NeoRecormon is a clear, colourless solution for injection under the skin (subcutaneously) or into a vein (intravenously). It contains a hormone called epoetin beta, which stimulates the production of red blood cells. Epoetin beta is produced by a specialised genetic technology and works in exactly the same way as the natural hormone erythropoietin.
NeoRecormon injections are used for:
- Treating symptomatic anaemia caused by chronic kidney disease (renal anaemia) in patients on dialysis, or not yet on dialysis.
- Preventing anaemia in premature infants (weighing 750 to 1500 g and born at less than 34 weeks).
- Treating anaemia with related symptoms in adult cancer patients receiving chemotherapy
- Treating people donating their own blood before surgery. The injections of epoetin beta will increase the amount of blood that can be taken from your body before surgery and given back during or after the operation (this is an autologous transfusion).
|Table of Contents|
|What do you have to consider before using it?|
|How is it used?|
|What are possible side effects?|
|How should it be stored?|
Do not use NeoRecormon:
- if you are allergic(hypersensitive) to epoetin beta or any of the other ingredients of NeoRecormon
- if you have blood pressure problems that cannot be controlled
- if you are donating your own blood before surgery, and: ? you had a heart attack or stroke in the month before your treatment ? you have unstable angina pectoris ? new or increasing chest pain ? you are at risk of blood clots in the veins (deep venous thrombosis) ? for example, if you have had clots before. If any of these apply to you, or might apply, tell your doctor at once.
Take special care with NeoRecormon:
- if your anaemia does not improve with epoetin treatment
- if you are low in certain B vitamins(folic acid or vitamin B12)
- if you have very high levels of aluminium in your blood
- if your blood platelet count is high
- if you have chronic liver disease
- if you have epilepsy
- if you have developed anti-erythropoietin antibodies andpure red cell aplasia (reduced or stopped production of red blood cells) during prior exposure to any erythropoietic substance. In this case you should not be switched to NeoRecormon. If any of these apply to you, tell your doctor.
Take special care with other products that stimulate red blood cell production: NeoRecormonis one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does. Your healthcare professional will always record the exact product you are using.
During treatment with Neorecormon
If you are a patient with chronic kidney disease, your doctor will check that your haemoglobin does not exceed a certain level as high haemoglobin 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 are a cancer patient you should be aware that NeoRecormon 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.
If you are a nephrosclerotic patient and you are not on dialysis, your doctor will decide whether treatment is right for you. This is because one cannot rule out a possible acceleration of progression of kidney disease with absolute certainty.
Your doctor may do regular blood tests to check:
- your potassium level. If you have high or rising potassium levels your doctor may reconsider your treatment
- your blood platelet count. The number of platelets can rise slightly to moderately during epoetin treatment, and this can cause changes in blood clotting.
If you are a kidney patient under haemodialysis, your doctor may adjust your dose of heparin. This should avoid a blockage in the tubing of the dialysis system.
If you are a kidney patient under haemodialysis and at risk of shunt thrombosis, blood clots (thromboses) may form in your shunt (vessel used for connection to the dialysis system). Your doctor might prescribe acetylsalicylic acid or modify the shunt.
If you are donating your own blood before surgery, your doctor will need to:
- check that you are capable of giving blood, especially if you weigh less than 50 kg
- check that you have a sufficient level of red blood cells (haemoglobin of at least 11 g/dL)
- make sure that only 12 % of your blood will be donated at once.
Do not misuse NeoRecormon
Misuse of NeoRecormon by healthy people may lead to an increase in blood cells and consequently thicken the blood. This can in turn lead to life-threatening complications of the heart or blood vessels.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
There is not much experience with NeoRecormon in pregnant women or women who are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No effects on ability to drive or use machines have been observed.
Important information about some of the ingredients of NeoRecormon
This medicine contains phenylalanine. May be harmful for people with phenylketonuria. If you have phenylketonuria, talk to your doctor about your treatment with NeoRecormon. NeoRecormon is almost sodium-free.
NeoRecormon therapy is started by a doctor who is an expert on your condition. The first dose is usually given to you under medical supervision, because of the possibility of an allergic reaction.
NeoRecormon injections can then be given by a trained nurse, doctor or other professional. Once you have been shown how, you can also inject the solution yourself.
