
Indications for Use
- Treatment of HIV-1 infection in adults and adolescents aged 12 years and older weighing at least 35 kg as part of combination antiretroviral therapy.
Contraindications
- Hypersensitivity to emtricitabine, tenofovir alafenamide, or any excipients of the product.
- Severe renal impairment (creatinine clearance <30 mL/min).
- Concurrent use with other medications containing tenofovir or emtricitabine.
Adverse Effects
Common:
- Nausea, vomiting, diarrhea, headache, dizziness, rash, fatigue.
Rare:
- Lactic acidosis, hepatomegaly, renal impairment, osteomalacia.
Very rare:
- Pancreatitis, rhabdomyolysis, allergic reactions.
Recommendations for Use
Administration:
- Take orally, preferably with food, once daily.
Special Instructions:
- Before initiating therapy, conduct HIV testing and assess renal and hepatic function.
- Regular monitoring of renal function and viral load is essential during treatment.
Drug Interactions:
- Avoid concurrent use with nephrotoxic drugs and other antiretroviral agents containing tenofovir or emtricitabine.
Before starting therapy, consult a healthcare provider and review the complete prescribing information.
Oral coated tablets for oral administration
- Administered once daily as part of a combination antiretroviral therapy regimen or for PrEP purposes
- Tablets are intended for adults and adolescents 12 years of age and older (and body weight ≥35 kg).