Your doctor has given you Darbepoetin alfa (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. Darbepoetin alfa 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.
If you have chronic renal failure
Darbepoetin alfa 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 Darbepoetin alfa to treat your anaemia.
If you are receiving chemotherapy
Darbepoetin alfa 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.
||•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: Darbepoetin alfa 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 Darbepoetin alfa. If you experience these symptoms you should contact your doctor.
•If you are a cancer patient you should be aware that Darbepoetin alfa 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.
||•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 Darbepoetin alfa.
|Drug Special Care
||•high blood pressure which is being controlled with medicines prescribed by your doctor;
•sickle cell anaemia;
•epileptic fits (seizures);
•convulsions (fits or seizures);
•significant lack of response to medicines used to treat anaemia;
•an allergy to latex (the needle cover on the pre-filled syringe contains a derivative of latex); or
|Drug Drug Interactions
||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.
|Drug Pregnancy Interaction
||Darbepoetin alfa has not been tested in pregnant women. It is important to tell your doctor if you:
•think you may be pregnant; or
•plan to get pregnant.
|Drug Breast feeding Interaction
||It is not known whether darbepoetin alfa is excreted in human milk. You must stop breastfeeding if you use Darbepoetin alfa.
|Drug Machinery Interaction
||Darbepoetin alfa should not affect your ability to drive or use machinery.
|Drug More Information
||Food and drink do not affect Darbepoetin alfa.
|How to take the
||no data available
||Injecting Darbepoetin alfa yourself
Your doctor may decide that it is best for you or a carer to inject Darbepoetin alfa. 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 Darbepoetin alfa into a vein yourself.
If you have chronic renal failure
Darbepoetin alfa 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 Darbepoetin alfa 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
If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by gene-technology) to Darbepoetin alfa, they will choose whether you should receive your Darbepoetin alfa 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
Darbepoetin alfa 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 Darbepoetin alfa per kilogram of your body weight), or
•2.25 micrograms (once weekly) of Darbepoetin alfa 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 Darbepoetin alfa. In some cases, your doctor may recommend that you take iron supplements.
||Following blood tests, your doctor has decided you need Darbepoetin alfa as your haemoglobin level is 10 g/dl or less. Your doctor will tell you how much and how often you must take Darbepoetin alfa 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.
|Excess Drug Consumption
||You could have serious problems if you take more Darbepoetin alfa 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
|Forgot Drug Consumption
||If you have forgotten a dose of Darbepoetin alfa, you should contact your doctor to discuss when you should inject the next dose.
|Stop Drug Consumption
||Do not stop the drug untill your doctor says you to do so.
||•Fluid retention (oedema)
•High blood pressure (hypertension)
|Common Drug Side Effects
||•Pain around the area injected
•Rash and/or redness of the skin
|Rare Drug Side Effects
||•Blood clots (thrombosis)
•Pain around the area injected
•Rash and/or redness of the skin
•Blood clots (thrombosis)
|Very Rare Drug Side Effects
||•Pure red cell aplasia (PRCA) – (anaemia, unusual tiredness, lack of energy)
|Drug Side Effects Symptoms
||•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)
•Convulsions (fits and seizures) have been reported in patients treated with Darbepoetin alfa
|How to Store the
|How to Store the Medicine
||Keep out of the reach and sight of children. Do not use Darbepoetin alfa 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 Darbepoetin alfa 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 Darbepoetin alfa 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.