BIKTARVY FILM-COATED TABLETS 50MG/200MG/25MG

GILEAD SCIENCES SINGAPORE PTE. LTD.

GILEAD SCIENCES SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**2 DOSAGE AND ADMINISTRATION** **2.1 Testing When Initiating and During Treatment with BIKTARVY** Prior to or when initiating BIKTARVY, test patients for hepatitis B virus infection _\[see Warnings and Precautions (5.1)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. Prior to or when initiating BIKTARVY, and during treatment with BIKTARVY, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, also assess serum phosphorus _\[see Warnings and Precautions (5.4)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. **2.2 Recommended Dosage** BIKTARVY is a three-drug fixed dose combination product containing 50 mg of bictegravir (BIC), 200 mg of emtricitabine (FTC), and 25 mg of tenofovir alafenamide (TAF). The recommended dosage of BIKTARVY is one tablet taken orally once daily with or without food in: - adults and pediatric patients weighing at least 25 kg and estimated creatinine clearance greater than or equal to 30 mL per minute; or - virologically-suppressed adults with estimated creatinine clearance below 15 mL per minute who are receiving chronic hemodialysis. On days of hemodialysis, administer the daily dose of BIKTARVY after completion of hemodialysis treatment. BIKTARVY should generally be avoided but may be used in these patients if the potential benefits are considered to outweigh the potential risks \[see Use in Specific Populations (8.5) and Clinical Pharmacology (11.3) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. **2.3 Not Recommended in Patients with Severe Renal Impairment** BIKTARVY is not recommended in patients with: - severe renal impairment (estimated creatinine clearance of 15 to below 30 mL per minute); or - end stage renal disease (ESRD; estimated creatine clearance below 15 mL per minute) who are not receiving chronic hemodialysis; or - no antiretroviral treatment history and ESRD who are receiving chronic hemodialysis _\[see Dosage and Administration (2.2) and Use in Specific Populations (8.5)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. **2.4 Not Recommended in Patients with Severe Hepatic Impairment** BIKTARVY is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) _\[see Use in Specific Populations (8.6) and Clinical Pharmacology (11.3)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_.