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Title: Bevacizumab Plus Sunitinib Linked to Rare Anaemia in Metastatic Renal Cancer, Warns Health Canada
URL: http://www.pslgroup.com/dg/225876.htm
Doctor's Guide
July 11, 2008

OTTAWA, Ontario -- July 11, 2008 -- Health Canada has issued a notice on the association of microangiopathic haemolytic anaemia (MAHA) with the combined use of bevacizumab (Avastin) and sunitinib malate in metastatic renal cell carcinoma.

Based on review of clinical trial reports, in 2 recent US clinical trials combining bevacizumab 10 mg/kg IV Q2W and sunitinib malate 50 mg QD, 7 of 19 patients (37%) with metastatic renal cell carcinoma exhibited laboratory findings consistent with MAHA.

In this group of 19 patients, grade 4 hypertension was noted in 3 patients (16%) and reversible posterior leukoencephalopathy syndrome (RPLS) was noted in 2 patients (11%).

Bevacizumab is not authorised for use in combination with sunitinib malate or for use at dosages exceeding 5 mg/kg Q2W.

The bevacizumab Canadian Product Monograph will be updated to reflect this new information.

SOURCE: Health Canada

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