Recormon® (Epoetin beta)

RECORMON contains the active ingredient epoetin beta (recombinant human erythropoietin). This active ingredient in RECORMON is a hormone that stimulates the production of red blood cells.

WHAT IS IT

RECORMON is used to treat anaemia caused by kidney disease, to prevent or treat anaemia caused by some anti-cancer medicines, to treat anaemia caused by some cancers of the blood (multiple myeloma, non-Hodgkin's lymphoma or leukaemia) and to prevent anaemia in babies born more than six weeks early.

RECORMON is also used to increase the amount of blood that can be given by patients who are donating their own blood for an up-coming operation (increasing the yield of your own blood). It is normally only used or this purpose if large amounts of blood are required, and the patient is anaemic but is not low in iron.

Ask your doctor if you have any questions about why RECORMON has been prescribed for you. Your doctor may have prescribed RECORMON for another purpose. This medicine is available only with a doctor's prescription.

BEFORE YOU TAKE IT

When you must not use it

Do not use RECORMON if:

You have had an allergic reaction to RECORMON or any ingredients listed at the end of this page
You have poorly controlled hypertension (high blood pressure)
If RECORMON is being used to increase the yield of your own blood, do not use RECORMON if:

In the month before starting RECORMON you have had a heart attack or stroke
You have poorly controlled angina
You have, or have had, problems with blood clots in your veins

The package is torn or shows signs of tampering
The expiry date printed on the pack has passed
If you have this medicine after the expiry date has passed, it may not work as well.

If you are not sure if you should be using RECORMON, talk to your doctor.

Before you use it, tell your doctor if:

you are pregnant or plan to become pregnant
It is not known whether RECORMON is harmful to an unborn baby when used by a pregnant woman. RECORMON should not be used during pregnancy.
you are breastfeeding or plan to breastfeed
Breast-feeding is not recommended if you are using RECORMON.
you have any other health problems, especially the following:

refractory anaemia (anaemia where previous treatments have not been successful)
epilepsy
increased level of platelets in the blood (thrombocytosis)
liver disease
a deficiency in folic acid or Vitamin B12 (cyanocobalamin)
excess levels of aluminium in the blood as a result of kidney disease treatment
severe phenylketonuria - each RECORMON pre-filled syringe contains up to 0.3mg phenylalanine

if you are using RECORMON for increasing the yield of your own blood, tell your doctor if you weigh less than 50kg
you are allergic to any other medicines, foods, dyes or preservatives

If you have not told your doctor about any of the above, you should do so before you start using RECORMON.

NOTE: Misuse of RECORMON by healthy people may lead to an excessive increase in the number of blood cells in the blood. Such an increase may cause life-threatening effects on the heart and blood circulation systems.

Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you have bought from a pharmacy, supermarket or health food shop.

Generally, RECORMON is unlikely to have any effect on other medications you may be taking. However, your doctor or pharmacist may have information on medicines to be careful with or avoid while having RECORMON.

Ask your doctor or pharmacist if you are not sure about any medicine.

HOW TO TAKE IT

Your doctor will tell you how much RECORMON to inject, and how often each week you should inject it.

Treatment of anemia due to kidney disease

Treatment with RECORMON is normally divided into two phases - a correction phase and a maintenance phase. The correction phase will treat your anaemia. The maintenance phase is intended to help prevent your anaemia from coming back.

Correction Phase

Subcutaneous Administration (injection just under the skin)

It is recommended that your doctor or nurse administer the first dose. The usual initial dose is 20IU per kg bodyweight three times a week. This dosage may be increased every four weeks by 20IU per kg bodyweight three times a week depending on your response to the medicine. RECORMON may also be administered daily - your doctor will tell you the dose.

Intravenous Administration (injection directly into a vein)

The usual initial dose is 40IU per kg bodyweight three times a week. This dose may be raised after 4 weeks to 80IU per kg bodyweight three times per week, and then increased by 20IU per kg bodyweight three times a week every four weeks depending on your response to the medicine.

For both routes of administration, the maximum dose would not usually exceed 720IU per kg bodyweight per week.

Maintenance Phase

Once the desired packed cell volume (number of blood cells in your blood) has been achieved in the correction phase, treatment will move on to the maintenance phase. Usually, the weekly dosage is initially reduced to half that of the correction phase. Then the weekly dose may be adjusted every one or two weeks depending on your response to the medicine. The number of injections per week may stay the same as in the correction phase or be reduced to as few as one per week.

Prevention and treatment of anaemia due to some anti-cancer medicines

The usual initial dose of RECORMON is 450IU per kg bodyweight each week, subcutaneously. This dosage may be increased after four weeks to 900IU per kg bodyweight each week and further adjustments may be made depending on your response to the medicine.

The weekly dose will be divided into 3 or 7 single doses - your doctor will advise you on how much to inject and on what days to have the injection. RECORMON may be continued for up to three weeks after your anti-cancer treatment has stopped. RECORMON treatment may be stopped at any time depending on your blood counts.

