How does it work?

Aranesp injection contains the active ingredient darbepoetinalfa, which is a synthetic version of the naturally-occurring hormoneerythropoietin. Erythropoietin is produced by healthy kidneys. It stimulatesthe bone marrow to produce red blood cells, which carry oxygen around the body.

Darbepoetin alfa is used to treat anaemia in people with chronickidney failure who are undergoing dialysis, and in people with impaired kidneyfunction who do not yet need dialysis. These people produce very littleerythropoietin as a result of their kidney disease, so the number of red bloodcells in their blood is low (anaemia). When darbepoetin alfa is injected, itstimulates the bone marrow to produce more red blood cells, and this correctsthe anaemia.

Darbepoetin alfa is also used to treat anaemia in adults withcancer who are receiving chemotherapy. Chemotherapy often kills normal healthycells such as red blood cells, as well as the cancer cells. Darbepoetin alfastimulates the bone marrow to produce more red blood cells and this treats theanaemia and reduces the chances of needing a blood transfusion.

Aranesp is given by injection into a vein (intravenously) totreat anaemia in people having kidney dialysis. The injection is administeredunder the skin (subcutaneously) to treat anaemia in cancer patients and kidneypatients who are not having dialysis.

Your doctor may also prescribe you iron supplements while youare receiving this medicine so that the body has adequate iron stores forproducing new red blood cells.

What is it used for?

• Treating anaemia (low numbers of red blood cells) that is causing symptoms in adults and children with chronic kidney failure.
• Treating anaemia that is causing symptoms in adults with cancer (non-myeloid) being treated with chemotherapy.

Warning!

• All other causes of anaemia, eg iron deficiency, vitamin B12 deficiency or folate deficiency, should be considered by your doctor and treated if necessary, before you start treatment with this medicine.
• While receiving treatment with this medicine you should have regular blood tests to monitor the levels of salts (electrolytes such as potassium), haemoglobin and blood cells in your blood.
• Your blood pressure should be regularly monitored while you are being treated with this medicine. If your blood pressure rises too high you may be prescribed a medicine to lower it.
• Tell your doctor if you experience sudden stabbing migraine-like headaches while receiving this medicine, as this may be a possible warning sign that your blood pressure is too high.
• On very rare occasions, people treated with synthetic erythropoietin medicines such as this one have produced neutralising antibodies against erythropoietin. This can stop this medicine from working and can cause the body to suddenly stop or reduce the production of red blood cells (a condition called pure red cell aplasia). This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy. If you experience these symptoms you should contact your doctor. If your body produces neutralising antibodies, your doctor will need to stop treatment with this medicine and determine the best course of action to treat your anaemia.
• Aranesp should be stored in a refrigerator at 2 to 8°C. Do not freeze. Keep the container in the outer carton, in order to protect from light.

Use with caution in

• Liver disease.
• Epilepsy.
• Sickle cell anaemia.
• High blood pressure (hypertension).
• High platelet count (thrombocytosis).
• Malignant disease.
• High levels of potassium in the blood (hyperkalaemia).

Not to be used in

• Poorly controlled high blood pressure (hypertension).
• People who have experienced a sudden drop in red blood cell production (pure red cell aplasia) during previous treatment with a synthetic erythropoietin.
• Breastfeeding.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such an allergy.

If you feel you have experienced an allergic reaction, stopusing this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• The safety of this medicine for use during pregnancy has not been established. It should be used with caution during pregnancy and only if the potential benefits outweigh any possible risks to the developing baby. Seek medical advice from your doctor.
• It is not known if this medicine passes into breast milk. It should not be used by breastfeeding mothers. Mothers who need treatment with this medicine should not breastfeed. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience thator any side effect.

• Pain at injection site.
• Headache.
• Rise in blood pressure.
• Pain in the joints in cancer patients.
• Swelling of the feet or ankles (peripheral oedema) in cancer patients.
• Increased risk of blood clots in the blood vessels, eg in a vein of the leg (deep vein thrombosis) or in the lungs (pulmonary embolism) in cancer patients.
• Convulsions in kidney failure patients.
• Allergic reactions, including shortness of breath and itchy blistering skin rash.

The side effects listed above may not include all of the sideeffects reported by the drug's manufacturer.

For more information about any other possible risks associatedwith this medicine, please read the information provided with the medicine orconsult your doctor or pharmacist.

How can this medicine affect other medicines?

This medicine is not known to affect other medicines. However,it is important to tell your doctor or pharmacist what medicines you arealready taking, including those bought without a prescription and herbalmedicines, before you start treatment with this medicine. Similarly, alwayscheck with your doctor or pharmacist before taking any new medicines while youare having treatment with this one, to ensure that thecombination is safe.

This medicine may theoretically affect the blood level of theimmunosuppressant medicines ciclosporin and tacrolimus.

If you are having haemodialysis to treat kidney failure you mayneed an increased dose of heparin while using this medicine. This is becausedarbepoetin increases the volume of cells in the blood and may thereforeincrease the risk of blood clotting in the dialysis system.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain darbepoetin alfa as the active ingredient.