Bortezomib for Injection is a proteasome inhibitor indicated for:

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Treatment of adult patients with multiple myeloma. (1.1)

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Treatment of adult patients with mantle cell lymphoma. (1.2)

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For subcutaneous or intravenous use only. Each route of administration has a different reconstituted concentration; Exercise caution when calculating the volume to be administered. (2.1, 2.10)

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The recommended starting dose of Bortezomib for Injection is 1.3 mg/m2 administered either as a 3 to 5 second bolus intravenous injection or subcutaneous injection. (2.2, 2.4, 2.6)

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Retreatment for multiple myeloma: May retreat starting at the last tolerated dose. (2.6)

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Hepatic Impairment: Use a lower starting dose for patients with moderate or severe hepatic impairment. (2.8)

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Dose must be individualized to prevent overdose. (2.10)

For injection: 1 mg or 2.5 mg of bortezomib as a lyophilized powder in a single-dose vial for reconstitution and withdrawal of the appropriate individual patient dose. (3)

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Patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. (4)

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Contraindicated for intrathecal administration. (4)

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Peripheral Neuropathy: Manage with dose modification or discontinuation. (2.7) Patients with pre-existing severe neuropathy should be treated with Bortezomib for Injection only after careful risk-benefit assessment. (2.7, 5.1)

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Hypotension: Use caution when treating patients taking antihypertensives, with a history of syncope, or with dehydration. (5.2)

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Cardiac Toxicity: Worsening of and development of cardiac failure has occurred. Closely monitor patients with existing heart disease or risk factors for heart disease. (5.3)

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Pulmonary Toxicity: Acute respiratory syndromes have occurred. Monitor closely for new or worsening symptoms and consider interrupting Bortezomib for Injection therapy. (5.4)

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Posterior Reversible Encephalopathy Syndrome: Consider MRI imaging for onset of visual or neurological symptoms; discontinue Bortezomib for Injection if suspected. (5.5)

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Gastrointestinal Toxicity: Nausea, diarrhea, constipation, and vomiting may require use of antiemetic and antidiarrheal medications or fluid replacement. (5.6)

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Thrombocytopenia/Neutropenia: Monitor complete blood counts regularly throughout treatment. (5.7)

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Tumor Lysis Syndrome: Closely monitor patients with high tumor burden. (5.8)

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Hepatic Toxicity: Monitor hepatic enzymes during treatment. Interrupt Bortezomib for Injection therapy to assess reversibility. (5.9)

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Thrombotic Microangiopathy: Monitor for signs and symptoms. Discontinue Bortezomib for Injection if suspected. (5.10)

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Embryo-Fetal Toxicity: Bortezomib for Injection can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.11)

Most commonly reported adverse reactions (incidence ≥20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc., at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Strong CYP3A4 Inhibitors: Closely monitor patients with concomitant use. (7.1)

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Strong CYP3A4 Inducers: Avoid concomitant use. (7.1)

Patients with diabetes may require close monitoring of blood glucose and adjustment of antidiabetic medication. (8.8)