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Xgeva®120mg Solution for Injection (denosumab): Updated recommendations to minimise the risk of severe symptomatic hypocalcaemia (SSH) and osteonecrosis of the jaw (ONJ)

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Date: 23 March 2015

Description:

The NPCB has approved a Direct Healthcare Professional Communication (DHPC) on new recommendations to reduce the risk of SSH and ONJ associated with Xgeva®. Calcium levels should be monitored prior to starting the drug and through treatment. Patients are recommended to undergo a dental examination with appropriate preventive dentistry before starting therapy, and practice good oral hygiene. GlaxoSmithKline Pharmaceuticals (M) Sdn. Bhd.is updating the prescribing information Xgeva® to reflect this new safety information. Further information can be obtained from the DHPC.

 

National Pharmaceutical Regulatory Agency (NPRA)

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