Nespo - patient leaflet, side effects, dosage

2. BEFORE YOU USE NESPO

DO NOT use Nespo:

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 Nespo (darbepoetin alfa), r-HuEPO or to any of the other ingredients in Nespo.

Take special care with Nespo

Please tell your doctor if you are suffering

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 drugs used to treat anaemia; or

ergy to latex (the needle cover on the pre-filled syinge contains a derivative of latex).

Special warnings

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.

Using other medicines

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. or

Please tell your doctor if you are taking or have recently taken any other medicines, includi medicines obtained without a prescription.

Using Nespo with food and drink

Food and drink do not affect Nespo.

Pregnancy and breast-feeding

Nespo has not been tested in pregnant women. It is important

are pregnant;

think you may be pregnant; or

It is not known whether darbepoetin alfa is excreted in human milk. You must stop breast-feeding if you use Nespo.

Driving and using machines

Nespo should not affect your ability to drive or use machinery.

ests, your doctor has decided you need Nespo as your haemoglobin level is 10 g/dl doctor will tell you how much and how often you must take Nespoin order to maintain a in level between 10 and 12 g/dl. This may vary depending on whether you are an adult or a

Injecting Nespo yourself

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.

If you have chronic renal failure

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 treat

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 genetechnology) 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.

If you are receiving chemotherapy

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.

If you use more Nespo than you should

♦ c

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 forget to inject Nespo

If you have forgotten a dose of Nespo, you should contact your doctor to discuss when you should inject the next dose.

4. POSSIBLE SIDE EFFECTS

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:

Very Common (seen in more than 10 in 100 people)

High blood pressure (hypertension) Fluid retention (oedema)

Common (seen in more than 1 in 100 people)

Blood clots (thrombosis)

Pain around the area injected

Rash and/or redness of the skin

Rare (seen in more than 1 in 10,000 people)

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)

Very rare (seen in less than 1 in 10,000 people)

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.

5. HOW TO STORE NESPO

Keep out of the reach and sight of children. Keep in the original package in order to protect from light.

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.

• 6. FURTHER INFORMATION

What Nespo contains

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.

What Nespo looks like and contents of the pack

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.

Marketing Authorisation Holder :

Dompé Biotec S.p.A.

Via San Martino 12

I-20122 Milan

Italy

Manufacturer:

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Further information

If you want more information about this medicine, please contact the local representative of the company that is authorised to market Nespo.

This leaflet was last approved in.

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site:

• 7. INSTRUCTIONS FOR INJECTING WITH THE NESPO PRE-FILLED SYRINGE

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.

How do you or the person injecting you, use the Nespo pre-filled syringe?

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.

Equipment:

To give yourself an injection you will need:

• a new Nespo pre-filled syringe; and
• alcohol wipes or similar.

What should I do before I give myself a subcutaneous injection of Nespo?

• 1. 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.

• 2. Do not shake the pre-filled syringe.

• 3. Do not remove the cover from the syringe until you are ready to inject.

• 4. Check that it is the correct dose that your doctor has prescribed.

• 5. 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.

• 6. 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.

• 7. Wash your hands thoroughly.

• 8. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.

How do I prepare my Nespo injection?

Before you inject Nespo you must do the following:

• 1. To avoid bending the needle, gently pull the cover from the needle without twisting as shown in pictures 1 and 2.

• 2. Do not touch the needle or push the plunger.

• 3. 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.

• 4. You can now use the pre-filled syringe.

Where should I give my injection

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.

You may change the injection site if you notice the area is red or sore.

• 1. Disinfect your skin by using an alcohol wipe and pinch (without squeezing) the skin between your thumb and forefinger.

• 2. Put the needle fully into the skin as shown by your nurse or doctor.

• 3. 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.

• 4. Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty.

• 5. Remove the needle and let go of your skin.

• 6. 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.

• 7. Only use each syringe for one injection. Do not use any Nespo that is left in the syringe.