ARANESP darbepoetin alfa (rch) 20 microgram/0.5mL injection syringe with automatic needle guard

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Darbepoetin alfa, Quantity: 40 microgram/mL

Available from:

Amgen Australia Pty Ltd

INN (International Name):

Darbepoetin alfa

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous, Intravenous

Units in package:

1 x syringe, 4 x syringes

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
®
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING ARANESP?
Aranesp contains the active ingredient darbepoetin alfa. Aranesp is
used to treat anaemia that is associated with chronic renal
failure (kidney failure) and anaemia in cancer patients who are
receiving chemotherapy.
For more information, see Section 1. Why am I using Aranesp? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ARANESP?
Do not use if you have ever had an allergic reaction to Aranesp or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Aranesp? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Aranesp and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ARANESP?
•
Following blood tests, your doctor will prescribe the strength of
Aranesp that is best for you.
•
Aranesp can be self-administered by injection under the skin after
training from your doctor or nurse. It can also be injected into
a vein by a doctor or nurse.
More instructions can be found in Section 4. How do I use Aranesp? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ARANESP?
THINGS YOU
SHOULD DO
•
Tell your doctor if you are pregnant, think you may be pregnant or are
planning to have a baby.
•
Keep all of your doctor's appointments so that your progress can be
monitored.
•
Remind your doctor, dentist, nurse or pharmacist on your visit that
you are using Aranesp.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•

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