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Epoetin Alfa

Class: Hematopoietic Agents
VA Class: BL400
Chemical Name: 1-165-Erythropoietin (human clone λHEPOFL13 protein moiety)
Molecular Formula: C809H1301N229O240S5
CAS Number: 113427-24-0
Brands: Epogen, Procrit

Medically reviewed on October 23, 2017

Warning

    Risk of Increased Mortality and Serious Adverse Events
  • Increased risk of death, serious cardiovascular events, and stroke reported in patients with chronic kidney disease (CKD) receiving therapy with epoetin alfa or other erythropoiesis-stimulating agents (ESAs) targeted to hemoglobin concentrations >11 g/dL in controlled clinical studies.1 400 585 586 587 588 589 590 594 597 602 603 604 615 620 622 624 (See Increased Mortality and Cardiovascular and Thromboembolic Events under Cautions.)

  • No trial has identified a hemoglobin target, ESA dosage, or dosing strategy that does not increase these risks.1 400

  • Use lowest ESA dosage sufficient to reduce need for RBC transfusion in patients with CKD.1 400 624

  • ESA therapy shortened overall survival and increased risk of tumor progression or recurrence in some studies in patients with breast, non-small cell lung, head and neck, lymphoid, or cervical cancers.1 400 589 590 597 599 600 602 603 604 605 606 (See Increased Mortality and/or Tumor Progression under Cautions.)

  • To decrease these risks and risk of serious cardiovascular and thromboembolic events in anemic patients with cancer, use lowest ESA dosage sufficient to avoid RBC transfusion.1 400 585 586 587 588 589 590 597

  • Use ESAs in cancer patients only for treatment of anemia caused by concomitant myelosuppressive chemotherapy.1 400 589 590 597 602 603 604 605

  • ESAs not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.1 400 597 608

  • Discontinue ESAs following completion of a course of chemotherapy.1 400 597

  • Due to increased risk of DVT, DVT prophylaxis recommended in surgical patients receiving epoetin alfa perioperatively.1 400 589 590 602 604

Introduction

Biosynthetic (recombinant DNA origin) form of the glycoprotein hormone erythropoietin, a hematopoietic agent that principally affects erythropoiesis.1 2 3 4 5 7 8 10 11 13 14 18 19 21 23 25 32 33 34 37 43 51 52 53 54 55 58 70 71 72 120 121 122 159 164 166 169 174 187 206 222 236 246 255 305 336 346 366 399 400 405 408 414 418 453 464

Uses for Epoetin Alfa

Anemia of Chronic Kidney Disease

Treatment of anemia associated with chronic kidney disease (CKD) to reduce need for RBC transfusions; designated an orphan drug by FDA for this use.1 3 4 5 11 22 23 32 50 51 52 53 59 65 66 68 70 76 77 119 122 159 165 173 283 312 322 324 336 366 371 400 410 414 519

First-line therapy for appropriately selected patients with anemia of CKD.2 51 453 510 565 601

Used to increase and/or maintain hemoglobin concentrations and hematocrit and decrease the need for RBC transfusions.1 3 4 5 11 22 23 32 66 70 119 173 303 324 366 400 410

Used in CKD patients who currently are undergoing dialysis therapy, as well as predialysis patients with CKD and severe symptoms of anemia who do not yet require maintenance dialysis.1 3 4 5 11 22 23 32 50 51 52 53 59 65 66 68 70 76 77 119 122 159 165 173 283 312 322 324 336 366 371 400 410 414 Manufacturers and some authorities recommend use in patients with end-stage kidney disease who currently are undergoing hemodialysis or peritoneal dialysis therapy and also in predialysis patients with CKD who have a hematocrit <30% or hemoglobin concentration <10 g/dL.1 6 11 34 66 112 119 173 247 278 298 312 322 324 400 410 601

Some evidence suggests once-weekly darbepoetin alfa has similar safety and efficacy as equivalent doses of epoetin alfa given 2 or 3 times weekly in patients with CKD undergoing hemodialysis or peritoneal dialysis.573 574 575 576 577 578 579 580

ESAs, including epoetin alfa, may increase risk for death, stroke, and serious cardiovascular events when targeted to hemoglobin concentrations >11 g/dL in patients with CKD.1 114 166 187 261 336 400 518 584 585 586 587 594 610 615 620 622 624 625 (See Boxed Warning.) FDA has issued public health advisories regarding these risks.584 585 586 587 588 589 590 602 603 604 624 Weigh potential benefits of ESAs in reducing RBC transfusions against risk of serious cardiovascular events in patients with CKD.1 400 624 Individualize therapy and use lowest possible dosage that will reduce need for RBC transfusion.1 400 624

Not intended for patients with CKD who require acute correction of severe anemia; do not use as a substitute for emergency transfusion.1 366 400

Not established that ESAs improve quality of life, fatigue, or patient well-being.1 400

Zidovudine-induced Anemia in HIV-infected Patients

Treatment of anemia associated with zidovudine therapy in patients with HIV infection; indicated in patients with endogenous serum erythropoietin concentrations ≤500 milliunits/mL and who are receiving zidovudine dosages of ≤4.2 g per week (designated an orphan drug by FDA for this use).1 2 122 124 187 199 286 293 294 335 400 429 444 452 478 519 554 1 2 122 124 187 199 286 293 294 335 400 429 444 452 554

Used to increase and/or maintain hemoglobin concentrations and hematocrit and decrease the need for transfusions.1 2 122 124 187 199 286 293 294 335 400 429 444 452 554

Has been used to treat anemia associated with HIV infection in patients not receiving zidovudine.452 523

Not intended for patients who require acute correction of severe anemia; do not use as a substitute for emergency transfusion.1 400

Not established that ESAs improve quality of life, fatigue, or patient well-being.1 400

Chemotherapy-induced Anemia in Patients with Nonmyeloid Malignancies

Treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies in whom chemotherapy is planned for at least 2 additional months; used to decrease the need for blood transfusions in such patients.1 187 247 288 296 344 348 358 359 400 524 525 527 528 530 534 535 536 537 538 572 583

ESAs not indicated in patients with chemotherapy-induced anemia when the anticipated outcome is cure of the underlying malignancy.1 400 608 ESAs do not improve outcomes of cancer chemotherapy (e.g., in terms of greater tumor shrinkage, delayed tumor progression, increased survival).1 400 589 590 597 599 600 602 603 604 607 608 609 614 Not established that ESAs improve quality of life, fatigue, or patient well-being.1 400 589 590

Not intended for patients who require acute correction of severe anemia; do not use as a substitute for emergency transfusion.1 400

Chronic Anemia Associated with Malignancy

Epoetin alfa and other ESAs not indicated for use in anemic patients with active malignant disease who are not receiving cancer chemotherapy.1 400 597

Has been used for the treatment and prevention of the normocytic, normochromic anemia associated with malignancy;4 10 122 187 247 296 348 349 404 405 411 412 413 461 464 510 518 524 525 529 530 601 however, ESAs have been shown to decrease survival in certain cancer patients who are not receiving chemotherapy or radiation therapy.1 400

Reduction of Allogeneic Blood Transfusions in Anemic Surgical Patients

Treatment of anemic patients (hemoglobin >10 to ≤13 g/dL) scheduled to undergo elective, noncardiac, nonvascular surgery; used perioperatively to reduce the need for allogeneic blood transfusions.1 161 173 174 187 199 211 239 247 344 377 400 406 419 453 464 510

Indicated for such patients who are at high risk for perioperative blood loss. 1 400

Not intended for patients who require acute correction of severe anemia; do not use as a substitute for emergency transfusion.1 400

Not indicated in patients who are willing to donate autologous blood prior to elective surgery.1 400

Not indicated for reduction of allogeneic RBC transfusions in patients undergoing cardiac or vascular surgery.1 400 597 601 (See Increased Mortality and Cardiovascular and Thromboembolic Events under Cautions.)

