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Aranesp SureClick

Last Updated on eMC 14-Aug-2013 View changes  | Amgen Ltd Contact details

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Please click on the link to the left to view the PIL in PDF format.

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Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: EU/1/01/185/068, EU/1/01/185/056, EU/1/01/185/059, EU/1/01/185/047, EU/1/01/185/061, EU/1/01/185/049, EU/1/01/185/063, EU/1/01/185/051, EU/1/01/185/064, EU/1/01/185/052, EU/1/01/185/065, EU/1/01/185/053, EU/1/01/185/066, EU/1/01/185/054, EU/1/01/185/067, EU/1/01/185/055, EU/1/01/185/073, EU/1/01/185/072.



Aranesp SureClick

Package leaflet: Information for the user

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

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1. What Aranesp is and what is it used for
2. What you need to know before you use Aranesp
3. How to use the Aranesp
4. Possible side effects
5. How to store Aranesp
6. Contents of the pack and other information
7. Instructions for injecting with the Aranesp pre-filled pen

1. What Aranesp is and what it is used for

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).

If you have chronic renal failure

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.

If you are receiving chemotherapy

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.

2. What you need to know before you use Aranesp

Do not use Aranesp:

  • if you are allergic to darbepoetin alfa or any of the other ingredients of this medicine (listed in section 6).
  • if you have been diagnosed with high blood pressure which is not being controlled with other medicines prescribed by your doctor.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Aranesp

Please tell your doctor if you are suffering or have suffered from:

  • high blood pressure which is being controlled with medicines prescribed by your doctor;
  • sickle cell anaemia;
  • epileptic fits (seizures);
  • convulsions (fits or seizures);
  • liver disease;
  • significant lack of response to medicines used to treat anaemia;
  • an allergy to latex (the needle cover on the pre-filled pen contains a derivative of latex); or
  • hepatitis C.

Special warnings:

  • If you have symptoms which include unusual tiredness and a lack of energy this could mean you have pure red cell aplasia (PRCA), which has been reported in patients. PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia. If you experience these symptoms you should contact your doctor who will determine the best course of action to treat your anaemia.
  • Take special care with other products that stimulate red blood cell production: Aranesp is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does. Your healthcare professional should always record the exact product you are using.
  • Your doctor should try to keep your haemoglobin between 10 and 12 g/dl. Your doctor will check that your haemoglobin does not exceed a certain level, as high haemoglobin concentrations could put you at risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
  • If you have chronic renal failure there is an increased risk of serious problems with your heart or blood vessels (cardiovascular events) if your haemoglobin is kept too high.
  • If you have symptoms which include severe headache, drowsiness, confusion, problems with your eyesight, nausea, vomiting or fits (seizures), it could mean that you have very high blood pressure. If you experience these symptoms you should contact your doctor.
  • If you are a cancer patient you should be aware that Aranesp may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer. Depending on your individual situation a blood transfusion may be preferable. Please discuss this with your doctor.
  • Misuse by healthy people can cause life-threatening problems with the heart or blood vessels.

Other medicines and Aranesp

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.

Using Aranesp with food and drink

Food and drink do not affect Aranesp.

Pregnancy and breast-feeding

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:

  • are pregnant;
  • think you may be pregnant; or
  • plan to get pregnant.

It is not known whether darbepoetin alfa is excreted in human milk. You must stop breast-feeding if you use Aranesp.

Driving and using machines

Aranesp should not affect your ability to drive or use machinery.

Aranesp contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

3. How to use the Aranesp

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.

Injecting Aranesp yourself

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.

If you have chronic renal failure

For all adult and paediatric patients ≥ 11 years 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:

  • 0.75 micrograms once every two weeks, or
  • 0.45 micrograms once weekly

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 ≥ 11 years of age with chronic renal failure, once your anemia is corrected you will continue to receive Aranesp given as a single injection, either once a week or once every two weeks. If you are 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.

Once your anaemia is corrected, your doctor will continue to regularly check your blood and your dose may be adjusted further in order to maintain long-term control of your anaemia. Your doctor will inform you if your dose changes.

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.

