emtricitabine + tenofovir disoproxil maleate: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
emtricitabine + tenofovir disoproxil maleate: clinical details
Prescribing considerations
- For PrEP, confirm HIV-negative status and assess for acute HIV infection; use within a broader prevention strategy.
- For HIV treatment, use as part of combination antiretroviral therapy and consider resistance history, including K65R.
- Assess renal, hepatitis B and bone risk before initiation.
- Review nephrotoxic medicines, boosted protease inhibitors and hepatitis C antivirals.
- The selected product contains lactose.
Contraindications and cautions
- Hypersensitivity to either active substance or an excipient.
- Use as PrEP when HIV-1 status is positive or unknown.
Monitoring
- HIV antigen/antibody testing before and during PrEP, with further assessment if acute infection is suspected.
- Creatinine clearance and serum phosphate before and during use; monitor more frequently with renal risk factors or interacting medicines.
- Clinical and laboratory follow-up after discontinuation in people with hepatitis B.
- Investigate persistent bone pain, fractures, muscle weakness or evidence of proximal tubulopathy.
- For HIV treatment, monitor virological response and metabolic and hepatic parameters as clinically appropriate.
Clinical pharmacology
Emtricitabine is a cytidine nucleoside analogue and tenofovir an adenosine nucleotide analogue formed from the disoproxil prodrug. Their phosphorylated metabolites inhibit HIV reverse transcriptase and terminate viral DNA chains. Both are predominantly eliminated through the kidneys, with low potential for CYP450-mediated interactions.
Formulation and product differences
- The selected product is a light-green, capsule-shaped film-coated tablet marked “M” and “ETD”.
- It contains lactose monohydrate and is unsuitable for certain rare hereditary disorders of galactose metabolism.
- The tablet may be disintegrated in water, orange juice or grape juice and taken immediately.
- Separate component preparations may be needed if one component must be changed or discontinued.
emtricitabine + tenofovir disoproxil maleate preparations and strengths
Tablet
Route: Oral
Strengths: 200 mg + 245 mg
emtricitabine + tenofovir disoproxil maleate interactions
Check prescribed, over-the-counter and complementary products because kidney toxicity or duplicate antiviral treatment may result.
NSAIDs, including high-dose or multiple ibuprofen or diclofenac products
May increase kidney injury risk, particularly with renal risk factors.
Other nephrotoxic medicines
Concurrent or recent use can increase kidney toxicity and should generally be avoided or closely monitored.
Didanosine
Raises didanosine exposure and has been associated with toxicity and virological failure; co-administration is not recommended.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.