NeoRecormon
epoetin beta
epoetin beta
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 only. Do not pass it on to others. It may harm them, even if their signs or illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What NeoRecormon is and what it is used for
What you need to know before you use NeoRecormon
How to use NeoRecormon
Possible side effects
How to store NeoRecormon
Content of the pack and other information
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:
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.
Talk to your doctor before using NeoRecormon
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.
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 potassium levels. 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.
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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription.
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.
No effects on ability to drive or use machines have been observed.
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’.
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.
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.
People who are not on haemodialysis will usually have injections under the skin.
Treatment with NeoRecormon is divided into two stages:
weight, given three times per week.
your dose at monthly intervals if necessary.
The weekly dose can also be divided into daily doses.
your dose may be switched to once every two weeks administration. In this case dose increases may be necessary.
Treatment with NeoRecormon is normally a long-term therapy. However, it can be interrupted at any time, if necessary.
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.
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 therapy should be continued for up to 4 weeks after the end of chemotherapy.
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.
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.
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 have missed an injection, or injected too little, talk to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using NeoRecormon if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.
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).
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 via the national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use NeoRecormon after the expiry date which is stated on the carton and label.
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).
Keep the pre-filled syringe in the outer carton, in order to protect from light.
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 protect the environment.
The active substance is epoetin beta. One pre-filled syringe contains either 500, 2000, 3000, 4000, 5000, 6000, 10,000, 20,000 or 30,000 IU (international units) epoetin beta in 0.3 ml or
0.6 ml solution.
The other ingredients are:
urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine,
L-Threonine, L-Glutamic acid, and L-Phenylalanine and water for injections.
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.
Roche Registration GmbH Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen Germany
D-79639 Grenzach-Wyhlen Germany
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
N.V. Roche S.A.
Tél/Tel: +32 (0) 2 525 82 11
UAB “Roche Lietuva”
Tel: +370 5 2546799
Рош България ЕООД Тел: +359 2 818 44 44
(Voir/siehe Belgique/Belgien)
Roche s. r. o.
Tel: +420 - 2 20382111
Roche (Magyarország) Kft.
Tel: +36 - 1 279 4500
Roche a/s
Tlf: +45 - 36 39 99 99
(See Ireland)
Roche Pharma AG Tel: +49 (0) 7624 140
Roche Nederland B.V. Tel: +31 (0) 348 438050
Roche Eesti OÜ
Tel: + 372 - 6 177 380
Roche Norge AS
Tlf: +47 - 22 78 90 00
Roche (Hellas) A.E.
Τηλ: +30 210 61 66 100
Roche Austria GmbH Tel: +43 (0) 1 27739
Roche Farma S.A.
Tel: +34 - 91 324 81 00
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 88
Roche
Tél: +33 (0) 1 47 61 40 00
Roche Farmacêutica Química, Lda
Tel: +351 - 21 425 70 00
Roche d.o.o
Tel: +385 1 4722 333
Roche România S.R.L. Tel: +40 21 206 47 01
Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0700
Roche farmacevtska družba d.o.o. Tel: +386 - 1 360 26 00
Roche a/s
c/o Icepharma hf Sími: +354 540 8000
Roche S.p.A.
Tel: +39 - 039 2471
Roche Oy
Puh/Tel: +358 (0) 10 554 500
Γ.Α.Σταμάτης & Σια Λτδ.
Τηλ: +357 - 22 76 62 76
Roche AB
Tel: +46 (0) 8 726 1200
Roche Latvija SIA Tel: +371 - 6 7039831
Roche Products (Ireland) Ltd. Tel: +44 (0) 1707 366000
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:
Intravenous administration (into the vein or vein port), only to be performed by healthcare professionals.
Subcutaneous administration (under the skin).
Keep the syringe and needle and the puncture-resistant or sharps disposal container out of reach of children.
Contact your healthcare professional if you have any questions.
Keep your unused syringe(s) in the original carton and store in a refrigerator at 2˚C to 8˚C.
