Epogen


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Related to Epogen: Neupogen, Procrit

epoetin alfa

Epogen, Eprex (CA) (UK), Procrit

Pharmacologic class: Recombinant human erythropoietin

Therapeutic class: Biological response modifier

Pregnancy risk category C

Action

Binds to erythropoietin, stimulating mitotic activity of erythroid progenitor cells in bone marrow and causing release of reticulocytes from bone marrow into bloodstream, where they become mature RBCs

Availability

Injection: 2,000 units/ml, 3,000 units/ml, 4,000 units/ml, 10,000 units/ml; 10,000 units/ml and 20,000 units/ml in multidose vials

Indications and dosages

Anemia associated with chronic kidney disease (CKD) in patients on dialysis or not on dialysis

Adults: Initially, 50 to 100 units/kg I.V. or subcutaneously three times weekly. Don't increase dosage more frequently than once q 4 weeks. May decrease dosage more frequently but avoid frequent dosage adjustments.

Anemia in children with chronic CKD who are on dialysis

Children ages 1 month to 16 years: Initially, 50 units/kg I.V. or subcutaneously three times weekly. Don't increase dosage more frequently than once q 4 weeks. May decrease dosage more frequently but avoid frequent dosage adjustments.

Anemia caused by zidovudine therapy in patients with human immunodeficiency virus infection

Adults: 100 units/kg I.V. or subcutaneously three times weekly for 8 weeks or until hematocrit level is adequate. If desired response isn't reached after 8 weeks, dosage may be increased by 50 to 100 units/kg I.V. or subcutaneously three times weekly; after 4 to 8 weeks, dosage may be further increased, as prescribed, to a maximum dosage of 300 units/kg I.V. or subcutaneously three times weekly.

Anemia due to effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy

Adults: 150 units/kg subcutaneously three times weekly until completion of a chemotherapy course, or 40,000 units subcutaneously weekly until completion of a chemotherapy course Children ages 5 to 18: 600 units/kg I.V. weekly until completion of a chemotherapy course

To reduce need for blood transfusion in surgical patients

Adults: 300 units/kg subcutaneously daily for 10 days before surgery, on day of surgery, and for 4 days after surgery; or 600 units/kg subcutaneously weekly starting 3 weeks before surgery, followed by additional dose on day of surgery

Contraindications

• Serious allergic reactions
• Uncontrolled hypertension
• Pure red cell aplasia that begins after treatment
• Use of multidose vials in neonates, infants, and pregnant and breastfeeding patients

Precautions

Use cautiously in:
• renal insufficiency, CV disease
• pregnant or breastfeeding patients
• children younger than age 1 month (safety and efficacy not established).

Administration

• Don't shake drug and don't use if it has been shaken or frozen.
• Don't dilute or mix with other drug solutions. However, preservative-free epoetin alfa from single-use vials may be admixed in a syringe with bacteriostatic 0.9% sodium chloride injection with benzyl alcohol 0.9% (bacteriostatic saline) in a 1:1 ratio using aseptic technique at time of administration; keep in mind that risks are associated with benzyl alcohol use in some patients.
• Don't reenter preservative-free vials.
• For patients with CKD on dialysis, start drug when hemoglobin level is less than 10 g/dl. If hemoglobin level approaches or exceeds 11 g/dl, reduce dosage or interrupt dosing.
• For patients with CKD not on dialysis, consider starting drug only when hemoglobin level is less than 10 g/dl and the following considerations apply: Rate of hemoglobin decline indicates the likelihood of requiring an RBC transfusion and reducing the risk of alloimmunization or other RBC transfusion-related risks is a goal. If hemoglobin level exceeds 10 g/dl, reduce dosage or interrupt dosing and use lowest dosage sufficient to reduce the need for RBC transfusions.
• Be aware that in patients undergoing surgery, deep venous thrombosis prophylaxis is strongly recommended during epoetin alfa therapy.
• For I.V. use, give single dose by direct I.V. injection over at least 1 minute, and follow with saline flush.
• If patient is on hemodialysis, administer drug into venous return line of dialysis tubing after patient completes dialysis session.
• Know that supplemental iron may be needed to support erythropoiesis and avoid iron depletion.