The NeoRecormon pre-filled syringe is ready for use. Each syringe should be used for a single injection only. Do not mix NeoRecormon with other injections or infusion solutions.
Instructions for use
First wash your hands!
1 Remove one syringe from the pack.
Check the liquid in the syringe:
- is it clear?
- is it colourless?
- is it free of particles? If the answer is NO to any question, do not administer the injection. Dispose of it and start again with a different syringe. If you answer yes to all three, remove the cap from the syringe and go to step 2.
2 Remove a needle from the pack, fix it securely on to the syringe and remove the protective cap
from the needle.
3 Expel air from the syringe and needle. Do this by lightly tapping on the upper half of the
syringe. This will cause any air bubbles to rise to the top. Then hold the syringe vertically and the needle upwards, and gently push the plunger upwards. Keep pushing the plunger until the amount of NeoRecormon in the syringe is as prescribed.
4 Clean the skin at the injection site using an alcohol wipe. Form a skin fold by pinching the
skin between thumb and forefinger.
5 Holding the syringe near the needle, insert the needle into the skin fold with a quick, firm
action. Inject the NeoRecormon solution. Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.
The dose of NeoRecormon depends on your disease condition, the way the injection is given (under the skin or into a vein) and your body weight. Your doctor will work out the right dose for you.
- Symptomatic anaemia caused by chronic kidney disease
Your injections are given under the skin or into a vein. If the solution is given into your vein it should be injected over about 2 minutes, eg people on haemodialysis will receive the injection via the arterio-venous fistula at the end of dialysis.
People who are not on haemodialysis will usually have injections under the skin.
Treatment with NeoRecormon is divided into two stages:
a) Correcting the anaemia The initial dose for injections under the skin is 20 IU per injection for every 1 kg of your body weight, given three times per week. After 4 weeks, the doctor will do tests and, if the treatment response is not sufficient, your dose may be raised to 40 IU/kg per injection, given three times per week. The doctor may continue to increase your dose at monthly intervals if necessary. The weekly dose can also be divided into daily doses. The initial dose for injections into veins is 40 IU per injection for every 1 kg of your body weight, given three times per week. After 4 weeks, the doctor will do tests and, if the treatment response is not sufficient, your dose may be raised to 80 IU/kg per injection, given three times per week. The doctor may continue to increase your dose at monthly intervals if necessary. For both types of injection, the maximum dose should not exceed 720 IU for every 1 kg of your body weight per week.
b) Maintaining sufficient red blood cell levels The maintenance dose: Once your red blood cells reach an acceptable level, the dose is reduced to half of the dose used to correct the anaemia. The weekly dose can be given once per week, or divided into three or seven doses per week. If your red blood cell level is stable on a once weekly dosing regimen, your dose may be switched to once every two weeks administration. In this case dose increases may be necessary. Every one or two weeks, the doctor may adjust your dose to find your individual maintenance dose. Children will start by following the same guidelines. In trials, children usually needed higher doses of NeoRecormon (the younger the child, the higher the dose). Treatment with NeoRecormon is normally a long-term therapy. However, it can be interrupted at any time, if necessary.
- Anaemia in premature infants
Injections are given under the skin.
The initial dose is 250 IU per injection for every 1 kg the infant weighs, three times a week.
Treatment with NeoRecormon should start as early as possible, preferably by day 3 of the infant?s life. Premature infants who have been transfused before the start of treatment with NeoRecormon are not likely to benefit as much as untransfused infants.
The treatment should last for 6 weeks.
- Adults with symptomatic anaemia receiving chemotherapy for cancer
Injections are given under the skin.
Your doctor may initiate treatment with NeoRecormon if your haemoglobin level is 10 g/dL or less. After initiation of therapy, your doctor will maintain your haemoglobin level between 10 and 12 g/dL.
The initial weekly dose is 30,000 IU. This may be given as one injection per week, or in divided doses as 3 to 7 injections per week. Your doctor will take regular blood samples. He or she may raise or lower your dose, or interrupt your treatment according to the test results.The haemoglobin values should not exceed a value of 12 g/dL.
The therapy should be continued for up to 4 weeks after the end of chemotherapy.
The maximum dose should not exceed 60,000 IU per week.
- People donating their own blood before surgery
Injections are given into a vein over 2 minutes, or under the skin.
