- What is epoetin alfa, and how does it work (mechanism of action)?
- What brand names are available for epoetin alfa?
- Is epoetin alfa available as a generic drug?
- Do I need a prescription for epoetin alfa?
- What are the side effects of epoetin alfa?
- What is the dosage for epoetin alfa?
- Which drugs or supplements interact with epoetin alfa?
- Is epoetin alfa safe to take if I'm pregnant or breastfeeding?
- What else should I know about epoetin alfa?
What is epoetin alfa, and how does it work (mechanism of action)?
Epoetin alfa is a man-made, injectable drug for treating anemia. Erythropoietin is a protein that normally is made in the body by the kidney. It causes the bone marrow to produce oxygen-carrying red blood cells. Under normal conditions, when the body senses a decrease in red blood cells or a deficiency in the supply of oxygen, more erythropoietin is produced, and this increases the number of red blood cells. When this natural mechanism is not working, it may become necessary to stimulate the bone marrow to produce red blood cells. The erythropoietin that is used for therapy, called epoetin alfa, is man-made. It is a product of the genetic engineering of ovarian cells of the Chinese hamster and is produced through recombinant DNA technology in bacteria. It does not cure the underlying cause of the anemia, and unless the underlying cause can be reversed, treatment with epoetin alfa must be continued indefinitely.
Epoetin alfa belongs to a class of drugs called colony-stimulating factors because of their ability to stimulate cells in the bone marrow to multiply and form colonies of identical cells. Other colony-stimulating factors include filigrastim (Neupogen) and sargramostim (Leukine). Epogen and Procrit are both epoetin alfa, but they are marketed by two different pharmaceutical companies. The FDA approved epoetin alfa in June 1989.
What are the side effects of epoetin alfa?
The most common side effects of epoetin alfa in patients with kidney failure on dialysis are:
In HIV-infected patients receiving zidovudine, the most common side effects with epoetin alfa are fever, headache, rash, and nasal or chest congestion. Rare cases of seizures or severe rash have occurred in these patients.
The most common side effects in patients undergoing surgery with anemia are:
Blood clots in veins, referred to as a deep venous thrombosis, also may occur.
Among patients with cancer receiving chemotherapy, the most common side effects of epoetin alfa are:
- tissue swelling,
- shortness of breath,
- paresthesia (abnormal sensations like burning or prickling that may occur anywhere in the body), and
- upper respiratory infection.
Treatment with epoetin alfa may increase the growth of several types of cancer and reduce survival, and, therefore, its use should be restricted to the conditions discussed previously.
What is the dosage for epoetin alfa?
Epoetin alfa is administered intravenously or subcutaneously (under the skin) at 50-100 units/kg of body weight, three times weekly. The dose is tailored to each patient based on targeted hemoglobin levels. Adult patients with cancer receiving chemotherapy may be treated with 40,000 units weekly or 150 units/kg 3 times weekly.
Zidovudine treated patients should receive 100 units/kg 3 times weekly.
Surgery patients should receive 300 units/kg per day daily for 14 days or 600 units/kg weekly. The smallest effective dose should be used.
In clinical trials, the risk of death or serious heart problems, and stroke occurred more often when epoetin alpha was administered to target a hemoglobin level greater than 11 g/dL. Epoetin alfa vials should not be shaken since the drug may be damaged, and bubbles may form that prevent some of the drug from being drawn up into the syringe during injection. Iron stores should be evaluated before therapy and supplemental iron should be administered if needed.
Which drugs or supplements interact with epoetin alfa?
No clinical studies have been done to demonstrate epoetin alfa drug interactions.
Is epoetin alfa safe to take if I'm pregnant or breastfeeding?
There are no studies of epoetin alfa use in pregnant women. Polyhydramnios and intrauterine growth restriction was reported in a small number of pregnant women who received epoetin alpha. Multiple dose vials contain benzyl alcohol and should not be administered to pregnant women.
It is not known if epoetin alfa is excreted into breast milk. Multiple dose vials contain benzyl alcohol and should not be administered to nursing mothers.
What else should I know about epoetin alfa?
What preparations of epoetin alfa are available?
Vials containing liquid for injection: 2000, 3000, 4000, 10000, 20000 and 40000 U/ml as well as 20000 U/2ml
How should I keep epoetin alfa stored?
Epoetin alfa should be stored at 2 C - 8 C (36 F - 46 F). It should not be frozen. Multiple-use vials should be used within 21 days of the first use.
Reference: FDA Prescribing Information
Epoetin alfa (Epogen, Procrit) is a drug prescribed for the treatment of anemia associated with chronic kidney failure who are or will be receiving dialysis. Epoetin alfa is also used to treat anemia in individuals with HIV infection and in patients with cancer who are receiving chemotherapy.
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Anemia is the condition of having less than the normal number of red blood cells or less than the normal quantity of hemoglobin in the blood. The oxygen-carrying capacity of the blood is, therefore, decreased. There are several types of anemia such as iron deficiency anemia (the most common type), sickle cell anemia, vitamin B12 anemia, pernicious anemia, and aplastic anemia. Symptoms of anemia may include
- hair loss,
- menstruation, and
Treatment for anemia includes treating the underlying cause for the condition. Iron supplements, vitamin B12 injections, and certain medications may also be necessary.
Biologics Biologic Drug Class
A biologic drug is a product that is produced from living organisms or contain components of living organisms. Biologics include recombinant proteins, tissues, genes, allergens, cells, blood components, blood, and vaccines. Biologics are used to treat numerous disease and conditions, for example:
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- Hemophilia Respiratory syncytial virus (RSV) prophylaxis
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Side effects of biologics depend upon the specific biologic drug; however, common side effects may include:
- High blood glucose levels
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Drugs: What You Should Know About Your DrugsImportant information about your drugs should be reviewed prior to taking any prescription drug. Side effects, drug interactions, warnings and precauctions, dosage, what the drug is used for, what to do if you miss a dose, how the drug is to be stored, and generic vs. brand names.
ErythropoietinErythropoietin (EPO) is a hormone created by the kidney. EPO promotes red blood cell formation via the bone marrow. Low levels of EPO may indicate anemia. Elevated EPO levels may indicate polycythemia rubra vera or hormone misuse by some athletes whose performance benefit from higher red blood cell counts. Such athletes include:
- long-distance runners,
- speed skaters,
- and Nordic (cross-country) skiers.
HematocritHematocrit in the blood is the proportion of the blood that consists of red blood cells, by volume. A low hematocrit level may signal anemia, or other conditions such as loss of blood, nutritional deficiency, bone marrow problems, and abnormal hematocrit. High hematocrit levels may be due to chronic smoking, living at high altitudes, dehydration, or other conditions and diseases.
HemoglobinHemoglobin is the oxygen-carrying protein molecule in the blood, specifically in the red blood cells. High hemoglobin count may be caused by dehydration, smoking, emphysema, tumors, or abuse of Epogen. Low levels of hemoglobin may be caused by anemia, blood loss, nutritional deficiency, bone marrow problems, chemotherapy, kidney failure, or sickle cell disease.