Avoid using multidose vials in neonates, infants, and pregnant and breastfeeding patients because of benzyl alcohol content, which has been associated with serious adverse events and death, including "gasping syndrome."

Adverse reactions

CNS: headache, paresthesia, fatigue, dizziness, asthenia, seizures

CV: hypertension, increased clotting of arteriovenous grafts

GI: nausea, vomiting, diarrhea

Metabolic: hyperuricemia, hyperphosphatemia, hyperkalemia

Musculoskeletal: joint pain

Respiratory: cough, dyspnea

Skin: rash, urticaria

Other: fever, edema, injection site pain

Interactions

Drug-diagnostic tests.Blood urea nitrogen, creatinine, phosphate, potassium, uric acid: increased levels

Patient monitoring

• Monitor vital signs and cardiovascular status, especially for hypertension and edema.
• Assess arteriovenous graft for patency, because drug may increase clotting at graft.
• Monitor electrolyte and uric acid levels. Watch closely for hyperuricemia, hyperkalemia, and hyperphosphatemia.
• Check temperature for fever.
• Monitor neurologic status for signs and symptoms of impending seizure.
• Evaluate nutritional status and hydration in light of GI adverse effects.

Patient teaching

• Tell patient who will self-administer drug to follow exact directions for injection and needle disposal.

Instruct patient to monitor weight and blood pressure regularly and to immediately report hypertension, sudden weight gain, or swelling.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, motor skills, and alertness.
• Tell patient to minimize GI upset by eating small, frequent servings of food and drinking plenty of fluids.
• Advise female patient to discuss pregnancy or breastfeeding with prescriber before starting drug.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests mentioned above.

epoetin

(e-poe-e-tin) ,

Epogen

(trade name),

Eprex

(trade name),

erythropoietin

(trade name),

Procrit

(trade name)

Classification

Therapeutic: antianemics
Pharmacologic: hormones
Pregnancy Category: C

Indications

Anemia associated with chronic kidney disease (CKD).Anemia secondary to zidovudine (AZT) therapy in HIV-infected patients.Anemia from chemotherapy in patients with nonmyeloid malignancies.Reduction of need for allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.Anemia of prematurity in neonates

Action

Stimulates erythropoiesis (production of red blood cells).

Therapeutic effects

Maintains and may elevate RBCs, decreasing the need for transfusions.

Pharmacokinetics

Absorption: Well absorbed after subcut administration.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Children and Adults–4–13 hr; Neonates—11–17 hr.

Time/action profile (increase in RBCs)

ROUTEONSET†PEAKDURATION
IV, Subcut7–10 dayswithin 2 mo2 wk‡
†Increase in reticulocytes‡After discontinuation

Contraindications/Precautions

Contraindicated in: Hypersensitivity to albumin or mammalian cell-derived products;Uncontrolled hypertension;Patients with erythropoietin levels >200 mUnits/mL;Patients receiving chemotherapy when anticipated outcome is cure;Neutropenia in newborns.
Use Cautiously in: History of seizures or stroke;Cardiovascular disease;History of porphyria; Obstetric: Evidence of fetal harm in animal studies—use only if potential benefit outweighs potential risk to fetus; Obstetric / Lactation: Little published information, however, erythropoetin alfa is a normal constituent of breast milk; Pediatric: Multidose vials contain benzyl alcohol, which can cause potentially fatal gasping syndrome in neonates.

