(epoetin alfa)

Brand name: Eprex.

Active ingredient: Epoetin alfa (erythropoietin), 1,000 IU in 0.5 ml; 2,000, 4,000 and 10,000 lU/ml in vials and 1,000 IU/0.5 ml, 2,000 IU/0.5 ml, 3,000 IU/ 0.3 ml, 4,000 IU/0.4 ml and 10,000 lU/ml pre-filled syringes.

Sodium chloride, sodium citrate dihydrate, citric acid anhydrous, human serum albumin, water for injection (vials).

Sodium chloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate, human serum albumin, water for injection (pre-filled syringe).

Eprex comes in packs of six, clear glass vials or pre-filled injection syringes, each containing a clear, colourless solution.

Eprex is a medicine which contains epoetin alfa, a hormone that stimulates the bone marrow to produce more red blood cells.

Product licence holder: Janssen-Cilag Limited, Saunderton, High Wycombe, Buckinghamshire HP14 4HJ.

Manufactured by: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340, Beerse, Belgium

and/or Hoffman La-Roche, Grenzacher Strasse 124, Basel, Switzerland

and/or Vetter Pharma-Fertigung, Schutzenstrasse 99101, 7980 Ravensburg, Germany.

Eprex is used to treat the anaemia associated with kidney disease. If you have kidney disease, your kidney may not produce enough erythropoietin (necessary for red cell production) and your doctor may wish to correct this by prescribing Eprex. This medicine stimulates your bone marrow to produce more red blood cells, helping to treat your anaemia.

Eprex can also be used to treat anaemia in patients who are receiving platinum-chemotherapy.

Doctors can also prescribe Eprex to mildly anaemic patients who are going to have surgery and prior to it, donate blood so that their own blood can be given to them during or after surgery. Because Eprex stimulates the production of red blood cells, a higher volume of blood can be taken from these patients.

Your doctor may prescribe this medicine for other reasons. You should discuss this with him/her.

Do not use this medicine if you have high blood pressure which is not properly controlled with blood pressure-lowering drugs.

Please tell your doctor if you know you are suffering or have suffered, from any of the following:

• heart disease (such as angina)
• disorders of blood circulation resulting in pins and needles or cold hands or feet; or muscle cramps in the legs
• blood clotting disorders
• epileptic fits or seizures
• cancer
• liver disease

Also, tell your doctor if:

• you know you are allergic to any of the ingredients in Eprex
• you are pregnant or think you may be pregnant or are breast feeding

Eprex does not normally react with other medicines but please tell your doctor if you are using, or have recently used anything else to treat your present symptoms.

If you are taking a drug called cyclosporin to suppress your immune system after a kidney transplant, your doctor may order special blood tests to measure cyclosporin levels while you are taking Eprex.

Iron supplements and other blood stimulants may increase the effectiveness of Eprex. Your doctor will decide if it is right for you to take them.

Eprex should be given alone. It should not be mixed with other liquids for injection.

If you are receiving dialysis treatment when you begin treatment with Eprex your dialysis regimen may need to be adjusted. Your doctor will decide this.

Remember to tell your doctor that you are receiving Eprex if you have to visit the hospital or family doctor for any treatment, or to visit the clinic for a blood test; Eprex may affect the results.

Your doctor will conduct investigations, for example blood tests, to help decide if it is necessary for you to have Eprex. He/she will work out the right dose of Eprex for you to use and for how long the treatment should last. These decisions will be influenced by whether you are receiving dialysis or not and if you are receiving dialysis, whether this is through a vein (haemodialysis) or your abdomen (peritoneal dialysis) .

Only one dose of Eprex should be taken from each injection vial. Any fluid which remains should be thrown away.

If Eprex is injected under the skin (subcutaneously) the amount injected in any one place should not normally exceed one millilitre (1 ml).

Eprex injection should not be shaken.

The dose you receive is based on your body weight in kilograms. The usual starting dose of Eprex is 50 International Units (IU) per kilogram. This is given three times a week by injection into a vein (over 1-2 minutes) or under the skin. Depending on how your anaemia responds to treatment, the dose may be adjusted approximately every four weeks until your condition is controlled. Your doctor may order regular blood tests to see that this is being achieved. The dose you receive should not normally exceed 200 IU per kilogram, three times a week.

When your condition has been brought under control, you will receive regular doses of Eprex, two or three times a week. These doses may not be as high as those you received initially.

Eprex should be given after you have received a dialysis session.

