emtricitabine + tenofovir disoproxil phosphate: clinical use

Prescribing considerations

• Exclude HIV infection before PrEP and investigate possible acute seroconversion before initiation.
• For HIV treatment, use only within an effective combination regimen and consider resistance history.
• Establish hepatitis B status; withdrawal can cause severe hepatitis exacerbation.
• Assess renal and bone risk, concurrent nephrotoxins and suitability for the fixed combination.
• PrEP complements broader HIV and STI prevention measures.

Contraindications and cautions

• Hypersensitivity to either active substance or an excipient.
• Use as PrEP when HIV-1 status is positive or unknown.
• The selected product contains lactose and is unsuitable for specified rare hereditary disorders of galactose handling.

Monitoring

• Renal function and serum phosphate before treatment and periodically thereafter, with more frequent assessment when renal risk is increased.
• HIV testing during PrEP and whenever acute HIV infection is suspected.
• Clinical and laboratory follow-up after stopping in people with hepatitis B.
• Assess persistent bone pain, fractures, muscular weakness or evidence of proximal tubulopathy.

Clinical pharmacology

Emtricitabine triphosphate and tenofovir diphosphate competitively inhibit HIV reverse transcriptase and terminate viral DNA chains. CYP-mediated interaction potential is low; both components are principally cleared through the kidneys, including active tubular secretion.

Formulation and product differences

• The selected Lupin product is a blue, oval film-coated fixed-combination tablet.
• It contains lactose monohydrate and phosphate and is essentially sodium-free.
• It may be dispersed in water, orange juice or grape juice for immediate administration.
• Separate component products may be required if one component must be modified or discontinued.

Tablet

Route: Oral

Strengths: 200 mg + 245 mg