ARANESP darbepoetin alfa (rch) 500 microgram/1.0mL solution for injection syringe with automatic needle guard

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Darbepoetin alfa, Quantity: 500 microgram

Available from:

Amgen Australia Pty Ltd

INN (International Name):

Darbepoetin alfa

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; water for injections; polysorbate 80; dibasic sodium phosphate; monobasic sodium phosphate monohydrate

Administration route:

Subcutaneous, Intravenous

Units in package:

4 syringes, 1 syringe

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Aranesp is indicated for the treatment of anaemia associated with chronic renal failure (CRF). Aranesp is also indicated for the treatment of anaemia and reduction of transfusion requirements in patients with non-myeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-06-17

Patient Information leaflet

ARANESP
®
1
ARANESP
®
_darbepoetin alfa _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Aranesp
(darbepoetin alfa). It does not contain
all the available information.
It does not take the place of talking to
your doctor, nurse or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Aranesp
against the benefits he/she expects it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE
YOU START ARANESP AND KEEP IT WITH
THE MEDICINE.
You may need to read it again.
WHAT ARANESP IS USED
FOR
Aranesp is used to treat anaemia in
cancer patients who are receiving
chemotherapy. Anaemia is when
your blood does not contain enough
red blood cells.
Anaemia can occur as a result of
chemotherapy medicines used to treat
cancer. Some chemotherapy
medicines can affect the bone
marrow's ability to make red blood
cells. When your red blood cell
count falls too low, you become
anaemic. Some affects of anaemia
can include tiredness, dizziness,
increased heart beat, depression,
anorexia, nausea, feeling cold and
pale skin colour.
Aranesp is a recombinant
erythropoietic protein produced by
special mammalian cells. Your
doctor has given you Aranesp to treat
the anaemia caused by the
chemotherapy medicines used to treat
your cancer and where blood
transfusion is not considered
appropriate. Aranesp will help your
bone marrow to produce more red
blood cells, like your natural
erythropoietin. The active ingredient
of Aranesp is darbepoetin alfa that
works in exactly the same way as the
natural hormone erythropoietin.
It will take your body a short time to
make red blood cells, so it will be
about 4 weeks before you notice any
effect.
Anaemia can occur as a result of
cancer. Aranesp should not be used
to treat anaemia that results from
cancer.
Your doctor may have prescribed
Aranesp for another reason. Ask your
doctor if you have any questions
about

Summary of Product characteristics

PRODUCT INFORMATION – ARANESP
darbepoetin alfa Sponsor address (10/03/2022)
PAGE 1 OF 32
AUSTRALIAN PRODUCT INFORMATION
ARANESP
® (DARBEPOETIN ALFA)
Use in Cancer
In some studies, use of Erythropoiesis Stimulating Agents (ESAs) to
treat anaemia in
patients with cancer has been associated with increased mortality.
ESAs should only be
used to treat anaemia that has developed as a result of concomitantly
administered
chemotherapy, and only when blood transfusion is not considered
appropriate.
Haemoglobin levels should not exceed 120 g/L (see section 4.4 Special
warnings and
precautions for use).
1.
NAME OF THE MEDICINE
Darbepoetin alfa
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ARANESP darbepoetin alfa (rch) 10 µg/0.4mL injection syringe within a
pen injector
ARANESP darbepoetin alfa (rch) 15 µg/0.38mL injection syringe within
a pen injector
ARANESP darbepoetin alfa (rch) 20 µg/0.5mL injection syringe within a
pen injector
ARANESP darbepoetin alfa (rch) 30 µg/0.3mL injection syringe within a
pen injector
ARANESP darbepoetin alfa (rch) 40 µg/0.4mL injection syringe within a
pen injector
ARANESP darbepoetin alfa (rch) 50 µg/0.5mL injection syringe within a
pen injector
ARANESP darbepoetin alfa (rch) 60 µg/0.3mL injection syringe within a
pen injector
ARANESP darbepoetin alfa (rch) 80 µg/0.4mL injection syringe within a
pen injector
ARANESP darbepoetin alfa (rch) 100 µg/0.5mL injection syringe within
a pen injector
ARANESP darbepoetin alfa (rch) 150 µg/0.3mL injection syringe within
a pen injector
ARANESP darbepoetin alfa (rch) 200 µg/0.4mL injection syringe within
a pen injector
ARANESP darbepoetin alfa (rch) 300 µg/0.6mL injection syringe within
a pen injector
ARANESP darbepoetin alfa (rch) 500 µg/1.0mL solution for injection
syringe within a pen
injector
PRODUCT INFORMATION – ARANESP
darbepoetin alfa Sponsor address (10/03/2022)
PAGE 2 OF 32
ARANESP darbepoetin alfa (rch) 15 µg/0.38mL injection syringe with
automatic needle
guard
ARANESP darbepoetin alfa (rch) 20 µg/0.5mL injection syringe with