BORTEZOMIB MEDOMIE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BORTEZOMIB

Available from:

MEDOMIE PHARMA 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:

MSN LABORATORIES PRIVATE LIMITED, INDIA

Therapeutic area:

BORTEZOMIB

Therapeutic indications:

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

2021-10-04

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bortezomib medomie
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3.5 mg of bortezomib (as a mannitol boronic ester).
After reconstitution, 1 ml of solution for subcutaneous injection
contains 2.5 mg bortezomib.
After reconstitution, 1 ml of solution for intravenous injection
contains 1 mg bortezomib.
For the full list of excipients, see _12. DESCRIPTION_.
Powder for solution for injection I.V., S.C.
3
THERAPUETIC INDICATIONS
3.1
Multiple Myeloma
Bortezomib medomie for injection is indicated for the treatment of
adult patients with multiple myeloma.
3.2
Mantle Cell Lymphoma
Bortezomib medomie for injection is indicated for the treatment of
patients with mantle cell
lymphoma who have received at least one prior therapy.
Bortezomib medomie 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 IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY. Bortezomib
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 is 1.3 mg/m
2
. Bortezomib 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 4.9). When
administered intravenously, bortezomib is administered as a 3 to 5
second bolus intravenous injection.
4.1
Dosage in Previously Untreated Multiple Myeloma
Bortezomib 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 is
admi