Patient Leaflet Updated 04-Apr-2022 | Amgen Ltd
Aranesp Sure-Click Pen
Aranesp 10 micrograms solution for injection in pre-filled pen (SureClick)
Aranesp 15 micrograms solution for injection in pre-filled pen (SureClick)
Aranesp 20 micrograms solution for injection in pre-filled pen (SureClick)
Aranesp 30 micrograms solution for injection in pre-filled pen (SureClick)
Aranesp 40 micrograms solution for injection in pre-filled pen (SureClick)
Aranesp 50 micrograms solution for injection in pre-filled pen (SureClick)
Aranesp 60 micrograms solution for injection in pre-filled pen (SureClick)
Aranesp 80 micrograms solution for injection in pre-filled pen (SureClick)
Aranesp 100 micrograms solution for injection in pre-filled pen (SureClick)
Aranesp 130 micrograms solution for injection in pre-filled pen (SureClick)
Aranesp 150 micrograms solution for injection in pre-filled pen (SureClick)
Aranesp 300 micrograms solution for injection in pre-filled pen (SureClick)
Aranesp 500 micrograms solution for injection in pre-filled pen (SureClick)
darbepoetin alfa
1. What Aranesp is and what it is used for
2. What you need to know before you use Aranesp
3. How to use Aranesp
4. Possible side effects
5. How to store Aranesp
6. Contents of the pack and other information
Your doctor has given you Aranesp (an anti-anaemic) to treat your anaemia. Anaemia is when your blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and shortness of breath.
Aranesp works in exactly the same way as the natural hormone erythropoietin. Erythropoietin is produced in your kidneys and encourages your bone marrow to produce more red blood cells. The active substance of Aranesp is darbepoetin alfa produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
Aranesp is used to treat symptomatic anaemia that is associated with chronic renal failure (kidney failure) in adults and children. In kidney failure, the kidney does not produce enough of the natural hormone erythropoietin which can often cause anaemia.
Because it will take your body some time to make more red blood cells, it will be about four weeks before you notice any effect. Your normal dialysis routine will not affect the ability of Aranesp to treat your anaemia.
Aranesp is used to treat symptomatic anaemia in adult cancer patients with non-bone marrow cancers (non-myeloid malignancies) who are receiving chemotherapy.
One of the main side effects of chemotherapy is that it stops the bone marrow producing enough blood cells. Towards the end of your chemotherapy course, particularly if you have had a lot of chemotherapy, your red blood cell count may fall making you anaemic.
Talk to your doctor, pharmacist or nurse before using Aranesp
Please tell your doctor if you are suffering or have suffered from:
Special warnings:
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Cyclosporin and tacrolimus (medicines which suppress the immune system) may be affected by the number of red cells in your blood. It is important to tell your doctor if you are taking either of these medicines.
Food and drink do not affect Aranesp.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Aranesp has not been tested in pregnant women. It is important to tell your doctor if you:
It is not known whether darbepoetin alfa is excreted in human milk. You must stop breast-feeding if you use Aranesp.
Aranesp should not affect your ability to drive or use machinery.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Following blood tests, your doctor has decided you need Aranesp as your haemoglobin level is 10 g/dL or less. Your injection is to be given under the skin (subcutaneous), and so you may use the Aranesp pre-filled pen. Your doctor will tell you how much and how often you must take Aranesp in order to maintain a haemoglobin level between 10 and 12 g/dL. This may vary depending on whether you are an adult or a child.
Your doctor has decided that the Aranesp pre-filled pen is the best way for you, a nurse or a carer to inject Aranesp. Your doctor, nurse or pharmacist will show you how to inject yourself with the pre-filled pen. Do not try to inject yourself if you have not been trained. Never inject Aranesp into a vein yourself. The pre-filled pen is designed to inject the area under your skin only.
For instructions on use of the pre-filled pen, please read the section at the end of this leaflet.
For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, Aranesp pre-filled pen is given as a single injection, under your skin (subcutaneous).
In order to correct your anaemia, your initial dose of Aranesp per kilogram of your body weight will be either:
For adult patients not on dialysis, 1.5 micrograms/kg once monthly may also be used as the initial dose.
For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, once your anaemia is corrected you will continue to receive Aranesp given as a single injection, either once a week or once every two weeks. For all adults and paediatric patients ≥ 11 years of age not on dialysis, Aranesp could also be given as an injection once monthly.
Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose once every four weeks as necessary in order to maintain long term control of your anaemia.
Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
If you do not respond adequately to Aranesp, your doctor will check your dose and will inform you if you need to change doses of Aranesp.
Your blood pressure will also be checked regularly, particularly at the beginning of your treatment.
