Biktarvy 50 mg/200 mg/25 mg film-coated tablets
1. Name of the medicinal product
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine, and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Purplish-brown, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “9883” on the other side of the tablet. Each tablet is approximately 15 mm × 8 mm.
4. Clinical particulars
4.1 Therapeutic indications
Biktarvy is indicated for the treatment of adults infected with human immunodeficiency virus-1 (HIV-1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir (see section 5.1).
4.2 Posology and method of administration
Therapy should be initiated by a physician experienced in the management of HIV infection.
Posology
One tablet to be taken once daily.
Missed doses
If the patient misses a dose of Biktarvy within 18 hours of the time it is usually taken, the patient should take Biktarvy as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Biktarvy by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
If the patient vomits within 1 hour of taking Biktarvy another tablet should be taken. If a patient vomits more than 1 hour after taking Biktarvy they do not need to take another dose of Biktarvy until the next regularly scheduled dose.
Elderly
There are limited data on the use of Biktarvy in patients aged 65 years and over. No dose adjustment of Biktarvy is required in elderly patients (see sections 5.1 and 5.2).
Renal impairment
No dose adjustment of Biktarvy is required in patients with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
Initiation of Biktarvy is not recommended in patients with estimated CrCl below 30 mL/min, as there are insufficient data available regarding the use of Biktarvy in this population (see section 5.2).
Hepatic impairment
No dose adjustment of Biktarvy is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. Biktarvy has not been studied in patients with severe hepatic impairment (Child-Pugh Class C), therefore Biktarvy is not recommended for use in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Paediatric population
The safety and efficacy of Biktarvy in children under the age of 18 years have not yet been established. No data are available.
Method of administration
Oral use
Biktarvy can be taken with or without food (see section 5.2).
The film-coated tablets should not be chewed, crushed or split.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Co-administration with rifampicin and St John's Wort (Hypericum perforatum) (see section 4.5).
4.4 Special warnings and precautions for use
While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission should be taken in accordance with national guidelines.
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