Dynepo
epoetin delta
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What Dynepo is and what it is used for
Before you take Dynepo
How to take Dynepo
Possible side effects
How to store Dynepo
Medicinal product no longer authorised
Further information
Epoetin delta is a human erythropoietin made by a technology process called gene-activation, which uses a human cell line.
Epoetin delta is a hormone which stimulates the production of red blood cells in the bone marrow. Red blood cells are very important since they contain haemoglobin, a protein which distributes oxygen in your body.
Dynepo is used for treating the symptoms of anaemia (which include tiredness, weakness and shortness of breath) associated with chronic renal failure in adult patients, Anaemia is a blood disorder characterised by a decrease in red blood cells. Dynepo may be used in patients on dialysis (a blood clearance technique) or in patients not on dialysis.
if you are allergic (hypersensitive) to epoetin delta or any of the other ingredients of Dynepo.
if you have difficulties controlling your blood pressure.
Your doctor will closely monitor your haemoglobin concentration level to keep it within the target range of 10 to 12 g/dl and may therefore need to change your dosage of Dynepo accordingly. Occasionally, your individual haemoglobin values may be above and below this recommended target level. Your doctor will manage your dosage so that haemoglobin concentrations will not consistently be above 12 g/dl which may be associated with a higher risk of cardiovascular events (e.g. heart attacks).
Your blood pressure needs to be checked closely before and during treatment with Dynepo. If your blood pressure rises, your doctor may give you medicines to reduce your blood pressure or increase the dosage of your existing blood pressure lowering medication. It may also be necessary to reduce your dose of Dynepo or to stop the treatment for a short period of time.
If you have severe headache, stabbing migraine-like headaches or fits, you should see your doctor at once. It could be a consequence of a marked rise in your blood pressure.
Your doctor will measure your blood iron level during treatment with Dynepo and may give you iron supplements.
Your doctor will monitor the different chemical levels in your blood including: creatinine, potassium. During dialysis, an increase in the dose of the anticoagulation treatment is frequently required since the
increased number of red blood cells may cause blocking of the dialysis tubes.
Dynepo may not be suitable for patients under 18 years old, or for patients with renal or liver problems.
Dynepo should not be used by healthy persons. Severe reactions, possibly fatal, involving the heart and blood vessels may occur.
Dynepo is not approved for use in cancer patients.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Medicinal product no longer authorised
However, so far, no interactions with other medicines have been reported during treatment with Dynepo.
Food and drink has no influence on Dynepo.
Inform your doctor if you are pregnant or breast-feeding or think you might be pregnant. Your doctor will consider what is the best treatment for you during your pregnancy.
No effects on ability to drive and use machines have been observed.
Your doctor will be experienced in the treatment of renal failure and the use of erythropoietin. Your first dose will be given under medical supervision as rarely, an allergic-type reaction may occur.
Dynepo may be administered intravenously (into a vein) or subcutaneously (under the skin). In patients not on haemodialysis, where intravenous access is not readily available, Dynepo is usually given subcutaneously.
When given subcutaneously, the site of injection should be changed with each injection.
Your dose of Dynepo will be determined by your doctor and will be adjusted individually according to your personal needs.
Your doctor should maintain your haemoglobin level within the target range of 10 to 12 g/dl. Occasionally, your individual haemoglobin values may be below and above this recommended target level. However your haemoglobin level should not consistently exceed 12 g/dl. You will be monitored
closely to ensure the lowest dose of Dynepo is used to provide adequate control of your symptoms of anaemia.
Always take Dynepo exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.
The usual starting dose is 50 IU/kg three times a week if administered intravenously or 50 IU/kg twice a week if administered subcutaneously.
The maintenance dose will be then decided by your doctor to maintain the level of your haemoglobin within the target range.
Mainly because of the time required for the production of new red blood cells, an interval of approximately 4 weeks may occur between the dose and an improvement in your anaemia. Your doctor will probably not make changes to your dosage more than once a month.
After any change to the dose, you will have frequent blood tests (once a week) until your haemoglobin level reaches the target range. Your haemoglobin level should then be controlled at regular intervals.
