Efesa® Efepoetin Alfa

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.

A Long-Acting Treatment for Anemia

People with Chronic Kidney Disease (CKD) develop anemia. This happens when the kidneys produce less erythropoietin, a hormone needed to make red blood cells.
This condition is called renal anemia.

Efesa's Approved Indications

Important Safety Information

Efesa is approved by BPOM Indonesia for anemia in non-dialysis Chronic Kidney Disease

Efesa is approved by MOH Cambodia for anemia in non-dialysis Chronic Kidney Disease

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