Epoetin Alfa

Epoetin Alfa is a prescription medication used to treat Chronic Kidney Disease-Associated Anemia, Zidovudine-Related Anemia, Chemotherapy-Related Anemia, and Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery.

• Epoetin Alfa is available under the following different brand names: Epogen, Procrit, Eprex, Erythropoietin, Retacrit, Epoetin Alfa-epbx

Adult and pediatric dosage

Injectable solution

• 2000 units/mL (Epogen, Procrit, Retacrit)
• 3000 units/mL (Epogen, Procrit, Retacrit) 
• 4000 units/mL (Epogen, Procrit, Retacrit)
• 10,000 units/mL (Epogen, Procrit, Retacrit)
• 20,000 units/mL (Epogen, Procrit, Retacrit)
• 40,000 units/mL (Retacrit)

Biosimilar to Epogen and Procrit 

• Retacrit (Epoetin alfa-epbx)

Chronic Kidney Disease-Associated Anemia

Adult dosage

Patients with CKD on dialysis

• 50-100 units/kg IV/SC 3 times weekly initially 

Patients with CKD not on dialysis

• 50-100 units/kg IV 3 times weekly initially 

Pediatric dosage

• Children younger than 1 month of age: Safety and efficacy not established
• Children 1 month of age or older: 50 units/kg IV/SC 3 times weekly initially; if a patient on dialysis, IV route recommended

Zidovudine-Related Anemia

Adult dosage

Epogen, Procrit, Retacrit 

• 100 units/kg IV/SC 3 times weekly initially

Pediatric dosage

• Children younger than 8 months of age: Safety and efficacy not established
• Children 8 months-17 years: 50-400 units/kg SC/IV 2-3 times weekly

Chemotherapy-Related Anemia

Adult dosage 

Epogen, Procrit, Retacrit

• 150 units/kg IV/SC 3 times weekly initially; alternatively, 40,000 units SC once weekly until completion of a chemotherapy course

Pediatric dosage

• Children younger than 5 years of age: Safety and efficacy not established
• Children 5-18 years of age: 600 units/kg IV once weekly; not to exceed 40,000 units

Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery

Adult dosage

Epogen, Procrit, Retacrit

• 300 units/kg SC once daily for 15 consecutive days (10 days preceding surgery, day of surgery, 4 days following surgery)
• Alternatively, 600 units/kg SC in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Epoetin Alfa include:

• fever, 
• chills, 
• cough, 
• shortness of breath, 
• low potassium, 
• low white blood cells, 
• blood vessel blockage, 
• high blood sugar, 
• joint pain, 
• bone pain, 
• muscle pain or spasm, 
• itching, 
• rash, 
• mouth pain, 
• trouble swallowing, 
• nausea, 
• vomiting, 
• headache, 
• dizziness, 
• trouble sleeping, 
• depressed mood, 
• weight loss, and
• pain or redness where the medicine was injected

Serious side effects of Epoetin Alfa include:

• hives, 
• sweating, 
• rapid pulse, 
• wheezing, 
• trouble breathing, 
• severe dizziness, 
• fainting, 
• swelling in the face or throat, 
• fever, 
• sore throat, 
• burning eyes, 
• skin pain, 
• red or purple skin rash with blistering and peeling, 
• chest pain or pressure, 
• pain spreading to the jaw or shoulder, 
• nausea, 
• sweating, 
• pain, swelling, warmth, redness, cold feeling, or pale appearance of an arm or leg, 
• sudden numbness or weakness (especially on one side of the body), 
• sudden severe headache, 
• slurred speech, 
• problems with vision or balance, 
• unusual tiredness, 
• seizure, 
• increased thirst, 
• increased urination, 
• dry mouth, 
• fruity breath odor, 
• leg cramps, 
• constipation, 
• irregular heartbeats, 
• fluttering in the chest, 
• numbness or tingling, 
• muscle weakness or limp feeling, 
• blurred vision, 
• pounding in the neck or ears, 
• anxiety, and
• nosebleed

Rare side effects of Epoetin Alfa include:

