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Tenofovir alafenamide and renal adverse effects

Medicines Safety Update

6 January 2022

The Product Information (PI) for tenofovir alafenamide is being updated to include a warning about renal adverse effects. Health professionals should be aware of predisposing risk factors for these adverse effects and monitor patients appropriately.

Tenofovir alafenamide is an antiviral nucleoside analogue marketed under several brand names in Australia. It is a prodrug which is available as monotherapy (Vemlidy) and as part of fixed-dose combination products.

Tenofovir alafenamide containing products are indicated for:

  • treatment of chronic hepatitis B in adults (Vemlidy).
  • treatment of HIV infection (Biktarvy, Genvoya, Odefsey, Symtuza).
  • treatment and pre-exposure prophylaxis of HIV (Descovy).

Adverse events reported to the TGA

To 7 December 2021, 14 cases of renal adverse events in people taking tenofovir alafenamide have been reported to the TGA.

These reports are included in our Database of Adverse Event Notifications (DAEN). Internationally, there have also been updates to product information sheets to include renal adverse effects.

Following an evaluation by the TGA, a warning is being added to section 4.4 of the PI:

'Post marketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide containing products; while most of these cases were characterised by potential confounders that may have contributed to the reported renal events, it is also possible these factors may have predisposed patients to tenofovir-related adverse events.

Patients taking tenofovir prodrugs who have impaired renal function and those taking nephrotoxic agents, including non-steroidal anti-inflammatory drugs, are at increased risk of developing renal-related adverse reactions.

Prior to or when initiating tenofovir alafenamide, and during treatment with tenofovir alafenamide on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Discontinue tenofovir alafenamide in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.'

Section 4.8 of the PI listing adverse effects is being updated to include:

'Renal and Urinary disorders: acute renal failure, proximal renal tubulopathy and Fanconi syndrome.'

Information for health professionals

Renal adverse events with tenofovir alafenamide can have serious consequences for patients and should be managed promptly. Risk factors include existing renal impairment and concomitant use of nephrotoxic drugs, such as non-steroidal anti-inflammatory drugs.

Renal function should be assessed before patients start tenofovir alafenamide, and then monitored during treatment. Consider stopping the medicine if you suspect declining renal function or Fanconi syndrome.

See the latest PI documents for tenofovir alafenamide-containing products for further information.


What to report? You don't need to be certain, just suspicious!

The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.

We particularly request reports of:

  • all suspected reactions to new medicines (look for the Black Triangle in PI and CMI documents - this symbol identifies medicines that are new or being used differently)
  • all suspected medicines interactions
  • suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.

Reports may be submitted:

For more information about reporting, visit www.tga.gov.au or contact the TGA's Pharmacovigilance and Special Access Branch ADR.Reports@tga.gov.au.

Disclaimer

Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.

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For correspondence or further information about Medicines Safety Update, contact the TGA's Pharmacovigilance and Special Access Branch at .

Medicines Safety Update is written by staff from the Pharmacovigilance Branch.

Editor: Dr Catherine Brogan

Deputy Editor: Mr Michael Pittman

TGA Principal Medical Adviser: Dr Tim Greenaway

Contributors include: Mr Gilbert Yeap, Dr Emma Knott