Educational guide
Epogen: Uses, Side Effects & Dosage | Healio
Topics Epogen Brand Names Epogen, Procrit, Retacrit Generic Name epoetin alfa Phonetic Name (e-POE-tin AL-fa) Clinical Uses This medication is used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic kidney failu
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Topics
Epogen
Brand Names
Epogen, Procrit, Retacrit
Generic Name
epoetin alfa
Phonetic Name
(e-POE-tin AL-fa)
Clinical Uses
This medication is used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic kidney failure), people receiving zidovudine to treat HIV, and people receiving chemotherapy for some types of cancer (cancer that does not involve the bone marrow or blood cells). It may also be used in anemic patients to reduce the need for blood transfusions before certain planned surgeries that have a high risk of blood loss (usually given with an anticoagulant/"blood thinner" medication such as warfarin to lower the risk of serious blood clots). Epoetin alfa works by signaling the bone marrow to make more red blood cells. This medication is very similar to the natural substance in your body (erythropoietin) that prevents anemia. This monograph is about the following epoetin alfa products: epoetin alfa and epoetin alfa-epbx.
Dosage and Administration
Administration Notes
Read the Medication Guide and, if available, the Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This medication is given as an injection under the skin or into a vein as directed by your doctor, usually 1 to 3 times a week. Patients getting this medication before surgery may have a special dosing schedule. Hemodialysis patients should receive this medication by injection into a vein. If injecting this medication under the skin, the injection is given in the upper arms, abdomen, front of the middle thighs, or upper outer area of the buttocks. The dosage is based on your medical condition, weight, labs, and response to treatment. If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Do not shake this medication. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. If you are injecting this medication under the skin, before each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is tender, red, bruised, hard, or has scars or stretch marks. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely. Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day(s) of the week as directed. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. It may take 2 to 6 weeks before your red blood cell count increases. Tell your doctor if your symptoms do not get better or if they get worse.
Missed Dose Instructions
If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
Label Warnings
Keep in refrigerator. Do not freeze. Do not shake Protect from light Bring to room temperature before preparing for use.
Indications
- anemia in chronic kidney disease
- chemotherapy-induced anemia
- anemia due to chemotherapy and radiotherapy combination
- reduction of allogeneic blood transfusion in surgery
- zidovudine-induced anemia
- anemia due to myelodysplastic syndrome
- anemia of prematurity
This medication is used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic kidney failure), people receiving zidovudine to treat HIV, and people receiving chemotherapy for some types of cancer (cancer that does not involve the bone marrow or blood cells). It may also be used in anemic patients to reduce the need for blood transfusions before certain planned surgeries that have a high risk of blood loss (usually given with an anticoagulant/"blood thinner" medication such as warfarin to lower the risk of serious blood clots). Epoetin alfa works by signaling the bone marrow to make more red blood cells. This medication is very similar to the natural substance in your body (erythropoietin) that prevents anemia. This monograph is about the following epoetin alfa products: epoetin alfa and epoetin alfa-epbx.
Contraindications
- pure red cell aplasia
- severe uncontrolled hypertension
- acute decompensated heart failure
- acute myocardial infarction
- cerebrovascular accident
- coronary artery disease
- deep venous thrombosis
- hypertension
- pulmonary thromboembolism
- thromboembolic disorder
- vascular access thrombosis
- folate deficiency
- iron deficiency anemia
- lower seizure threshold
- porphyria
- seizure disorder
- vitamin B12 deficiency
Common Adverse Effects
- Anorexia
- Arthralgia
- Cough
- Diarrhea
- Fatigue
- Fever
- General weakness
- Injection site sequelae
- Insomnia
- Leukopenia
- Muscle spasm
- Nausea
- Vomiting
- Bone pain
- Depression
- Dizziness
- Dysphagia
- Hyperglycemia
- Myalgia
- Stomatitis
- Upper respiratory infection
- Chills
- Flu-like symptoms
- Hyperhidrosis
- Skin rash
Serious Adverse Effects
- Edema
- Hypertension
- Tachycardia
- Vascular access thrombosis
- Acute myocardial infarction
- Cerebrovascular accident
- Headache disorder
- Hypokalemia
- Pulmonary thromboembolism
- Seizure disorder
- Thrombotic disorder
- Transient cerebral ischemia
- Anaphylaxis
- Angioedema
- Chest pain
- Chronic heart failure
- Deep venous thrombosis
- Erythema multiforme
- Porphyria