• none 

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Epoetin Alfa has severe interactions with no other drugs.
• Epoetin Alfa has serious interactions with no other drugs.
• Epoetin Alfa has moderate interactions with the following drugs:
  • cyclosporine
  • dichlorphenamide
  • methyltestosterone
• Epoetin Alfa has minor interactions with the following drugs:
  • danazol
  • fluoxymesterone
  • oxandrolone
  • oxymetholone
  • testosterone
  • testosterone buccal system
  • testosterone topical

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity to epoetin alfa or albumin or mammalian cell-derived products
• Cancer patients whose anemia is caused by factors other than chemotherapy
• Uncontrolled hypertension
• Pure red-cell aplasia that begins after treatment with any erythropoietin protein drugs
• Use of multidose vials containing benzyl alcohol in neonates, infants, or pregnant or nursing females)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Epoetin Alfa?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Epoetin Alfa?”

Cautions

• Increased incidence of death, myocardial infarction (MI), stroke, and thromboembolism: Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit (see Black Box Warnings)
• Use caution in hypertension, iron deficiency, folate or B12 deficiency, congestive heart failure (CHF), coronary artery disease (CAD), seizure disorder, sickle-cell disease, hemolytic anemia, porphyria, hematologic disorders
• Cancer patients: Increased tumor progression rate when dosed to achieve a hemoglobin level of greater than 12 mg/dL
• Chronic renal failure: At the initiation of therapy, transferrin saturation should be 20% or greater and ferritin 100 ng/mL or greater.
• Patients undergoing surgery are at increased risk for DVT; concomitant DVT prophylaxis is strongly recommended
• Epogen multidose formulations contain benzyl alcohol, which is associated with potentially fatal "gasping syndrome" in premature neonates
• Zidovudine-treated patients may show response only when zidovudine dosage is less than 4200 mg/wk and endogenous epoetin is less than 500 U/mL
• To prescribe or dispense to patients with cancer and anemia due to myelosuppressive chemotherapy, prescribers and hospitals must enroll in and comply with ESA APPRISE Oncology Program
• Increased risk of seizures during first 90 days of therapy in CKD; monitor closely
• Dialysis patients: IV administration recommended to reduce red-cell aplasia risk; increased anticoagulation with heparin may be required to prevent clotting of extracorporeal circuit during hemodialysis
• Do not increase the dose more frequently than once monthly
• Contains albumin; may carry an extremely remote risk for transmission of viral diseases or Creutzfeldt-Jakob disease
• Blistering and skin exfoliation reactions including erythema multiforme and Stevens-Johnson syndrome (SJS)/ toxic epidermal necrolysis (TEN), reported in the postmarketing setting; discontinue therapy immediately if severe cutaneous reaction, such as SJS/TEN, is suspected
• Cases of PRCA and severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin reported in patients treated with epoetin alfa

Retacrit only

• Each 1 mL single-dose vial of 2,000, 3,000, 4,000, 10,000, 40,000 Units of epoetin-alfa-epbx injection contains 0.5 mg of phenylalanine
• Before prescribing Retacrit to a patient with PKU, consider the combined daily amount of phenylalanine from all sources

Pregnancy and Lactation

• Limited data available on epoetin alfa use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes
• Multiple-dose vials contain benzyl alcohol and are contraindicated in pregnant women; there is potential for similar risks to fetuses exposed to benzyl alcohol in utero; when therapy is needed during pregnancy, use a benzyl alcohol-free formulation (i.e., single-dose vial); do not mix with bacteriostatic saline when administering to pregnant women because it contains benzyl alcohol
• There is no information regarding the presence of epoetin alfa products in human milk, the effects on the breastfed infant, or the effects on milk production
• However, endogenous erythropoietin is present in human milk
• Because many drugs are present in human milk, exercise caution when epoetin alfa is administered to a lactating woman
• Multiple-dose vials contain benzyl alcohol and are contraindicated in lactating women; advise a lactating woman not to breastfeed for at least 2 weeks after the last dose; preservative benzyl alcohol has been associated with serious adverse reactions and death when administered intravenously to neonates and infants; there is a potential for similar risks to infants exposed to benzyl alcohol through human milk