- Approval Id
- 4825a734ea85aaa4
- Drug Name
- BIKTARVY FILM-COATED TABLETS 50MG/200MG/25MG
- Product Name
- BIKTARVY FILM-COATED TABLETS 50MG/200MG/25MG
- Approval Number
- SIN15604P
- Approval Date
- 2019-01-02
- Registrant
- GILEAD SCIENCES SINGAPORE PTE. LTD.
- Licence Holder
- GILEAD SCIENCES SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 Testing When Initiating and During Treatment with BIKTARVY</strong></p>
<p>Prior to or when initiating BIKTARVY, test patients for hepatitis B virus infection <em>[see Warnings and Precautions (5.1)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p>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 <em>[see Warnings and Precautions (5.4)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p><strong>2.2 Recommended Dosage</strong></p>
<p>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 <em>[see Dosage and Administration (2.3)]</em>:</p>
<ul>
<li>adults and pediatric patients weighing at least 25 kg and estimated creatinine clearance greater than or equal to 30 mL per minute; or</li>
<li>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) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</li>
</ul>
<p><strong>2.3 Recommended Dosage in Pregnant Individuals</strong></p>
<p>The recommended dosage of BIKTARVY in pregnant individuals is one tablet containing 50 mg of BIC, 200 mg of FTC, and 25 mg of TAF taken orally once daily with or without food in pregnant individuals who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known substitutions associated with resistance to any of the individual components of BIKTARVY. Lower exposures of BIKTARVY were observed during pregnancy; therefore, viral load should be monitored closely [see Drug Interactions (7.5), Use in Specific Populations (8.1), and Clinical Pharmacology (11.3) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p>
<p><strong>2.4 Not Recommended in Patients with Severe Renal Impairment</strong></p>
<p>BIKTARVY is not recommended in patients with <em>[see Dosage and Administration (2.2), and Use in Specific Populations (8.5)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>:</p>
<ul>
<li>severe renal impairment (estimated creatinine clearance of 15 to below 30 mL per minute); or</li>
<li>end stage renal disease (ESRD; estimated creatine clearance below 15 mL per minute) who are not receiving chronic hemodialysis; or</li>
<li>no antiretroviral treatment history and ESRD who are receiving chronic hemodialysis.</li>
</ul>
<p><strong>2.5 Not Recommended in Patients with Severe Hepatic Impairment</strong></p>
<p>BIKTARVY is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) <em>[see Use in Specific Populations (8.6) and Clinical Pharmacology (11.3)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 25 kg:</p>
<ul>
<li>who have no antiretroviral treatment history or</li>
<li>to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.</li>
</ul>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>BIKTARVY is contraindicated to be co-administered with:</p>
<ul>
<li><p>dofetilide due to the potential for increased dofetilide plasma concentrations and associated serious and/or life-threatening events <em>[see Drug Interactions (7.5)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p></li>
<li><p>rifampin due to decreased BIC plasma concentrations, which may result in the loss of therapeutic effect and development of resistance to BIKTARVY <em>[see Drug Interactions (7.5)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p></li>
</ul>
- Atc Code
- J05AR20
- Atc Item Name
- emtricitabine, tenofovir alafenamide and bictegravir
- Pharma Manufacturer Name
- GILEAD SCIENCES SINGAPORE PTE. LTD.
