Revisions cover reduced initial dosing in patients with moderate or severe hepatic impairment-- Jeff Muise
Wednesday, January 27, 2010 (Last Updated: 01/28/2010)
WEDNESDAY, Jan. 27 (HealthDay News) -- Takeda Oncology and the U.S. Food and Drug Administration have announced important revisions to the prescribing information for the drug Velcade (bortezomib) related to dosing in patients with hepatic impairment.
A change to section 2.5 of the prescribing information cautions that patients with moderate or severe hepatic impairment should be started on Velcade at a reduced dose during the first cycle, followed by subsequent dose escalation. However, patients with mild hepatic impairment can be treated with the recommended Velcade dose.
In a second change, the safety information in section 5.11 now states: "Bortezomib is metabolized by liver enzymes. Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with Velcade at reduced starting doses and closely monitored for toxicities."
"Velcade is indicated for the treatment of patients with multiple myeloma. Velcade also is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy," according to the Jan. 26 safety alert issued by the FDA.
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