Abraxane

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

paclitaxel

Beschikbaar vanaf:

Bristol-Myers Squibb Pharma EEIG

ATC-code:

L01CD01

INN (Algemene Internationale Benaming):

paclitaxel

Therapeutische categorie:

Antineoplastic agents

Therapeutisch gebied:

Breast Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung

therapeutische indicaties:

Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.

Product samenvatting:

Revision: 29

Autorisatie-status:

Authorised

Autorisatie datum:

2008-01-11

Bijsluiter

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE USER
ABRAXANE 5 MG/ML POWDER FOR DISPERSION FOR INFUSION
paclitaxel
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 nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Abraxane is and what it is used for
2.
What you need to know before you are given Abraxane
3.
How to use Abraxane
4.
Possible side effects
5.
How to store Abraxane
6.
Contents of the pack and other information
1.
WHAT ABRAXANE IS AND WHAT IT IS USED FOR
WHAT ABRAXANE IS
Abraxane contains, as its active substance, paclitaxel attached to the
human protein albumin, in the form
of tiny particles known as nanoparticles. Paclitaxel belongs to a
group of medicines called “taxanes” used
in cancer.
•
Paclitaxel is the part of the medicine that affects the cancer, it
works by stopping cancer cells from
dividing – this means that they die.
•
Albumin is the part of the medicine that helps paclitaxel dissolve in
the blood and get across the
walls of the blood vessels into the tumour. This means that other
chemicals that can cause side
effects that can be life threatening are not needed. Such side effects
occur far less with Abraxane.
WHAT ABRAXANE IS USED FOR
Abraxane is used to treat the following types of cancer:
Breast Cancer
•
Breast cancer which has spread to other parts of the body (this is
called “metastatic” breast cancer).
•
Abraxane is used in metastatic breast cancer when at least one other
therapy has been tried but has
not worked and you are unsuitable for treatments containing a group of
medicines called
“ant

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Abraxane
5 mg/ml powder for dispersion for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of paclitaxel formulated as albumin bound
nanoparticles.
Each vial contains 250 mg of paclitaxel formulated as albumin bound
nanoparticles.
After reconstitution, each ml of dispersion contains 5 mg of
paclitaxel formulated as albumin bound
nanoparticles.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for dispersion for infusion.
The reconstituted dispersion has a pH of 6-7.5 and an osmolality of
300-360 mOsm/kg.
The powder is white to yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abraxane monotherapy is indicated for the treatment of metastatic
breast cancer in adult patients who
have failed first-line treatment for metastatic disease and for whom
standard, anthracycline containing
therapy is not indicated (see section 4.4).
Abraxane in combination with gemcitabine is indicated for the
first-line treatment of adult patients with
metastatic adenocarcinoma of the pancreas.
Abraxane in combination with carboplatin is indicated for the
first-line treatment of non-small cell lung
cancer in adult patients who are not candidates for potentially
curative surgery and/or radiation therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Abraxane should only be administered under the supervision of a
qualified oncologist in units specialised
in the administration of cytotoxic agents. It should not be
substituted for or with other paclitaxel
formulations.
Posology
_Breast cancer _
The recommended dose of Abraxane is 260 mg/m
2
administered intravenously over 30 minutes every 3
weeks.
_Dose adjustments during treatment of breast cancer _
Patients who experience severe neutropenia (neutrophil count < 500
cells/mm
3
for a week or longer) or
severe sensory neuropathy during Abraxane therapy should have the dose
reduced to 220 mg/m
2
for
subsequent courses. Following recurrence of severe ne