Starting Dosage Adjusted for Cancer Drug Velcade (bortezomib)

The Food and Drug Administration has announced changes to the starting dosage for the cancer drug Velcade when it is used in patients with moderate to severe liver impairment.

Velcade, also known generically as bortezomib, is made by Takeda Oncology and approved for treating patients with multiple myeloma, a form of cancer affected plasma cells in bone marrow, as well as patients with mantle cell lymphoma who have received at least one prior therapy, the FDA said.

In patients with advanced kidney damage (hepatic impairment), starting the drug at the formerly recommended doses could cause injury, the FDA said. Incorrect doses of prescription and over-the-counter drugs are a leading cause of consumer injuries related to the use of medications.

“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,” the FDA told doctors in a warning letter sent earlier this month.

The changes in staring doses of Velcade do not apply to patients with mild hepatic impairment, who should continue to treatment with the recommended Velcade dose. However, patients with moderate or severe hepatic impairment should be started on Velcade at a reduced dose of 0.7 mg/m2 per injection during the first cycle, and a subsequent dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 may be considered based on patient tolerance, the FDA said.

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