BORTEZOMIB: Package Insert and Label Information

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.

Table 1: Dosage Regimen for Patients with Previously Untreated Multiple Myeloma

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

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
Table 2: Dose Modifications During Cycles of Combination Bortezomib for Injection, Melphalan and Prednisone Therapy

Toxicity

Dose Modification or Delay

Hematological toxicity during a cycle:If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia withbleeding 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 × 109 /L or ANC is not above 0.75 × 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 dose level (from 1.3 mg/m2 to 1 mg/m2 , or from 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)].

2.4 Dosage in Previously Untreated Mantle Cell Lymphoma

Bortezomib for Injection (1.3 mg/m2) is administered intravenously in combination with intravenous rituximab, cyclophosphamide, doxorubicin and oral prednisone (VcR-CAP) for 6, three week treatment cycles as shown in Table 3. Bortezomib for Injection is administered first followed by rituximab. Bortezomib for Injection is administered twice weekly for two weeks (Days 1, 4, 8, and 11) followed by a ten day rest period on Days 12 to 21. For patients with a response first documented at Cycle 6, two additional VcR-CAP cycles are recommended. At least 72 hours should elapse between consecutive doses of Bortezomib for Injection.

Table 3: Dosage Regimen for Patients with Previously Untreated Mantle Cell Lymphoma
*
Dosing may continue for two more cycles (for a total of eight cycles) if response is first seen at Cycle 6.

Twice Weekly Bortezomib for Injection (6, Three Week Cycles) *

Week

1

2

3

Bortezomib for Injection (1.3 mg/m2)

Day1

-‑

-‑

Day4

-‑

Day8

Day11

rest period

Rituximab (375 mg/m2) Cyclophosphamide (750 mg/m2) Doxorubicin (50 mg/m2)

Day1

-‑

-‑

-‑

-‑

rest period

Prednisone (100 mg/m2)

Day1

Day2

Day3

Day4

Day5

-‑

-‑

rest period

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