Velcade is indicated for the treatment of patients with Mantle Cell Lymphoma

INN:

Subtype:

Mantle Cell Lymphoma (MCL)

License:

FDA

Class:

PI

Newly Diagnosed

PI: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021602s040lbl.pdf

1. Approved Labelling

Velcade is indicated for the treatment of patients with Mantle Cell Lymphoma.

2. Treatment Regimen

The recommended starting dose of Velcade is 1.3 mg/m2. Velcade may be administered intravenously at a concentration of 1 mg/mL, or subcutaneously at a concentration of 2.5 mg/mL.

Velcade (1.3 mg/m2) is administered intravenously in combination with intravenous rituximab, cyclophosphamide, doxorubicin and oral prednisone (VcR-CAP) for six 3-week treatment cycles. VELCADE is administered first followed by rituximab. Velcade is administered twice weekly for two weeks (Days 1, 4, 8, and 11) followed by a 10-day rest period on Days 12-21.

For patients with a response first documented at cycle 6, two additional VcR-CAP cycles are recommended. At least 72 hours should elapse between consecutive doses of Velcade.

3. AE/Warnings

Please see section 5 of the PI

 

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