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Eloctate

Generic Name: Antihemophilic Factor (recombinant), Fc Fusion Protein
Class: Hemostatics

Introduction

Antihemophilic factor (recombinant), fc fusion protein is a hemostatic agent.

Uses for Eloctate

Antihemophilic factor (recombinant), fc fusion protein has the following uses:

Antihemophilic factor (recombinant), fc fusion protein is a recombinant DNA derived, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.1

Antihemophilic factor (recombinant), fc fusion protein has the following limitation of use:

Antihemophilic factor (recombinant), fc fusion protein is not indicated for the treatment of von Willebrand disease.1

Eloctate Dosage and Administration

General

Antihemophilic factor (recombinant), fc fusion protein is available in the following dosage form(s) and strength(s):

For injection: nominally 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU or unit), lyophilized powder in single-use vials for reconstitution.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

For intravenous use after reconstitution only. 1

  • Each vial of antihemophilic factor (recombinant), fc fusion protein is labeled with the amount of recombinant Factor VIII in international units (IU or unit). One unit per kilogram body weight will raise the Factor VIII level by 2% (units/dL).1

  • For on-demand treatment and control of bleeding episodes and for perioperative management of bleeding, calculate dose using the following formulas:

    Estimated Increment of Factor VIII (units/dL or % of normal) = [Total Dose (units)/body weight (kg)] x 2 (units/dL per units/kg)

    Required Dose (units) = Body Weight (kg) x Desired Factor VIII Rise (units/dL or % of normal) x 0.5 (units/kg per units/dL). 1

  • For routine prophylaxis to reduce the frequency of bleeding episodes: 50 units/kg every 4 days. Adjust dose based on patient response with dosing in the range of 25-65 units/kg at 3-5 day intervals.1

  • For routine prophylaxis in children less than 6 years of age to reduce the frequency of bleeding episodes: 50 units/kg twice weekly. Adjust dose based on patient response with dosing in the range of 25-65 units/kg at 3-5 day intervals. More frequent or higher doses up to 80 units/kg may be required.1

Cautions for Eloctate

Contraindications

Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to antihemophilic factor (recombinant), fc fusion protein.1

Warnings/Precautions

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, are possible with antihemophilic factor (recombinant), fc fusion protein. Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.1

Neutralizing Antibodies

Formation of neutralizing antibodies (inhibitors) to Factor VIII can occur following administration of antihemophilic factor (recombinant), fc fusion protein. Monitor all patients for the development of Factor VIII inhibitors by appropriate clinical observations and laboratory tests. If the plasma Factor VIII level fails to increase as expected or if bleeding is not controlled after antihemophilic factor (recombinant), fc fusion protein administration, suspect the presence of an inhibitor (neutralizing antibody).1

Monitoring Laboratory Tests

  • Monitor plasma Factor VIII activity by performing a validated test (e.g., one stage clotting assay), to confirm that adequate Factor VIII levels have been achieved and maintained.1

  • Monitor for the development of Factor VIII inhibitors. Perform a Bethesda inhibitor assay if expected Factor VIII plasma levels are not attained, or if bleeding is not controlled with the expected dose of antihemophilic factor (recombinant), fc fusion protein. Use Bethesda Units (BU) to report inhibitor levels.1

Specific Populations

Pregnancy

There are no studies of antihemophilic factor (recombinant), fc fusion protein use in pregnant women to inform a drug-associated risk. The background risk of major birth defects and miscarriage in the indicated population is unknown; however, the background risk of major birth defects in the U.S. general population is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.1 Animal reproductive and developmental toxicity studies have not been conducted with antihemophilic factor (recombinant), fc fusion protein. In a placental transfer study, antihemophilic factor (recombinant), fc fusion protein was detected in murine fetal blood samples at approximately 1% of the maternal blood levels (range, 0.2% to 1.9%), 3 to 4 hours following dosing of pregnant mice with 260 to 650 times the clinical dose of 20 to 50 units/kg antihemophilic factor (recombinant), fc fusion protein.1 It is not known whether antihemophilic factor (recombinant), fc fusion protein can cause fetal harm when administered to a pregnant woman, or whether it can affect reproduction capacity. If antihemophilic factor (recombinant), fc fusion protein is clearly needed to treat a pregnant woman, advise the patient that the risks to the mother and to the fetus are unknown.1

