Bortezomib Hospira

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

bortezomib

Available from:

Pfizer Europe MA EEIG

ATC code:

L01XG01

INN (International Name):

bortezomib

Therapeutic group:

Other antineoplastic agents

Therapeutic area:

Multiple Myeloma

Therapeutic indications:

Bortezomib Hospira as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.Bortezomib Hospira in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.Bortezomib Hospira in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.Bortezomib Hospira 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.

Product summary:

Revision: 13

Authorization status:

Authorised

Authorization date:

2016-07-22

Patient Information leaflet

56
B. PACKAGE LEAFLET
57
PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB HOSPIRA 1 MG POWDER FOR SOLUTION FOR INJECTION
BORTEZOMIB HOSPIRA 2.5 MG POWDER FOR SOLUTION FOR INJECTION
BORTEZOMIB HOSPIRA 3 MG POWDER FOR SOLUTION FOR INJECTION
BORTEZOMIB HOSPIRA 3.5 MG POWDER FOR SOLUTION FOR INJECTION
bortezomib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bortezomib Hospira is and what it is used for
2.
What you need to know before you use Bortezomib Hospira
3.
How to use Bortezomib Hospira
4.
Possible side effects
5.
How to store Bortezomib Hospira
6.
Contents of the pack and other information
1.
WHAT BORTEZOMIB
HOSPIRA IS AND WHAT IT IS USED FOR
Bortezomib Hospira
contains the active substance bortezomib, a so-called ‘proteasome
inhibitor’.
Proteasomes play an important role in controlling cell function and
growth. By interfering with their
function, bortezomib can kill cancer cells.
Bortezomib is used for the treatment of multiple myeloma (a cancer of
the bone marrow) in patients
older than 18 years:
-
alone or together with the medicines pegylated liposomal doxorubicin
or dexamethasone, for
patients whose disease is worsening (progressive) after receiving at
least one prior treatment and
for whom blood stem cell transplantation was not successful or is
unsuitable.
-
in combination with the medicines melphalan and prednisone, for
patients whose disease has not
been previously treated and are unsuitable for high-dose chemotherapy
with blood stem cell
transplantation.
-
in combination with the medicines dexamethasone or dexamethasone
together with thalidomide,
for patients whose disease has not been previously treated and before
receiving high-

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Bortezomib Hospira 1 mg powder for solution for injection
Bortezomib Hospira 2.5 mg powder for solution for injection
Bortezomib Hospira 3 mg powder for solution for injection
Bortezomib Hospira 3.5 mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bortezomib Hospira 1 mg powder for solution for injection
Each vial of powder contains 1 mg bortezomib (as a mannitol boronic
ester).
Bortezomib Hospira 2.5 mg powder for solution for injection
Each vial of powder contains 2.5 mg bortezomib (as a mannitol boronic
ester).
Bortezomib Hospira 3 mg powder for solution for injection
Each vial of powder contains 3 mg bortezomib (as a mannitol boronic
ester).
Bortezomib Hospira 3.5 mg powder for solution for injection
Each vial of powder contains 3.5 mg 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 section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
White to off-white cake or powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bortezomib Hospira as monotherapy or in combination with pegylated
liposomal doxorubicin or
dexamethasone is indicated for the treatment of adult patients with
progressive multiple myeloma who
have received at least 1 prior therapy and who have already undergone
or are unsuitable for
haematopoietic stem cell transplantation.
Bortezomib Hospira in combination with melphalan and prednisone is
indicated for the treatment of
adult patients with previously untreated multiple myeloma who are not
eligible for high-dose
chemotherapy with haematopoietic stem cell transplantation.
3
Bortezomib Hospira in combination with dexamethasone, or with
dexamethasone and thalidomide, is
indicated for the induction treatment of adult patients with
previously untreated multip