The dose you receive is based on your body weight in kilograms. The usual starting dose is 50 IU per kilogram. This is given twice a week, injected under the skin. Depending on how your anaemia responds, the dose may be adjusted approximately every four weeks until your condition is controlled. Your doctor may order regular blood tests to see that this is being achieved. The total weekly dose that you receive should not normally exceed 200 IU per kilogram.

The dose you receive is based on your body weight in kilograms. The usual starting dose is 50 IU per

kilogram. This is given three times a week by injection usually under the skin but sometimes into a vein.

The starting dose may be adjusted by your doctor until your condition is controlled. Your doctor may order regular blood tests to see that control is being achieved. After your condition has been brought under control, you will receive regular doses of Eprex, three times a week. The dosage should not normally exceed 200 IU per kilogram, three times a week.

The dose you receive is based on your body weight in kilograms. The usual starting dose is 150 IU per kilogram. This is given 3 times a week by injection under the skin. The starting dose may be adjusted by your doctor depending on how your anaemia responds to treatment; you will usually receive Eprex until one month after the end of chemotherapy.

The dose you receive is based on your body weight in kilograms. The usual starting dose is 600 IU per kilogram. This is given 2 times a week by injection into a vein. You will receive Eprex during the 3 weeks before your surgery. You will also take iron supplements before and during Eprex treatment to increase the effectiveness of Eprex.

The dose for children is based on body weight in kilograms. The usual starting dose is 50 IU per kilogram. This is given three times a week, injected into a vein (over 1-2 minutes). Depending on how the anaemia responds, the dose may be adjusted approximately ever 4 weeks until the condition is controlled. Your doctor will order regular blood tests to see that this is being achieved.

Eprex should be given after the child has received a dialysis session.

Once your condition is controlled you will receive regular doses of Eprex. Your doctor may decide that it is better for you to receive Eprex by injection under the skin (subcutaneous) rather than into a vein (intravenous).The dose should remain the same while the change is being made. Afterwards, your doctor may order blood tests to see if any adjustment in dose is required.

At the start of your therapy, Eprex may be injected by medical or nursing staff. However, your doctor may decide that it is right for you to learn how to inject Eprex under the skin (subcutaneously) yourself. You will receive appropriate training for you to do this. Under no circumstances should you attempt to inject yourself unless you have been trained to do so.

Eprex has a wide safety margin and side effects due to an overdose of taking Eprex are unlikely. You should inform the doctor or nurse immediately if you think too much Eprex has been injected.

As with any other medicine, Eprex may cause unwanted side effects.If you experience headaches, particularly sudden, stabbing migraine-like headaches or start to feel confused or have fits, tell your doctor or nursing staff immediately. These may be the warning signs of a sudden rise in blood pressure which requires urgent treatment.

Other side effects may include:

• raised blood pressure which may require treatment with drugs or adjustment of the dosage of drugs you already take for high blood pressure. Your doctor will monitor your blood pressure regularly while you are taking Eprex.
• flu-like symptoms, such as headache, aches and pains in the joints, feeling of weakness, tiredness dizziness and chills. These may be more common at the start of treatment. If you experience these symptoms during the injection of Eprex into a vein, slower injection may help to avoid them.
• fits (seizures), skin rashes and accumulation of fluid under the skin of the eyelids (oedema), which may result from an allergic reaction.
• an increase in levels of small cells (called platelets) in your blood may occur, particularly when starting treatment. Your doctor will check on this.

• a raised level of potassium in the blood (hyperkalaemia). Your doctor will be able to detect this from a blood test. If it is found, he may decide to stop treatment with Eprex until it is controlled.
• Blood clot formation (thrombosis) in your shunt. This is more likely if you have low blood pressure or if your fistula has complications. If this is the case your doctor may recommend aspirin.
• clotting of blood in the haemodialysis system. There may be a need to increase your heparin dose during dialysis.

In hospital vials and pre-filled syringes are stored unopened in a refrigerator between 2 and 8 degrees centigrade. Vials and pre-filled syringes should be protected from light.

If you are using Eprex at home, it is important that

this too is stored in your refrigerator although not in the freezer compartment. Eprex should not be frozen. Leave Eprex vial or syringe to stand for a few minutes until it reaches room temperature prior to using it.

Eprex should not be used:

• after the expiry date on the label
• if the seal is broken
• if the liquid is coloured or you can see particles floating in it
• if you know, or think that it may have been accidentally frozen

Always keep medicine out of the reach of children.

Date of preparation of this leaflet: February 1995

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