Active ingredient
- epoetin beta
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/97/031/025, EU/1/97/031/026, EU/1/97/031/029, EU/1/97/031/030, EU/1/97/031/031, EU/1/97/031/032, EU/1/97/031/033, EU/1/97/031/034, EU/1/97/031/043, EU/1/97/031/044, EU/1/97/031/035, EU/1/97/031/036, EU/1/97/031/037, EU/1/97/031/038, EU/1/97/031/045, EU/1/97/031/046, EU/1/97/031/041, EU/1/97/031/042.
Neorecormon Solution for Injection in Pre-Filled Syringe
Package leaflet: Information for the user
NeoRecormon 500 IU
NeoRecormon 2000 IU
NeoRecormon 3000 IU
NeoRecormon 4000 IU
NeoRecormon 5000 IU
NeoRecormon 6000 IU
NeoRecormon 10,000 IU
NeoRecormon 20,000 IU
NeoRecormon 30,000 IU
solution for injection in pre-filled syringe
epoetin beta
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What NeoRecormon is and what it is used for
2. What you need to know before you use NeoRecormon
3. How to use NeoRecormon
4. Possible side effects
5. How to store NeoRecormon
6. Content of the pack and other information
1. What NeoRecormon is and what it is used for
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.
You must talk to your doctor if you do not feel better or if you feel worse.
NeoRecormon is indicated for:
2. What you need to know before you use NeoRecormon
Do not use NeoRecormon
If any of these apply to you, or might apply, tell your doctor at once.
Warnings and precautions
Talk to your doctor before using NeoRecormon
Take special care with other products that stimulate red blood cell production:
NeoRecormon is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does. Your doctor will always record the exact product you are using.
Serious skin reaction including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-likes symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications.
If you develop a serious rash or another of these skin symptoms, stop taking NeoRecormon and contact your doctor or seek medical attention immediately.
Special Warning:
During treatment with NeoRecormon
If you are a patient with chronic kidney disease, and particularly if you do not respond properly to NeoRecormon, your doctor will check your dose of NeoRecormon because repeatedly increasing your dose of NeoRecormon if you are not responding to treatment may increase the 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:
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:
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.
Other medicines and NeoRecormon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
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.
NeoRecormon has not shown evidence of impaired fertility in animals. The potential risk for humans is unknown.
Driving and using machines
No effects on ability to drive or use machines have been observed.
NeoRecormon contains phenylalanine and sodium
This medicine contains phenylalanine. May be harmful for people with phenylketonuria.
If you have phenylketonuria, talk to your doctor about your treatment with NeoRecormon.
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.
3. How to use NeoRecormon
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
If you do not respond adequately to NeoRecormon, your doctor will check your dose and will inform you if you need to change doses.
Treatment must be started under the supervision of your doctor.
Further injections are given by your doctor or, after you have been trained, you can inject NeoRecormon yourself (see instructions at the end of this leaflet.)
NeoRecormon can be injected under the skin in the abdomen, arm or thigh, or into a vein. Your doctor will decide which is best for you.
Your doctor will carry out regular blood tests to monitor how your anaemia is responding to treatment by measuring your haemoglobin level.
NeoRecormon dosing
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. Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
If you do not respond adequately to NeoRecormon, your doctor will check your dose and will inform you if you need to change doses of NeoRecormon.
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, e.g. people on haemodialysis will receive the injection via the arteriovenous 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 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.
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.
Premature infants who have been transfused before the start of treatment with NeoRecormon are not likely to benefit as much as untransfused infants.
The recommended treatment duration is 6 weeks.
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.
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
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 use 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects which can affect any patient
Additional side effects in people with chronic kidney disease (renal anaemia)
Additional side effects in adults receiving chemotherapy for cancer
Additional side effects in people donating their own blood before surgery
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below) By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store NeoRecormon
6. Contents of the pack and other information
What NeoRecormon contains
What NeoRecormon looks like and contents of the pack
NeoRecormon is a solution in a pre-filled syringe for injection
The solution is colourless, clear to slightly opalescent.
