Eloctate (antihemophilic factor (FVIII) recombinant, Fc fusion protein)
Antihemophilic Products Intravenous Vial (EA)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Antihemophilic factor (recombinant), Fc fusion protein is a biosynthetic (recombinant DNA origin) preparation of blood coagulation factor VIII consisting of a single molecule of B-domain-deleted factor VIII covalently linked to the Fc domain of human immunoglobulin G1 (IgG1).
Antihemophilic factor (recombinant), Fc fusion protein is a biosynthetic (recombinant DNA origin) preparation of blood coagulation factor VIII consisting of a single molecule of B-domain-deleted human coagulation factor VIII covalently linked to the Fc domain of human immunoglobulin G1 (IgG1). The Fc portion of the fusion protein prolongs half-life of factor VIII through interaction with the Fc neonatal receptor, a receptor that is part of a naturally occurring recycling pathway that delays lysosomal degradation of immunoglobulins by cycling them back into the circulation. Preclinical and clinical studies have shown that the half-life of antihemophilic factor (recombinant), Fc fusion protein is approximately 1.5- to 1.7-fold longer than that of currently available preparations of antihemophilic factor (recombinant).
The factor VIII portion of antihemophilic factor (recombinant), Fc fusion protein is similar in structure and function to endogenous factor VIII.
Coagulation factor VIII is essential for blood clotting and maintenance of hemostasis. Patients with hemophilia A have decreased levels of endogenous factor VIII or dysfunctional factor VIII, resulting in a hemorrhagic tendency and clinical manifestations such as bleeding into soft tissues, muscles, and weight-bearing joints. The clinical severity and frequency of bleeding in patients with hemophilia A correlate with the degree of deficiency in factor VIII activity.
Patients with mild hemophilia A generally have 5-40% of normal clotting factor activity, patients with moderate disease generally have 1-5% of normal activity, and those with severe disease have <1% of normal activity. Administration of antihemophilic factor (recombinant), Fc fusion protein to patients with hemophilia A results in increased plasma levels of factor VIII and temporarily corrects the coagulation defect in these patients. When antihemophilic factor (recombinant), Fc fusion protein is used for replacement therapy, administration of 1 IU/kg generally increases plasma factor VIII level by approximately 2 IU/dL.
Treatment with antihemophilic factor (recombinant), Fc fusion protein normalizes the activated partial thromboplastin time (aPTT), which is prolonged in patients with hemophilia A.
Antihemophilic factor (recombinant), Fc fusion protein (Eloctate(R)) is produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line and undergoes a series of purification and viral inactivating/removal processes (e.g., 15-nm filtration, affinity chromatography, detergent treatment). The HEK cell line used to produce Eloctate(R) secretes B-domain-deleted recombinant factor VIII into a defined cell culture medium that does not contain any proteins derived from animal or human sources. Compared with plasma-derived antihemophilic factor preparations, recombinant preparations of antihemophilic factor are associated with a substantially reduced risk of transmission of bloodborne human viruses (e.g., human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV)).
Following administration of a single 50-unit/kg dose of antihemophilic factor (recombinant), Fc fusion protein given as a 10-minute IV injection in adults with hemophilia A, the terminal half-life of the drug was approximately 19.7 hours and the average time to reach 1% factor VIII activity was approximately 5.1 days. For each 1 unit/kg of antihemophilic factor (recombinant), Fc fusion protein administered, the mean recovery of factor VIII was approximately 2.26 IU/dL. In pediatric patients, the half-life of antihemophilic factor (recombinant), Fc fusion protein was approximately 12.7 hours for those 1-5 years of age, 14.9 hours for those 6-11 years of age, and 16.4 hours for those 12-17 years of age following administration of a single 50-unit/kg dose of the drug; the mean incremental recovery of factor VIII in these respective age groups was 1.92, 2.44, and 1.85 units/dL.
Compared with conventional preparations of recombinant antihemophilic factor, the half-life of antihemophilic factor (recombinant), Fc fusion protein is prolonged (1.5- to 1.7-fold longer),clearance is reduced, and time to 1% factor VIII activity above baseline is longer; however, peak plasma concentrations and incremental recovery are similar. These differences may allow less frequent dosing with prophylactic regimens.
USES: This medication is used to control and prevent bleeding that happens to people (usually males) with an inherited medical condition, hemophilia A (low levels of factor VIII). It is also given before surgery to prevent too much bleeding in people with this condition. Factor VIII is a protein (clotting factor) that is in normal blood, and helps form blood clots and stop bleeding after an injury.
People with low factor VIII levels may bleed longer than normal after an injury/surgery and may have bleeding inside the body (especially in the joints and muscles). This medication contains man-made factor VIII (antihemophilic factor) to temporarily replace factor VIII in the body, connected to an antibody (immunoglobulin) that helps the man-made factor VIII work longer. When used to control and prevent bleeding, this medication may help relieve pain and long-term damage caused by hemophilia A.
This medication should not be used to treat von Willebrand disease.