Adverse Reactions/Side Effects

Central nervous system

  • seizures (life-threatening)
  • headache

Cardiovascular

  • hf (life-threatening)
  • mi (life-threatening)
  • stroke (life-threatening)
  • thromboembolic events (especially with hemoglobin >11 g/dL) (life-threatening)
  • hypertension (most frequent)

Dermatologic

  • transient rashes

Endocrinologic

  • restored fertility
  • resumption of menses

Miscellaneous

  • ↑ mortality and ↑ tumor growth (with hemoglobin ≥12 g/dL)

Interactions

Drug-Drug interaction

May ↑ requirement for heparin anticoagulation during hemodialysis.

Route/Dosage

Anemia of CKD

(Do not initiate if hemoglobin ≥10 g/dL)
Subcutaneous Intravenous (Adults) 50–100 units/kg 3 times weekly initially; use lowest dose sufficient to ↓ the need for red blood cell transfusions (do not exceed hemoglobin of 10 g/dL [patients on dialysis] or 11 g/dL [patients not on dialysis]); if Hgb ↑ by >1.0 g/dL in 2 wk, ↓ dose by 25%; if Hgb ↑ by <1.0 g/dL after 4 wk of therapy (with adequate iron stores), ↑ dose by 25%; do not ↑ dose more frequently than q 4 wk.
Subcutaneous Intravenous (Children 1 mo–16 yr) 50 units/kg 3 times weekly initially; use lowest dose sufficient to ↓ the need for red blood cell transfusions (do not exceed hemoglobin of 10 g/dL [patients on dialysis] or 11 g/dL [patients not on dialysis]); if Hgb ↑ by >1.0 g/dL in 2 wk, ↓ dose by 25%; if Hgb ↑ by <1.0 g/dL after 4 wk of therapy (with adequate iron stores), ↑ dose by 25%; do not ↑ dose more frequently than q 4 wk.

Anemia Secondary to AZT Therapy

Subcutaneous Intravenous (Adults) 100 units/kg 3 times weekly for 8 wk; if inadequate response, may ↑ by 50–100 units/kg every 4–8 wk (max: 300 units/kg 3 times weekly).
Subcutaneous Intravenous (Children 8 mo–17 yr) 50–400 units/kg 2–3 times weekly.

Anemia from Chemotherapy

(Use only for chemotherapy-related anemia and discontinue when chemotherapy course is completed; do not initiate if hemoglobin ≥10 g/dL)
Subcutaneous (Adults) 150 units/kg 3 times weekly or 40,000 units weekly; adjust dose to maintain lowest hemoglobin level sufficient to avoid blood transfusions (do not exceed hemoglobin of 12 g/dL); if Hgb ↑ by >1.0 g/dL in 2 wk or reaches a level needed to avoid red blood cell transfusions, ↓ dose by 25%; if Hgb ↑ by <1.0 g/dL (and remains < 10 g/dL) after initial 4 wk of therapy (with adequate iron stores), ↑ dose to 300 units/kg 3 times weekly or 60,000 units weekly.
Intravenous (Children 5–18 yr) 600 units/kg weekly; adjust dose to maintain lowest hemoglobin level sufficient to avoid blood transfusions (do not exceed hemoglobin of 12 g/dL); if Hgb ↑ by >1.0 g/dL in 2 wk or reaches a level needed to avoid red blood cell transfusions, ↓ dose by 25%; if Hgb ↑ by <1.0 g/dL (and remains < 10 g/dL) after initial 4 wk of therapy (with adequate iron stores), ↑ dose to 900 units/kg (maximum = 60,000 units) weekly.

Surgery

Subcutaneous (Adults) 300 units/kg/day for 10 days before surgery, day of surgery, and 4 days after or 600 units/kg 21, 14, and 7 days before surgery and on day of surgery.

Anemia of Prematurity

Intravenous Subcutaneous (Neonates) 500–1250 units/week divided into 2–5 doses for 10 doses. Supplement with oral iron therapy 3–8 mg/kg/day.