The dose of NeoRecormon depends on your condition, red blood cell levels and how much blood will be donated before surgery.
The dose worked out by your doctor will be given twice per week for 4 weeks. When you donate blood, NeoRecormon will be given to you at the end of a donation session.
The maximum dose should not exceed
- for injections into veins: 1600 IU for every 1 kg of your body weight per week
- for injections under the skin: 1200 IU for every 1 kg of your body weight per week.
If you inject too much NeoRecormon
Do not increase the dose your doctor has given you. If you think you have injected more NeoRecormon than you should, contact your doctor. It is unlikely to be serious. Even at very high blood levels, no symptoms of poisoning have been observed.
If you forget to take NeoRecormon
If you have missed an injection, or injected too little, talk to your doctor.
Do not take a double dose to make up for any forgotten doses.
If you have any further questions on the use of this product, as your doctor or pharmacist.
Like all medicines, NeoRecormon can cause side effects, although not everybody gets them.
Side effects which can affect any patient
- Most people get lower levels of iron in their blood. Almost all patients have to be treated with iron supplements during their NeoRecormon therapy.
- Rarely, allergies or skin reactions, such as rash or hives, itching or reactions around the injection site have occurred.
- Very rarely a severe form of allergic reaction has occurred, especially just after an injection. It needs to be treated at once. If you get unusual wheezing or difficulty breathing; swollen tongue, face or throat, or swelling around the injection site; if you feel lightheaded or faint or if you collapse, call your doctor at once.
- Very rarely people experienced flu-like symptoms, especially when they just started treatment. These include fever, chills, headaches, pain in the limbs, bone pain and/or feeling generally unwell. These reactions were usually mild to moderate and went away within a few hours or days.
Additional side effects in people with chronic kidney disease (renal anaemia)
- Increase in blood pressure, worsening of existing high blood pressure and headache are the most common side effects. Your doctor will regularly check your blood pressure, particularly at the beginning of therapy. Your doctor may treat the high blood pressure with drugs or temporarily interrupt your NeoRecormon therapy.
- Call a doctor at once if you get headaches, especially sudden, stabbing, migraine-like headaches, confusion, speech disturbance, unsteady walking, fits or convulsions. These may be signs of severely elevated blood pressure (hypertensive crisis), even if your blood pressure is usually normal or low. It needs to be treated at once.
- If you have low blood pressure or shunt complications you may be at risk of shunt thrombosis (a blood clot in the vessel used for connection to the dialysis system).
- Very rarely, patients have had rising levels of potassium or phosphates in the blood. This can be treated by your doctor.
- Pure red cell aplasia (PRCA) caused by neutralising antibodies has been observed during erythropoietin therapy, including in isolated cases during therapy with NeoRecormon. PRCA means that the body stopped or reduced the production of red blood cells. This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy. If your body produces neutralising antibodies, your doctor will discontinue therapy with NeoRecormon, and determine the best course of action to treat your anaemia.
Additional side effects in adults receiving chemotherapy for cancer
- Increase in blood pressure and headache may occasionally occur. Your doctor may treat the high blood pressure with drugs.
- An increase in the occurrence of blood clots has been observed.
Additional side effects in people donating their own blood before surgery
- A slight increase in the occurrence of blood clots has been observed.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- Keep out of the reach and sight of children.
- Do not use NeoRecormon after the expiry date which is stated on the pack.
- Keep the pre-filled syringe in the outer carton, in order to protect from light.
- Store in a refrigerator (2°C ? 8°C).
- The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 3 days (but not above 25°C).
- 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 NeoRecormon contains
- The active substance is epoetin beta. One pre-filled syringe contains either 500, 1,000, 2,000, 3,000, 4,000, 5,000, 6,000, 10,000, 20,000 or 30,000 IU (international units) epoetin beta in 0.3 ml or 0.6 ml water for injections.
- The other ingredients are urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, disodium phospate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, and L-Phenylalanine.
What NeoRecormon looks like and contents of the pack
Colourless, clear to slightly opalescent solution.
NeoRecormon is provided as a solution for injection in 1, 4 or 6 pre-filled syringes with 1, 4 or 6 needles.
Pack size of 1, 4 or 6.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Roche Registration Limited
6 Falcon Way
Welwyn Garden City
Roche Diagnostics GmbH
Sandhofer Str. 116
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
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