INDICATIONS AND USAGE（适应症）

Multiple Myeloma

VELCADE is indicated for the treatment of adult patients with multiple myeloma.

Mantle Cell Lymphoma

VELCADE is indicated for the treatment of adult patients with mantle cell lymphoma.

DOSAGE（服用剂量）

Important Dosing Guidelines

VELCADE is for intravenous or subcutaneous use only. Do not administer VELCADE by any other route.

Because each route of administration has a different reconstituted concentration, use caution when calculating the volume to be administered.

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

VELCADE retreatment may be considered for patients with multiple myeloma who had previously responded to treatment with VELCADE and who have relapsed at least six months after completing prior VELCADE treatment. Treatment may be started at the last tolerated dose.

When administered intravenously, administer VELCADE as a 3 to 5 second bolus intravenous injection.

Dosage in Previously Untreated Multiple Myeloma

VELCADE is administered in combination with oral melphalan and oral prednisone for 9, six week treatment cycles as shown in Table 1. In Cycles 1 to 4, VELCADE is administered twice weekly (Days 1, 4, 8, 11, 22, 25, 29 and 32). In Cycles 5 to 9, VELCADE is administered once weekly (Days 1, 8, 22 and 29). At least 72 hours should elapse between consecutive doses of VELCADE.

Dosage in Previously Untreated Mantle Cell Lymphoma

VELCADE (1.3 mg/m2) is administered intravenously in combination with intravenous rituximab, cyclophosphamide, doxorubicin and oral prednisone (VcR-CAP) for 6, three week treatment cycles as shown in Table 3. VELCADE is administered first followed by rituximab. VELCADE is administered twice weekly for two weeks (Days 1, 4, 8, and 11) followed by a ten day rest period on Days 12 to 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.

ADVERSE REACTIONS（不良反应）

Peripheral Neuropathy

Hypotension

Cardiac Toxicity

Pulmonary Toxicity

Posterior Reversible Encephalopathy Syndrome (PRES)

Gastrointestinal Toxicity

Thrombocytopenia/Neutropenia

Tumor Lysis Syndrome

Hepatic Toxicity

Thrombotic Microangiopathy

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/1521d321-e724-4ffc-adad-34bf4f44fac7/spl-doc?hl=VELCADE

BORTENATinformation