Do not use Epoetin alfa HEXAL:
- if you are allergic (hypersensitive) to epoetin alfa or any of the other ingredients of Epoetin alfa HEXAL
- if you have developed Pure Red Cell Aplasia (reduced or stopped production of red blood cells) following treatment with any erythropoietin
- if you have high blood pressure which is not properly 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
- if you cannot receive adequate treatment for the prevention of blood clots (antithrombotic prophylaxis)
- if you are due to have major orthopaedic surgery, and:
- you have severe disorders of blood circulation of the heart (coronary heart disease), arteries of the legs or arms (peripheral arterial occlusive disease), neck vessels (vascular disease of the carotids) or the brain (cerebrovascular disease)
- you had a recent heart attack or stroke
If any of these applies to you, or might apply, tell your doctor at once.
Take special care with Epoetin alfa HEXAL:
When you receive Epoetin alfa HEXAL therapy your blood pressure should be closely monitored. If you have high blood pressure (hypertension) it may be necessary to start antiyhypertensive therapy, or if your blood pressure is still high although you already take blood pressure medication, it may be necessary to initiate or increase treatment against high blood pressure. If your blood pressure cannot be controlled, Epoetin alfa HEXAL treatment should be stopped.
If you receive epoetin alfa you should have your haemoglobin levels measured on a regular basis until a stable level is achieved, and periodically thereafter. There is a potential increased risk of rare thromboembolic events (e.g. heart attacks, strokes, and pulmonary embolism) when haemoglobin levels increase above the target range.
All other potential causes of anaemia, e.g. iron deficiency, damage of red blood cells (haemolysis), blood loss, vitamin B 12 or folate deficiency, need to be taken into account and treated prior to initiating therapy with Epoetin alfa HEXAL. Your doctor may do blood tests to decide, if you need iron supplements in order to ensure optimum response to Epoetin alfa HEXAL.
In addition, your doctor may do regular blood tests to check your blood platelet count during the first 8 weeks of therapy. There may be a moderate dose-dependent increase in the platelet count within the normal range during treatment with Epoetin alfa HEXAL, which gradually regresses during the course of continued therapy.
Take special care with Epoetin alfa HEXAL if you have epilepsy or chronic liver disease.
There have been rare reports of patients developing antibodies against epoetin alfa resulting in a failure of red blood cell development, a condition called antibody-mediated Pure Red Cell Aplasia (PRCA). PRCA can result in sudden and severe anaemia, the symptoms of which are unusual tiredness, feeling dizzy or breathlessness. If you experience these symptoms you should talk to your doctor at once. If you develop PRCA your Epoetin alfa HEXAL therapy will be discontinued and your doctor will decide how best to treat your anaemia.
If you are a patient with hepatitis C and you receive interferon and ribavirin, you should discuss this with your doctor because a combination of erythropoiesis stimulating agents (ESAs) with interferon and ribavirin has lead to a loss of effect and development of a condition called pure red cell aplasia (PRCA), a severe form of anemia, in rare cases. ESAs are not approved in the management of anaemia associated with hepatitis C.
There is not much experience with subcutaneous use (injection into the skin) of Epoetin alfa HEXAL in kidney patients. Therefore, if you are being treated for anaemia associated with kidney disease, Epoetin alfa HEXAL has to be given by injection into a vein (intravenously).
The correction of your anaemia may lead to increased appetite, and thus increased potassium and protein intake. If an elevated or increasing serum potassium level is detected, your doctor may consider to discontinue the treatment with Epoetin alfa HEXAL until the potassium level has returned to the normal range.
An increase in dose of a particular blood-thinning medicine (heparin) during haemodialysis is frequently required during the course of therapy with Epoetin alfa HEXAL. Inadequate thinning of the blood by heparin (heparinisation) may lead to occlusion of the dialysis system.
Cancer patients receiving treatment with erythropoietin have an increased risk of blood clots/blood clotting disorders (thrombotic vascular events), particularly if they are obese or have a history of thrombotic vascular events (e.g. deep vein thrombosis or pulmonary embolism). This risk should be carefully weighed against the potenital benefit derived from treatment with epoetin alfa.
If you are a cancer patient you should be aware that Epoetin alfa HEXAL 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.
Patients donating their own blood before surgery
Your doctor will consider warnings and precautions associated with autologous blood predonation, especially volume replacement.
Patients scheduled for orthopaedic surgery
If you are due to have major orthopaedic surgery, the cause of anaemia should be established and treated, if possible, before the start of Epoetin alfa HEXAL treatment. Your doctor will weight this risk carefully against the benefits to be derived from treatment with epoetin alfa.You should receive adequate measures in order to prevent blood clots (thrombotic prophylaxis), particularly if you have cardiovascular disorders.
If your levels of the red blood pigment (haemoglobin) are too high you should not receive Epoetin alfa HEXAL, since you have an increased risk of blood clotting after the surgery.
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.
If you are taking ciclosporin (medicine to suppress your immune system) during therapy with Epoetin alfa HEXAL, your doctor may order special blood tests to measure ciclosporin levels.
Take special care with other products that stimulate red blood cell production
Epoetin alfa HEXAL is 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.
Pregnancy and breast-feeding
There is not much experience with epoetin alfa in pregnant women or women who are breast-feeding.
Therefore, in kidney patients, Epoetin alfa HEXAL should be used in pregnancy only if the potential benefit outweighs the potential risk to the baby. In pregnant or breast-feeding patients donating their own blood before surgery, the use of epoetin alfa is not recommended.
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or when you are breast-feeding.
Driving and using machines
No effects on ability to drive or use machines have been observed.
Important information about some of the ingredients of Epoetin alfa HEXAL
This medicinal product contains less than 1 mmol sodium (23 mg) per pre-filled syringe i.e. essentially ?sodium-free?.