BIKTARVY

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Turkey, UK.

Active ingredients

The drug BIKTARVY contains a combination of these active pharmaceutical ingredients (APIs):

1
UNII 4L5MP1Y7W7 - BICTEGRAVIR SODIUM
 

Bictegravir is a type of antiviral agent called an ‘integrase inhibitor’. It blocks an enzyme called integrase that is needed by the HIV virus to make new copies of itself in the body.

 
Read more about Bictegravir
2
UNII G70B4ETF4S - EMTRICITABINE
 

Emtricitabine is a synthetic nucleoside analogue of cytidine with activity that is specific to HIV-1, HIV-2 and HBV. Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate, which competitively inhibits HIV-1 reverse transcriptase, resulting in DNA chain termination. Emtricitabine is a weak inhibitor of mammalian DNA polymerase α, β and ε and mitochondrial DNA polymerase γ.

 
Read more about Emtricitabine
3
UNII FWF6Q91TZO - TENOFOVIR ALAFENAMIDE FUMARATE
 

Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir. Tenofovir alafenamide enters primary hepatocytes by passive diffusion and by the hepatic uptake transporters OATP1B1 and OATP1B3. Tenofovir alafenamide is primarily hydrolysed to form tenofovir by carboxylesterase 1 in primary hepatocytes. Intracellular tenofovir is subsequently phosphorylated to the pharmacologically active metabolite tenofovir diphosphate. Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain termination. Tenofovir has activity that is specific to HBV and HIV (HIV-1 and HIV-2).

 
Read more about Tenofovir alafenamide

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 BIKTARVY Film-coated tablet MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
J05AR20 J Antiinfectives for systemic use → J05 Antivirals for systemic use → J05A Direct acting antivirals → J05AR Antivirals for treatment of HIV infections, combinations
Discover more medicines within J05AR20

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
AU Pharmaceutical Benefits Scheme 11649D
BR Câmara de Regulação do Mercado de Medicamentos 546820060000707
CA Health Products and Food Branch 02478579
EE Ravimiamet 1774986, 1774997
ES Centro de información online de medicamentos de la AEMPS 1181289001
FI Lääkealan turvallisuus- ja kehittämiskeskus 097317
FR Base de données publique des médicaments 62844771
GB Medicines & Healthcare Products Regulatory Agency 356400
HK Department of Health Drug Office 65914
IL מִשְׂרַד הַבְּרִיאוּת 8287
JP 医薬品医療機器総合機構 6250117F1020
LT Valstybinė vaistų kontrolės tarnyba 1085785, 1085786
NL Z-Index G-Standaard, PRK 159115
NZ Medicines and Medical Devices Safety Authority 20516
PL Rejestru Produktów Leczniczych 100408146
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W65900001, W65900002, W69346001, W69346002
SG Health Sciences Authority 15604P
TR İlaç ve Tıbbi Cihaz Kurumu 8698760090250, 8698760090267
US FDA, National Drug Code 50090-6247, 61958-2501, 61958-2505

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