Monograph Details
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Neoplasms
> Miscellaneous oncology agents
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VELCADE |
| Manufacturer |
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Millennium Pharmaceuticals, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Proteasome inhibitor. |
| Generic Name |
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Bortezomib 3.5mg/vial; pwd for IV inj after reconstitution; contains mannitol. |
| Indications |
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Multiple myeloma. Mantle cell lymphoma in patients who have received at least one prior therapy. |
| Children |
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Not recommended. |
| Adults |
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Give as a 3–5 second IV bolus inj. Previously untreated multiple myeloma: Treat for nine 6-week cycles in combination with oral melphalan and oral prednisone. Cycles 1–4: 1.3mg/m2 twice weekly (days 1, 4, 8, 11, 22, 25, 29, 32); Cycles 5–9: 1.3mg/m2 once weekly (days 1, 8, 22, 29). Relapsed multiple myeloma or mantle cell lymphoma: Standard schedule: 1.3mg/m2 twice weekly for 2 weeks (days 1, 4, 8, 11) then 10 day rest period (days 12–21); Extended therapy (if using >8 cycles): may use standard schedule, or maintenance schedule: 1.3mg/m2 once weekly for 4 weeks (days 1, 8, 15, 22) then 13 day rest period (days 23–35). Allow at least 72 hours between consecutive doses. Adjust dose if toxicity develops: see literature. |
| Contraindications |
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Boron or mannitol sensitivity. |
| Precautions |
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Hepatic impairment. Monitor for development or worsening of peripheral neuropathy; consider dose or schedule adjustment. Diabetes. History of syncope. Avoid dehydration; give fluids and electrolytes. Heart disease (monitor for CHF). Monitor CBC and platelets and for toxicities. High tumor burden (monitor for tumor lysis syndrome). Pregnancy (Cat.D); avoid. Nursing mothers: not recommended. |
| Interactions |
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Potentiated by ketoconazole, other potent CYP3A inhibitors. Increased risk of peripheral neuropathy with other agents that can cause neuropathy (eg, amiodarone, antivirals, isoniazid, metronidazole, statins, nitrofurantoin, or previous neurotoxic agents). Caution with hypotensives and hypoglycemics. Monitor drugs metabolized by CYP3A4. |
| Adverse Reactions |
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Asthenia, GI upset, peripheral neuropathy, decreased appetite, thrombocytopenia, anemia, orthostatic hypotension, pyrexia, headache, insomnia, psychiatric disorders, arthralgia, neutropenia, hypercalcemia, pain, edema, paresthesia, dysesthesia, dyspnea, cough, pruritus, dizziness, blurred vision, pneumonia, CHF, decreased LVEF, herpes reactivation, hepatotoxicity; rare: pulmonary disorders, reversible posterior leukoencephalopathy syndrome (discontinue if occurs). |
| How Supplied |
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Single-dose vial—1 |
| Additional Resources |
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• Related Prescribing Note |
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