Zaltrap® (aflibercept): Information on the risk of osteonecrosis of the jaw

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Date: 14 December 2016

 

Description:

Cases of osteonecrosis of the jaw (ONJ) have been reported in cancer patients who have been treated with Zaltrap® (aflibercept). Patients who have also previously or concomitantly received an intravenous bisphosphonate may be at particular risk. Avoid invasive dental procedures, where possible, in patients being treated with Zaltrap® who have previously received, or are currently receiving, an intravenous bisphosphonate. During treatment, advise patients to: maintain good oral hygiene; receive routine dental check-ups; and to report any oral symptoms such as dental mobility, pain, or swelling. Please refer to the Direct Healthcare Professional Communication (DHPC) issued by sanofi-aventis (Malaysia) Sdn. Bhd. for further information.

National Pharmaceutical Regulatory Agency (NPRA)

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