RECENT MAJOR CHANGES

INDICATIONS AND USAGE

VELCADE is a proteasome inhibitor indicated for:

• treatment of patients with multiple myeloma (1.1)
• treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy (1.2)

DOSAGE AND ADMINISTRATION

The recommended dose of VELCADE is 1.3 mg/m2 administered as a 3 to 5 second bolus intravenous injection. (2.1, 2.3)

Dose adjustment may be used to manage adverse events that occur during treatment (2.2, 2.4)

DOSAGE FORMS AND STRENGTHS

• 1 single use vial contains 3.5 mg of bortezomib. Dose must be individualized to prevent overdose. (3)

CONTRAINDICATIONS

• VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. (4)

WARNINGS AND PRECAUTIONS

• Women should avoid becoming pregnant while being treated with VELCADE. Pregnant women should be apprised of the potential harm to the fetus. (5.1, 8.1)
• Peripheral neuropathy, including severe cases, may occur - manage with dose modification or discontinuation. (2.2, 2.4) Patients with preexisting severe neuropathy should be treated with VELCADE only after careful risk-benefit assessment. (2.2, 2.4, 5.2)
• Hypotension can occur. Caution should be used when treating patients receiving antihypertensives, those with a history of syncope, and those who are dehydrated. (5.3)
• Patients with risk factors for, or existing heart disease, should be closely monitored. (5.4)
• Acute diffuse infiltrative pulmonary disease has been reported. (5.5)
• Nausea, diarrhea, constipation, and vomiting have occurred and may require use of antiemetic and antidiarrheal medications or fluid replacement. (5.7)
• Thrombocytopenia or neutropenia can occur; complete blood counts should be regularly monitored throughout treatment. (5.8)
• Tumor Lysis Syndrome (5.9), Reversible Posterior Leukoencephalopathy Syndrome (5.6), and acute hepatic failure (5.10) have been reported.

ADVERSE REACTIONS

Most commonly reported adverse reactions (incidence ≥30%) in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia and anemia. Other adverse reactions, including serious adverse reactions, have been reported. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Millennium Pharmaceuticals at 1-866 VELCADE or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

• Women should be advised against breast feeding or becoming pregnant while being treated with VELCADE. (5.1, 8.1, 8.3)
• Patients with diabetes may require close monitoring of blood glucose and adjustment of anti-diabetic medication. (8.8)
• Hepatic Impairment: In patients with moderate or severe hepatic impairment, use a lower starting dose (2.5, 5.11, 8.7, 12.3)

1 INDICATIONS AND USAGE

1.1 Multiple Myeloma

1.2 Mantle Cell Lymphoma

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Previously Untreated Multiple Myeloma

2.2 Dose Modification Guidelines for Combination Therapy with VELCADE, Melphalan and Prednisone

2.3 Dos

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