ABRAXANE nanoparticle albumin-bound paclitaxel 250 mg powder for injection (suspension) vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paclitaxel, Quantity: 250 mg

Available from:

Abraxis Bioscience Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: Albumin; sodium octanoate; sodium acetyltryptophanate

Administration route:

Intravenous

Units in package:

1 x 100mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Metastatic Breast Cancer ABRAXANE is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. Non-small Cell Lung Cancer ABRAXANE, in combination with carboplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation. Metastatic Adenocarcinoma of the Pancreas ABRAXANE, in combination with gemcitabine, is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.

Product summary:

Visual Identification: White to yellow, lyophilised powder.; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-12-07

Patient Information leaflet

November 2018
CMI FOR ABRAXANE
________________________________________________________________________________
20181127_ABX_CMI_AUNZ_Cat1-250mg_Approved
1
ABRAXANE
Ò
Paclitaxel
(pak-li-TAX-el)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ABRAXANE.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
ABRAXANE against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR. YOUR DOCTOR OR
PHARMACIST CAN PROVIDE YOU WITH
MORE INFORMATION ABOUT
ABRAXANE.
KEEP THIS LEAFLET
You may need to read it again.
WHAT ABRAXANE IS USED FOR
This medicine is used to treat:
•
Breast cancer
•
Lung Cancer
•
Pancreatic Cancer
This medicine belongs to a group
of medicines called antineoplastic
or cytotoxic medicines. You may
also hear of these being called
chemotherapy medicines.
It works by killing cancer cells and
stopping them from multiplying.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only
with a doctor’s prescription
.
BEFORE YOU ARE GIVEN
ABRAXANE
WHEN YOU MUST NOT BE GIVEN IT
YOU MUST NOT BE GIVEN
ABRAXANE IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
paclitaxel
•
any of the ingredients listed at
the end of this leaflet
Some of the symptoms of an
allergic reaction may include
shortness of breath, wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE A VERY LOW
WHITE BLOOD CELL (WBC) COUNT.
TELL YOUR DOCTOR IF YOU HAVE AN
INFECTION OR HIGH TEMPERATURE.
Your doctor may decide to delay
your treatment until the infection is
gone. A mild illness, su

Summary of Product characteristics

20200609_ABX_PI_AU_SRR(CCDSv17)_final
1
PRODUCT INFORMATION
ABRAXANE (NANOPARTICLE ALBUMIN-BOUND PACLITAXEL)
1
NAME OF THE MEDICINE
nanoparticle albumin-bound paclitaxel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ABRAXANE (nanoparticle albumin-bound paclitaxel) powder for injection
(suspension) is an
albumin nanoparticle form of paclitaxel
with a mean particle size of approximately 130 nanometres.
Paclitaxel exists in the nanoparticles in a non-crystalline, amorphous
state. Each vial of ABRAXANE
contains paclitaxel and human albumin in the ratio of 1:9. The
paclitaxel is contained within
nanoparticles that consist of a majority of paclitaxel bound to human
albumin.
Each single-use vial contains the following: Paclitaxel 100 mg or 250
mg.
ABRAXANE is free of solvents.
100 mg vial: The reconstituted medicinal product contains
approximately 85 mg sodium per vial
when reconstituted with 0.9% sodium chloride.
250 mg vial: The reconstituted medicinal product contains
approximately 213 mg sodium per vial
when reconstituted with 0.9% sodium chloride.
The active agent in ABRAXANE is paclitaxel, a natural product with
antitumour activity. Paclitaxel
is obtained from
Taxus media
.
Excipient(s) with known effect
Not applicable. For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ABRAXANE is supplied as a white to yellow, sterile, lyophilised powder
in the following
presentations:
100 mg paclitaxel in a 50 mL glass vial
250 mg paclitaxel in a 100 mL glass vial
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
METASTATIC BREAST CANCER
ABRAXANE is indicated for the treatment of metastatic carcinoma of the
breast after failure of
anthracycline therapy.
NON-SMALL CELL LUNG CANCER
ABRAXANE, in combination with carboplatin, is indicated for the
first-line treatment of non-small
cell lung cancer in patients who are not candidates for potentially
curative surgery and/or radiation.
METASTATIC ADENOCARCINOMA OF THE PANCREAS
ABRAXANE, in combination with gemcitabine, is indicated for the
first-li