NeoRecormon 500 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU and 6000 IU: Each pre-filled syringe contains 0.3 ml solution.
NeoRecormon 10,000 IU, 20,000 IU and 30,000 IU: Each pre-filled syringe contains 0.6 ml solution.
NeoRecormon is provided in the following pack-sizes:
NeoRecormon 500 IU
1 pre-filled syringe with 1 needle (30G1/2) or
6 pre-filled syringes with 6 needles (30G1/2).
NeoRecormon 2000 IU, 3000 IU, 4000 IU, 5000 IU, 6000 IU, 10,000 IU and 20,000 IU
1 pre-filled syringe with 1 needle (27G1/2) or
6 pre-filled syringes with 6 needles (27G1/2).
NeoRecormon 30,000 IU
1 pre-filled syringe with 1 needle (27G1/2) or
4 pre-filled syringes with 4 needles (27G1/2).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in December 2020
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
NeoRecormon pre-filled syringe
Instructions for Use
The following instructions explain how to give an injection of NeoRecormon. Be sure that you read, understand and follow the Instructions for Use as well as the package leaflet before injecting NeoRecormon. Your healthcare provider will show you how to prepare and inject NeoRecormon properly before you use it for the first time. Do not inject yourself unless you have received training.
Consult your healthcare provider if you require further information.
NeoRecormon can be administered through 2 manners, your doctor will decide which way is right for you:
Before you begin
Storage Instructions
Supplies needed to give your injection
Included in the carton:
Note: Each carton contains either 1 syringe/1 needle, 4 syringes/4 needles or 6 syringes/6 needles.
Not included in the box:
Preparing for injection
1 Find a well-lighted, clean, flat, working surface.
2 Check the carton has not been damaged and check the expiration date on the carton has not passed.
3 Take one syringe out of the carton and one needle from the needle box. Be careful when taking out the syringe. Make sure you always hold the syringe as shown in the picture below.
Remark: If you have a multipack, put the carton with the remaining syringe(s) and needle(s) back into the refrigerator
4 Inspect the syringe and needle closely
5 Place the syringe on a clean, flat surface.
Remark: If the syringe does not reach room temperature, this could cause the injection to feel uncomfortable and make it hard to push the plunger.
6 Attach the needle to the syringe.
7 Place the syringe on a clean, flat surface until ready for use.
8 Wash your hands with soap and water.
9 Choose an injection site:
10 Wipe the injection site with an alcohol swab and let it air dry for 10 seconds.
Administering the subcutaneous injection
11 Move the safety shield away from the needle towards the syringe barrel.
12 Hold the syringe and needle tightly at the hub and carefully pull the injection needle cap away from the syringe. Use the syringe within 5 minutes of removing the cap; otherwise, the needle may clog.
Throw away the needle cap in a sharps disposal container immediately.
13 Hold the syringe with the needle pointing up. Remove the larger air bubbles by gently tapping the syringe barrel with your fingers until the air bubbles rise to the top of the syringe. Then, slowly push the plunger up to push the air bubbles out of the syringe.
14 Adjust to your prescribed dose by slowly pushing the plunger.
15 Pinch the selected injection site and fully insert the needle at a 45° to 90° angle with a quick, firm action.
Once the needle is inserted, release the pinch and hold the syringe tightly in place.
16 Slowly inject your prescribed dose by gently pushing the plunger all the way down
After the injection
17 There may be a little bleeding at the injection site. You can press a dry sterile pad over the injection site. Do not rub the injection site.
18 Move the safety shield forward 90°, away from the syringe barrel (A).
Holding the syringe with one hand, press the safety shield down against a flat surface with a firm, quick motion until you hear a “click” (B).
19 Put your used syringe in a sharps disposal container right away after use.
Important: Always keep the sharps disposal container out of the reach of children.
uk-pil-NeoRecormon-clean-201208-pfs
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