Anemia Associated with Rheumatoid Arthritis and Rheumatic Disease

Has been used for treatment of anemia associated with rheumatoid arthritis and/or rheumatic disease.2 4 5 7 10 122 154 174 187 247 336 344 373 420 437 462 464 510

Anemia of Prematurity

May be beneficial in the treatment of anemia of prematurity.2 18 36 37 187 331 336 338 350 453 465 519 562 563 564 Optimal patient selection criteria not established.338 562 563 564

Myelodysplastic Syndrome

Has been used in patients with myelodysplastic syndromes (designated an orphan drug by FDA for this use).460 464 519 531 532 533 Relatively limited response rates reported; effects of the hormone on nonerythroid cell lines and potential risks of leukemic transformation require elucidation.460 464 531 532 533

Misuse and Abuse

Potential exists for abuse of the drug by athletes, especially those participating in high-aerobic demand, endurance-type events.4 21 247 385 386 453 468 469 501 Effects of epoetin alfa would be expected to be similar to those of homologous or autologous RBC cell transfusions (“blood doping”), which have been used by athletes to increase cardiac output, maximal oxygen uptake capacity of blood, and aerobic exercise endurance by increasing arterial blood oxygen content; effects may be particularly evident in individuals with greater initial aerobic fitness.21 340 341 342 343 385 386 501

Abuse by athletes is difficult to detect; no reliable way to distinguish epoetin alfa from the endogenous hormone using readily available drug-screening methods (e.g., immunoradiometric assay).4 385 386

Medical and sports experts, including the US and International Olympic Committees and the National Collegiate Athletic Association, consider the use of epoetin alfa to enhance athletic ergogenic potential inappropriate and unacceptable; use by athletes is contrary to the rules and ethical principles of athletic competition.469 504 508 510 518

Epoetin Alfa Dosage and Administration

General

  • In controlled trials of patients with CKD, ESA therapy targeted to hemoglobin concentrations >11 g/dL did not provide additional benefit beyond that achieved with lower hemoglobin targets and was associated with greater risk of death and serious adverse cardiovascular events; no trial to date has identified a target hemoglobin concentration, ESA dosage, or dosing strategy that does not increase these risks.1 400 624 (See Boxed Warning.) Weigh benefits of epoetin alfa against these risks in patients with CKD.1 400 624 Use lowest dosage necessary to reduce the need for RBC transfusion.1 400 589 590

  • To decrease risks of shortened survival, tumor progression or recurrence in patients with cancer, use lowest dosage sufficient to reduce the need for RBC transfusion and discontinue following completion of a chemotherapy course.1 400

  • Evaluate iron status (i.e., transferrin saturation, serum ferritin) prior to and during therapy.1 400 Administer supplemental iron if serum ferritin <100 mcg/L or transferrin saturation <20%.1 400

  • Exclude or correct other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding) prior to initiating therapy.1 400

Administration

Administer by IV or sub-Q injection.1 IV injection recommended in patients with CKD undergoing hemodialysis.1 400 581 582

Do not dilute or shake prior to use.1 400

Commercially available epoetin alfa injection generally should not be diluted or mixed with other drug solutions except in certain cases of sub-Q administration.1 400 (See Sub-Q Administration under Administration.)

IV Administration

Administer by direct IV injection.1 400

In patients undergoing hemodialysis, injection into the venous return line of the dialysis tubing following dialysis eliminates the need for additional venous access.1 50 51 59 65 66 68 70 112 115 122 138 173 187 233 247 256 306 400

Sub-Q Administration

At the time of administration, preservative-free epoetin alfa (single-use vial) can be admixed in a syringe with bacteriostatic 0.9% sodium chloride injection (preserved with benzyl alcohol) in a 1:1 ratio; presence of benzyl alcohol may ameliorate injection site discomfort.1 400 HID Because of risks of toxicity, do not admix with benzyl alcohol-preserved solutions in neonates, infants, or pregnant or nursing women.1 400

Dosage

Potency of epoetin alfa has been expressed in units of activity per mg of protein268 509 as tested against the WHO Second International Reference Preparation of human urinary erythropoietin.268 355

Pediatric Patients

Anemia of Chronic Kidney Disease
IV or Sub-Q

Children and infants ≥1 month of age on dialysis: Initially, 50 units/kg 3 times weekly; IV administration recommended in patients undergoing hemodialysis.1 400

Initiate therapy when hemoglobin concentration <10 g/dL.1 400 624 Reduce or interrupt therapy if hemoglobin approaches or exceeds 11 g/dL.1 400

Children ≥3 months of age who do not require dialysis: 50–250 units/kg 1–3 times weekly has been used.1 400

Dosage Modifications

Adjust dosage based on hemoglobin concentrations.1 Consider rate of hemoglobin increase or decrease, ESA responsiveness, and hemoglobin variability when determining whether adjustments are needed; a single hemoglobin excursion may not require a dosage change.1 Avoid frequent dosage changes.1

Monitor hemoglobin concentration at least weekly following initiation of therapy and after each dosage adjustment until stable, then at least monthly thereafter.1 400 624

If hemoglobin concentration increases by >1 g/dL in any 2-week period, reduce dosage by 25% or more as necessary to reduce risk of a rapid response.1 400

If hemoglobin has not increased by >1 g/dL after 4 weeks of therapy, increase dosage by 25%.1 400

Do not increase dosage more frequently than once every 4 weeks.1 400 If an adequate response not obtained within 12 weeks, evaluate for other causes of anemia; further dosage increase not likely to improve patient response and may increase risks of therapy.1 400 624 (See Boxed Warning.) Use lowest dosage sufficient to reduce need for RBC transfusions; discontinue drug if responsiveness does not improve.1

Zidovudine-associated Anemia in HIV-infected Patients
IV or Sub-Q

Children 8 months to 17 years of age have received dosages of 50–400 units/kg 2 or 3 times weekly.1 400

Chemotherapy-induced Anemia in Patients with Nonmyeloid Malignancies
IV

Pediatric patients 5–18 years of age: Initially, 600 units/kg once weekly.1 400 583 601

Initiate only if hemoglobin concentration <10 g/dL and at least 2 additional months of chemotherapy is planned.1 400

Discontinue epoetin alfa therapy following completion of a course of chemotherapy.1 400 589 590 (See Boxed Warning.)

