Eprex ® 000 Iu

EPREX is a solution for injection, which contains erythropoietin, a protein that stimulates the bone marrow to produce more red blood cells, which carry haemoglobin (a substance that transports oxygen). Epoetin alfa is a copy of the human protein erythropoietin and acts in the same way.

• EPREX is used to treat symptomatic anaemia caused by kidney disease
• EPREX is also used to treat anaemia if you are receiving chemotherapy for some cancers.
• EPREX is used in moderately anaemic people who donate some of their blood before surgery, so that it can be given back to them during or after the operation. Because EPREX stimulates the production of red blood cells, doctors can take more blood from these people.
• EPREX can be used in moderately anaemic adults about to have major orthopaedic surgery (for example hip or knee replacement operations), to reduce the need for potential blood transfusions.

If you are being treated for anaemia associated with kidney disease, EPREX should be given by intravenous injection. You should not be given EPREX:

• if you develop antibody-mediated pure red cell aplasia (PRCA) [i.e. the bone marrow cannot produce enough red blood cells] following treatment with any erythropoietin.
• if you have high blood pressure, which is not properly controlled.
• If you are hypersensitive (allergic) to animal derived products.
• If you are hypersensitive (allergic) to the active substance (erythropoietin) or any of the other ingredients of EPREX. (Refer to WHAT EPREX CONTAINS, above).
• If you are a cancer patient be aware that EPREX may act as a growth factor and therefore may affect the progression of your cancer. Please discuss this with your doctor.
• If for any reason you cannot receive medicines to thin blood. If you can’t take medicines that prevent blood clotting, you must not have EPREX.
• If you are due to have major surgery and have not predonated your own blood and have severe heart disease or disorders of the veins and arteries, or have had a recent heart attack or stroke.

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

• heart disease (such as angina)
• disorders of blood circulation
• blood clots/blood clotting disorders
• epileptic fits or seizures
• cancer
• anaemia from other causes
• liver disease
• porphyria

Take special care with EPREX: Haemoglobin levels should be measured on a regular basis. If you are receiving dialysis treatment when you begin treatment with EPREX, your dialysis regimen may need to be adjusted. Your doctor will decide on this.

Pregnancy and Breastfeeding: If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or health care professional. There are no adequate and well-controlled studies in pregnant women. It is not known whether EPREX is distributed into human milk.

Taking other medicines with EPREX: If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of EPREX with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other health care professional, for advice. If you are taking a medicine called cyclosporin to suppress your immune system, your doctor may order special blood tests to measure cyclosporin levels while you are using EPREX.

Your doctor will conduct investigations, for example blood tests, to determine if you need to receive EPREX and to determine the correct dose and route of administration of EPREX and for how long the treatment should continue. Only one dose of EPREX should be taken from each injection syringe. Any fluid that remains should be thrown away. EPREX injection should not be shaken. The dose you receive is based on your body weight in kilograms.

Chronic renal failure patients

• Adult haemodialysis patients
  The usual starting dose of EPREX is 50 International Units (IU) per kilogram (/kg). This is given three times a week by injection into a vein (over 1 to 5 minutes). 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. When your condition is brought under control, you will receive regular doses of EPREX, two to three times a week.
• Adult peritoneal dialysis patients
  The usual starting dose is 50 IU per kilogram. This is given twice a week by injection into a vein or subcutaneously. 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.
• Adult kidney disease patients not yet receiving dialysis
  The usual starting dose is 50 IU per kilogram. This is given three times a week by injection into a vein or subcutaneously. The starting dose may be adjusted by your doctor until your condition is controlled. Your doctor may order regular blood tests to see that this is being achieved.

Cancer patients
The usual starting dose is 150 IU per kilogram. This is given three times a week by injection under the skin. Alternatively, your doctor may recommend a starting dose of 40 000 IU once per week. 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.

Adult patients in an autologous predonation program
The usual dose is 150 to 600 IU per kilogram. This is given 2 times a week by injection into the 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.

Adult elective surgery patients not in an autologous predonation program
The recommended dose of 600 IU per kilogram is given weekly for three weeks before surgery and on the day of surgery by injection under the skin. In cases where there is a need to shorten the period before the operation is carried out, a dose of 300 IU/kg is given on each of the next ten days before surgery, on the day of surgery and for four days immediately afterwards. If blood tests in the period before the operation show your haemoglobin level is too high, the treatment will be stopped.

It is also important that levels of iron in your blood are normal throughout EPREX treatment. Where appropriate you will receive oral doses of iron each day, ideally starting before the EPREX treatment begins.

If you receive more EPREX than you should: The response to EPREX is related to the size of the dose and may differ from patient to patient. In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control center.

EPREX can cause side effects. Tell your doctor or nurse immediately if you notice any of the effects in this list.

Frequent side effects

• Flu-like symptoms, such as headache, aches and pains in the joints, feeling of weakness, tiredness and dizziness. These may be more common at the start of treatment. If you have these symptoms during intravenous injection, a slower delivery of the injection may help to avoid them in future.
• Increased blood pressure in people with cancer. Headaches, particularly sudden, stabbing migraine-like headaches, feeling confused or having fits may be signs of a sudden increase in blood pressure. This requires urgent treatment. Raised blood pressure may require treatment with medicines (or adjustment to any medicines you already take for high blood pressure).
• Chest pain, breathlessness, painful swelling in the leg which may be symptoms of blood clots (thrombosis).
• Skin rashes and swelling around the eyes (oedema), which may result from an allergic reaction.

If you are receiving haemodialysis:

• Blood clots (thrombosis) may form in your dialysis shunt. This is more likely if you have low blood pressure or if your fistula has complications.
• Blood clots may also form in your haemodialysis system. Your doctor may decide to increase your heparin dose during dialysis.

Less frequent side effects

• Symptoms of pure red cell aplasia (PRCA) PRCA means the inability to produce enough red blood cells in the bone marrow. PRCA can result in sudden and severe anaemia. The symptoms are:
• unusual tiredness,
• feeling dizzy,
• breathlessness.
• PRCA has been very rarely reported after months to years of treatment with EPREX and other products that stimulate red blood cell production in patients with chronic renal failure.
• If you are receiving haemodialysis an increase in levels of small blood cells (called platelets), which are normally involved in the formation of a blood clot may occur, particularly when starting treatment. Your doctor will check on this.
• You may experience redness, burning and pain at the site of injection. Tell your doctor or nurse immediately if you are aware of any of these effects, or if you notice any other effects while you are receiving treatment with EPREX.

Not all side effects reported for EPREX are included in this leaflet. Should your general health worsen while using EPREX, please consult your doctor, pharmacist or other health care professional for advice.

Store EPREX in the original package (to protect it from light) in a refrigerator between 2 and 8 °C. Do not freeze or shake EPREX. EPREX can be kept for only a limited period. EPREX pre-filled syringes that are being used or about to be used can be kept at room temperature (not above 25 °C) for a maximum single period of 3 days.

Do not use EPREX:

• after the date (month and year) mentioned after “EXP”, even if it has been stored properly;
• 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; or
• if there has been a refrigerator failure.

Keep all medicines out of the reach and sight of children.