- Pure red cell aplasia
- Shortened time to tumor progression
- Stevens-Johnson syndrome
- Thromboembolic disorder
- Toxic epidermal necrolysis
- Urticaria
Elderly Precautions
Pregnancy Precautions
Lactation Precautions
Pediatric Precautions
Drug Interactions
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Drug Interactions Table
Toxicology
Commercially available multidose vials of epoetin alfa products contain benzyl alcohol as a preservative. Administration of injections preserved with benzyl alcohol has been associated with neurologic and other toxicity in neonates. Such toxicities include a potentially fatal ''gasping syndrome'' characterized by CNS depression, metabolic acidosis, gasping respirations, and high concentrations of benzyl alcohol and its metabolites in blood and urine. Other manifestations may include gradual neurologic deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hypotension, bradycardia, cardiovascular collapse, and hepatic or renal failure. Toxicity appears to have resulted from administration of large amounts (i.e., 99-234 mg/kg daily) of benzyl alcohol in these neonates. Premature or low-birthweight infants also appear to be at increased risk. Avoid the use of drugs preserved with benzyl alcohol in neonates and infants whenever possible. Only use single-dose vials (i.e., the benzyl-alcohol free formulation) in women who are pregnant or breastfeeding, neonates, and infants; do not admix epoetin alfa product from single-dose vials with bacteriostatic saline containing benzyl alcohol for these populations.
Pharmacokinetics
A maximum serum concentration was achieved within 5-24 hours after subcutaneous administration of epoetin alfa. In adult and pediatric patients with CKD who received IV administration of epoetin alfa, the half-life ranged from 4-13 hours. The half-life of epoetin alfa is similar in adults older or younger than 65 years of age. In patients with impaired renal function, the elimination half-life does not appear to be affected by hemodialysis. Little, if any, accumulation of the drug appears to occur at dosages of 50-150 units/kg given IV or subcutaneously 3 times weekly or at dosages of 40,000 units weekly given subcutaneously in the setting of cancer chemotherapy administration. The pharmacokinetics of epoetin alfa in children and adolescents appear to be similar to that of adults. Limited data are available in neonates. Data from a study in preterm, very low birth-weight neonates receiving IV erythropoietin indicate that the volume of distribution and clearance of the drug were approximately 1.5-2 and 3 times higher, respectively, than in healthy adults. The pharmacokinetics of the drug in patients infected with HIV have not been determined.
Pharmacology
Epoetin alfa products are hematopoietic agents that principally influence erythropoiesis by acting as erythropoietin-stimulating agents (ESAs). Most studies of the pharmacology of epoetin alfa have been performed using the recombinant glycoprotein hormone. The amino acid sequence and biologic properties of epoetin alfa products are identical to those of endogenous human erythropoietin. Endogenous human erythropoietin, a growth factor, is a glycosylated protein hormone that appears to be secreted principally by renal peritubular interstitial cells of the kidney. Approximately 20% of the hormone is also produced in the liver and possibly in other extrarenal sites in adults, and fetal erythropoietin production occurs mainly in the liver. Secretion of erythropoietin occurs principally in response to reductions in tissue oxygenation in the kidney. Once released into the plasma, erythropoietin induces the production of erythrocytes mainly by stimulating the proliferation and differentiation of committed erythroid precursors, thereby leading to an increase in RBC production. Thereafter, the oxygen carrying capacity of the blood is enhanced and further erythropoietin production is inhibited via a negative feedback loop. Plasma iron and ferritin concentrations decrease with new erythrocyte formation as a result of iron incorporation into these cells and subsequent mobilization of tissue iron stores. The usual serum concentration of endogenous erythropoietin in healthy individuals with normal hematocrit is approximately 4-30 milliunits/mL; the erythropoietic response in patients with severe anemia may be associated with erythropoietin concentrations up to 1000 times greater than these concentrations. Epoetin alfa products increase reticulocyte count within 10 days of starting therapy; increases in hematocrit, hemoglobin, and RBC count follow within 2 to 6 weeks. The rise in hemoglobin following the administration of epoetin alfa products is dose dependent.
Storage Requirements
Store in the refrigerator. Do not freeze. Keep the medication in the original carton to protect from light. For the single-use vials, discard any unused medication right away. For the multi-use vials, store opened vials in the refrigerator and discard any unused medication after 3 weeks. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
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