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Neupogen® (filgrastim) & Neulastim® (pegfilgrastim): Risk of capillary leak syndrome in patients with cancer (filgastrim & pegfilgastrim) and in healthy donors (filgastrim only)

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Date: 16 August 2014

Description: The NPCB would like to alert healthcare professionals that cases of capillary leak syndrome (CLS) have been reported in recipients of filgrastim including patients undergoing chemotherapy and a healthy donor undergoing peripheral blood progenitor cell mobilisation. CLS has also been reported in recipients of pegfilgrastim undergoing chemotherapy. Patients and healthy donors should be monitored closely for CLS symptoms such as oedema, difficulty breathing, and tiredness. For further details, please refer to the Direct Healthcare Professional Communication (DHPC) issued by Roche (Malaysia) Sdn. Bhd. in agreement with NPCB.

 

National Pharmaceutical Regulatory Agency (NPRA)

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