Availability

Injection: 2000 units/mL, 3000 units/mL, 4000 units/mL, 10,000 units/mL, 20,000 units/mL, 40,000 units/mL

Nursing implications

Nursing assessment

  • Monitor BP before and during therapy. Inform health care professional if severe hypertension is present or if BP begins to increase. Additional antihypertensive therapy may be required during initiation of therapy.
  • Monitor for symptoms of anemia (fatigue, dyspnea, pallor).
  • Monitor dialysis shunts (thrill and bruit) and status of artificial kidney during hemodialysis. Heparin dose may need to be increased to prevent clotting. Monitor patients with underlying vascular disease for impaired circulation.
  • Lab Test Considerations: May cause ↑ in WBCs and platelets. May ↓ bleeding times.
    • Monitor serum ferritin, transferrin, and iron levels to assess need for concurrent iron therapy. Transferrin saturation should be at least 20% and ferritin should be at least 100 ng/mL.
  • Anemia of Chronic Kidney Disease: Monitor hematocrit before and twice weekly during initial therapy, for 2–6 wk after a change in dose, and regularly after target range (30–36%) has been reached and maintenance dose is determined. Monitor other hematopoietic parameters (CBC with differential and platelet count) before and periodically during therapy. If hemoglobin ↑ and approached 11 g/dL or ↑ by more than 1 g/dL in a 2-wk period, ↓ dose by 25% and monitor hemoglobin twice weekly for 2–6 wk. If ↑ in hemoglobin continues and exceeds 11 g/dL, dose should be withheld until hemoglobin begins to ↓; epoetin is then reinitiated at a dose 25% lower than previous dose. If hemoglobin ↑ by <1 g/dL over 4 wk (and iron stores are adequate), ↑ dose by 25%; monitor hemoglobin twice weekly for 2–6 wk; further dose ↑ may be made at 4-wk intervals until desired response attained. If no response after 12 wk of escalation, further dose ↑ is unlikely to improve response and may increase risks. Use lowest dose that will maintain Hgb level sufficient to reduce need for transfusions.
    • Monitor renal function studies and electrolytes closely; resulting increased sense of well-being may lead to decreased compliance with other therapies for renal failure. Increases in BUN, creatinine, uric acid, phosphorus, and potassium may occur.
  • Anemia Secondary to Zidovudine Therapy: Before initiating therapy, determine serum erythropoietin level before transfusion. Patients receiving zidovudine with endogenous serum erythropoietin levels >500 mUnits/mL may not respond to therapy. Monitor hemoglobin weekly during dose adjustment. If response does not reduce transfusion requirements or increase hemoglobin effectively after 8 wk of therapy, dose may be ↑ by 50–100 units/kg 3 times weekly. Evaluate response and adjust dose by 50–100 units/kg every 4–8 wk thereafter. If a satisfactory response is not obtained with a dose of 300 units/kg 3 times weekly, it is unlikely that a higher dose will produce a response. Once the desired response is attained, maintenance dose is titrated based on variations of zidovudine dose and concurrent infections. If hemoglobin exceeds 12 g/dL, discontinue dose until hemoglobin drops to <11 g/dL, then ↓ dose by 25%.
  • Anemia from Chemotherapy: Monitor hemoglobin weekly until stable. Do not initiate if hemoglobin ≥10 g/dL. Patients with lower baseline serum erythropoietin levels may respond more rapidly; not recommended if levels >200 mUnits/mL. If hemoglobin exceeds 12 g/dL, withhold dose until hemoglobin approaches level where transfusions may be required and then reinitiate at a dose 25% lower than previous dose. If hemoglobin ↑ by >1.0 g/dL in any 2-wk period, ↓ dose by 25%. For 3 times weekly dosing regimens, if response is not adequate (no ↓ in transfusion requirements or no ↑ in hemoglobin) after 8 wk of therapy, dose may be ↑ up to 300 units/kg 3 times weekly. If no response is obtained to this dose, it is unlikely that higher doses will produce a response. For weekly dosing regimens, if response is not adequate (no ↑ in hemoglobin by ≥1 g/dL after 4 wk in absence of RBC transfusion), ↑ dose to 60,000 units weekly (adults) or 900 units/kg (max: 60,000 units) (children).
  • Surgery: Determine that hemoglobin is >10 to ≤13 g/dL before therapy. Epoetin has been used for 10 days before surgery, on the day of surgery and for 4 days post surgery. Implement prophylaxis of deep venous thrombosis during surgical use.