Dosage Modifications

Monitor hemoglobin concentrations at least weekly following initiation of therapy and after each dosage adjustment until stable and sufficient to minimize need for RBC transfusions.1 400

If the hemoglobin has not increased by ≥1 g/dL within 4 weeks and remains <10 g/dL, increase weekly dosage to 900 units/kg (maximum 60,000 units weekly).1 400

If hemoglobin increases by >1 g/dL in any 2-week period or reaches a concentration sufficient to avoid RBC transfusion, reduce dosage by 25%.1 400 If hemoglobin exceeds a level needed to avoid RBC transfusion, withhold therapy until the hemoglobin falls to a level where RBC transfusion may be required, then resume at a dosage 25% less than the previous dosage.1 400 601

Discontinue epoetin alfa therapy after 8 weeks if no response based on hemoglobin concentrations or if RBC transfusions are still required.1 400

Adults

Anemia of Chronic Kidney Disease
IV or Sub-Q

Patients on dialysis: Initially, 50–100 units/kg 3 times weekly; IV administration recommended in patients undergoing hemodialysis.1 400 Initiate therapy when hemoglobin concentration <10 g/dL.1 400 624 Reduce or interrupt therapy if hemoglobin approaches or exceeds 11 g/dL.1 400 (See Boxed Warning.)

Patients not on dialysis: Initially, 50–100 units/kg 3 times weekly.1 400 Consider initiating therapy when hemoglobin <10 g/dL and the following 2 conditions apply: rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and a goal of therapy is to reduce risk of alloimmunization and/or other risks associated with RBC transfusions.1 400 Reduce or interrupt therapy if hemoglobin >10 g/dL.1 400 (See Boxed Warning.)

Dosage Modifications

Adjust dosage based on hemoglobin concentrations.1 400 Consider rate of hemoglobin increase or decrease, ESA responsiveness, and hemoglobin variability when determining whether adjustments are needed; a single hemoglobin excursion may not require a dosage change.1 400 Avoid frequent dosage changes.1 400

Monitor hemoglobin concentration at least weekly following initiation of therapy and after each dosage adjustment until stable, then at least monthly thereafter.1 400

If hemoglobin increases by >1 g/dL in any 2-week period, reduce dosage by 25% or more as necessary to reduce risk of a rapid response.1 400

If hemoglobin has not increased by >1 g/dL after 4 weeks of therapy, increase dosage by 25%.1 400

Do not increase more frequently than once every 4 weeks.1 400 If an adequate response not obtained within 12 weeks, evaluate for other causes of anemia.1 400 (See Lack or Loss of Response to Therapy under Cautions.) Further dosage increases are not likely to improve patient response and may increase risks of therapy; use lowest dosage sufficient to reduce need for RBC transfusions and discontinue drug if responsiveness does not improve.1 400 (See Boxed Warning.)

Zidovudine-associated Anemia in HIV-infected Patients
IV or Sub-Q

Initially, 100 units/kg 3 times weekly in patients with endogenous serum erythropoietin concentrations ≤500 milliunits/mL receiving ≤4.2 g/week of zidovudine.1 400 601

Dosage Modifications

Monitor hemoglobin concentration at least weekly following initiation of therapy and after each dosage adjustment until stable and sufficient to minimize need for RBC transfusions.1 400

If hemoglobin does not increase after 8 weeks, increase the 3-times-weekly dose by 50–100 units/kg at 4- to 8-week intervals until an adequate hemoglobin concentration or a dosage of 300 units/kg 3 times weekly is reached.1 400 Discontinue therapy if hemoglobin does not increase after 8 weeks of treatment with 300 units/kg 3 times weekly.1 400

If hemoglobin >12 g/dL, withhold therapy until hemoglobin decreases to <11 g/dL.1 400 Reduce dosage by 25% upon reinitiation.1 400

Chemotherapy-induced Anemia in Patients with Nonmyeloid Malignancies
Sub-Q

Initiate only if hemoglobin concentration <10 g/dL and at least 2 additional months of chemotherapy is planned.1 400 Discontinue following completion of a chemotherapy course.1 400

3-times-weekly regimen: Initially, 150 units/kg 3 times weekly.1 400

Once-weekly regimen: Initially, 40,000 units weekly.1 400

Dosage Modifications

3-times-weekly regimen: If hemoglobin concentration has not increased by ≥1 g/dL within 4 weeks and remains <10 g/dL, increase dosage to 300 units/kg 3 times weekly.1 400

Once-weekly regimen: If hemoglobin has not increased by ≥1 g/dL within 4 weeks and remains <10 g/dL, increase dosage to 60,000 units weekly.1 400

If hemoglobin reaches a concentration sufficient to avoid the need for RBC transfusion or increases by >1 g/dL in any 2-week period, reduce dosage by 25%.1 400 If the hemoglobin exceeds a concentration needed to avoid RBC transfusion, temporarily withhold therapy until the hemoglobin falls to a concentration where RBC transfusion may be required, then resume at a dosage 25% less than the previous dosage.1 400 601

Discontinue therapy after 8 weeks if no response based on hemoglobin concentrations or if RBC transfusions are still required.1 400

Reduction of Allogeneic RBC Transfusions in Anemic Surgical Patients
Sub-Q

Prior to therapy, obtain hemoglobin to ensure concentration >10 but ≤13 g/dL.1 400

300 units/kg once daily for 10 days prior to surgery, on the day of surgery, and for 4 days after surgery.1 400

Alternatively, 600 units/kg once weekly for 3 weeks prior to surgery (i.e., days 21, 14, and 7 before surgery), with an additional dose given on the day of surgery.1 400

Prescribing Limits

Pediatric Patients

Chemotherapy-induced Anemia in Patients with Nonmyeloid Malignancies
IV

Maximum 60,000 units once weekly.1 400

Adults

Zidovudine-associated Anemia in HIV-infected Patients
IV or Sub-Q

Patients not responding to 300 units/kg 3 times weekly are unlikely to respond to higher dosages.1 400

Special Populations

Geriatric Patients

Patients with CKD: Individualize dosing.1 400

Cancer patients receiving concomitant chemotherapy: Dosage requirements similar to those in younger adults.1 400

Surgical patients: Dosage requirements similar to those in younger adults.1 400

Cautions for Epoetin Alfa

Contraindications

  • Uncontrolled hypertension.1 400

  • Pure red cell aplasia (PRCA) following treatment with epoetin alfa or other erythropoietin proteins.1 400

  • Serious allergic reactions to epoetin alfa.1 400

Warnings/Precautions

Warnings

Increased Mortality and Cardiovascular and Thromboembolic Events

Increased risk of death and serious cardiovascular events reported in patients with CKD receiving therapy with epoetin alfa and other ESAs targeted to hemoglobin concentrations >11 g/dL.1 400 585 586 587 594 595 610 615 620 622 624 (See Boxed Warning.) In controlled clinical studies comparing higher (13–14 g/dL) to lower (9–11.3 g/dL) hemoglobin targets, an increased risk of death, MI, stroke, CHF, hemodialysis vascular access thrombosis, and other thromboembolic events was observed in the higher target groups.1 60 400 585 586 590 610 620 622 624 625 Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at greater risk.1 400 597 Increases in hemoglobin >1 g/dL during any 2-week period also may contribute to these risks.1 400

Increased mortality reported in patients (without CKD) undergoing coronary artery bypass and receiving perioperative epoetin alfa; death associated with thrombotic events reported during drug administration.1 400 612 ESAs are not indicated for reduction of allogeneic RBC transfusions in patients undergoing cardiac surgery.1 400

Increased mortality and incidence of fatal thrombotic vascular events reported in women with metastatic breast cancer receiving cancer chemotherapy and ESAs targeted to hemoglobin concentrations of 12–14 g/dL.1 400 (See Boxed Warning.)