Keep your syringe out of direct sunlight.
Always keep the syringe dry.
•NeoRecormon pre-filled syringe(s).
Injection needle(s) (27G or 30G) (depending on the prescribed strengths of the medicine) with safety shield (used for priming, setting the dose and injecting the medicine).
Note: Each carton contains either 1 syringe/1 needle, 4 syringes/4 needles or 6 syringes/6 needles.
Instructions for Use and a package leaflet.
1 alcohol swab.
1 dry sterile pad.
1 puncture-resistant container or sharps container for safe disposal of rubber cap, needle cap and used syringe.
Find a well-lighted, clean, flat, working surface.
Take the carton with the syringe(s) and needle(s) out of the refrigerator
Check the carton has not been damaged and check the expiration date on the carton has not passed.
Do not use if the expiration date has passed, if the syringe is dropped or damaged, or if the carton appears to be tampered with. In this case, proceed to step 19 and contact your healthcare provider.
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
Inspect the syringe and needle closely
Check the syringe and needle for any damage. Do not use the syringe if you have dropped the syringe or if any part of the syringe appears to be damaged.
Check the expiration date on the syringe and the needle. Do not use the syringe or the needle if the expiration date has passed.
Check the liquid in the syringe. The liquid should be clear and colourless. Do not use the syringe if the liquid is cloudy, discoloured, or has particles.
Place the syringe on a clean, flat surface.
Set aside the syringe for 30 minutes so it can warm up on its own to room temperature. Leave the needle cap on while it warms up.
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.
Attach the needle to the syringe.
Remove the needle from its blister.
Pull the rubber cap off the end of the syringe (A).
Dispose of the rubber cap in a puncture-resistant or sharps disposal container immediately.
Hold the syringe by the barrel and push the needle onto the syringe (B).
Gently twist until it is fully attached (C)
A)
B)
C)
Place the syringe on a clean, flat surface until ready for use.
Wash your hands with soap and water.
Choose an injection site:
The recommended injection sites are the top of your thigh or the lower part of your abdomen below the belly button. Do not inject within the 5 cm (2 inches) area directly around your belly button.
Choose a different injection site for each new injection.
Wipe the injection site with an alcohol swab and let it air dry for 10 seconds.
Move the safety shield away from the needle towards the syringe barrel.
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.
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.
Adjust to your prescribed dose by slowly pushing the plunger.
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.
Slowly inject your prescribed dose by gently pushing the plunger all the way down
Remove the needle and syringe from the injection site at the same angle as inserted.
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.
If needed, you may cover the injection site with a small bandage.
In case of skin contact with medicine, wash the area that touched the medicine with water.
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).
If you do not hear a click, look to see that the needle is fully covered by the safety shield.
Keep your fingers behind the safety shield and away from the needle at all times.
A)
B)
Put your used syringe in a sharps disposal container right away after use.
The following Instructions for Use explain how to give an intravenous injection of NeoRecormon. Be sure that you read, understand and follow the Instructions for Use as well as the package leaflet before injecting NeoRecormon.
Preparing for injection: follow steps 1 to 8
Select a vein. Change vein with each injection to prevent soreness in one spot.
Clean the skin above the vein with an alcohol swab and let dry.
Prepare the syringe and needle: follow steps 11 to 14
Insert the needle into the vein.
Slowly inject the prescribed dose by gently pushing the plunger all the way down. Remove the needle and syringe from the injection site at the same angle as inserted.
After the injection: follow steps 17 to 19
Preparing for injection: follow steps 1 to 8.
Clean the skin above the injection port with an alcohol swab and let dry. Clean the injection port as instructed by the provider.
Prepare the syringe and needle: follow steps 11 to 14.
Insert the needle into the injection port (follow the instruction of the injection port provider)
Slowly inject the prescribed dose by gently pushing the plunger all the way down. Remove the needle and syringe from the injection port at the same angle as inserted.
After the injection: follow steps 17 to 19.