What Aranesp contains
- The active substance is darbepoetin alfa.The pre-filled pen contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 or 500 micrograms of darbepoetin alfa.
- The other ingredients are sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 and water for injections.
What Aranesp looks like and contents of the pack
Aranesp is a clear, colourless or slightly pearly solution for injection in a pre-filled pen.
Aranesp (SureClick) is available in packs containing 1 or 4 pre-filled pens. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Amgen Europe B.V.
NL-4817 ZK Breda
If you want more information about this medicine, please contact the local representative of the company that is authorised to market Aranesp.
BelgiëBelgiqueBelgien s.a. Amgen n.v. TelTél 32 02 7752711 LuxembourgLuxemburg s.a. Amgen BelgiqueBelgien TelTél 32 02 7752711
359 02 805 7020 Magyarország Amgen Kft. Tel. 36 1 35 44 700
eská republika Amgen s.r.o. Tel 420 2 21 773 500 Malta Amgen B.V. The Netherlands Tel 31 076 5732500
Danmark Amgen filial af Amgen AB, Sverige Tlf 45 39617500 Nederland Amgen B.V. Tel 31 076 5732500
Deutschland AMGEN GmbH Tel. 49 089 1490960 Norge Amgen AB Tel 47 23308000
Eesti Amgen Switzerland AG Eesti filiaal Tel 372 512 5501 Österreich Amgen GmbH Tel 43 01 50 217
Genesis Pharma S.A. 30 210 8771500 Polska Amgen Sp. z o.o. Tel. 48 22 581 3000
España Amgen S.A. Tel 34 93 600 19 00 Portugal AMGEN Biofarmacêutica, Lda. Tel 351 21 4220550
France Amgen S.A.S. Tél 33 01 40 88 27 00 România Amgen România SRL Tel. 4021 527 30 00
Slovenija AMGEN zdravila d.o.o. Tel 386 1 585 1767 Ireland Amgen Limited United Kingdom Tel 44 01223 420305
Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Amgen Switzerland AG, Slovakia Tel 421 33 321 13 22
Italia Amgen Dompé S.p.A. Tel 39 02 6241121 SuomiFinland Amgen AB, sivuliike SuomessaAmgen AB, filial i Finland PuhTel 358 09 54900500
K Genesis Pharma Cyprus Ltd 357 22 76 99 46 Sverige Amgen AB Tel 46 08 6951100
Latvija Amgen Switzerland AG Rgas filile Tel 371 29284 807 United Kingdom Amgen Limited Tel 44 01223 420305
Amgen Switzerland AG Vilniaus filialas
Tel: +370 6983 6600
This leaflet was last approved in
INSTRUCTIONS FOR INJECTING WITH THE ARANESP PRE-FILLED PEN
This section contains information on how to properly use the Aranesp pre-filled pen. It is importantthat you do not try to give yourself the injection unless you have received training from your doctor,
nurse, or pharmacist. If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.
How do you, or the person injecting you, use Aranesp pre-filled pen (SureClick)?
Your doctor has prescribed the Aranesp pre-filled pen for injection into the tissue just under the skin. Your doctor, nurse, or pharmacist will tell you how much Aranesp you need and how frequently it should be injected. Only use each pre-filled pen for one injection.
To give yourself an injection you will need:
- a new Aranesp pre-filled pen and
- alcohol wipes or similar.
Preparing for an Aranesp injection?
1. Remove the pen from the refrigerator. For a more comfortable injection, leave the pen at room temperature for approximately 30 minutes. Do not warm Aranesp in any other way (for example, do not warm it in a microwave or in hot water). Additionally, do not leave the pre-filled pen exposed to direct sunlight.
2. Do not shake the pre-filled pen.
3. Do not remove the grey needle cap from the pre-filled pen until you are ready to inject.
4. Check that it is the correct dose that your doctor has prescribed.
5. Check the expiry date on the pre-filled pen label (EXP:). Do not use it if the date has passed the last day of the month shown
6. Check the appearance of Aranesp through the inspection window. It must be a clear, colourless or slightly pearly liquid. If it is cloudy or there are particles in it, you must not use it.
7. Wash your hands thoroughly.
8. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Grey needle cap Red button Inspection window
7a. Choosing and preparing an injection site
1. Choose an injection site
The injection site must be firm for the device to work properly.
The preferred injection site for using the Aranesp pre-filled pen is the front of the thigh.
Rotate injection site:
You may rotate the site for each injection to avoid soreness at any one site.
Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks.
2a. Instructions for preferred injection site
The front of the thigh is the preferred injection site.
2b. Instructions for alternate injection sites
When using alternate injection sites, it is particularly important to create enough surface tension on the site to be able to successfully complete the injection.
Stretch technique Stretch Make sure that skin under and around the pre-filled pen is firm and tight to provide enough resistance to fully retract the safety guard and unlock the pen.
You can use the abdomen, except for the 2 inch5 cm area around the belly button navel. For the abdomen, it is recommended to lie down on your back, and stretch the skin at the injection site to create a firm and tight surface.
If someone else is giving you the injection, they can also use the outer area of the upper arms. For the upper arms, it is recommended to stretch the skin at the injection site to create a firm and tight surface
3. Prepare the site
To prepare the area of skin where Aranesp will be injected, wipe the injection site with an alcohol wipe. Do not touch this area again before giving the injection.
7b. Injecting Aranesp using the pre-filled pen
1. Pull off the grey needle cap.
Pull off the grey needle cap Do not twist the grey needle cap Do not try to put the needle cap back onto the pre-filled pen Do pull the grey cap straight off Safety guard
2. Do not touch the red button. Press the pre-filled pen onto the skin to unlock the safety guard.
Locked with safety guard
Unlocked with safety
guard fully retracted
Do not press the red button until the safety guard is fully retracted.
Do keep enough downward pressure to fully retract the yellow safety guard and to keep the red button unlocked. Do hold the pre-filled pen at a right angle 90 to the injection site.
3. Briefly press and release red button.
- Do maintain pressure on the skin during the injection
4. Count slowly to 15 seconds for injection to end.
Medicine will be automatically injected
Do not move the pre-filled pen during the injection.
Do wait for the injection to finish before releasing pressure. You may hear a second click as the red button pops back up.
5. Check window to confirm delivery of full dose
Do check the inspection window to confirm it has turned yellow. If the inspection window is not yellow, you must contact your doctor, nurse or pharmacist. Safety guard down after use.
There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site
Do not rub the injection site.If needed, you may cover the injection site with a plaster.
If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Disposing of used pre-filled pens
- The Aranesp pre-filled pen should NEVER be reused.
- NEVER put the grey needle cap back into the used pre-filled pen.
- The used pre-filled pen should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Optional separate additional insert:
FRONT- Aranesp getting started guide:
Aranesp SureClick Pre-filled pen - Read package leaflet before use ENPreferred site is front of the thigh Turn over for injection steps Alternate sites are the abdomen or outer area of upper arms Stretch the skin on alternate injection sites GLISHStretch Injection site must be firm and tight
BACK- Aranesp getting started guide:
1 Pull off grey needle cap 5 Check window EN3 Briefly press and release red button. 4 Count slowly to 15 for injection to end. GLISH 2 Do not touch red button. Press the pen onto the skin to unlock safety guard. X Locked Click Complete when yellow Do not twist the grey needle cap Unlocked Keep unlocked against skin