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.
What do you have to consider before using it?
DO NOT use Aranesp:
Take special care with Aranesp
Please tell your doctor if you are suffering or have suffered from:
Special warnings
pressure. This has been reported in patients with chronic renal failure treated with Aranesp. If you experience these symptoms you should contact your doctor.
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:
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.
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:
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
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.
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)
Common (seen in more than 1 in 100 people)
Rare (seen in more than 1 in 10,000 people)
Cancer patients
Very common (seen in more than 10 in 100 people)
Common (seen in more than 1 in 100 people)
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)
Frequency unknown
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 pre-filled syringe 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 syringe in the outer carton in order to protect from light.
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 if you notice the pre—filled syringe 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.