(2003; 15 pages)
MOROCTOCOG ALFA - Reports of lack of effect in prophylaxis patients
Canada. Wyeth Canada is informing physicians of changes to the Precautions and Adverse Reactions sections of the product monograph for moroctocog alfa (Refacto, Recombinant Anti-haemophilic Factor). Moroctocog alfa (Refacto, Antihaemophilic Factor Recombinant) has been licensed in Canada since 2002 and is indicated for the control and prevention of haemorrhagic episodes and for routine and surgical prophylaxis in patients with haemophilia A. Reports of lack of effect, mainly in prophylaxis patients, have been received during the clinical trials and in the post-marketing setting with this product (Refacto, Antihaemophilic Factor) in Canada. The lack of effect and/or low factor VIII recovery has been reported in patients with inhibitors and also in patients who had no evidence of inhibitors. The lack of effect has been described as bleeding into target joints, bleeding into new joints, other bleeding or a subjective feeling by the patient of new onset bleeding. The product insert now reflects these observations and advises that, in view of these reports of less than expected therapeutic effect, it is important to individually titrate and monitor each patient’s dose of moroctocog alfa (ReFacto), particularly when initiating treatment, to ensure an adequate therapeutic response.
‘Dear Healthcare Professional’ letter from Wyeth Canada, 30 Sept 2003.
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