Dynepo therapy is usually a long-term treatment.
Dynepo can be given in a very large range of doses. If you accidentally give yourself too large a dose, tell your doctor. It may be necessary to monitor your blood.
Medicinal product no longer authorised
Do not take a double dose to make up for a forgotten individual dose. Take your next dose at the normal time.
Do not stop taking Dynepo before discussing the implications with your doctor or pharmacist.
Your doctor may decide that it would be best for you to inject Dynepo yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been trained.
For information on how to inject Dynepo yourself, please read the instructions at the end of this leaflet.
Like all medicines, Dynepo can cause side effects, although not everybody gets them.
If any of the side effects get serious, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
The most frequent side effects observed (in 1% to 10% of patients) with Dynepo are:
increase in blood pressure. Even patients with normal blood pressure may have a marked rise in their blood pressure and existing high blood pressure can get worse (See 2. Before you take Dynepo).
if you are on haemodialysis you may experience blockage of the dialysis tubes as your anaemia improves (increase in red blood cells). An increase in the dose of the anticoagulation treatment is frequently required to prevent the blockage occurring.
headache
Other side effects that occur less frequently (in 0.1% to 1% of patients) include itching, pain, reaction at the site of injection (such as soreness and bleeding), flu-syndrome, diarrhoea, nausea.
Convulsions have been rarely reported (less than 1 every 1000 patients).
Dynepo may also cause changes in the composition of your blood. This includes increase in the number of red blood cells and in the number of platelets.
There may be also changes in the chemistry of your blood, including increase of creatinine, potassium levels.
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the carton and on the label of the syringe after “EXP”. The expiry date refers to the last day of the month.
Store in a refrigerator (2oC to 8oC). Keep the container in the outer carton in order to protect from light. Do not freeze.
Unopened pre-filled syringes may be kept un-refrigerated but below 25oC for a sinlge maximum period of 5 days. The 5 day period must end before the expiry date stated on the carton and label of the syringe after ‘EXP’. Following 5 days storage at below 25oC the pre-filled syringes must be discarded.
The solution is clear, colourless and waterlike with no visible particles. Do not use it if it is cloudy or has visible particles. Do not shake the syringe before use.
Discard the syringe after initial single use.
Medicinal product no longer authorised
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.
What Dynepo contains
The active substance is epoetin delta, 0.5 ml of the solution containing 1,000 IU (International Units) (2,000 IU/ml), 0.5 ml of the solution containing 2,000 IU (4,000 IU/ml), 0.3 ml of the solution containing 3,000 IU (10,000 IU/ml), 0.4ml of the solution containing 4,000 IU (10,000 IU/ml), 0.5 ml of the solution containing 5,000 IU (10,000 IU/ml), 0.3 ml of the solution containing 6,000 IU (20,000 IU/ml), 0.4 ml of the solution containing 8,000 IU (20,000 IU/ml), or 0.5 ml of the solution containing 10,000 IU/ml (20,000 IU/ml) of epoetin delta.
The other ingredients of Dynepo are sodium phosphate monobasic (monohydrate), sodium phosphate dibasic (heptahydrate), polysorbate 20, sodium chloride and water for injections
Dynepo contains less than 1mmol of sodium (23 mg) per dose, i.e. it is essentially "sodium-free".
What Dynepo looks like and contents of the pack
Solution for injection in a pre-filled syringe.
The dosage of solution is:
- 1,000 IU in 0.5 ml
- 2,000 IU in 0.5 ml
- 3,000 IU in 0.3 ml
- 4,000 IU in 0.4 ml
- 5,000 IU in 0.5 ml
- 6,000 IU in 0.3 ml
- 8,000 IU in 0.4 ml
- 10,000 IU in 0.5 ml
Available in packs of 6 pre-filled syringes.
Dynepo is a clear, colourless and waterlike solution for injection containing epoetin delta.
The marketing authorisation holder for Dynepo is Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, United Kingdom
The manufacturer is Shire Human Genetic Therapies AB, Åldermansgatan 2, P.O. Box 1117 SE-221 04 Lund, Sweden.
