Indications : התוויות

3.    THERAPEUTIC INDICATIONS
3.2    Multiple Myeloma
Bortezomib Taro 3.5 mg is indicated for the treatment of patients with multiple myeloma.
3.3    Mantle Cell Lymphoma
Bortezomib Taro 3.5 mg is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
Bortezomib Taro 3.5 mg in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.


4.    DOSAGE AND ADMINISTRATION
General Dosing Guidelines
BORTEZOMIB TARO 3.5 MG IS FOR INTRAVENOUS OR SUBCUTANEOUS USE
ONLY. Bortezomib Taro 3.5 mg must not be administered by any other route. Intrathecal administration has resulted in death.
Because each route of administration has a different reconstituted concentration, caution should be used when calculating the volume to be administered.
The recommended starting dose of Bortezomib Taro 3.5 mg is 1.3 mg/m2. Bortezomib Taro 3.5 mg may be administered intravenously at a concentration of 1 mg/mL, or subcutaneously at a concentration of 2.5 mg/mL (see reconstitution/preparation for intravenous and subcutaneous administration (section 4.8)). When administered intravenously, Bortezomib Taro 3.5 mg is administered as a 3 to 5 second bolus intravenous injection.



4.1       Dosage in Previously Untreated Multiple Myeloma
Bortezomib Taro 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 Taro is administered twice weekly (Days 1, 4, 8, 11, 22, 25, 29 and 32). In Cycles 5 to 9, Bortezomib Taro is administered once weekly (Days 1, 8, 22 and 29). At least 72 hours should elapse between consecutive doses of Bortezomib Taro.

TABLE 1 - Dosage Regimen for Patients with Previously Untreated Multiple Myeloma Twice Weekly Bortezomib Taro (Cycles 1 to 4)
Week                   1                   2          3          4           5          6 Bortezomib
Day                Day Day Day           rest    Day Day Day Day           rest Taro (1.3
1                 4      8      11    period   22    25     29    32    period mg/m2)
Melphalan
(9 mg/m2)   Day Day Day Day                          rest                              rest Prednisone    1     2     3     4                   period                            period (60 mg/m2)
Once Weekly Bortezomib Taro (Cycles 5 to 9 when used in combination with Melphalan and Prednisone)
Week                   1                   2          3          4           5          6 Bortezomib Day
Day             rest    Day         Day           rest
Taro (1.3     1
8            period   22           29          period mg/m )2

Melphalan
(9 mg/m2)   Day Day Day Day                          rest                              rest Prednisone 1        2     3     4                   period                            period (60 mg/m2)