Bortezomib Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Lymphoma

For use in the treatment of mantle cell lymphoma:

1.3 mg/m2 as a bolus intravenous injection or subcutaneously twice weekly for two weeks (days 1, 4, 8, and 11) followed by a ten day rest period (days 12 through 21)

The three week period is considered a treatment cycle.

A minimum of 72 hours should elapse between consecutive doses of bortezomib.

Usual Adult Dose for Multiple Myeloma

For use in the treatment of previously untreated multiple myeloma:

Usual dose: 1.3 mg/m2 administered as a 3 to 5 second bolus IV injection or subcutaneously in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles.

In cycles 1 through 4, bortezomib is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29 and 32). In cycles 5 through 9, bortezomib is administered once weekly (days 1, 8, 22 and 29). At least 72 hours should elapse between consecutive doses of bortezomib.

For use in the treatment of relapsed multiple myeloma:

1.3 mg/m2 as a bolus intravenous injection or subcutaneously twice weekly for two weeks (days 1, 4, 8, and 11) followed by a ten day rest period (days 12 through 21)

The three week period is considered a treatment cycle.

A minimum of 72 hours should elapse between consecutive doses of bortezomib.

Renal Dose Adjustments

Dosing adjustments are not necessary for patients with renal insufficiency.

Liver Dose Adjustments

The manufacturer recommends that patients with moderate or severe hepatic impairment (bilirubin levels greater than 1.5 times the upper limit of the normal range ) be treated with bortezomib at reduced starting doses and closely monitored for toxicities. Bortezomib should be reduced to 0.7 mg/m2 in the first cycle. Dose escalation to 1 mg/m2 or further dose reduction to 0.5 mg/m2 may be considered in subsequent cycles based on patient tolerability.

Dose Adjustments

Dose Modification Guidelines for Combination Therapy with bortezomib, melphalan and prednisone:

Prior to initiating any cycle of therapy with bortezomib in combination with melphalan and prednisone, the platelet count should be greater than or equal to 70 x 10^9/L and the ANC should be greater than or equal to 1.0 x 10^9/L.

Non-hematological toxicities should have resolved to grade 1 or baseline.

Hematological toxicity during a cycle:
If prolonged grade 4 neutropenia, thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle, then reduction of the melphalan dose by 25% in the next cycle should be considered.
If the platelet count is less than or equal to 30 × 10^9/L or ANC less than or equal to 0.75 x 10^9/L on a bortezomib dosing day (other than day 1), then the bortezomib dose should be withheld. If several bortezomib doses in consecutive cycles are withheld due to toxicity bortezomib dose should be reduced by 1 dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2)

Non-hematological toxicities greater than or equal to grade 3:
Bortezomib therapy should be withheld until symptoms of the toxicity have resolved to grade 1 or baseline. Then, bortezomib may be reinitiated with one dose level reduction (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2).


Dose Modification Guidelines for Relapsed Multiple Myeloma and Mantle Cell Lymphoma:

Bortezomib should be withheld at the onset of any grade 3 nonhematologic or grade 4 toxicities excluding neuropathy. Once the symptoms of the toxicity have been resolved, bortezomib therapy may be reinitiated at a 25% reduced dose (1.3 mg/m2 is reduced to 1 mg/m2, 1 mg/m2 is reduced to 0.7 mg/m2).

Patients with preexisting severe neuropathy should be treated with bortezomib only after a careful risk/benefit assessment.


Dose Modification Guidelines for all patients on bortezomib:
For patients who experience bortezomib related neuropathic pain and/or peripheral sensory neuropathy the following modifications in the dose or regimen is recommended:

Grade 1 (paresthesias and/or loss of reflexes) without pain or loss of function - no action is required.

Grade 1 with pain or Grade 2 (interfering with function but not with activities of daily living) - reduce the dose of bortezomib to 1 mg/m2.

Grade 2 with pain or Grade 3 (interfering with activities of daily living) - withhold bortezomib therapy until toxicity resolves. Once the toxicity resolves, reinitiate therapy with a reduced dose of bortezomib at 0.7 mg/m2 and change the frequency to once a week.

Grade 4 (permanent sensory loss that interferes with function) - discontinue bortezomib.

Precautions

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Because dialysis may reduce bortezomib concentrations, the drug should be administered after the dialysis procedure.

Other Comments

The manufacturer's product information should be consulted for current reconstitution, dilution and administration recommendations.

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