ARANESP PFS

Aranesp 10 micrograms solution for injection in a pre-filled syringe

Aranesp 15 micrograms solution for injection in a pre-filled syringe

Aranesp 20 micrograms solution for injection in a pre-filled syringe

Aranesp 30 micrograms solution for injection in a pre-filled syringe

Aranesp 40 micrograms solution for injection in a pre-filled syringe

Aranesp 50 micrograms solution for injection in a pre-filled syringe

Aranesp 60 micrograms solution for injection in a pre-filled syringe

Aranesp 80 micrograms solution for injection in a pre-filled syringe

Aranesp 100 micrograms solution for injection in a pre-filled syringe

Aranesp 130 micrograms solution for injection in a pre-filled syringe

Aranesp 150 micrograms solution for injection in a pre-filled syringe

Aranesp 300 micrograms solution for injection in a pre-filled syringe

Aranesp 500 micrograms solution for injection in a pre-filled syringe

darbepoetin alfa

Please read this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, nurse or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

In this leaflet

• 1. What Aranesp is and what is it used for


• 2. Before you use Aranesp


• 3. How to use Aranesp


• 4. Possible side effects


• 5. How to store Aranesp


• 6. Further information


• 7. Instructions for injecting with the Aranesp pre-filled syringe

What Aranesp Is And What Is It 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. At first, only white blood cells seem to be affected. This is because the red blood cells have a much longer life span in the circulating blood. 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.

Before You Use Aranesp

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 Aranesp (darbepoetin alfa), r-HuEPO 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 drugs used to treat anaemia;


• an allergy to latex (the needle cover on the pre-filled syringe 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.


• Your doctor should try to keep your haemoglobin between 10 and 12 g/dl.


• 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 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

Ciclosporin and tacrolimus 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 drugs.

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.

How To Use Aranesp

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.

Injecting Aranesp yourself

Your doctor may decide that it is best for you or a carer to inject Aranesp. Your doctor, nurse or pharmacist will show you how to inject yourself with the pre-filled syringe. Do not try to inject yourself if you have not been trained. Never inject Aranesp into a vein yourself.

If you have chronic renal failure

Aranesp is given as a single injection, 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 take 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 forget to inject Aranesp

If you have forgotten a dose of Aranesp, you should contact your doctor to discuss when you should inject the next dose.

ARANESP PFS 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 taking Aranesp:

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

• High blood pressure (hypertension)


• 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

Rare (seen in more than 1 in 10,000 people)

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)

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

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

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

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 To Store Aranesp

Keep out of the reach and sight of children. Keep in the original package in order to protect from light.

Store in a refrigerator (2°C – 8°C). Do not freeze. Do not use Aranesp if you think it has been frozen.

When your syringe 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 after the expiry date which is stated on the carton and on the pre-filled syringe label after EXP. The expiry date refers to the last day of that month.

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

Aranesp comes in a pre-filled syringe that contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 or 500 micrograms of the active substance darbepoetin alfa.

Aranesp also contains 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 liquid. If it is cloudy or there are particles in it, you must not use it.

Aranesp is available in packs of 1 or 4 pre-filled syringes (not all pack sizes may be marketed). The syringes are provided either with (1- & 4-pack) or without (1-pack) a blister-wrapping.

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.

United Kingdom

Amgen Limited

Tel:+44 (0)1223 420305

This leaflet was last approved in March 2010.

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

Instructions For Injecting With The Aranesp Pre-Filled Syringe

This section contains information on how to give yourself an injection of Aranesp. 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 the Aranesp pre-filled syringe?

Your doctor has prescribed an Aranesp pre-filled syringe 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.

Equipment:

To give yourself an injection you will need:

• a new Aranesp pre-filled syringe; and


• alcohol wipes or similar.

What should I do before I give myself a subcutaneous injection of Aranesp?

• 1. Remove the pre-filled syringe from the refrigerator. Leave the pre-filled syringe at room temperature for approximately 30 minutes. This will make the injection more comfortable. 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 syringe exposed to direct sunlight.


• 2. Do not shake the pre-filled syringe.


• 3. Do not remove the cover from the syringe 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 syringe label (EXP:). Do not use it if the date has passed the last day of the month shown.


• 6. Check the appearance of Aranesp. 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.

How do I prepare my Aranesp injection?

Before you inject Aranesp you must do the following:

• 1. To avoid bending the needle, gently pull the cover from the needle without twisting as shown in pictures 1 and 2.


• 2. Do not touch the needle or push the plunger.


• 3. You may notice a small air bubble in the pre-filled syringe. You do not have to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless.


• 4. You can now use the pre-filled syringe.

Where should I give my injection?

The best places to inject yourself are the top of your thighs and the abdomen. If someone else is injecting for you, they can also use the back of your arms.

You may change the injection site if you notice the area is red or sore.

How do I give my injection?

• 1. Disinfect your skin by using an alcohol wipe and pinch (without squeezing) the skin between your thumb and forefinger.


• 2. Put the needle fully into the skin as shown by your nurse or doctor.


• 3. Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, pull the needle out and re-insert it in another place.


• 4. Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty.


• 5. Remove the needle and let go of your skin.


• 6. If you notice a spot of blood you may gently dab it away with a cotton ball or tissue. Do not rub the injection site. If needed, you may cover the injection site with a plaster.


• 7. Only use each syringe for one injection. Do not use any Aranesp that is left in the syringe.

Remember: If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.

Disposing of used syringes

• Do not put the cover back on used needles, as you may accidentally prick yourself.


• Keep used syringes out of the reach and sight of children.


• The used pre-filled syringe 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.