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ABOUT EFESA
Find out more about Efesa and its side effects
WHAT IS EFESA?
EFESA as a long-acting ESA works by mimicking the natural hormone erythropoietin (EPO) to stimulate the bone marrow to produce more red blood cells. EFESA helps to treats renal anemia, with its unique protein molecule that allows a more sustained release of the EPO, allowing lesser hospital visits – up to once a month – while making sure red blood cells level maintained at a stable level.
WHY AND HOW EFESA CAN HELP PATIENTS?
Our clinical trials on patients with CKD not-on-dialysis (CKD-ND) proved that EFESA is effective to increase and maintain red blood cell level, in a relatively safe way. 91.28% of our subjects on our clinical trials were able to maintain red blood cells level at an optimal and stable range.
Currently, EFESA is indicated for CKD patients not on dialysis.
Consult to your physician to get more information on ESA treatment, and what you can do to manage renal anemia.
SIDE EFFECTS OF EFESA
Like all drugs, EFESA may causes side effects, although it may not happen to everyone.
Possible side effects include (% of total subject from our clinical trial):
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Hypertension - 2.1%
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Diarrhea, vomiting - 1%
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Dizziness, headache - 1%
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Oropharyngeal pain, leukocytosis, blood and lymphatic system disorder - 1%
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Iron deficiency anemia - 0.5%
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Insomnia - 0.5%
Side effects listed are not what will possibly happen on EFESA usage. Please informed your physicians upon experiencing.
Understanding and Dealing with Anemia
Brief information about anemia, its relationship with chronic kidney disease, and treatment options.
What is Anemia?
Anemia is when your body doesn't have enough healthy red blood cells to carry oxygen to your organs and tissues. It's like having too few delivery trucks (red blood cells) to bring oxygen (the package) to your body's parts. When there aren't enough trucks or they're not working well, your body's cells don't get the oxygen they need, making you feel tired, weak, or dizzy. Causes can vary, complex, and sometimes overlap each other include low iron, vitamin deficiencies, blood loss, or chronic illness sucha s chronic kidney disease (CKD), and treatment depends on what's causing the shortage.
What is Chronic Kidney Disease (CKD)?
Chronic Kidney Disease (CKD) is a long-term condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. Imagine your kidneys as the body's built-in water filters-when they're damaged, waste builds up in your system, which can cause problems throughout your body.
Early on, CKD might not cause noticeable symptoms, but as it gets worse, it can lead to complications like high blood pressure, anemia (low red blood cell count), weak bones, swelling in the legs, and a higher risk of heart disease. In advanced stages, it may lead to kidney failure, which can require dialysis or a kidney transplant. Common causes include diabetes and high blood pressure, but with early detection and proper management, its progression can often be slowed.
What is Anemia on CKD?
Anemia in chronic kidney disease (CKD) or often called renal anemia, occurs when the kidneys are damaged and produce less erythropoietin, a hormone that stimulates red blood cell production. This leads to a lower number of red blood cells, reducing the oxygen-carrying capacity of the blood. It is a common complication of CKD especially in later stages. Treatments on renal anemia may vary depending on every patient’s condition, and there is no definitive universal treatment that can apply to everyone, as every patient is unique. Treatments such as iron supplements, erythropoiesis-stimulating agents (ESAs), or other medications may help manage and improve red blood cell levels.
Treatment Options
Approximately 1 in 3 patients with chronic kidney disease (CKD) suffers from renal anemia, and the frequency increases as CKD progresses, and one of the modality treatments is with Erythropoietin-stimulating agents (ESAs). Commonly, short-acting ESA treatment would require frequent hospital visit, up to twice a week, and that can cause inconveniences to the patient.
Special care should be taken with EFESA:
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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).
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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.
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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.
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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).
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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.
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If you suffer from epilepsy. If you suffer from seizures more frequently with the use of EFESA, you should tell your doctor.
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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.
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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.
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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.
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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.
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If you have a liver disease, you should not receive EFESA as there is no information regarding the safety of EFESA in liver disease.
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If you are elderly as there is no specific information regarding the safety and efficacy of EFESA in the elderly.
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If EFESA is to be given to a child, as there is no information regarding the use of EFESA in children.
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.
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.
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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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