What is it and how is it used?

This NeoRecormon presentation contains white lyophilisate and solvent. After dissolving, NeoRecormon is injected 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.
  • 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?
Further information

What do you have to consider before using it?

Do not use NeoRecormon:

  • if you are allergic(hypersensitive) to epoetin beta or any of the other ingredients of NeoRecormon or benzoic acid, a metabolite of benzyl alcohol
  • 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.
  • in infants or young children up to 3 years, since NeoRecormon Multidose solvent contains benzyl alcohol as a preservative

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.

Special Warning

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.

How is it used?

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.

This multidose preparation can be used for several patients over a period of 1 month after reconstitution. To avoid the risk of cross-infection always follow aseptic techniques and use disposable sterile syringes and needles to administer each dose. Please check that only one vial of NeoRecormon Multidose is in use (i.e. reconstituted) at any one time.
Do not mix NeoRecormon with other injections or infusion solutions.
Use only plastic materials for injection.

Instructions for use

First wash your hands!

Preparation of NeoRecormon Multidose solution (medical care staff)(1) Take the lyophilisate vial out of the package. Write the date of reconstitution and expiry on the label (expiry is 1 month after reconstitution).
(2) Remove the plastic cap from the vial.
(3) Disinfect the rubber seal with alcohol.
(4) Take the reconstitution and withdrawal device (which allows sterile air exchange) out of the blister and remove the protective cover from the spike.
(5) Attach the device to the vial until the snap lock clicks home
(6). Put the green needle on the syringe contained in the package and remove the needle cover. (7) Hold the OPC (One-Point-Cut) ampoule with the blue point upwards. Shake or tap the ampoule to get any fluid in the stem into the body of the ampoule. Take hold of the stem and snap off away from you. Withdraw all the solvent into the syringe. Disinfect the rubber seal of the device with alcohol. (8) Penetrate the seal with the needle to a depth of about 1 cm and slowly inject the solvent into the vial. Then disconnect the syringe (with needle) from the device.
(9) Swirl the vial gently until the lyophilisate has dissolved. Do not shake. Check that the solution is clear, colourless and free of particles. If not, do not administer the injection. Put the protective cap on the top of the device.
(10) Before and after reconstitution NeoRecormon Multidose must be stored in a refrigerator at2°C ? 8°C.

Preparation of a single injection (medical care staff)(1) Before withdrawing each dose disinfect the rubber seal of the device with alcohol.

(2) Place a 26G needle onto an appropriate single-use syringe (max. 1 ml).
(3) Remove the needle cover and insert the needle through the rubber seal of the device. Withdraw NeoRecormon solution into the syringe, expel air from the syringe into the vial and adjust the amount of NeoRecormon solution in the syringe to the dose prescribed. Then disconnect the syringe (with needle) from the device.
(4) Replace the needle by a new one (the new needle should have the size which you normally use for injections).
(5) Remove the needle cover and carefully expel air from the needle by holding the syringe vertically and gently pressing the plunger upwards.

For subcutaneous injection, clean the skin at the site of injection using an alcohol wipe. Form a skin fold by pinching the skin between the thumb and the forefinger. Hold the syringe near to the needle and insert the needle into the skin with a quick, firm action. Inject NeoRecormon solution. Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.

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.

  • 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 dosefor 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.

  • 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 two 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, ask your doctor or pharmacist.

What are possible side effects?

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.

How should it be stored?

  • Keep out of the reach and sight of children.
  • Do not use NeoRecormon after the expiry date which is stated on the pack.
  • Store in a refrigerator (2°C ? 8°C).
  • The vial can be removed from the refrigerator and left at room temperature for a single period of maximum 5 days (but not above 25°C).
  • The reconstituted solution may be stored for 1 month in a refrigerator at2°C ? 8°C.
  • Keep the container 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 to protect the environment.

Further information

What NeoRecormon contains

  • The active substance is epoetin beta. One vial contains either 50,000 IU or 100,000 IU (international units) epoetin beta.
  • The other ingredients are urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate, disodium hydrogen phospate, calcium chloride, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, and L-Phenylalanine.
  • The solvent contains benzyl alcohol and benzalkonium chloride as preservatives in 10 ml (for the NeoRecormon Multidose 50,000 IU) or 5 ml (for the NeoRecormon Multidose 100,000 IU) water for injections.
What NeoRecormon looks like and contents of the pack

White lyophilisate and clear, colourless solvent

NeoRecormon Multidose is provided as a lyophilisate vial and solvent ampoule for solution for injection. Pack size of 1.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Manufacturer

Roche Diagnostics GmbH
Sandhofer Str. 116
68305 Mannheim
Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

LuxembourgLuxemburg Voirsiehe BelgiqueBelgien BelgiëBelgiqueBelgien N.V. Roche S.A. TélTel 32 0 2 525 82 11

359 2 818 44 44 Magyarország Roche Magyarország Kft. Tel 36 - 23 446 800

Malta See United Kingdom eská republika Roche s. r. o. Tel 420 - 2 20382111

Danmark Roche as Tlf 45 - 36 39 99 99 Nederland Roche Nederland B.V. Tel 31 0 348 438050

Deutschland Roche Pharma AG Tel 49 0 7624 140 Norge Roche Norge AS Tlf 47 - 22 78 90 00

Eesti Roche Eesti OÜ Tel 372 - 6 177 380 Österreich Roche Austria GmbH Tel 43 0 1 27739

Roche Hellas A.E. 30 210 61 66 100 Polska Roche Polska Sp.z o.o. Tel 48 - 22 345 18 88

España Roche Farma S.A. Tel 34 - 91 324 81 00 Portugal Roche Farmacêutica Química, Lda Tel 351 - 21 425 70 00

France Roche Tél 33 0 1 46 40 50 00 România Roche România S.R.L. Tel 40 21 206 47 01

Ireland Roche Products Ireland Ltd. Tel 353 0 1 469 0700 Slovenija Roche farmacevtska druba d.o.o. Tel 386 - 1 360 26 00

Slovenská republika Roche Slovensko, s.r.o. Tel 421 - 2 52638201 Ísland Roche as co Icepharma hf Sími 354 540 8000

Italia Roche S.p.A. Tel 39 - 039 2471 SuomiFinland Roche Oy PuhTel 358 0 10 554 500

K .. . 357 - 22 76 62 76 Sverige Roche AB Tel 46 0 8 726 1200

Latvija Roche Latvija SIA Tel 371 - 7 039831 United Kingdom Roche Products Ltd. Tel 44 0 1707 366000

Lietuva

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Tel: +370 5 2546799

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