ARANESP darbepoetin alpha (rch) 60 microgram/0.3mL injection syringe with automatic needle guard

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Darbepoetin alfa, Quantity: 200 microgram/mL

Available from:

Amgen Australia Pty Ltd

INN (International Name):

Darbepoetin alfa

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous, Intravenous

Units in package:

4 x syringes with automatic needle guard, 1 x syringe with automatic needle guard

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:

Licence status A

Authorization date:

2010-06-17

Patient Information leaflet

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 that
comes about because of chronic renal
failure (kidney failure). Anaemia is
when your blood does not contain
enough red blood cells.
In kidney failure, the kidney does not
produce enough of the natural
hormone erythropoietin.
Erythropoietin encourages your bone
marrow to produce more red blood
cells. Kidney failure can often cause
anaemia, which may require you to
have blood transfusions.
Aranesp is a recombinant
erythropoietic protein produced by
special mammalian cells. Your
doctor has given you Aranesp to treat
your anaemia. It will reduce your
need for blood transfusions. 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. If you are on dialysis, your
normal dialysis routine will not affect
the ability of Aranesp to treat your
anaemia.
Your doctor may have prescribed
Aranesp for another reason. Ask your
doctor if you have any questions
about why Aranesp has been
prescribed for you.
BEFORE YOU USE IT
_WHEN YOU MUST NOT USE IT_
DO NOT USE ARANESP IF YOU HAVE:
•
High blood pressure that is not
controlled by other medicines

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