If you are receiving chemotherapy

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

  • 500 micrograms once every three weeks (6.75 micrograms of Aranesp per kilogram of your body weight), or
  • 2.25 micrograms (once weekly) of Aranesp per kilogram of your body weight.

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.

If you use more Aranesp than you should

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.

If you forget to use Aranesp

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 stop using Aranesp

If you want to stop using Aranesp, you should discuss it with your doctor first.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been experienced by some patients taking Aranesp:

Chronic renal failure patients

Very common: may affect more than 1 in 10 people

  • High blood pressure (hypertension)
  • Allergic reactions

Common: may affect up to 1 in 10 people

  • Stroke
  • Pain around the area injected
  • Rash and/or redness of the skin

Uncommon: may affect up to 1 in 100 people

  • Blood clots (thrombosis)
  • Convulsions (fits and seizures)

Not known: frequency cannot be estimated from available data

  • Pure red cell aplasia (PRCA) – (anaemia, unusual tiredness, lack of energy)

Cancer patients

Very common: may affect more than 1 in 10 people

  • Allergic reactions
  • Fluid retention (oedema)

Common: may affect up to 1 in 10 people

  • High blood pressure (hypertension)
  • Blood clots (thrombosis)
  • Pain around the area injected
  • Rash and/or redness of the skin

Uncommon: may affect up to 1 in 100 people

  • Convulsions (fits and seizures)

All patients

Not known: frequency cannot be estimated from available data

  • Serious allergic reactions which may include:
    • Sudden life-threatening allergic reactions (anaphylaxis)
    • Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
    • Shortness of breath (allergic bronchospasm)
    • Skin rash
    • Hives (urticaria)

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Aranesp

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.

6. Contents of the pack and other information

What Aranesp contains

  • The active substance is darbepoetin alfa, r-HuEPO (erythropoietin produced by gene technology).
    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:

Marketing Authorisation Holder:

Amgen Europe B.V.
Minervum 7061
NL-4817 ZK Breda
The Netherlands

Manufacturer:

Amgen Technology Ireland (ADL)
Pottery Road
Dun Laoghaire
Co Dublin
Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom
Amgen Limited
Tel:+44 (0)1223 420305

This leaflet was last revised in July 2013.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

7. Instructions for injecting with the Aranesp pre-filled pen (SureClick)

This section contains information on how to properly use the Aranesp pre-filled pen. It is important that 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.

Equipment:

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. Do not use the pre-filled pen if:

  • The solution is cloudy or there are particles in it
  • The pre-filled pen or syringe appears cracked or broken:
    • If dropped onto a hard surface the syringe in the pre-filled pen may have broken and a break may not be visible.

7. Wash your hands thoroughly.
8. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.

The Aranesp pre-filled pen has a red button at one end and a grey needle cap at the other. There is an inspection window in the barrel of the pen near the grey needle cap end.

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

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 inch/5 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. When you are ready to inject, pull the grey needle cap straight off to avoid damaging the needle inside the pre-filled pen. Do not twist or bend the grey needle cap while you are removing it. Do not try and put the grey needle cap back onto the pre-filled pen.

When you remove the grey needle cap, there may be a drop of liquid at the end of the needle, this is normal.

When the grey needle cap is removed, a yellow safety guard can be seen extending beyond the end of the pen barrel.

  • 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

2. Do not touch the red button. Press the pre-filled pen onto the skin to unlock the safety guard.

When pushing the pen at a right angle (90°) against the skin, keep thumb clear of the red button.

The yellow safety guard retracts fully when the pen is pushed firmly against the skin.

  • 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

After removing the pen from the skin, the needle safety guard extends fully below the needle and locks automatically in place. The inspection window is yellow.

  • 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.

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.

Remember

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.

Company contact details

Amgen Ltd

Company image
Address

240 Cambridge Science Park, Milton Road, Cambridge, CB4 0WD

Fax

+44 (0)1223 426 314

Medical Information e-mail
Medical Information Fax

+44 (0)1223 426 314

Telephone

+44 (0)1223 420 305

Medical Information Direct Line

+44 (0)1223 436 441

Customer Care direct line

+44 (0)808 0100 321

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

darbepoetin alfa

Legal categories

POM - Prescription Only Medicine

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