Bortezomib Actavis 3.5mg powder for solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BORTEZOMIB

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

L01XX32

INN (International Name):

BORTEZOMIB 3.5 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

BORTEZOMIB 3.5 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2015-06-05

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB ACTAVIS 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 possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bortezomib Actavis is and what it is used for
2.
What you need to know before you use Bortezomib Actavis
3.
How to use Bortezomib Actavis
4.
Possible side effects
5.
How to store Bortezomib Actavis
6.
Contents of the pack and other information
1.
WHAT BORTEZOMIB ACTAVIS IS AND WHAT IT IS USED FOR
Bortezomib Actavis 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 Actavis 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-dose chemotherapy with blood stem cell transplantation (induction
treatment).
Bortezomib Actavis is used for the treatment of mantle cell lymphoma
(a type of cancer affecting
the lym

Summary of Product characteristics

Page
1
of
37
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bortezomib Actavis 3.5 mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial 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 Actavis 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 Actavis 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 Actavis 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 Actavis 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.
Page
2
of
37
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated and administered under the supervision of
a physician qualified and
experienced in the use of chemotherapeutic agents. Bortezomib Actavis
must be reconstituted by a
healthcare professional.
Posology for treatment