BORTEZOMIB
BORTEZOMIB- bortezomib injection, powder, lyophilized, for solution
Baxter Healthcare Corporation
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 . 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) | ||||||||||||
| Week | 1 | 2 | 3 | 4 | 5 | 6 | ||||||
| Bortezomib for Injection(1.3 mg/m2) | Day1 | -‑ | -‑ | Day4 | Day8 | Day11 | rest period | Day22 | Day25 | Day29 | Day32 | rest period |
| Melphalan (9 mg/m2)Prednisone (60 mg/m2) | Day1 | Day2 | Day3 | Day4 | -‑ | -‑ | rest period | -‑ | -‑ | -‑ | -‑ | rest period |
| Once Weekly Bortezomib for Injection (Cycles 5 to 9 when used in combination with Melphalan and Prednisone) | ||||||||||||
| Week | 1 | 2 | 3 | 4 | 5 | 6 | ||||||
| Bortezomib for Injection(1.3 mg/m2) | Day1 | -‑ | -‑ | Day8 | rest period | Day22 | Day29 | rest period | ||||
| Melphalan (9 mg/m2)Prednisone (60 mg/m2) | Day1 | Day2 | Day3 | Day4 | -‑ | -‑ | rest period | -‑ | -‑ | -‑ | -‑ | rest period |
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