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choolouncenue ( Gast )
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17.07.2008 23:25
FDA Updates name for Avandia to categorize Clinical Findings Antworten

ROCKVILLE, Md., July 14, 2008--Genentech, Inc. alert to healthcare professionals of blasts of diverse cases of microangiopathic hemolytic anemia (MAHA) in patients with concrete tumors receiving Avastin in solution with sunitinib malate. Avastin is not approved for use in solution with sunitinib malate and this parathesis is not recommended. Twenty-five patients were enrolled in a time I portion-escalation read combining Avastin and sunitinib malate. The read consisted of
3 cohorts using a unwavering portion of Avastin at 10mg/kg/IV every 2 weeks and escalating dosages of sunitinib that subsumed 25, 37.5, and 50 mg orally quotidian premised in a 4 weeks on/ 2 weeks off schedule. Five of 12 patients at the highest sunitinib dispense plain exhibited laboratory findings undeviating with MAHA. Two of these cases were considered sober with show of thrombocytopenia, anemia, reticulocytosis, reductions in serum haptoglobin, schistocytes on circumferential defile,
demure increases in serum creatinine knock downs, and sober hypertension, reversible latter leukoencephalopathy syndrome, and proteinuria. The findings in these two cases were reversible within three weeks upon discontinuation of both drugs without additional inmterventions. Healthcare professionals should story cases of MAHA or any sober adverse events suspected to be associated with the use of Avastin.

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