Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
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).
Therapy should be initiated by a physician experienced in the management of HIV infection.
One tablet to be taken once daily.
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.
No dose adjustment of Biktarvy is required in patients aged ≥65 years (see sections 4.8 and 5.2).
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 sections 4.4 and 5.2). 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 section 5.2).
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).
The safety and efficacy of Biktarvy in children under the age of 18 years have not yet been established. No data are available.
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.
If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8). Treatment of overdose with Biktarvy consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
There is no specific antidote for overdose with Biktarvy. As bictegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis. Emtricitabine can be removed by haemodialysis, which removes approximately 30% of the emtricitabine dose over a 3-hour dialysis period starting within 1.5 hours of emtricitabine dosing. Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%. It is not known whether emtricitabine or tenofovir can be removed by peritoneal dialysis.
Bottle: 3 years.
Blister: 2 years.
Bottle: Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not use if seal over bottle opening is broken or missing.
Blister: Store in the original package in order to protect from moisture. Do not use if foil over blister is broken or pierced.
The following pack configurations are available:
White, high density polyethylene (HDPE) bottle with a polypropylene continuous-thread, child-resistant cap, lined with an induction activated aluminium foil liner containing 30 film-coated tablets. Each bottle contains silica gel desiccant and polyester coil.
Blister packs consisting of polyvinyl chloride/polyethylene/polychlorotrifluoroethylene (PVC/PE/PCTFE) film, sealed to aluminium foil lidding material fitted with a molecular sieve desiccant within each blister cavity.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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