Medicinal product no longer authorised
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Shire Pharmaceuticals Ltd
Hampshire International Business Park, Chineham, Basingstoke
Hampshire, RG 24 8EP
Vereinigtes Königreich/Royaume-Uni, Verenigd Kononkrijk
Tel. : +44 1256 894 894
Shire Pharmaceuticals Ltd
Hampshire International Business Park, Chineham, Basingstoke
Hampshire, RG 24 8EP,
Vereinigtes Königreich/Royaume-Uni Tel. : +44 1256 894 894
Shire Pharmaceuticals Ltd
Hampshire International Business Park, Chineham, Basingstoke
Hampshire, RG 24 8EP, Великобритания /Velká Británie/Storbritannien/Ühendkuningriik/
Hνωµέυο Βασίλειο/United Kingdom/Bretland/ Lielbritānija/Jungtinė Karalystė/Nagy- Britannia/Verenigd Koninkrijk/ Storbritannia/Wielka Brytania/ Marea Britanie
Medicinal product no longer authorised
/Velika Britanija/Vel’ká Británia/Iso- Britannia/Storbritannien Tel/Tlf/Tηλ/Sími/Puh: +44 1256 894 894
Shire France S.A. 88, rue du Dome
92514 Boulogne-Billancourt Cedex
Tel.: +33 (1) 46 10 90 00
Shire Deutschland GmbH Siegburger Str. 229b 50679 Köln
Tel.: + 49 221 802 500
Shire Pharmaceuticals Iberica, S.L. Paseo Pintor Rosales, 40 Bajo Izda. 28008 Madrid, Espanha
Tel. : +34 91 550 06 91
Shire Pharmaceuticals Iberica, S.L. Paseo Pintor Rosales, 40 Bajo Izda. 28008 Madrid
Tel. : +34 91 550 06 91
Shire Italia S.p.A Corso Italia, 29
50123 Firenze Tel.: + 39 055 288860
This leaflet was last approved on MM/YYYY
Information on how to give yourself an injection of Dynepo
This section contains information on how to give yourself an injection of Dynepo. It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. Dynepo is provided with a needle guard for your protection and you will be shown how to
use this by your doctor or nurse. If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.
How do I inject Dynepo myself?
You will need to give yourself an injection into the tissue under the skin, known as a subcutaneous injection. Your dose of Dynepo may vary depending on your weight and on your response to the treatment. Your doctor or nurse will tell you how much Dynepo you need and how frequently it should be injected.
Equipment that you need
To give yourself a subcutaneous injection you will need a new pre-filled syringe of Dynepo with needle guard.
What should I do before I give myself a subcutaneous injection of Dynepo?
Take your Dynepo pre-filled syringe out of the refrigerator.
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 Dynepo. It must be clear. If it is cloudy or there are particles in it, you must not use it.
For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in you hand for a few minutes. Do not warm Dynepo in any other way (for example, do not warm it in a microwave or in hot water).
Medicinal product no longer authorised
Find a comfortable, well-lit place and put the Dynepo pre-filled syringe where you can reach it. How do I prepare my Dynepo injection?
Before you inject Dynepo you must do the following:
Hold the syringe assembly by the sides of the device and gently remove the plastic cover and rubber guard from the needle without twisting. Pull straight. 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. Where should I give my injection?
The most suitable places to inject yourself are:
The top of your thighs; and
The abdomen, except for the area around the naval.
Change the place that you inject each time so you don’t become sore in one area. If someone else is injecting for you, they can also use the back of your arms.
How do I give my injection?
Clean your skin and then pinch the skin between your thumb and forefinger, without squeezing it.
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, remove the needle and put it in another place.
Depress the plunger slowly and evenly while holding the syringe barrel, always keeping your skin pinched.
Ensure that you only inject the amount as instructed by your doctor or nurse.
After injecting the liquid, remove the needle and let go of your skin.
Let go of the plunger allowing the syringe to move up inside the device until the entire needle is guarded.
Only use each syringe for one injection. Remember
If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice. Disposing of used syringes
Medicinal product no longer authorised
Your Dynepo syringe is provided with a needle guard to prevent needle stick injuries after use, so no special disposal precautions are required.