SIRTURO Tablet (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

SIRTURO 20 mg tablets. SIRTURO 100 mg tablets.

Qualitative and quantitative composition

SIRTURO 20 mg tablets: Each tablet contains bedaquiline fumarate equivalent to 20 mg of bedaquiline. SIRTURO 100 mg tablets: Each tablet contains bedaquiline fumarate equivalent to 100 mg ...

Pharmaceutical form

SIRTURO 20 mg tablets: Tablet. Uncoated, white to almost white oblong tablet (12.0 mm long x 5.7 mm wide), with score line on both sides, debossed with 2 and 0 on one side and plain on other side. ...

Therapeutic indications

SIRTURO is indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult and paediatric patients (5 years to less than 18 years of age ...

Posology and method of administration

Treatment with SIRTURO should be initiated and monitored by a physician experienced in the management of multi-drug resistant Mycobacterium tuberculosis. Consideration should be given to WHO guidelines ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

There are no clinical data on the use of SIRTURO to treat: extra-pulmonary tuberculosis (e.g. central nervous system, bone) infections due to mycobacterial species other than Mycobacterium tuberculosis ...

Interaction with other medicinal products and other forms of interaction

The elimination of bedaquiline has not been fully characterised in vivo. CYP3A4 is the major CYP isoenzyme involved in vitro in the metabolism of bedaquiline and the formation of the ...

Fertility, pregnancy and lactation

Pregnancy There are limited data on the use of SIRTURO in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a ...

Effects on ability to drive and use machines

Bedaquiline may have a minor influence on the ability to drive and use machines. Dizziness has been reported in some patients taking bedaquiline and should be considered when assessing a patients ability ...

Undesirable effects

Summary of the safety profile Adverse drug reactions for SIRTURO were identified from pooled Phase IIb clinical trial data (both controlled and uncontrolled, C208 and C209) containing 335 adult patients ...

Overdose

Cases of intentional or accidental acute overdose with bedaquiline were not reported during clinical trials. In a study in 44 healthy adult subjects receiving a single 800 mg dose of SIRTURO, adverse reactions ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antimycobacterials, drugs for treatment of tuberculosis ATC code: J04AK05 Mechanism of action Bedaquiline is a diarylquinoline. Bedaquiline specifically inhibits mycobacterial ...

Pharmacokinetic properties

The pharmacokinetic properties of bedaquiline have been evaluated in adult healthy subjects and in multi-drug resistant tuberculosis-infected patients 5 years of age and older. Exposure to bedaquiline ...

Preclinical safety data

Animal toxicology studies have been conducted with bedaquiline administration up to 3 months in mice, up to 6 months in rats, and up to 9 months in dogs. The plasma bedaquiline exposure (AUC) in rats and ...

List of excipients

SIRTURO 20 mg tablet: Microcrystalline cellulose Crospovidone Silica, colloidal anhydrous Hypromellose Polysorbate 20 Sodium stearyl fumarate SIRTURO 100 mg tablet: Lactose monohydrate Maize ...

Incompatibilities

Not applicable.

Shelf life

Shelf life SIRTURO 20 mg tablets: 3 years. SIRTURO 100 mg tablets: 3 years.

Special precautions for storage

This medicinal product does not require any special temperature storage conditions. SIRTURO 20 mg tablets: Store in the original container and keep the container tightly closed in order to protect ...

Nature and contents of container

SIRTURO 20 mg tablets: White, opaque, high-density polyethylene (HDPE) bottle with child-resistant polypropylene (PP) closure with aluminium induction seal liner. Each bottle contains 60 tablets ...

Special precautions for disposal and other handling

This medicinal product may pose a risk to the environment (see section 5.3). Any unused product or waste material should be disposed of in accordance with local requirements (see section 5.3). SIRTURO ...

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium

Marketing authorization number(s)

EU/1/13/901/001 EU/1/13/901/002 EU/1/13/901/003

Date of first authorization / renewal of the authorization

Date of first authorisation: 5 March 2014 Date of latest renewal: 11 January 2021

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