Nespo
darbepoetin alfa
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.
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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.
What Nespo is and what is it used for
Before you use Nespo
How to use Nespo
Possible side effects
How to store Nespo
Further information
Instructions for injecting with the Nespo pre-filled syringe
Your doctor has given you Nespo (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.
Nespo 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 Nespo is darbepoetin alfa produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
Nespo 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 Nespo to treat your anaemia.
Nespo 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.
if you have been diagnosed with high blood pressure which is not being controlled with other medicines prescribed by your doctor; or
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if you are allergic to Nespo (darbepoetin alfa), r-HuEPO or to any of the other ingredients in Nespo.
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; or
an allergy to latex (the needle cover on the pre-filled syinge contains a derivative of latex).
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 Nespo 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.
Cyclosporin 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.
Nespo has not been tested in pregnant women. It is important to tell your doctor if you:
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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 Nespo.
Nespo should not affect your ability to drive or use machinery.
Following blood tests, your doctor has decided you need Nespo as your haemoglobin level is 10 g/dl or less. Your doctor will tell you how much and how often you must take Nespoin 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.
Your doctor may decide that it is best for you or a carer to inject Nespo. 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 Nespo into a vein yourself.
Nespo 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 Nespo 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 Nespo, they will choose whether you should receive your Nespo 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.
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Nespo 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 Nespo per kilogram of your body
weight), or
2.25 micrograms (once weekly) of Nespo 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 Nespo.
In some cases, your doctor may recommend that you take iron supplements.
You should have no serious problems if you take more Nespo than you need. However, 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 have forgotten a dose of Nespo, you should contact your doctor to discuss when you should inject the next dose.
Like all medicines, Nespo may cause side effects, although not everybody gets them. The following side effects have been experienced by some patients taking Nespo:
High blood pressure (hypertension)
Fluid retention (oedema)
Blood clots (thrombosis)
Pain around the area injected
Rash and/or redness of the skin
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 (dyspnoea)
Skin rash
Hives (urticaria)
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Pure red cell aplasia (PRCA) – (anaemia, unusual tiredness, lack of energy) Convulsions (fits and seizures) have been reported in patients treated with Nespo.
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.
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 Nespo 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 Nespo after the expiry date which is stated on the carton and on the pre-filled pen 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.
Nespo 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.
Nespo also contains sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 and water for injections.
Nespo is a clear, colourless or slightly pearly liquid. If it is cloudy or there are particles in it, you must not use it.
Nespo 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.
Via San Martino 12 I-20122 Milan
Italy
NL-4817 ZK Breda
The Netherlands
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If you want more information about this medicine, please contact the local representative of the company that is authorised to market Nespo.
This section contains information on how to give yourself an injection of Nespo. 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.
Your doctor has prescribed an Nespo pre-filled syringe for injection into the tissue just under the skin. Your doctor, nurse, or pharmacist will tell you how much Nespo you need and how frequently it should be injected.
To give yourself an injection you will need:
a new Nespo pre-filled syringe; and
alcohol wipes or similar.
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 Nespo 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.
Do not shake the pre-filled syringe.
Check that it is the correct dose that your doctor has prescribed.
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.
Check the appearance of Nespo. 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.
Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
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Before you inject Nespo you must do the following:
To avoid bending the needle, gently pull the cover from the needle without twisting as shown in pictures 1 and 2.
Do not touch the needle or push the plunger.
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.
You can now use the pre-filled syringe.
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The best places to inject yourself arethe top of your thighs andthe abdomen. If someone else is injecting for you, they can also use the back of your arms.
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You may change the injection site if you notice the area is red or sore.
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Disinfect your skin by using an alcohol wipe and pinch (without squeezing) the skin between your thumb and forefinger.
Put the needle fully into the skin as shown by your nurse or doctor.
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.
Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty.
Remove the needle and let go of your skin.
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.
Only use each syringe for one injection. Do not use any Nespo that is left in the syringe.
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.
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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.