Bortezomib Waverley 1 mg powder for solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bortezomib

Available from:

Waverley Pharma Europe Limited

ATC code:

L01XX; L01XX32

INN (International Name):

Bortezomib

Dosage:

1 milligram(s)

Pharmaceutical form:

Powder for solution for injection

Therapeutic area:

Other antineoplastic agents; bortezomib

Authorization date:

2020-03-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Bortezomib Waverley 1 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 WAVERLEY 1 MG POWDER FOR SOLUTION FOR INJECTION is and
what it is
used for
2.
What you need to know before you use BORTEZOMIB WAVERLEY 1 MG POWDER
FOR
SOLUTION FOR INJECTION
3.
How to use BORTEZOMIB WAVERLEY 1 MG POWDER FOR SOLUTION FOR INJECTION
4.
Possible side effects
5.
How to store BORTEZOMIB WAVERLEY 1 MG POWDER FOR SOLUTION FOR
INJECTION
6.
Contents of the pack and other information
1.
WHAT BORTEZOMIB WAVERLEY1 MG POWDER FOR SOLUTION FOR INJECTION IS AND
WHAT IT IS
USED FOR
Bortezomib Waverley 1 mg powder for solution for injection 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 Waverley 1 mg powder for solution for injection 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,

Summary of Product characteristics

Health Products Regulatory Authority
11 August 2021
CRN00CGSD
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bortezomib Waverley 1 mg powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg bortezomib (as a mannitol boronic ester).
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
Waverley
powder
for
solution
for
injection
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 Waverley powder for solution for injection 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 Waverley powder for solution for injection 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 Waverley powder for solution for injection 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Bortezomib
Waverley
powder
for
solution
for
injection
treatment
must
be
initiated
under
supervision
of
a
physician
experienced in the treatment of cance