Treatment of anaemia caused by some cancers of the blood

The usual maximum dose is 900IU per kg bodyweight each week. The weekly dose will be divided into 3 or 7 single doses - your doctor will advise you on how much to inject and on what days to have the injection. RECORMON may be continued for up to four weeks after your anti-cancer treatment has stopped. RECORMON treatment may be stopped at any time depending on your blood counts.

Increasing the yield of your own blood

RECORMON may be given intravenously or subcutaneously. The dose is calculated specifically for you depending on the amount of blood required and your own blood reserves. The dose is usually administered two times a week for 4 weeks, so long as your blood counts indicate that treatment can continue. Normally the treatment would be given immediately after you have donated blood.

The usual maximum total dose each week is 1600IU per kg bodyweight for intravenous administration and 1200IU per kg bodyweight for subcutaneous administration. Your doctor may ask you to take iron supplements (by mouth or by injection) while you are using RECORMON to increase your blood yield.

Prevention of anaemia in premature babies

The usual dose is 250IU per kg bodyweight given three times a week, as an injection just under the skin. Treatment will normally start by the third day after the baby is born and lasts about six weeks. The baby may also be given an iron supplement.

Intravenous administration

Only a health professional should administer RECORMON intravenously.

Subcutaneous administration

RECORMON would normally be given to premature babies by a health professional. For other uses, you may be able to administer RECORMON yourself.

First wash your hands!!

Remove one syringe from the pack and check that the solution is clear, colourless and practically free from visible particles. Remove the cap from the syringe
Remove one needle from the pack, fix it on the syringe and remove the protective cap from the needle.
Expel air from the syringe and needle by holding the syringe vertically and gently pressing the plunger upwards. Keep pressing the plunger until the amount of RECORMON in the syringe is as prescribed.
Clean the skin at the site of subcutaneous injection using an alcohol wipe. Form a skin fold by pinching the skin between thumb and forefinger. Hold the syringe barrel near to the needle and insert the needle into the skin fold with a quick, firm action. Inject the RECORMON solution. Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.

Note: The instructions from your doctor or nurse on how to inject RECORMON yourself may be different from the method given above. RECORMON in prefilled syringes is a sterile but unpreserved product. Under no circumstances should more than one dose be administered from the syringe.

POSSIBLE SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are having RECORMON. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

Changes in your blood levels of iron, which may make you pale, feel tired and lack energy. Your doctor may prescribe an iron supplement for you.

Tell your doctor immediately or go to your nearest Accident and Emergency centre if you notice any of the following:

headache, particularly sudden stabbing migraine-like headaches
confusion
slurred speech or unsteady gait
numbness or weakness of the arms and legs
collapse
severe pain in the chest
very painful and swollen calf muscle (muscle of the lower leg)
seizures
sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing

These may be serious side effects. You may need urgent medical attention.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known. Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list. Ask your doctor or pharmacist if you don't understand anything in this list. Do not be alarmed by this list of possible side effects. You may not experience any of them.

STORING IT

Keep your RECORMON in the packet until it is time to have it.
Keep RECORMON in the refrigerator where the temperature stays between 2 and 8 degrees.
When away from home RECORMON prefilled syringes may be removed from the refrigerator and stored at room temperature (below 25 degrees) for one single period of up to 3 days.
Do not store RECORMON or any other medicine in a bathroom or near a sink or any other place where there is high humidity.
Do not leave RECORMON in the car or on windowsills. Heat and dampness can destroy some medicines.
Keep RECORMON where young children cannot reach it.

Disposal

If your doctor tells you to stop having RECORMON, or the injections have passed their expiry date, ask your pharmacist what to do with any medicine that is left over.

FURTHER INFORMATION

Availability

RECORMON prefilled syringes come in seven strengths - 1000IU in 0.3mL, 2000IU in 0.3mL, 3000IU in 0.3mL, 4000IU in 0.3mL, 5000IU in 0.3mL, 6000IU in 0.3mL and 10,000IU in 0.6mL.

Each pre-filled syringe pack contains 6 pre-filled syringes with solution for injection and 6 needles.

Active ingredient - epoetin beta

each 1000IU prefilled syringe contains 1000IU (8.3mcg) epoetin beta
each 2000IU prefilled syringe contains 2000IU (16.6mcg) epoetin beta
each 3000IU prefilled syringe contains 3000IU (24.9mcg) epoetin beta
each 4000IU prefilled syringe contains 4000IU (33.2mcg) epoetin beta
each 5000IU prefilled syringe contains 5000IU (41.5mcg) epoetin beta
each 6000IU prefilled syringe contains 6000IU (49.8mcg) epoetin beta
each 10,000IU prefilled syringe contains 10,000IU (83mcg) epoetin beta

Inactive ingredients - each strength of RECORMON also contains urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate, sodium monohydrogen phosphate, calcium chloride, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine and water for injection.

For more information about this medicinal product, please contact your doctor or pharmacist.