Generic name: antihemophilic factor (FVIII) recombinant, Fc fusion protein
Pronunciation: (AN-tye-HEE-moe-FIL-ik FAK-tor)
Drug class: Antihemophilic Products
Therapeutic class: Hematological Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Eloctate
Indications
The following indications are listed for Eloctate:
- Bleeding Episode In Hemophilia A
- Bleeding Prevention In Hereditary Factor Viii Deficiency
- Hemophilia A
Also known as: Bleeding Prevention In Classic Hemophilia, Bleeding Prevention In Congenital Factor Viii Deficiency, Bleeding Prevention In Hemophilia A, Bleeding Prophylaxis In Hemophilia A, Congenital Factor Viii Deficiency Disease, Hemorrhage Prophylaxis In Hemophilia A, Hemorrhaging In Hemophilia A, Prevention Of Bleeding Episode In Hemophilia A.
Dosing
Dosage and potency of antihemophilic factor (recombinant), Fc fusion protein are expressed in terms of international units (IU) of antihemophilic factor activity; 1 IU is equivalent to the amount of factor VIII activity in 1 mL of normal human plasma. Potency is determined by a chromogenic substrate assay; however, both chromogenic assays and one-stage clotting assays are routinely used in US clinical laboratories for the measurement of plasma factor VIII activity. In general, administration of 1 IU/kg of antihemophilic factor (recombinant), Fc fusion protein increases circulating factor VIII levels by approximately 2 IU/dL.
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No dosing information is available for this tab.
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Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Igg Antibodies And Derivatives/Efgartigimod-Alfa
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)
DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)
Igg Antibodies And Derivatives/Nipocalimab-Aahu
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)
DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)
Moderate Interaction: Assess the risk to the patient and take action as needed.
Igg Antibodies And Derivatives/Rozanolixizumab-Noli
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)
DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)
Contraindications
Life-threatening hypersensitivity reactions (e.g., anaphylaxis) to antihemophilic factor (recombinant), Fc fusion protein or other components of the preparation including sucrose, sodium chloride, L-histidine, calcium chloride, and polysorbate 20.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
Adverse effects observed in >0.5% of previously treatedpatients receiving antihemophilic factor (recombinant), Fc fusion protein in clinical trials include arthralgia, malaise, myalgia, headache, and rash.
Adverse effects observed in >=1% of previously untreated patients receiving antihemophilic factor (recombinant), Fc fusion protein in clinical trials include factor VIII inhibition, device-related thrombosis, and papularrash.
Less Frequent
- Allergic dermatitis
- Anaphylaxis
- Angioedema
- Dyspnea
- Erythema
- Fibrinogen excess
- Skin rash
- Thrombotic disorder
- Urticaria
Rare or Very Rare
- Acute myocardial infarction
- Cerebrovascular accident
- Chest tightness
- Disseminated intravascular coagulation
- Hemolytic anemia
- Hypersensitivity drug reaction
- Hypertension
- Injection site infection
- Pulmonary thromboembolism
- Thromboembolic disorder
- Wheezing
More Frequent
- Dizziness
- Fever
- Headache disorder
- Injection site sequelae
- Nausea
Less Frequent
- Chest discomfort
- Chills
- Drowsy
- Dyspepsia
- Flushing
- Insomnia
- Lethargy
- Pruritus of skin
- Upper respiratory infection
- Vomiting
Rare or Very Rare
- Acute abdominal pain
- Cough
- Diarrhea
- Dysgeusia
- Fatigue
- Hypotension
- Paresthesia
- Sensation of warmth
- Tachycardia
Precautions
No enhanced messaging available.
Safety and efficacy of antihemophilic factor (recombinant), Fc fusion protein were evaluated in previously treated adolescents 12-18 years of age in the principal efficacy study. Data from a separate study in pediatric patients younger than 12 (1-11) years of age indicate that children younger than 6 years of age have a shorter half-life and a substantially higher body weight-adjusted clearance than older individuals. Higher doses or more frequent dosing of antihemophilic factor (recombinant), Fc fusion protein may therefore be required in pediatric patients 1 to 5 years of age. The pharmacokinetics of antihemophilic factor (recombinant), Fc fusion protein in pediatric patients 6 years of age or older appear to be similar to that observed in adults, and the manufacturer states that dosage adjustments are not required in such pediatric patients.
It is not known whether antihemophilic factor (recombinant), Fc fusion protein can cause fetal harm when administered to pregnant women or affect reproductive capacity; the drug should be used during pregnancy only when clearly needed.
It is not known whether antihemophilic factor (recombinant), Fc fusion protein is distributed into human milk. The known benefits of breast-feeding should be considered along with the mother's clinical need for antihemophilic factor (recombinant), Fc fusion protein and any potential adverse effects of the drug or disease on the infant.
The manufacturer makes no specific dosage recommendations for geriatric patients.
Clinical studies of antihemophilic factor (recombinant), Fc fusion protein did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients.
ICD codes
| Code | Type | Description |
|---|---|---|
| Bleeding episode in hemophilia A | ||
| D66 | ICD10CM | Hereditary factor VIII deficiency |
| Z14.02 | ICD10CM | Symptomatic hemophilia A carrier |
| Bleeding prevention in hereditary factor VIII deficiency | ||
| D66 | ICD10CM | Hereditary factor VIII deficiency |
| Hemophilia A | ||
| D66 | ICD10CM | Hereditary factor VIII deficiency |
| Z14.02 | ICD10CM | Symptomatic hemophilia A carrier |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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