Decrease Velcade Starting Dosage in Patients With Liver Disease

Kate Traynor

BETHESDA, MD 27 January 2010—FDA on Tuesday announced revisions to the labeling of bortezomib, including a change in the recommended starting dosage for some patients with liver disease.

According to the revised labeling (PDF), patients with moderate or severe liver impairment should receive a starting dosage of 0.7 mg/m² per injection during the first treatment cycle. For subsequent treatment cycles, the dosage may be increased to 1.0 mg/m² per injection if the patient tolerates the initial doses or reduced to 0.5 mg/m² per injection if the initial doses prove unacceptably toxic.

Patients with moderate or severe liver disease should be monitored closely for toxicities while taking the cancer chemotherapy, the labeling states. No dosage adjustment is needed in patients with mild liver impairment.

Bortezomib is marketed as Velcade by Millennium Pharmaceuticals, a division of Takeda. The product is indicated for the treatment of multiple myeloma and mantle cell lymphoma.