BORTEZOMIB TARO 3.5 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BORTEZOMIB

Available from:

TARO INTERNATIONAL LTD, ISRAEL

ATC code:

L01XX32

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

BORTEZOMIB 3.5 MG/VIAL

Administration route:

I.V, S.C

Prescription type:

Required

Manufactured by:

TARO INTERNATIONAL LTD, ISRAEL

Therapeutic area:

BORTEZOMIB

Therapeutic indications:

Bortezomib is indicated for the treatment of patients with multiple myeloma.Bortezomib is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Bortezomib 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.

Authorization date:

2019-06-30

Summary of Product characteristics

Page 1 of 48
FULL PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Bortezomib Taro 3.5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
After reconstitution, each 1 mL of solution for subcutaneous injection
contains 2.5 mg
bortezomib.
After reconstitution, each 1 mL of solution for intravenous injection
contains 1 mg
bortezomib.
For the full list of excipients, see section 12.
PHARMACEUTICAL FORM
Powder for Solution for Injection
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/m
2
. 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.
Page 2 of 48
4.1
DOSAGE IN PREVIOUSLY UNTREATED MULTIPLE MYELOMA
Bortezomib Taro is administered in combination with oral melphalan and
oral prednisone fo