Eloctate

Drug overview for ELOCTATE (antihemophilic factor (fviii) recombinant, fc fusion protein):

Generic name: antihemophilic factor (FVIII) recombinant, Fc fusion protein (AN-tye-HEE-moe-FIL-ik FAK-tor)
Drug class: Antihemophilic Products
Therapeutic class: Hematological Agents

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).

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for ELOCTATE (antihemophilic factor (fviii) recombinant, fc fusion protein) have been approved by the FDA:

Indications:
Bleeding episode in hemophilia A
Bleeding prevention in hereditary factor VIII deficiency
Hemophilia A

Professional Synonyms:
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

The following drug interaction information is available for ELOCTATE (antihemophilic factor (fviii) recombinant, fc fusion protein):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 2 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
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)	VYVGART, VYVGART HYTRULO
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)	IMAAVY

Drug Interaction

Drug Names

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)

VYVGART, VYVGART HYTRULO

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)

IMAAVY

There are 1 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
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)	RYSTIGGO

Drug Interaction

Drug Names

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)

RYSTIGGO

Moderate List
No disease contraindications

The following adverse reaction information is available for ELOCTATE (antihemophilic factor (fviii) recombinant, fc fusion protein):

Overview
Severe
Less Severe

Adverse reaction overview.

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.

There are 20 severe adverse reactions.

More Frequent	Less Frequent
None.	Allergic dermatitis Anaphylaxis Angioedema Dyspnea Erythema Fibrinogen excess Skin rash Thrombotic disorder Urticaria

Rare/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

There are 24 less severe adverse reactions.

More Frequent	Less Frequent
Dizziness Fever Headache disorder Injection site sequelae Nausea	Chest discomfort Chills Drowsy Dyspepsia Flushing Insomnia Lethargy Pruritus of skin Upper respiratory infection Vomiting

Rare/Very Rare
Acute abdominal pain Cough Diarrhea Dysgeusia Fatigue Hypotension Paresthesia Sensation of warmth Tachycardia

The following precautions are available for ELOCTATE (antihemophilic factor (fviii) recombinant, fc fusion protein):

Pediatric
Pregnant
Lactation
Geriatric

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.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

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.

Bleeding episode in hemophilia A
D66	Hereditary factor VIII deficiency
Z14.02	Symptomatic hemophilia A carrier
Bleeding prevention in hereditary factor VIII deficiency
D66	Hereditary factor VIII deficiency
Hemophilia A
D66	Hereditary factor VIII deficiency
Z14.02	Symptomatic hemophilia A carrier