tenofovir disoproxil succinate: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
tenofovir disoproxil succinate: clinical details
Prescribing considerations
- Confirm HIV status before treating hepatitis B; monotherapy in unrecognised HIV infection risks resistance.
- For HIV/HBV co-infection, use only within an appropriate combination antiretroviral regimen.
- Assess renal and fracture risk, concomitant nephrotoxins and prior antiretroviral resistance.
- Avoid unplanned withdrawal in chronic hepatitis B because severe exacerbations can occur.
Contraindications and cautions
- Hypersensitivity to tenofovir disoproxil or any product excipient.
- The selected tablet contains lactose and is unsuitable for specified rare hereditary disorders of galactose metabolism or absorption.
- Severe renal impairment and haemodialysis are major limitations for this tablet formulation; use requires specialist benefit–risk assessment when alternatives are unavailable.
Monitoring
- Calculate creatinine clearance and assess serum phosphate before and during treatment; monitor more closely with renal risk factors or interacting medicines.
- Investigate declining renal function or low phosphate with potassium, glucose and urine glucose as appropriate.
- Consider bone assessment or specialist review for persistent bone pain, fractures, osteoporosis or suspected tubulopathy.
- Monitor virological response and relevant HIV or hepatitis B markers.
- After hepatitis B treatment stops, continue clinical and laboratory surveillance for hepatic exacerbation.
Clinical pharmacology
Tenofovir disoproxil is an ester prodrug converted to tenofovir and then intracellular tenofovir diphosphate. The active metabolite inhibits HIV-1 reverse transcriptase and HBV polymerase through substrate competition and DNA-chain termination. Tenofovir is principally eliminated by glomerular filtration and active tubular secretion, with little CYP450 interaction potential.
Formulation and product differences
- The selected product is a light-blue, almond-shaped film-coated tablet containing tenofovir disoproxil as the succinate salt.
- It contains lactose and is essentially sodium-free.
- Tenofovir also appears in products using different salts and in fixed-dose combinations; check all active ingredients to prevent duplication.
tenofovir disoproxil succinate preparations and strengths
Tablet
Route: Oral
Strengths: 245 mg
tenofovir disoproxil succinate interactions
Important examples include:
Other products containing tenofovir disoproxil or tenofovir alafenamide
Avoid duplication because exposure and toxicity may increase.
Adefovir dipivoxil
Should not be used concurrently with tenofovir disoproxil.
Didanosine
Tenofovir increases didanosine exposure and toxicity risk; 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.