BORTEZOMIB- bortezomib injection, powder, lyophilized, for solution
1 INDICATIONS AND USAGE
1.1 Multiple Myeloma
Bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma.
1.2 Mantle Cell Lymphoma
Bortezomib for injection is indicated for the treatment of adult patients with mantle cell lymphoma.
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosing Guidelines
Bortezomib for injection is for intravenous or subcutaneous use only. Do not administer Bortezomib for injection by any other route.
Because each route of administration has a different reconstituted concentration, use caution when calculating the volume to be administered.
The recommended starting dose of Bortezomib for injection is 1.3 mg/m2. Bortezomib for injection is administered intravenously at a concentration of 1 mg/mL, or subcutaneously at a concentration of 2.5 mg/mL [see Dosage and Administration (2.10)].
Bortezomib for injection retreatment may be considered for patients with multiple myeloma who had previously responded to treatment with Bortezomib for injection and who have relapsed at least six months after completing prior Bortezomib for injection treatment. Treatment may be started at the last tolerated dose [see Dosage and Administration (2.6)].
When administered intravenously, administer Bortezomib for injection as a 3 to 5 second bolus intravenous injection.
2.2 Dosage in Previously Untreated Multiple Myeloma
Bortezomib for injection is administered in combination with oral melphalan and oral prednisone for 9, six week treatment cycles as shown in Table 1. In Cycles 1 to 4, Bortezomib for injection is administered twice weekly (Days 1, 4, 8, 11, 22, 25, 29 and 32). In Cycles 5 to 9, Bortezomib for injection is administered once weekly (Days 1, 8, 22 and 29). At least 72 hours should elapse between consecutive doses of Bortezomib for injection.
|Twice Weekly Bortezomib for injection (Cycles 1 to 4)|
|Bortezomib for injection(1.3 mg/m2)||Day 1||—||—||Day 4||Day 8||Day 11||rest period||Day 22||Day 25||Day 29||Day 32||rest period|
|Melphalan (9 mg/m2)Prednisone (60 mg/m2)||Day1||Day2||Day 3||Day 4||—||—||rest period||—||—||—||—||rest period|
|Once Weekly Bortezomib for injection (Cycles 5 to 9 when used in combination with Melphalan and Prednisone)|
|Bortezomib for injection (1.3 mg/m2)||Day1||—||—||Day8||rest period||Day 22||Day 29||rest period|
|Melphalan (9 mg/m2)Prednisone (60 mg/m2)||Day1||Day2||Day3||Day4||—||—||rest period||—||—||—||—||rest period|
2.3 Dose Modification Guidelines for Bortezomib for injection When Given in Combination with Melphalan and Prednisone
Prior to initiating any cycle of therapy with Bortezomib for injection in combination with melphalan and prednisone:
- Platelet count should be at least 70 x 109 /L and the absolute neutrophil count (ANC) should be at least 1 x 109 /L
- Nonhematological toxicities should have resolved to Grade 1 or baseline
|Toxicity||Dose Modification or Delay|
|Hematological toxicity during a cycle:If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle||Consider reduction of the melphalan dose by 25% in the next cycle|
|If platelet count is not above 30 x 109 /Lor ANC is not above 0.75 x 109 /L on a Bortezomib for injection dosing day (other than Day 1)||Withhold Bortezomib for injection dose|
|If several Bortezomib for injection doses in consecutive cycles are withheld due to toxicity||Reduce Bortezomib for injection dose by one doselevel (from 1.3 mg/m2 to 1 mg/m2 , orfrom 1 mg/m2 to 0.7 mg/m2)|
|Grade 3 or higher nonhematological toxicities||Withhold Bortezomib for injection therapy until symptoms of toxicity have resolved to Grade 1 or baseline. Then, Bortezomib for injection 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). For Bortezomib for injection-related neuropathic pain and/or peripheral neuropathy, hold or modify Bortezomib for injection as outlined in Table 5.|
For information concerning melphalan and prednisone, see manufacturer’s prescribing information.
Dose modifications guidelines for peripheral neuropathy are provided [see Dosage and Administration (2.7)].
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