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Bictegravir/emtricitabine/tenofovir alafenamide

بیکتاروی (بیکتگراویر/امتریسیتابین/TAF)

⚠ Unverified

🦠 Antiinfectives For Systemic UseComplete single-tablet HIV regimen

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution 🇮🇷 Not found in Iran list ⛔ 1 contraindications 🇺🇸 FDA approved (NDA) NDA210251 ATC J05AR20

Market / country: 🇺🇸 USA

Biktarvy (US)

🧮 Dose calculator

Disease / regimen

HIV-1 infection (treatment) · Regimen source: FDA Biktarvy · 2.2 FDA Biktarvy · 2.3 FDA Biktarvy · 2.5 FDA Biktarvy · 2.6

⛔ One tablet once daily with or without food; CrCl ≥30. Not recommended at CrCl 15–<30, ESRD not on chronic haemodialysis, or severe hepatic impairment. FDA Biktarvy · 2.2 FDA Biktarvy · 2.3 FDA Biktarvy · 2.5 FDA Biktarvy · 2.6

🛡️ Safety & information

Contraindications

⛔ Concomitant dofetilide or rifampin. FDA Biktarvy · 4

Warnings

• Boxed warning: severe acute exacerbation of hepatitis B after discontinuation in HBV co-infection — monitor the liver for several months. FDA Biktarvy · Boxed Warning

Formulations

50/200/25 mg tablet (30/120/15 mg for 14–<25 kg) — tablet 🇺🇸 USA FDA Biktarvy · 3

👥 Special populations

🤰 PregnancyUse with caution
Label: observational and registry data have not established a drug-associated risk of major birth defects, miscarriage or adverse outcomes. FDA Biktarvy · 8.1
“Available data from observational studies and the APR with BIC, FTC and TAF use during pregnancy have not established a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Biktarvy · 8.2
“Risk Summary Data from the published literature report the presence of BIC, FTC, TAF, and tenofovir in human milk.”
👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Biktarvy · 8.4
“The safety and effectiveness of BIKTARVY have been established as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients weighing at least 14 kg: who have no antiretroviral treatment history, or with an antiretroviral treatment history and not virologically …”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Biktarvy · 8.5
“Clinical trials in virologically-suppressed participants (Trials 4449, 1844, and 1878) included 111 participants aged 65 years and over who received BIKTARVY, including 86 patients from an open-label, single-arm trial of participants aged 65 years and over who were switched from their previous antiretroviral regimen …”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)NDA210251
DailyMed (FDA label)FDA Biktarvy
MedlinePlus (NIH)❌ None
WHO ATC/DDDJ05AR20
Darooyab (Iran)❌ None

🇮🇷 Not found in Iran list Darooyab · search

Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Biktarvy · 3 FDA Biktarvy · 2.2 FDA Biktarvy · 2.3 FDA Biktarvy · 2.5 FDA Biktarvy · 2.6 FDA Biktarvy · 4 FDA Biktarvy · Boxed Warning FDA Biktarvy · SPL approval / marketing category FDA Biktarvy · 8.1 FDA Biktarvy · 8.2 FDA Biktarvy · 8.4 FDA Biktarvy · 8.5
UK SmPC (eMC / MHRA)❌ Not present
Published guideline❌ Not present
Licensed reference (medical school)❌ Not present
Iranian leaflet (IFDA)❌ Not present
Pharmacy website (secondary, unreliable)✅ Present
Darooyab · search
Clinical review⚠ Unverified

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