新 聞 及 資 訊
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| Health Sciences Authority in Singapore announced about post-marketing reports of renal impairment associated with zoledronic acid 5mg solution for infusion (Aclasta) (English only) |
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Novartis would like to update healthcare professionals on post-marketing reports of renal impairment following administration of Aclasta. Majority of the cases were reported in patients with pre-existing medical conditions, risk factors (advanced age, renal impairment, concurrent or preceding dehydration), or with concurrent exposure to nephrotoxic agents. Rare cases of renal failure requiring dialysis or with fatal outcomes have also been reported. Physicians are advised to consider thoroughly their patient's renal function before initiating Aclasta and not to use it in patients with severe renal impairment (CrCl < 35ml/min).
Please refer to the following website in Health Sciences Authority for details:
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/safety_information/DHCPL.html
In Hong Kong, Aclasta is for injection only which is registered by Novartis Pharmaceuticals (HK) Ltd. The current package insert in Hong Kong has mentioned that renal dysfunction has been observed following administration of Aclasta, especially in patients with pre-existing renal disease or additional risk factors (e.g. oncology patients on chemotherapy, concurrent nephrotoxic medication, severe dehydration). Renal dysfunction has also been observed following a single dose. It is not recommended in patient with severe renal impairment (creatinine clearance <35ml/minute). Serum creatinine should be determined prior to each dose. In addition, a “Dear Healthcare Professional” letter regarding this safety information has been issued in March 2010 by Novartis to alert healthcare professionals who are using Aclasta.
Ends/Thursday, April 8, 2010
Issued at HKT 14:30
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