Aranesp (darbepoetin alfa)

How does it work?

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

Darbepoetin alfa is used to treat anaemia in people with chronic kidney failure who are undergoing dialysis, and in people with impaired kidney function who do not yet need dialysis. These people produce very little erythropoietin as a result of their kidney disease, so the number of red blood cells in their blood is low (anaemia). When darbepoetin alfa is injected, it stimulates the bone marrow to produce more red blood cells, and this corrects the anaemia.

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

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

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

What is it used for?

Treating anaemia (low numbers of red blood cells) associated with chronic kidney failure in adults and children aged 11 years and over.

Treating anaemia 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 taking 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

High platelet count

Malignant disease

High levels of potassium in the blood (hyperkalaemia).

Not to be used in

Uncontrolled 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 or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

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

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, 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 individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or 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 side effects reported by the drug's manufacturer.

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

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