prolongation can occur with SIRTURO. Monitor ECGs and discontinue SIRTURO if significant ventricular arrhythmia or QTcF interval > 500 ms develops. ()
  • Hepatotoxicity may occur with use of SIRTURO. Monitor liver-related laboratory tests. Discontinue SIRTURO if evidence of liver injury occurs. ()
  • The following serious adverse reactions are discussed elsewhere in the labeling:
  • 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.
  • To report SUSPECTED ADVERSE REACTIONS, contact Janssen Therapeutics, Division of Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or n
  • The most common adverse reactions reported in 10% or more of adult patients treated with SIRTURO were nausea, arthralgia, headache, hemoptysis and chest pain. ()
  • The most common adverse reactions reported in 10% or more of pediatric patients (12 years to less than 18 years of age) treated with SIRTURO were arthralgia, nausea and abdominal pain. ()
  • The most common adverse reaction reported in 10% or more of pediatric patients (5 years to less than 12 years of age) treated with SIRTURO was elevation in liver enzymes. ()
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  • Avoid use of strong and moderate CYP3A4 inducers with SIRTURO. (, )
  • Avoid use for more than 14 consecutive days of systemic strong CYP3A4 inhibitors with SIRTURO unless the benefit outweighs the risk. Monitor for SIRTURO-related adverse reactions. ()
  • No data
  • Lactation: Monitor infants exposed to bedaquiline through breast milk for signs of bedaquiline-related adverse reactions, such as hepatotoxicity. (, )
  • Pediatrics: The safety and effectiveness of SIRTURO in pediatric patients less than 5 years of age and/or weighing less than 15 kg have not been established. ()
  • Use with caution in patients with severe hepatic impairment and only when the benefits outweigh the risks. Monitor for SIRTURO-related adverse reactions. ()
  • Use with caution in patients with severe renal impairment. ()
  • 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 (QT 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.
  • SIRTURO contains bedaquiline fumarate, a diarylquinoline antimycobacterial drug for oral administration. Each SIRTURO 20 mg tablet contains 20 mg of bedaquiline (equivalent to 24.18 mg of bedaquiline fumarate). Each SIRTURO 100 mg tablet contains 100 mg of bedaquiline (equivalent to 120.89 mg of bedaquiline fumarate).
  • Bedaquiline fumarate is a white to almost white powder and is practically insoluble in aqueous media. The chemical name of bedaquiline fumarate is (1, 2)-1-(6-bromo-2-methoxy-3-quinolinyl)-4-(dimethylamino)-2-(1-naphthalenyl)-1-phenyl-2-butanol compound with fumaric acid (1:1). It has a molecular formula of CHBrNOu2219CHO and a molecular weight of 671.58 (555.50 + 116.07). The molecular structure of bedaquiline fumarate is the following:
  • 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).
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  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Product of India
  • Finished Product Manufactured by: Recipharm Pharmaservices Pvt. Ltd., Bangalore, India
  • Manufactured for:
  • Janssen Therapeutics, Division of Janssen Products, LP
  • Titusville, NJ 08560
  • u00a9 2012 Janssen Products, LP
  • No data
  • NDC 59676-702-60
  • Sirturon (bedaquiline) Tablets
  • 20 mg
  • ATTENTION: Dispense the enclosed Medication Guide to each patient.
  • Each tablet contains 20 mg of bedaquiline (equivalent to 24.18 mg of bedaquiline fumarate).
  • Rx only60 Tablets
  • janssen
  • NDC 59676-701-01
  • Sirturo
  • 100 mg
  • Dispense Medication Guideto each patient
  • Attention Pharmacist:
  • 188 Tablets
  • Rx only
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GNH India is WHO GDP and ISO 9001 2015 Global Pharmaceutical Distributor/ Wholesaler/ Supplier/ Exporter/ Importer of Bedaquiline Fumarate (SIRTURO) which is also known as SIRTURO and manufactured by Janssen Products, LP. It is available in strength of 20 mg/1 per ml.

Bedaquiline Fumarate (SIRTURO) is supplied for Tenders/ Emergency imports/ Un-licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For clinical trials. Click to know price.

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