Myborte Dosage/Direction for Use

Adult: 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 extend therapy of more than 8 cycles, bortezomib may be administered on the standard schedule or on a maintenance schedule of once weekly (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 initiated 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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Dose adjustments: Prior to initiating any cycle of therapy with bortezomib in combination with melphalan and prednisone, platelet counts should be 70 x 10⁹/L or more and the absolute neutrophils count (ANC) should be 1.0 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: 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 4.)

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Induction Therapy Prior to Stem-Cell Transplantation: When used with dexamethasone as part of the bortezomib-dexamethasone regimen for induction therapy in patients newly diagnosed with multiple myeloma who were to undergo autologous stem-cell transplant, a bortezomib dosage of 1.3 mg/ml was administered by IV injection twice weekly for 2 weeks (days 1, 4, 8, and 11) followed by a 10-day rest period (days 12-21). In cycles 1 and 2, dexamethasone 40 mg was administered orally on days 1-4 and 9-12; in cycles 3 and 4, dexamethasone 40 mg was administered orally on days 1-4.
Renal function impairment: Dialysis may reduce bortezomib concentrations; administer after dialysis.
Hepatic function impairment: See Table 5.

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Preparation for administration: Different volumes of sodium chloride 0.9% are used to reconstitute the product for the different routes of administration. The reconstituted concentration of bortezomib for subcutaneous administration is greater than the reconstituted concentration of bortezomib for IV administration. Because each route of administration has a different reconstituted concentration, caution should be used when calculating the volume to be administered. (See Table 6.)

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Administration: Administer IV at a concentration of 1 mg/mL or subcutaneously at a concentration of 2.5 mg/ml. When administered IV, bortezomib is administered as a 3- to 5-second bolus IV injection. Bortezomib is for IV or subcutaneous use only. Bortezomib should not be administered by any other route. Fatal events have occurred with intrathecal administration; bortezomib is contraindicated for intrathecal administration.
When administered subcutaneously, sites for each injection (thigh or abdomen) should be rotated. New injections should be given at least 1 inch from an old site and never into areas where the site is tender, bruised, erythematous, or indurated.
If local injection-site reactions occur following bortezomib administration subcutaneously, a less concentrated bortezomib solution (1 mg/mL instead of 2.5 mg/ml) may be administered subcutaneously. Alternatively, the IV route of administration should be considered.