Potential Nursing Diagnoses

Activity intolerance (Indications)
Noncompliance (Patient/Family Teaching)

Implementation

  • Intravenous Administration
  • Prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense epoetin alfa to patients with cancer. Visit www.esa-apprise.com or call 1-866-284-8089.
  • Transfusions are still required for severe symptomatic anemia. Supplemental iron should be initiated with epoetin and continued throughout therapy.
    • Institute seizure precautions in patients who experience greater than a 4-point increase in hematocrit in a 2-wk period or exhibit any change in neurologic status. Risk of seizures is greatest during the first 90 days of therapy.
    • Do not shake vial; inactivation of medication may occur. Solution is clear and colorless; do not administer solutions that are discolored, cloudy, or contain a precipitate. Discard vial immediately after withdrawing dose from single-use 1-mL vial. Refrigerate multidose 2-mL vial; stable for 21 days after initial entry.
  • Subcutaneous: This route is often used for patients not requiring dialysis.
    • May be admixed in syringe immediately before administration with 0.9% NaCl with benzyl alcohol 0.9% in a 1:1 ratio to prevent injection site discomfort.
  • Diluent: Administer undiluted or dilute with an equal amount of 0.9% NaCl.Concentration: 1000–40,000 units/mL.
  • Rate: May be administered as direct injection or bolus over 1–3 minutes into IV tubing or via venous line at end of dialysis session.
  • Y-Site Compatibility: alfentanil, amikacin, aminophylline, ascorbic acid, atracurium, atropine, azathioprine, aztreonan, benztropine, bumetanide, buprenorphine, butorphanol, calcium chloride, calcium gluconate, cefazolin, cefoperazone, cefotaxime, cefotetan, cefoxitin, ceftazidime, ceftriaxone, cefuroxime, chloramphenicol, clindamycin, cyanocobalamin, cyclosporine, dexamethasone, digoxin, diphenhydramine, dobutamine, dopamine, doxycycline, enalaprilat, ephedrine, epinephrine, erythromycin, esmolol, famotidine, fentanyl, fluconazole, folic acid, furosemide, gentamicin, glycopyrrolate, heparin, hydrocortisone, imipenem-cilastatin, indomethacin, insulin, isoproterenol, ketorolac, labetalol, lidocaine, magnesium sulfate, mannitol, meperidine, metaraminol, methyldopate, methylprednisolone, metoclopramide, metoprolol, morphine, multivitamins, nafcillin, nalbuphine, naloxone, nitroglycerin, nitroprusside, norepinephrine, ondansetron, oxacillin, oxytocin, penicillin G, pentazocine, pentobarbital, phenobarbital, phentolamine, phenylephrine, phytonadione, potassium chloride, procainamide, promethazine, propranolol, protamine, pyridoxime, ranitidine, sodium bicarbonate, streptokinase, succinylcholine, sufentanyl, theophylline, ticarcillin/clavulanate, tobramycin, tolazoline, vasopressin, verapamil
  • Y-Site Incompatibility: amphotericin B colloidal, chlorpromazine, dantrolene, diazepam, diazoxide, haloperidol, midazolam, pentamidine, phenytoin, prochlorperazine, trimethoprim/sulfamethoxazole, vancomycin

