Bortero

Bortero Dosage/Direction for Use

bortezomib

Manufacturer:

Camber

Distributor:

Camber
Full Prescribing Info
Dosage/Direction for Use
General dosing consideration: Because each route of administration has a different reconstituted concentration, and because the drug quantity contained in 1 vial may exceed the usual single dose required, caution should be used when calculating the volume to be administered.
Administer with fluid and electrolyte replacement to prevent dehydration.
Starting bortezomib subcutaneously may be considered for patients with preexisting or at high risk of peripheral neuropathy. Patients with preexisting severe neuropathy should be treated with bortezomib only after careful risk-benefit assessment.
Patients experiencing new or worsening peripheral neuropathy during bortezomib therapy may require a decrease in the dose and/or a less dose intense schedule.
Adults: Mantle cell lymphoma: Usual dosage: 1.3 mg/m2/dose twice weekly for 2 weeks (days 1, 4, 8, and 11), followed by a 10-day rest period (days 12 to 21).
Maintenance dosage: For extended therapy of more than 8 cycles, bortezomib may be administered on the standard schedule or on a maintenance schedule of once weekly for 4 weeks (days 1, 8, 15, and 22), followed by a 13-day rest period (days 23 to 35). At least 72 hours should elapse between consecutive doses of bortezomib.
Dosage adjustment: Bortezomib should be withheld at the onset of any grade 3 nonhematological or grade 4 hematological toxicities, excluding neuropathy. Once the symptoms of the toxicity have resolved, bortezomib may be reinitiated at a 25% reduced dose (1.3 mg/m2/dose reduced to 1 mg/m2/dose; 1 mg/m2/dose reduced to 0.7 mg/m2/dose). (See Table 1.)

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Multiple myeloma, previously untreated: Usual dosage: See Table 2.

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Dosage adjustment: Prior to initiating any cycle of therapy with bortezomib in combination with melphalan and prednisone, platelet count should be 70 x 109/L or more and the absolute neutrophil count (ANC) should be 1 x 109/L or more; nonhematological toxicities should have resolved to grade 1 or baseline. (See Table 3.)

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Multiple myeloma, relapsed: Refer to Mantle Cell Lymphoma for dosing.
Renal function impairment: Because dialysis may reduce bortezomib concentrations, the drug should be administered after the dialysis procedure.
Hepatic function impairment: See Table 4.

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