Post-marketing reports of renal impairment associated with zoledronic acid 5mg solution for infusion (Aclasta®)

Novartis would like to update healthcare professionals on post-marketing reports of renal impairment following administration of Aclasta®. As of 14 Aug 09, there have been 139 reports of renal impairment, corresponding to a reporting rate of 18 cases per 100,000 patient-years. 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). Physicians are encouraged to consult the updated Aclasta® package insert available on HSA website before prescribing it to patients.

 
 
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.