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Efesa's Frequently Asked Questions

Find answers to common questions about Efesa

  • You can always ask more regarding your condition, especially around chronic kidney disease and anemia. Keep up to date with your lab test results, and ask them about potential treatment and the alternatives available, weighing every benefit and risks possible. You should also tell them any chronic conditions you have and whether you take routine medications and supplements.

  • Administer EFESA subcutaneously in the stomach, arm or thigh. Alternating the injection site is recommended to avoid discomfort at the site of injection.

    Prior to administration, you should visually inspect the solution for particulate matter and discoloration. The solution should not be used if discolored or cloudy or if foreign particulate matter i.e. clumps, large or colored particles, are present.

    You should allow the pre-filled syringe to reach room temperature before injecting, protect from direct light, and avoid shaking.

    If you’re not sure about administering EFESA yourself, consult with your corresponding physician.

  • If you missed your EFESA dose, you shouldn’t alter and administer the dose yourself. You should immediately contact your corresponding physician and discuss your next dose and appointment.

  • If you use EFESA more than the dose prescribed, please contact your corresponding physician immediately.

  • Consult with your corresponding physician if you take any other routine medication. Do not dilute or administer EFESA in conjunction with other drug solutions.

  • EFESA is contradicted for use in patients with:

    • Uncontrolled hypertension;

    • Hypersensitivity towards any EFESA composition or any other drug containing erythropoietin;

    • Hypersensitivity towards products derived from mammalian cells or its derivatives;

    • Patients who develop Pure Red Cell Aplasia (PRCA) after erythropoietin treatments, and patients who for any reason cannot receive adequate antithrombotic prophylaxis.

  • Special care should be taken with EFESA:

    • If you have heart problems, as certain heart, blood vessel and blood clotting conditions such as a heart attack (myocardial infarction), where the heart does not receive enough oxygen (myocardial ischaemia), brain bleed and stroke (cerebrovascular haemorrhage and infarction), mini-strokes (transient ischaemic attacks), clotting in the deep veins, arteries, retina, lungs (deep venous, arterial and retinal thrombosis, pulmonary emboli), and blockage of dialysis tubes have been reported in people receiving medicines from the same class as EFESA (ESAs).

      • There was a higher incidence of deep vein clotting (thrombosis) in patients who used medicine from the same class as EFESA (ESAs) before an operation to reduce the receipt of red blood cells from a donor.

      • Your doctor will give you the lowest dose of EFESA that will gradually increase your haemoglobin levels in order to lower the risk of heart problems.

    • If you have high blood pressure as treatment with EFESA may cause a rise in blood pressure. Your doctor will check your blood pressure before and during your treatment. If your blood pressure is high and cannot be controlled either by medicine or a special diet, your doctor will interrupt your treatment and reduce the dose. Swelling of the brain and seizures have been seen in people receiving medicines of the same class as EFESA (ESAs).

    • If you feel tired, weak or have shortness of breath as this could mean that your treatment with EFESA is not effective. Your doctor will check that you do not have other causes of anaemia and may perform blood tests or examine your bone marrow. If you have developed Pure Red Cell Aplasia your treatment with EFESA will be discontinued. Your doctor will not give you any other ESA as there is a risk that this will also cause a reaction.

    • If you suffer from epilepsy. If you suffer from seizures more frequently with the use of EFESA, you should tell your doctor.

    • If you start to develop severe, painful, red or purple rashes with blisters, peeling of the skin, you should tell your doctor as your treatment may need to be stopped as severe rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported with treatment with other ESAs.

    • If you have a history of hypersensitivity to medicines or are prone to allergies, EFESA should be given to you with care. If you have a serious reaction, your doctor will stop the EFESA treatment and you will be treated.

    • If you have any other underlying blood disorders such as where the red blood cells are destroyed faster than what the body can produce them (haemolytic anaemia), where the red blood cells become sickle-shaped (sickle cell anaemia), or where the production of haemoglobin which carries oxygen in the blood is abnormal (thalassemia), as the safety and efficacy of EFESA has not been established in these conditions.

    • Your doctor will check the amount of iron in your blood before and during treatment with EFESA. If the amount is too low, your doctor may give you an iron supplement.

    • If you have a liver disease, you should not receive EFESA as there is no information regarding the safety of EFESA in liver disease.

    • If you are elderly as there is no specific information regarding the safety and efficacy of EFESA in the elderly.

    • If EFESA is to be given to a child, as there is no information regarding the use of EFESA in children.

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    Other medicines and EFESA

    Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

    Do not use EFESA with any other medicine. The use of EFESA with other medicines has not been studied.

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    Pregnancy, breastfeeding, and fertility

    Pregnancy and breastfeeding

    If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before receiving EFESA. The safety of EFESA in pregnant women has not yet been established. There is no data available on the excretion of EFESA into human breast milk.

     

    Fertility

    There were no treatment-related changes of fertility in rats.

     

    Driving and using machines

    It is not always possible to predict to what extent EFESA may interfere with your daily activities. You should ensure that you do not engage in the above activities until you are aware of the measure to which EFESA affects you.

    ​

    EFESA may cause side effects that affect your ability to drive and operate machinery.

    ​

    EFESA contains sodium

    Sodium is the main component of cooking/table salt.

    • This medicine contains less than 1 mmol (23 mg) sodium per 0,6 mL, that is to say, essentially ‘sodium free’.

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