EPREX PREFILLED SYRINGES - Medsafe

1 EPREX PREFILLED . SYRINGES . (Epoetin alfa (rch)). Consumer Medicine Information What is in this leaflet including decreased production of a EPREX is not addictive. hormone called erythropoietin by the This medicine is available only This leaflet answers some common kidneys due to kidney failure, or as a with a doctor's prescription. questions about EPREX PREFILLED result of chemotherapy treatments for SYRINGES . It does not contain all the cancer. EPREX is virtually identical available information. It does not to your body's erythropoietin, and has a similar effect to naturally take the place of talking to your Before you use occurring erythropoietin in your doctor or pharmacist. body. EPREX . All medicines have risks and benefits. EPREX is used to treat the anaemia When you must not use it associated with kidney disease. If Current and updated information Do not use EPREX .

2 You have kidney disease, your kidney about benefits and side effects of may not produce enough If you have an allergy to EPREX . EPREX is contained in this leaflet. erythropoietin (necessary for red or any of the ingredients. See Your doctor has weighed the risks of blood cell production) and your Product Description at the end of you using EPREX against the doctor may wish to correct this by this leaflet for a list of benefits this medicine is expected to prescribing EPREX . This medicine ingredients. have for you. stimulates your bone marrow to Symptoms of an allergic or If you have any concerns about using produce more red blood cells, hypersensitivity reaction may EPREX ask your doctor or helping to treat your anaemia. include: pharmacist. EPREX can also be used to treat rash, itching or hives on the It is important that you read this anaemia and reduce the need for a skin leaflet.

3 Blood transfusion if you are receiving chemotherapy for cancer and your shortness of breath, wheezing Keep this leaflet with your medicine. or difficulty breathing doctor decides you may need a blood transfusion. swelling of the face, lips, Doctors can also prescribe EPREX tongue or other parts of the for mildly anaemic patients who are body What EPREX is used for going to have surgery and donate If you have high blood pressure blood before surgery, so that their that is not properly controlled own blood can be given to them with blood pressure-lowering EPREX PREFILLED SYRINGES contain the during or after surgery. Because drugs. active ingredient epoetin alfa, a EPREX stimulates the production of protein that stimulates bone marrow If you are a surgery patient who red blood cells, a higher volume of to produce more red blood cells.

4 Should not be given medicines to blood can be taken from these Red blood cells are responsible for thin the blood. patients. carrying oxygen to all parts of your If you are due to have elective EPREX can be used as an alternative body. A decrease in the number of surgery and you have severe heart to a blood transfusion in adult red blood cells can cause anaemia. disease, disorders of the veins or patients about to undergo major Some symptoms of anaemia are arteries, or have recently had a orthopaedic (bone) surgery where tiredness, breathlessness when heart attack or stroke. there is a potentially high risk from exercising, and feeling cold. blood transfusion complications. If you have been diagnosed with Anaemia may have many causes, Pure Red Cell Aplasia (your bone EPREX PREFILLED SYRINGE 1. marrow cannot produce enough since these may affect the use of dialysis and those on peritoneal red blood cells) after previous EPREX .

5 Dialysis EPREX can be treatment with an erythropoietin If you have used EPREX or another administered subcutaneously. The product, including EPREX . erythropoietin in the past, and you usual starting dose is 50 IU/kg If you cannot have transfusions lost the good response you were three times per week for adults with your own blood during or having, tell your doctor about this. and 25 IU/kg three times per after surgery. week for children, after which the If you have not told your doctor or dose may be changed by your Do not use EPREX if the packaging pharmacist about any of the above, doctor as needed. is torn or shows signs of tampering. tell them before you start using or are given EPREX . For patients who are scheduled Do not use EPREX beyond the for surgery and who are not expiry date (month and year) printed Your doctor will advise you whether storing their own blood the usual on the pack.

6 Or not to use EPREX or if you need dose is 300 IU/kg body weight to adjust the dose or adapt your for 10 days before surgery, on the Before you start to use it treatment. day of surgery and for 4 days You must tell your doctor if you after. Alternatively a dose of Taking other medicines 600 IU/kg may be administered have or have had: Tell your doctor or pharmacist if you weekly for 3 weeks before high blood pressure are taking any other medicines, surgery and on the day of surgery. heart disease (such as angina) including medicines you can buy The subcutaneous route is used. disorders of blood circulation without a prescription from a For anaemic cancer patients resulting in pins and needles or pharmacy, supermarket or health receiving chemotherapy, the cold hands or feet or muscle food shop. initial dose is 150 IU/kg three cramps in the legs.

7 Times per week. After 4 weeks Iron is also a constituent of red blood blood clotting disorders cells. Therefore, iron supplements your doctor will check your seizures or epileptic fits and other blood stimulating drugs response and increase the dose to may increase your response to 300 IU/kg three times weekly if cancer. If you are a cancer patient response has been insufficient. If EPREX treatment. Your doctor will be aware that erythropoietins like at any stage EPREX has produced decide whether you should take other EPREX may act as a growth too many red cells, your doctor medicines while using EPREX . factor and therefore in theory may will stop the drug and later re- affect the progression of your start it at a lower dose. The cancer. Please discuss this with subcutaneous route is used. your doctor. Using EPREX . anaemia from other causes Injecting EPREX under the liver disease How much to use: skin yourself gout At the start of your therapy, EPREX .

8 Your doctor will determine the porphyria (a rare blood pigment correct dose of EPREX . EPREX may be injected by medical or disorder). nursing staff. However, your doctor injection is administered either may decide that it is right for you to Also, tell your doctor if you are: into a vein (intravenously) or just under the skin (subcutaneously). learn how to inject EPREX under the pregnant or planning to become skin (subcutaneously) yourself. You After instruction, you can pregnant will receive appropriate training for administer it under the skin breastfeeding or wish to yourself if you wish. Your doctor you to do this. Under no breastfeed. circumstances should you attempt to can discuss with you whether inject yourself unless you have been In many women with severe kidney injection into the vein or under the skin is preferable.

9 Trained to do so. failure, their monthly periods may If EPREX is injected under the skin stop. In these women, erythropoietin For patients with anaemia due to may restart the monthly cycle. Before kidney failure, EPREX should be (subcutaneously), the amount starting EPREX , you should discuss injected is not normally more than given intravenously, (into a vein the need for contraception with your one millilitre (1 mL) in a single or a tube that goes into a vein) if doctor. intravenous access is routinely injection. Make sure you tell your doctor if you available (haemodialysis EPREX is given alone and not mixed have any other medical problems patients). For patients not yet on with other liquids for injection. EPREX PREFILLED SYRINGE 2. Only use EPREX if the solution is Do not remove the needle cover Therefore, once a syringe has been clear and colourless.

10 From the pre-filled syringe until opened, any remaining solution must Do not shake EPREX PREFILLED you are ready to inject your be discarded. SYRINGES . EPREX . If you do not understand the Prolonged vigorous shaking may Take the cover off the syringe instructions provided with this damage EPREX . If EPREX has been by holding the barrel and medicine, ask your doctor or shaken vigorously, don't use it. pulling the cover off carefully pharmacist for help. without twisting it. How to inject EPREX Don't push the plunger, touch the If you forget to use it The pre-filled SYRINGES are fitted with needle or shake the syringe. Administer your dose as soon as the PROTECS needle guard device Pinch a fold of skin you remember, and then continue to help prevent needle stick injuries to use it as you would normally. between your thumb and index after use.