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: No dose adjustment of Biktarvy is required in patients aged ≥65 years (see Adverse Reactions and Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment of Biktarvy is required in patients with estimated creatinine clearance (CrCl) ≥30 mL/min.
No dose adjustment of Biktarvy is required in adult patients with end stage renal disease (estimated creatinine clearance <15 mL/minute) who are receiving chronic haemodialysis. However, Biktarvy should generally be avoided and only be used in these patients if the potential benefits are considered to outweigh the potential risks (see Precautions and Pharmacology: Pharmacokinetics under Actions). On days of haemodialysis, administer the daily dose of Biktarvy after completion of haemodialysis treatment.
Initiation of Biktarvy should be avoided in patients with estimated creatinine clearance ≥15 mL/min and <30 mL/min, or <15 mL/min who are not receiving chronic haemodialysis, as the safety of Biktarvy has not been established in these populations (see Pharmacology: Pharmacokinetics under Actions).
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 Precautions and Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
The film-coated tablets should not be chewed, crushed or split.