Increased incidence of thromboembolic events also observed in patients undergoing orthopedic surgical procedures without prophylactic anticoagulation and receiving epoetin alfa to reduce allogeneic RBC transfusion requirements.1 400 589 590 Antithrombotic prophylaxis strongly recommended when ESAs are used in such patients.1 400

Correction of hemoglobin to concentrations >11 g/dL may increase risk of serious and life-threatening cardiovascular events in patients with CKD.1 400 584 585 586 587 588 589 590 624 The manufacturer and FDA recommend that treatment be initiated in patients with CKD only when hemoglobin concentration <10 g/dL.1 400 595 624 Use lowest dosage sufficient to reduce the need for transfusions.1 400 624

Increased anticoagulation with heparin may be needed during dialysis to prevent clotting of the extracorporeal circuit.1 400

Increased Mortality and/or Tumor Progression

Risk of increased mortality and tumor progression or recurrence in patients with cancer.1 400 (See Boxed Warning.)

Decreased overall survival observed in patients with non-small-cell lung cancer receiving only palliative radiotherapy or no active therapy and epoetin alfa targeted to a hemoglobin concentration of 12–14 g/dL.1 400 590 597

Shortened time to tumor progression observed in patients with advanced head and neck cancer receiving only radiation therapy and an ESA.1 400 600

An increased risk of death and no reduction in transfusion requirements observed in patients with cancer-related anemia who were not receiving cancer chemotherapy or radiation therapy while receiving another ESA, darbepoetin alfa.1 400 589 590

Hypertension and Seizures

Risk of new or worsening hypertension in patients with CKD, particularly during early phase of therapy.1 3 6 10 11 21 23 27 29 38 48 49 54 57 59 65 100 115 119 122 135 227 283 324 366 395 400 488 May require initiation of or increases in antihypertensive therapy.1 400 (See Advice to Patients.)

Monitor and appropriately control BP prior to and during therapy; reduce or withhold epoetin alfa if BP becomes difficult to control.1 400 Contraindicated in patients with uncontrolled hypertension.1 400

Seizures and hypertensive encephalopathy reported; risk appears greater in patients with CKD.1 400 Monitor closely for premonitory neurologic symptoms during first several months of therapy.1 400 (See Advice to Patients.)

Potential for Transmission of Viral Diseases

Contains albumin, a derivative of human blood; risk of transmitting viral diseases and/or Creutzfeldt-Jakob Disease (CJD) appears to be extremely remote.1 400 No cases of transmission of viral diseases or CJD ever identified for albumin.1 400

Pure Red Cell Aplasia

PRCA and severe anemia with or without other cytopenias reported in association with neutralizing antibodies to endogenous erythropoietin.1 400 581 582

PRCA occurred predominantly in patients with CKD receiving ESAs by sub-Q administration.1 400 581 582 PRCA also reported in patients with hepatitis C virus (HCV) infection receiving ESAs for anemia related to hepatitis treatment (non-FDA-labeled indication).1 616 617

Withhold therapy in any patient who develops severe anemia and low reticulocyte counts; evaluate for presence of neutralizing antibodies to erythropoietin.1 400 581 582 Contact the manufacturer (Janssen Biotech [formerly Centocor Ortho Biotech] at 800-457-6399, Amgen at 800-772-6436) to perform assays for binding and neutralizing antibodies.1 400 581 582

Discontinue permanently in any patient with PRCA.1 400 (See Contraindications.) Do not switch to another ESA.1 400

Sensitivity Reactions

Risk of severe allergic reactions, including anaphylactic reactions, angioedema, respiratory symptoms, skin rash, and urticaria.1 400 Discontinue immediately and initiate appropriate therapy if a serious allergic or anaphylactic reaction occurs; do not reinitiate.1 400

General Precautions

Patient Monitoring

Monitor hemoglobin concentrations weekly following initiation of therapy and after each dosage change until stable and sufficient to minimize RBC transfusions.1 400

Regularly monitor CBC, including reticulocyte count, blood cell differential, platelet count, and determination of erythrocyte indices (Wintrobe indices).1 70 114 245 400 510

Evaluate iron stores (i.e., transferrin saturation, serum ferritin) prior to and during therapy.1 400 583 Administer supplemental iron if transferrin saturation <20% or serum ferritin concentration <100 mcg/L.1 400 Virtually all patients with CKD will require supplemental iron.1 400 3 5 25 32 50 53 54 70 81 101 119 122 135 173 187 228 229 247 298 313 324 336 400 422

Lack or Loss of Response to Therapy

Evaluate patients who fail to respond or experience a loss of hemoglobin response for potential causative factors (e.g., iron deficiency, infection, inflammation, bleeding).1 400

In the absence of another etiology, evaluate for PRCA and test for presence of antibodies to erythropoietins.1 400 581 582 (See Pure Red Cell Aplasia under Cautions.)

Specific Populations

Pregnancy

Category C.1 400 Use during pregnancy only when potential benefits justify risks to the fetus; if used, use only single-dose formulation without benzyl alcohol.1 112 122 187 400 Women who become pregnant during epoetin alfa therapy are encouraged to enroll in the manufacturer’s Pregnancy Surveillance Program by calling 800-772-6436.1

Lactation

Not known whether epoetin alfa is distributed into human milk; use with caution in nursing women.1 122 187 400

When epoetin alfa therapy is needed during nursing, use a benzyl alcohol-free formulation.1

Pediatric Use

Safety and efficacy for treatment of anemia of CKD established in children and infants ≥1 month of age undergoing dialysis.1 400 Pattern of adverse effects similar to that reported in adults.1 400 Safety and efficacy not established in pediatric patients with CKD not on dialysis.1 400

Safety and efficacy established for the treatment of chemotherapy-induced anemia in pediatric patients ≥5 years of age.1 400 Adverse effects similar to those experienced in adults.1 400

Has been used for treatment of zidovudine-associated anemia in pediatric patients 8 months to 17 years of age.1 400

Has been used in pediatric patients for the treatment of anemia of prematurity.331 338 465 518 547 550

Commercially available multidose vials of epoetin alfa contain benzyl alcohol as a preservative,1 400 which has been associated with neurologic and other toxicity in neonates.1 400 556 557 558 559 560 561 Do not use epoetin alfa from multidose vials or from single-dose vials that have been admixed with bacteriostatic saline preserved with benzyl alcohol in neonates or infants.1 400

Geriatric Use

Patients with anemia associated with CKD or cancer chemotherapy: No overall differences in safety and efficacy relative to younger adults.1 400

Zidovudine-treated HIV-infected patients: Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1 400

Surgical patients: No overall differences in safety and efficacy relative to younger adults.1 400

Although special precautions usually not necessary,510 518 careful monitoring of blood chemistry and BP may be necessary because of a general increased risk of renal and/or cardiovascular complications in geriatric patients.510 518

