引 致 更 改 給 病 人 的 產 品 資 訊 的 藥 物 不 良 反 應 警 示
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| Australia: Tenofovir alafenamide and renal adverse effects (English only) |
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Therapeutic Goods Administration (TGA) announces that 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 and as part of fixed-dose combination products.
To 7 Dec 2021, 14 cases of renal adverse events in people taking tenofovir alafenamide have been reported to the TGA. These reports are included in the TGA’s 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.
Health professionals are advised that 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 they suspect declining renal function or Fanconi syndrome.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication-issue/tenofovir-alafenamide-and-renal-adverse-effects
In Hong Kong, there are 7 registered pharmaceutical products containing tenofovir alafenamide. All products are prescription-only medicines. So far, the Department of Health (DH) has received 6 cases of adverse drug reaction related to tenofovir alafenamide, but these cases were not related to renal adverse effects. In light of the above TGA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Thursday, Jan 6, 2022
Issued at HKT 15:00
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