In some cases, your doctor may recommend that you take iron supplements.
Your doctor may decide to change the way that your injection is given (either under the skin or into a vein). If this changes you will start on the same dose as you have been receiving and your doctor will take blood samples to make sure that your anaemia is still being managed correctly.
If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by gene-technology) to Aranesp, they will choose whether you should receive your Aranesp injection once weekly or once every two weeks. The route of injection is the same as with r-HuEPO but your doctor will tell you how much you should take, and when, and may adjust your dose if necessary.
Aranesp is given as a single injection, either once a week or once every three weeks, under your skin.
In order to correct your anaemia, your initial dose will be:
Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose as necessary. Your treatment will continue until approximately four weeks after the end of your chemotherapy. Your doctor will tell you exactly when to stop taking Aranesp.
In some cases, your doctor may recommend that you take iron supplements.
You could have serious problems if you use more Aranesp than you need, such as very high blood pressure. You should contact your doctor, nurse or pharmacist if this does happen. If you feel unwell in any way you should contact your doctor, nurse or pharmacist immediately.
Do not use a double dose to make up for a forgotten dose.
If you have forgotten a dose of Aranesp, you should contact your doctor to discuss when you should inject the next dose.
If you want to stop using Aranesp, you should discuss it with your doctor first.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Chronic renal failure patients
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Not known: frequency cannot be estimated from available data
Cancer patients
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
All patients
Not known: frequency cannot be estimated from available data
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the pre-filled pen label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze. Do not use Aranesp if you think it has been frozen.
Keep the pre-filled pen in the outer carton in order to protect from light.
When your pen has been removed from the refrigerator and left at room temperature for approximately 30 minutes before injection it must either be used within 7 days or disposed of.
Do not use this medicine if you notice the pre-filled pen contents are cloudy or there are particles in it.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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.
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in March 2022.
It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider.
There are additional educational materials available to train you on how to self administer Aranesp pre-filled pen, a dummy demonstration device and a poster-size instructions for use for patients/caregivers with diminished eyesight.
Important: Needle is inside the yellow safety guard.
Before you use the Aranesp SureClick pre-filled pen, read this important information:
Storing your Aranesp SureClick pre-filled pens
Using your Aranesp SureClick pre-filled pens
For more information or help, contact your healthcare provider.
A Remove one pre-filled pen from the carton.
Carefully lift the pre-filled pen straight up out of the carton.
Put the original carton with any unused pre-filled pens back in the refrigerator.
Leave the pre-filled pen at room temperature for at least 30 minutes before injecting.
B Inspect the pre-filled pen.
Make sure the medicine in the window is a clear and colourless liquid.
In all cases, use a new pre-filled pen and contact your healthcare provider.
C Gather all the materials needed for your injection.
Wash your hands thoroughly with soap and water.
On a clean, well-lit work surface, place the:
D Prepare and clean your injection site.
You can use:
Clean the injection site with an alcohol wipe. Let your skin dry.
Important: Follow your healthcare provider’s instructions about selecting sites for injection appropriate to you and about changing the site for each injection.
E Pull the grey cap straight off, only when you are ready to inject. Do not leave the grey cap off for more than five minutes. This can dry out the medicine.
It is normal to see a drop of liquid at the end of the needle or yellow safety guard.
If you are unable to inject, please contact your healthcare provider immediately.
F Stretch or pinch your injection site to create a firm surface.
Stretch method
Stretch your skin firmly by moving your thumb and fingers in opposite directions, creating an area about 5 cm (2-inches) wide.
OR
Pinch method
Pinch your skin firmly between your thumb and fingers, creating an area about 5 cm (2-inches) wide.
Important: It is important to keep your skin stretched or pinched while injecting.
G Keep stretching or pinching your skin. With the grey cap off, place the pre-filled pen on your skin at 90 degrees.
Important: Do not touch the red start button yet.
H Firmly push the pre-filled pen down onto your skin until it stops moving.
The safety guard retracts when pushed onto a firm injection site.
Important: You must push the pre-filled pen all the way down but do not touch the red start button until you are ready to inject.
I When you are ready to inject, press the red start button.
J Keep pushing the pre-filled pen down on your skin. Your injection could take about 15 seconds.
Window turns yellow when the injection is done
Note: After you remove the pre-filled pen from your skin, the needle will be automatically covered.
Important: When you remove the pre-filled pen, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose. Contact your healthcare provider immediately.
K Examine the injection site.
L Dispose of the used pre-filled pen and grey cap.
Put the used pre-filled pen in the sharps disposal container immediately after use.
Talk with your healthcare provider about proper disposal. There may be local guidelines for disposal.
Important: Always keep the sharps disposal container out of the sight and reach of children.
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