Common Adverse Effects

Patients with CKD: Hypertension, 1 3 4 5 6 10 11 16 21 23 25 27 29 38 46 47 48 49 50 52 53 54 56 57 59 61 65 74 84 86 90 100 104 105 106 112 114 115 119 122 135 166 187 189 214 227 233 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 261 276 298 299 300 312 315 323 324 336 366 394 395 400 401 414 426 400 arthralgias1 400 , muscle spasm,1 400 pyrexia,1 400 dizziness,1 400 medical device malfunction,1 400 vascular occlusion,1 400 upper respiratory tract infection.1 400

HIV-infected patients: Pyrexia, cough, rash, injection-site irritation.1 400

Cancer patients: Nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, thrombosis.1 400

Patients undergoing surgery: Nausea, vomiting, pruritus, injection-site pain, chills, deep-vein thrombosis, cough, hypertension, headache.1 400

Interactions for Epoetin Alfa

Specific Drugs

Drug

Interaction

Comments

Androgens

Possible increase in the sensitivity of erythroid progenitors425

Has been used for therapeutic effect 425

Desmopressin

Potential decrease in bleeding time39

Probenecid

Possible pharmacokinetic interaction187

Epoetin Alfa Pharmacokinetics

Absorption

Bioavailability

Following sub-Q administration, peak plasma concentrations achieved within 5–24 hours.1 400

Serum concentrations peak sooner and are substantially higher with IV compared with sub-Q injection, concentrations are less sustained; IV route of administration generally offers no clinical advantage.445 453 466 510

Sub-Q injection 3 times weekly can produce a hemoglobin response similar to that following IV injection but at lower dosages;41 466 518 dosages required for maintenance therapy generally are lower with sub-Q than IV injection.466 505

Onset

Increase in hemoglobin concentrations: 2–6 weeks.1 400

Distribution

Extent

Not fully elucidated.1 400

Not known whether epoetin alfa crosses the placenta or is distributed into milk.1 150 353 375 376 400 464

Special Populations

In preterm neonates, distribution volume approximately 1.5–2 times larger than in healthy adults.400

Elimination

Metabolism

Metabolic fate of endogenous erythropoietin and the recombinant hormone (i.e., epoetin alfa) poorly understood.21 174 187 304 308 381 466 Hepatic metabolism contributes only minimally to elimination of the intact hormone.187 308 466

Elimination Route

Approximately ≤10% is excreted unchanged in urine.6 53 187 188 200 249 344

Half-life

IV administration in healthy individuals and in patients with CKD: 4–16 hours.1 2 6 12 19 21 44 51 103 122 147 166 174 200 222 247 291 304 309 337 344 345 366 400 431 445 450 453

Special Populations

Elimination half-life does not appear to be affected by hemodialysis.1 187 400 518 The elimination characteristics of epoetin alfa appear to be similar in patients undergoing hemodialysis or peritoneal dialysis.466

Half-life similar in adults >65 or <65 years of age.400

In preterm neonates, clearance approximately 3 times higher than in healthy adults.400

Stability

Storage

Parenteral

Injection

Refrigerate at 2–8°C; do not freeze or shake.1 187 251 304 306 366 400 467 Protect from light.1 400

Store unused portions of multidose vial at 2–8°C and discard 21 days after initial entry into vial.1 400

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution CompatibilityHID

Compatible

Dextrose 10% in water with albumin human 0.05 or 0.1%

Incompatible

Dextrose 10% in water

Dextrose 10% in water with albumin human 0.01%

Sodium chloride 0.9%

Actions

Advice to Patients

  • Importance of informing patients about the increased risks of death, serious cardiovascular effects, thromboembolic events, and tumor progression in certain patient populations.1 400 (See Increased Mortality and Cardiovascular and Thromboembolic Events under Cautions and also see Boxed Warning.)

  • Patient instructions for use and medication guide must be provided prior to initiating therapy and each time drug is dispensed.1 400 598 615 619

  • If the patient or caregiver is to administer epoetin alfa, provide careful instructions regarding proper, safe use of the drug in this setting, including information on aseptic techniques and on storage and disposal of the drug and administration equipment.1 400 598 615 Advise such patients to follow the manufacturer’s “Patient Instructions for Use”.1

  • Importance of informing clinicians of heart disease, high BP, history of seizures or strokes, and blood disorders (e.g., sickle cell anemia, clotting disorders) prior to treatment initiation.598 615

  • Importance of informing patients of the risks associated with benzyl alcohol (preservative in some epoetin alfa formulations) in neonates, infants, pregnant and nursing women.1 400

  • Importance of informing patients of possible adverse effects, including signs and symptoms of allergic drug reactions.1 598 615 Importance of informing clinicians immediately if serious allergic reaction occurs (e.g., whole body rash, shortness of breath, wheezing, decreases in BP, swelling around mouth or eyes, fast pulse, sweating).598 615 Importance of advising patients of appropriate actions to take if adverse effects occur.1 584 598 615

  • Importance of reporting signs or symptoms of chest pain, pain in the legs with or without swelling, stroke, irregular heartbeats, seizures, confusion, dizziness or loss of consciousness, extreme tiredness, blood clots in hemodialysis vascular access ports, or increases in BP.598 615

  • Risk of seizures; importance of patients contacting a clinician if any new-onset seizures, premonitory symptoms, or change in seizure frequency occurs.1 400

  • Importance of informing clinician of redness, swelling, or itching at the injection site.598 615

  • Importance of adherence to antihypertensive treatment and dietary restrictions.1 400

  • Importance of regular monitoring of BP and hemoglobin concentration and of keeping appointments for determination of hemoglobin concentrations.1 400 584 588 590 598 615

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.1 400

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 400 598 615

  • Importance of informing patients of other important precautionary information.1 400 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Epoetin Alfa (Recombinant DNA Origin)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV or subcutaneous use

2000 units/mL

Epogen

Amgen

Procrit

Janssen Biotech, (formerly Centocor Ortho Biotech)

3000 units/mL

Epogen

Amgen

Procrit

Janssen Biotech, (formerly Centocor Ortho Biotech)

4000 units/mL

Epogen

Amgen

Procrit

Janssen Biotech, (formerly Centocor Ortho Biotech)

10,000 units/mL

Epogen

Amgen

Procrit

Janssen Biotech, (formerly Centocor Ortho Biotech)

20,000 units/mL

Epogen

Amgen

Procrit

Janssen Biotech, (formerly Centocor Ortho Biotech)

40,000 units/mL

Epogen

Amgen

Procrit

Janssen Biotech, (formerly Centocor Ortho Biotech)

AHFS DI Essentials. © Copyright 2018, Selected Revisions October 23, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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74. Buckner FS, Eschbach JW, Haley NR et al. Correction of the anemia in hemodialysis (HD) patients (pts) with recombinant human erythropoietin (rHuEPO): hemodynamic changes and risks for hypertension. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:2. Abstract.

75. Eschbach JW, Kelly MR, Haley NR et al. Correction of anemia in progressive renal failure with recombinant human erythropoietin (rHuEPO). Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:3. Abstract.

76. Haley NR, Matsumoto AM, Eschbach JW et al. Low testosterone (T) levels increase in male hemodialysis patients (HDP) treated with recombinant human erythropoietin (rHuEPO). Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11- 14, 1988. Thorofare, NJ: Special Projects Network; 1988:3. Abstract.

