Biktarvy

Biktarvy Dosage/Direction for Use

Manufacturer:

Gilead

Distributor:

DCH Auriga

Marketer:

DCH Auriga
Full Prescribing Info
Dosage/Direction for Use
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 Pharmacology: Pharmacokinetics under Actions).
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 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 see 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.
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