Patient/Family Teaching

  • Advise patient to read the Medication Guide prior to initiating therapy and with each Rx refill in case of changes. Patient must sign the patient-health care provider acknowledgment form before each course of therapy.
  • Explain rationale for concurrent iron therapy (increased red blood cell production requires iron).
    • Discuss ways of preventing self-injury in patients at risk for seizures. Driving and activities requiring continuous alertness should be avoided.
    • Inform patient that use of epoetin may result in shortened overall survival and/or ↓ time to tumor progression.
    • Advise patient to notify health care professional immediately if signs of blood clots (chest pain, trouble breathing or shortness of breath; pain in the legs, with or without swelling; a cool or pale arm or leg; sudden confusion; trouble speaking or trouble understanding others’ speech; sudden numbness or weakness in the face, arm, or leg, especially on one side of the body; sudden trouble seeing; sudden trouble walking, dizziness, loss of balance or coordination; loss of consciousness or fainting; hemodialysis vascular access stops working) occur.
    • Advise patient to inform health care professional of medication prior to treatment or surgery.
    • Discuss possible return of menses and fertility in women of child-bearing age. Patient should discuss contraceptive options with health care professional.
  • Anemia of Chronic Renal Failure: Stress importance of compliance with dietary restrictions, medications, and dialysis. Foods high in iron and low in potassium include liver, pork, veal, beef, mustard and turnip greens, peas, eggs, broccoli, kale, blackberries, strawberries, apple juice, watermelon, oatmeal, and enriched bread. Epoetin will result in increased sense of well-being, but it does not cure underlying disease.
  • Home Care Issues: Home dialysis patients determined to be able to safely and effectively administer epoetin should be taught proper dosage, administration technique, and disposal of equipment. Information for Home Dialysis Patients should be provided to patient along with medication.

Evaluation/Desired Outcomes

  • Increase in hematocrit to 30–36% with improvement in symptoms of anemia in patients with chronic renal failure.
  • Increase in hematocrit in anemia secondary to zidovudine therapy.
  • Increase in hematocrit in patients with anemia resulting from chemotherapy.
  • Reduction of need for transfusions after surgery.

Epogen

(ē′pə-jən)
A trademark for the drug epoetin alfa.
References in periodicals archive ?
Consequently, Amgen's financial performance will be subject to pricing pressures by Medicare on Epogen and other large third-party health care purchasers on Neupogen.
Domestic sales of Aranesp - Amgen's next-generation Epogen - are expected to increase by 20 percent in the next two years.
Epogen, a genetically altered form of a naturally occurring protein, erythropoietin, or EPO, bolsters the body's production of red blood cells.
EPOGEN should be discontinued in any patient with evidence of PRCA and the patient evaluated for the presence of antibodies to erythropoietin products.
In the third quarter, Epogen sales alone were $558 million.
Known as Epogen in the United States, Amgen's drug has been among the most successful anemia products for the Thousand Oaks-based company, generating sales of $570 million in the most recent quarter.
In fact, pharmaceuticals such as Epogen and Arithropoetin are specifically designed to stimulate the body's bone marrow to make more red blood cells.
Once the deal closes, Amgen - which also makes the widely used anemia drug Epogen - will own Enbrel, a top-selling drug that treats rheumatoid arthritis.
These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of Renal Care Group to differ materially from those expressed in or implied by the forward-looking statements, including risks related to: the integration of acquired companies; compliance with health care and other applicable laws; changes in the Medicare and Medicaid programs; risks related to the drug Epogen (EPO); payment reductions by private insurers, hospitals or managed care organizations; and changes in the health care delivery, financing or reimbursement systems.
Worldwide sales of the drug and its predecessor Epogen increased 53 percent to $959 million.
The United States alleged that it had civil claims against NMC under the False Claims Act and other federal laws because NMC had billed Medicare and other federal health care programs for a drug known as Epoetin Alfa, commonly known as "Epogen," when in fact NMC had received the Epogen for free from its manufacturer, Amgen, Inc.
Amgen) under which Amgen will supply FMC-NA's commercial requirements in the United States and Puerto Rico for erythropoiesis stimulating proteins for dialysis patients, inclusive of EPOGEN (Epoetin alfa) and Aranesp (Darbepoetin alfa).