77. Hampl H, Riedel E, Wendel G et al. Osmotic fragility of red blood cells (RBC) in hemodialysis (HD) patients with erythropoietin (rHuEPO) therapy. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:4. Abstract.

78. Canadian Erythropoietin Study Group. Description and performance characteristics of a kidney disease specific questionnaire (KDQ) in a clinical trial of recombinant human erythropoietin (EPO). Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:4. Abstract.

79. Opsahl JA, Halstenson CE, Rachael KM et al. Recombinant human erythropoietin (EPO) in chronic renal failure (CRF): no adverse effect on renal hemodynamics or progression of disease. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11- 14, 1988. Thorofare, NJ: Special Projects Network; 1988:5. Abstract.

80. Hori K, Kumagai H, Onoyama K et al. Effects of erythropoietin on anemia and hemodynamics in chronic renal failures without dialysis treatment. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:5. Abstract.

81. Kleinman KS, Schweitzer SU, Perdue ST et al. The use of recombinant human erythropoietin in the correction of anemia in predialysis patients and its effects on renal function: a double blind placebo controlled trial. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:6. Abstract.

82. Abraham PA, Opsahl JA, McLain LA et al. Determinants of blood pressure (BP) during chronic erythropoietin (EPO) therapy (Rx) in hemodialysis (HD) patients. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:6. Abstract.

83. Acchiardo S, Moore L, Miles D et al. Does erythropoietin (EPO) treatment change hemodialysis (HD) requirements? Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:7. Abstract.

84. Akiba T, Kurihara S, Katoh H et al. Hemodynamic changes of hemodialyzed patients by erythropoietin (EPO) treatment. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11- 14, 1988. Thorofare, NJ: Special Projects Network; 1988:7. Abstract.

85. Berkley V, Fouad F, Currie P et al. Serial echocardiographic evaluation of chronic hemodialysis (CHD) pts during long-term correction of anemia with recombinant human erythropoietin (rHuEPO). Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:8. Abstract.

86. Collins A, Keshaviah P, Berkseth R et al. Impact of erythropoietin (EPO) therapy (Rx) on rapid high efficiency hemodialysis (RHED). Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:8. Abstract.

87. Dosquet P, Haddoum F, Sporer P et al. In vitro multilineage increase of bone marrow haemotopoietic progenitors from haemodialysed patients treated with recombinant human erythropoietin (rHuEPO). Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:9. Abstract.

88. Düreke T, Zins B, Moynot A et al. Kinetics of erythropoiesis in hemodialysis patients (HD pts) on recombinant erythropoietin (rHuEPO) treatment. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:9. Abstract.

89. Evans RW, Rader B, Egrie J et al. Correction of anemia with recombinant human erythropoietin (rHuEPO) enhances the quality of life of hemodialysis (HD) patients (pts). Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:10. Abstract.

90. Gibilaro SD, Delano BG, Quinn R et al. Improved quality of life while receiving recombinant erythropoietin (rHuEPO). Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11- 14, 1988. Thorofare, NJ: Special Projects Network; 1988:10. Abstract.

91. Iseki K, Hori K, Onoyama K et al. Comparison of hemodynamic effects of blood transfusion and erythropoietin in chronic hemodialysis patients. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:11. Abstract.

92. Kurihara S, Akiba T, Kawabe M et al. Change of hematopoietic response to recombinant erythropoietin (rHuEPO) in hemodialyzed patients. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:11. Abstract.

93. Lazarus JM, Hakim RM, Newell J. Recombinant human erythropoietin and phlebotomy in the treatment of iron overload in chronic hemodialysis patients. Am J Kidney Dis. 1990; 16:101-8. http://www.ncbi.nlm.nih.gov/pubmed/2382644?dopt=AbstractPlus

94. Laver MC, MacCarthy EP, Clyne DH et al. Macrocytosis is a common occurrence in hemodialysis patients chronically receiving recombinant erythropoietin (EPO). Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:12. Abstract.

95. Mohini R, Michaels R, Trost C et al. Comparison of effect of recombinant human erythropoietin (rHuEPO) in patients on high flux (HF) versus conventional (C) hemodialysis. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:13. Abstract.

96. Nissenson AR, Marsh JT, Brown WS et al. Brain function improves in chronic hemodialysis (CHD) patients (pts) after recombinant erythropoietin (rEPO). Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:13. Abstract.

97. Quinn P, Acchiardo S, Cockrell S et al. Response to erythropoietin (EPO) in patients (pts) on conventional (CD) and high flux dialysis (HF). Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:15. Abstract.

98. Schaefer RM, Kokot F, Heidland A. Impact of recombinant human erythropoietin on sexual function in hemodialysis patients. Contrib Nephrol. 1989; 76:273-82. http://www.ncbi.nlm.nih.gov/pubmed/2684527?dopt=AbstractPlus

99. Shinaberger JH, Miller JH, Gardner PW et al. Disadvantages and risks of normal hematocrit (HCT) hemodialysis (HD). Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:15. Abstract.

100. Valderrabano F. Adverse drug effects of recombinant human erythropoietin (rHuEPO). Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:15. Abstract.

101. Van Wyck DB, Stivelman J, Kirlin L et al. Predicting iron status in patients receiving erythropoietin for dialysis- associated anemia. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:16. Abstract.

102. Wolcott DL, Schweitzer S, Nissenson AR. Recombinant erythropoietin (rEPO) improves cognitive function (CF) and quality of life (QL) of chronic hemodialysis (CHD) patients (Pts). Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:16. Abstract.

103. Macdougall IC, Coles GA, Williams JD. The pharmacokinetics of recombinant erythropoietin in CAPD patients. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11- 14, 1988. Thorofare, NJ: Special Projects Network; 1988:17. Abstract.

104. Jamgotchian N, Hu MS, Abdella P et al. Recombinant human erythropoietin (rHuEPO)-induced hypertension (HPT): development of an experimental model. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:18. Abstract.

105. Mayer G, Cada EM, Watzinger U et al. Pathophysiology of hypertension in dialysis patients treated with erythropoietin. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11- 14, 1988. Thorofare, NJ: Special Projects Network; 1988:18. Abstract.

106. Prior JE, Terzian A, Schwartz AB et al. Prolonged RBC survival and hematopoietic response to recombinant human erythropoietin (rHuEPO) in chronic renal failure (CRF). Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:19. Abstract.

107. Stockenhuber F, Geissler K, Sunder-Plassmann G et al. Recombinant human erythropoietin (rHuEPO) activates a broad spectrum of hematopoietic stem cells. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:19. Abstract.

108. Grutzmacher P, Radtke HW, Stahl RAK et al. Renal artery stenosis and erythropoietin. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:20. Abstract.

109. Schwartz AB, Mintz GS, Kim KE et al. Recombinant human erythropoietin (rHuEPO) increases MAP, TPRI and systolic and diastolic dysfunction with increased impedance to LV ejection due to increased HCT and RBC mass in pts with CRF. Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:20. Abstract.

110. Riedel E, Hampl H, Nundel M et al. Correction of amino acid (AA) metabolism by recombinant human erythropoietin (rHuEPO) in hemodialized patients (HD). Abstracts on recombinant erythropoietin from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:21. Abstract.

