What is it and how is it used?

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.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

DO NOT use Aranesp:

  • if you have been diagnosed with high blood pressure which is not being controlled with other medicines prescribed by your doctor; or
  • if you are allergic to darbepoetin alfa, r-HuEPO (erythropoietin produced by gene technology) or to any of the other ingredients in Aranesp.
Take special care with 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; 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. This has been reported in patients with chronic renal failure treated with Aranesp. 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.
Using 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.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using Aranesp with food and drink

Food and drink do not affect Aranesp.

Pregnancy and breast-feeding

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.

Important information about some of the ingredients of Aranesp

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

How is it used?

Following blood tests, your doctor has decided you need Aranesp as your haemoglobin level is 10 g/dl or less. 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.

The injections will be given by a healthcare professional.

If you have chronic renal failure

Aranesp is given as a single injection by a healthcare professional, either once a week, once every two weeks, or once every month either under your skin (subcutaneous) or into a vein (intravenous).

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 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 receive more Aranesp than you need. 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 miss a dose of Aranesp

If you miss a dose of Aranesp, you should contact your doctor to discuss when you should receive the next dose.

What are possible side effects?

Like all medicines, Aranesp may cause side effects, although not everybody gets them.

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

Chronic renal failure patients

Very Common (seen in more than 10 in 100 people)

  • High blood pressure (hypertension)
Common (seen in more than 1 in 100 people)

  • Pain around the area injected
  • Rash and/or redness of the skin
Rare (seen in more than 1 in 10,000 people)

  • Blood clots (thrombosis)
Cancer patients

Very common (seen in more than 10 in 100 people)

  • Fluid retention (oedema)
Common (seen in more than 1 in 100 people)

  • Blood clots (thrombosis)
  • Pain around the area injected
  • Rash and/or redness of the skin
The following side effects have been experienced by some patients after Aranesp has been marketed:

Very rare (seen in less than 1 in 10,000 people)

  • Pure red cell aplasia (PRCA) ? (anaemia, unusual tiredness, lack of energy)
Frequency unknown

  • 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)
  • Convulsions (fits and seizures) have been reported in patients treated with Aranesp
  • Hypertension

If you have any of these symptoms or you notice any side effects that are not mentioned in this leaflet, please tell your doctor, nurse or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Aranesp after the expiry date which is stated on the carton and on the vial 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 vial in the outer carton in order to protect from light.

When your vial 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 Aranesp if you notice the vial contents are cloudy or there are particles in it.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Aranesp contains

  • The active substance is darbepoetin alfa.The vial contains either 25, 40, 60, 100, 200 or 300 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 vial.

Aranesp is available in packs of 1 or 4 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Amgen Europe B.V.
Minervum 7061
NL-4817 ZK Breda
The Netherlands

Further information

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

Lietuva

Amgen Switzerland AG Vilniaus filialas
Tel: +370 6983 6600

This leaflet was last approved in

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