Pregnant, genetically-modified, FVIII-deficient mice (Hem A mice) were injected intravenously with a single dose of 400 units (approximately 13,000 units/kg) antihemophilic factor (recombinant), fc fusion protein at the end of pregnancy on Gestation Day 19. Blood samples were collected from the maternal mice and the fetuses 3 to 4 hours after dosing, and FVIII activity was measured in both maternal and fetal plasma using a FVIII chromogenic assay. After dosing pregnant Hem A mice with antihemophilic factor (recombinant), fc fusion protein, FVIII activity in fetal blood was approximately 1% of the maternal blood levels, suggesting that placental transfer of antihemophilic factor (recombinant), fc fusion protein may occur. The relevance of these data to humans is unknown.1

Lactation

There is no information regarding the presence of antihemophilic factor (recombinant), fc fusion protein in human milk, its effects on the breastfed infant, or its effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for antihemophilic factor (recombinant), fc fusion protein and any potential adverse effects on the breastfed infant from antihemophilic factor (recombinant), fc fusion protein or from the underlying maternal condition.1

Pediatric Use

Safety and efficacy studies have been performed in 82 previously treated, pediatric patients <18 years of age who received at least one dose of antihemophilic factor (recombinant), fc fusion protein as part of routine prophylaxis, on-demand treatment of bleeding episodes, or perioperative management. Adolescent subjects were enrolled in the adult and adolescent safety and efficacy trial, and subjects <12 were enrolled in a pediatric trial.1

Pharmacokinetic data from a pediatric study of the 54 evaluable subjects <12 years of age showed that no dose adjustment was required for patients ≥6 years old. Children age 1 to 5 years had a shorter half-life and higher clearance (adjusted for body weight); therefore, a higher dose or more frequent dosing may be needed in this age group.1

Geriatric Use

Clinical studies of antihemophilic factor (recombinant), fc fusion protein did not include sufficient numbers of subjects aged 65 and over to determine whether or not they respond differently from younger subjects.1

Common Adverse Effects

The most frequently occurring adverse reactions (>0.5% of subjects) in clinical trials were arthralgia, malaise, myalgia, headache, and rash.1

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Actions

Mechanism of Action

Antihemophilic factor (recombinant), fc fusion protein is a recombinant fusion protein that temporarily replaces the missing Coagulation Factor VIII needed for effective hemostasis. Antihemophilic factor (recombinant), fc fusion protein contains the Fc region of human immunoglobulin G1 (IgG1), which binds to the neonatal Fc receptor (FcRn). FcRn is part of a naturally occurring pathway that delays lysosomal degradation of immunoglobulins by cycling them back into circulation and prolonging their plasma half-life. 1

Advice to Patients

Patient Counseling Information

Advise patients to read the FDA approved patient labeling (Patient Information and Instructions for Use). 1

Advise patients to call their healthcare provider or go to the emergency department right away if a hypersensitivity reaction occurs. Early signs of hypersensitivity reactions may include rash, hives, itching, facial swelling, tightness of the chest, and wheezing. 1

Advise patients to contact their healthcare provider or treatment facility for further treatment and/or assessment if they experience a lack of a clinical response to Factor VIII therapy because this may be a sign of inhibitor development. 1

Additional Information

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

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.

Antihemophilic Factor (recombinant), Fc Fusion Protein

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection, for IV use only

Nominally 250 units

Eloctate

Biogen Inc.

Nominally 500 units

Eloctate

Biogen Inc.

Nominally 750 units

Eloctate

Biogen Inc.

Nominally 1000 units

Eloctate

Biogen Inc.

Nominally 1500 units

Eloctate

Biogen Inc.

Nominally 2000 units

Eloctate

Biogen Inc.

Nominally 3000 units

Eloctate

Biogen Inc.

AHFS DI Essentials. © Copyright, 2016, American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

Date published: September 13, 2016
Last reviewed: September 13, 2016
Date modified: October 12, 2016

References

1. Biogen Inc. Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion Protein) INTRAVENOUS prescribing information. 2016 Jan.

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