111. Ogden DA. Introduction. Semin Nephrol. 1989; 9(Suppl 2):1-2.

112. Van Stone JC. Who should receive recombinant human erythropoietin? Semin Nephrol. 1989; 9(Suppl 2):3-7.

113. Stivelman JC. Resistance to recombinant human erythropoietin therapy; a real clinical entity? Semin Nephrol. 1989; 9(Suppl 2):8-11.

114. Ogden DA. Monitoring considerations in recombinant human erythropoietin therapy. Semin Nephrol. 1989; 9(Suppl 2):12-5. http://www.ncbi.nlm.nih.gov/pubmed/2669080?dopt=AbstractPlus

115. Levin N. Management of blood pressure changes during recombinant human erythropoietin therapy. Semin Nephrol. 1989; 9(Suppl 2):16-20. http://www.ncbi.nlm.nih.gov/pubmed/2669081?dopt=AbstractPlus

116. Van Wyck DB. Iron deficiency in patients with dialysis- associated anemia during erythropoietin replacement therapy: strategies for assessment and management. Semin Nephrol. 1989; 9(Suppl 2):21-4. http://www.ncbi.nlm.nih.gov/pubmed/2669082?dopt=AbstractPlus

117. Nissenson AR. Recombinant human erythropoietin: impact on brain and cognitive function, exercise tolerance, sexual potency, and quality of life. Semin Nephrol. 1989; 9(Suppl 2):25-31. http://www.ncbi.nlm.nih.gov/pubmed/2669083?dopt=AbstractPlus

118. Casati S, Campise M, Ponticelli C. Erythropoietin concentrations during treatment. Lancet. 1989; 1:1078. http://www.ncbi.nlm.nih.gov/pubmed/2566024?dopt=AbstractPlus

119. Eschbach JW, Kelly MR, Haley NR et al. Treatment of the anemia of progressive renal failure with recombinant human erythropoietin. N Engl J Med. 1989; 321:158-63. http://www.ncbi.nlm.nih.gov/pubmed/2747747?dopt=AbstractPlus

120. Sasaki H, Bothner B, Dell A et al. Carbohydrate structure of erythropoietin expressed in Chinese hamster ovary cells by a human erythropoietin cDNA. J Biol Chem. 1987; 262:12059-76. http://www.ncbi.nlm.nih.gov/pubmed/3624248?dopt=AbstractPlus

121. Recny MA, Scoble HA, Kim Y. Structural characterization of natural human urinary and recombinant DNA-derived erythropoietin. J Biol Chem. 1987; 262:17156-63. http://www.ncbi.nlm.nih.gov/pubmed/3680293?dopt=AbstractPlus

122. Anon. Erythropoietin for anemia. Med Lett Drugs Ther. 1989; 31:85-86. http://www.ncbi.nlm.nih.gov/pubmed/2671624?dopt=AbstractPlus

123. Spivak JL, Barnes DC, Fuchs E et al. Serum immunoreactive erythropoietin in HIV-infected patients. JAMA. 1989; 261:3104-07. http://www.ncbi.nlm.nih.gov/pubmed/2716142?dopt=AbstractPlus

124. Walker RE, Parker RI, Kovacs JA et al. Anemia and erythropoiesis in patients with the acquired immunodeficiency syndrome (AIDS) and Kaposi sarcoma treated with zidovudine. Ann Intern Med. 1988; 108:372-376. http://www.ncbi.nlm.nih.gov/pubmed/3422548?dopt=AbstractPlus

125. Summerfield GP, Bellingham AJ. The effects of therapeutic dialysis and renal transplantation on uraemic serum inhibitors of erythropoiesis in vitro. Br J Haematol. 1984; 58:293-304.

126. Sawada K, Krantz SB, Kans JS et al. Purification of human erythroid colony-forming units and demonstration of specific binding of erythropoietin. J Clin Invest. 1987; 80:357-366. http://www.ncbi.nlm.nih.gov/pubmed/3038955?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=442245&blobtype=pdf

127. Rosenlöf K, Fyhrquist F, Pekonen F. Receptors for recombinant erythropoietin in human bone marrow cells. Scand J Clin Lab Invest. 1987; 47:823-827. http://www.ncbi.nlm.nih.gov/pubmed/2829343?dopt=AbstractPlus

128. Graf H, Mayer G, Cada E et al. Correction of anemia by recombinant human erythropoietin (r-HuEPO) enhances working capacity and exercise tolerance in patients on chronic hemodialysis. Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:2.

129. Paganini E, Garcia J, Ellis P et al. Clinical sequelae of correction of anemia with recombinant human erythropoietin (r- HuEPO): urea kinetics, dialyzer function and reuse. Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:3.

130. Cheung JY, Scaduto RC Jr, Tilotson DL et al. Mechanism of action of erythropoietin (EPO): a single cell study. Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:4.

131. Bocker A, Reimers E, Nonnast-Daniel B et al. Effect of erythropoietin (EPO) treatment on hemoglobin O2-affinity and physical performance in patients with renal anemia. Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:5.

132. Robertson HT, Haley NR, Adamson JW et al. Increase in maximal exercise capacity in hemodialysis (HD) patients following correction of the anemia with recombinant human erythropoietin (r-HuEPO). Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:6.

133. Paganini E, Thomas T, Fouad F et al. The correction of anemia in hemodialysis patients using recombinant human erythropoietin (r-HuEPO): hemodynamic effects. Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:7.

134. Lundin AP, Delano BG, Stein R et al. Recombinant human erythropoietin (r-HuEPO) treatment enhances exercise tolerance in hemodialysis patients (HD). Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:8.

135. Eschbach JW, Adamson JW. Correction of the anemia of hemodialysis (HD) patients with recombinant human erythropoietin (r-HuEPO): results of multicenter study. Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:9.

136. Van Stone JC, Jones ME, Hires CE. A controlled study of recombinant erythropoietin (EPO) in chronic hemodialysis patients. Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:10.

137. Nissenson AR, Marsh JT, Brown WS et al. Recombinant erythropoietin (r-HuEPO) improves brain function in chronic hemodialysis (CHD) patients (PTS). Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:11.

138. Hampl H, Riedel E, Wendel G et al. Influence of parathyroid hormone (PTH) on exogenous erythropoietin (EPO) stimulated erythropoiesis in hemodialysis (HD) patients. Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:12.

139. Delano BG, Lundin AP, Galonsky R et al. Dialyzer urea and creatinine clearances not significantly changed in r-HuEPO treated maintenance hemodialysis (MD) patients. Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:13.

140. Bargman JM, Breborowicz A, Rodela H et al. Absorption of recombinant human erythropoietin (r-HuEPO) from the peritoneal cavity in rabbits. Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:14.

141. Sun CH, Paul W, Ward HJ et al. Erythropoiesis and radioimmunoassayable recombinant human erythropoietin (r-HuEPO) in renal transplant (Tx) recipients. Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:15.

142. Brown CD, Kieran M, Dosunmu BV et al. Raised hematocrit (HCT) persists six-weeks after stopping treatment with human recombinant erythropoietin (r-HuEPO) in azotemic, anemic patients. Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:16.

143. Brown CD, Kieran M, Zhao ZH et al. Treatment of azotemic, anemic patients with human recombinant erythropoietin (r-HuEPO) raises whole blood viscosity (WBV) proportional to hematocrit (HCT). Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:17.

144. Van Wyck DB, Stivelman J, Ruiz J et al. Aluminum excess poses modest resistance to recombinant human erythropoietin (r- HuEPO) for dialysis anemia. Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:18.

145. Wolcott DL, Schweitzer S, Marsh JT et al. Recombinant erythropoietin (r-HuEPO) improves cognitive function (CF) and quality of life (QL) of chronic hemodialysis (CHD) patients (PTS). Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13- 16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:19.

146. Zehnter E, Pollok M, Longere F et al. Urea kinetics (UK) in patients on RDT treated with recombinant erythropoietin (EPO). Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13- 16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:20.

147. Egrie JC, Eschbach JW, McGuire T et al. Pharmacokinetics of recombinant human erythropoietin (r-HuEPO) administered to hemodialysis (HD) patients. Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:21.

148. Stivelman J, Van Wyck D, Kirlin L et al. Use of recombinant erythropoietin (r-HuEPO) with high efficiency dialysis (HED) does not worsen azotemia or shorten access survival. Selected abstracts on recombinant erythropoietin from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:22.

149. Miller BA, Scaduto RC Jr, Tilotson DL et al. Erythropoietin and GM-CSF stimulate a rise in intracellular free calcium concentraction [Cacm] in single early human erythroid precursors at specific stages of differentiation. Selected abstracts on hematopoietic growth factors from the American Society of Hematology 29th annual meeting, December 5-8, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:8.

150. Sawyer ST, Sawada K, Krantz SB. Structure of the receptor for erythropoietin in murine and human erythroid cells and murine placenta. Selected abstracts on hematopoietic growth factors from the American Society of Hematology 29th annual meeting, December 5-8, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:16.

151. Lacombe C, Bruneval P, Da Silva JL et al. Expression of the erythropoietin gene in the hypoxic adult mouse. Selected abstracts on hematopoietic growth factors from the American Society of Hematology 29th annual meeting, December 5-8, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:29.

152. Dubé S, Lin N, Manger R et al. Erythropoietin (EPO) requires specific addition of carbohydrate (CHO) side chains for intracellular processing and secretion. Selected abstracts on hematopoietic growth factors from the American Society of Hematology 29th annual meeting, December 5-8, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:39.

153. Reid CDL, Fidler J, Wine.dtd CG et al. The response of erythroid progenitors to administered recombinant human erythropoietin in hemodialysed renal failure patients. Selected abstracts on hematopoietic growth factors from the American Society of Hematology 29th annual meeting, December 5-8, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:48.

154. Means RT, Olsen NJ, Krantz SB et al. Treatment of the anemia of rheumatoid arthritis with recombinant human erythropoietin: clinical and in vitro results. Selected abstracts on hematopoietic growth factors from the American Society of Hematology 29th annual meeting, December 5-8, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:50.

155. McMahon RG, Ryan M, Phillips JH Jr et al. Safety and multiple dose pharmcokinetic profile of intravenous and subcutaneous recombinant human erythropoietin (r-HuEPO) in normal subjects: a double-blind, placebo controlled study. Selected abstracts on hematopoietic growth factors from the American Society of Hematology 29th annual meeting, December 5-8, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:52.

156. Mannucci PM, Moia M, Casati S et al. Recombinant human erythropoietin (r-HuEPO) improves hemostatic abnormalities in uremics. Selected abstracts on hematopoietic growth factors from the American Society of Hematology 29th annual meeting, December 5-8, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:52.

157. Al-Khatti A, Fritsch E, Papayannopoulou T et al. Erythropoietin stimulates fetal hemoglobin in macaques and produces an additive Hb F induction in baboons treated with hydroxyurea. Selected abstracts on hematopoietic growth factors from the American Society of Hematology 29th annual meeting, December 5-8, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:60.

158. Martin W, Villani GM, Jothianandan D et al. Selective blockade of endothelium-dependent and glyceryl trinitrate-induced relaxation by hemoglobin and by methylene blue in the rabbit aorta. J Pharmacol Exp Ther. 1985; 232:708-16. http://www.ncbi.nlm.nih.gov/pubmed/2983068?dopt=AbstractPlus

159. Laver J, Moore MAS. Clinical use of recombinant human hematopoietic growth factors. J Natl Cancer Inst. 1989; 81:1370-82. http://www.ncbi.nlm.nih.gov/pubmed/2674457?dopt=AbstractPlus

160. Cotes PM, Pippard MJ, Reid CDL et al. Continuing correction of anaemia by treatment with recombinant erythropoietin in patients maintained by haemodialysis. Exp Hematol. 1987; 15:437.

161. Goodnough LT, Rudnick S, Price TH et al. Increased preoperative collection of autologous blood with recombinant human erythropoietin therapy. N Engl J Med. 1989; 321:1163-8. http://www.ncbi.nlm.nih.gov/pubmed/2677725?dopt=AbstractPlus

162. Drüeke T, Zins B, Naret C et al. Erythropoietin and chronic renal failure. Nouv Rev Fr Hematol. 1989; 31:97-8. http://www.ncbi.nlm.nih.gov/pubmed/2771635?dopt=AbstractPlus

163. Krane NK. The role of erythropoietin in the anemia of renal failure. Henry Ford Hosp Med J. 1983; 31:177-81. http://www.ncbi.nlm.nih.gov/pubmed/6358139?dopt=AbstractPlus

164. Wang FF, Kung CKH, Goldwasser E. Some chemical properties of human erythropoietin. Endocrinology. 1985; 116:2286-92. http://www.ncbi.nlm.nih.gov/pubmed/3996312?dopt=AbstractPlus

165. Yoshimura N, Oka T, Ohmori Y et al. The effects of recombinant human erythropoietin on the anemia of renal transplant recipients with chronic rejection. Transplantation. 1989; 48:527-9. http://www.ncbi.nlm.nih.gov/pubmed/2675414?dopt=AbstractPlus

166. Ponticelli C, Casati S. Correction of anaemia with recombinant human erythropoietin. Nephron. 1989; 52:201-8. http://www.ncbi.nlm.nih.gov/pubmed/2662045?dopt=AbstractPlus

167. Sawyer ST. The two proteins of the erythropoietin receptor are structurally similar. J Biol Chem. 1989; 264:13343-7. http://www.ncbi.nlm.nih.gov/pubmed/2546955?dopt=AbstractPlus

168. Ganser A, Bergmann M, Völkers B et al. In vivo effects of recombinant human erythropoietin on circulating human hemopoietic progenitor cells. Exp Hematol. 1989; 17:433-5. http://www.ncbi.nlm.nih.gov/pubmed/2714423?dopt=AbstractPlus

169. Fukuda MN, Sasaki H, Lopez L et al. Survival of recombinant erythropoietin in the circulation: the role of carbohydrates. Blood. 1989; 73:84-9. http://www.ncbi.nlm.nih.gov/pubmed/2910371?dopt=AbstractPlus

170. Sytkowski AJ, Donahue KA. Immunochemical studies of human erythropoietin using site-specific anti-peptide antibodies: identification of a functional domain. J Biol Chem. 1987; 262:1161-5. http://www.ncbi.nlm.nih.gov/pubmed/2433274?dopt=AbstractPlus

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