Home Drug Guide Emapalumab-lzsg

Drug Guide

Generic Name

Emapalumab-lzsg

Brand Names Gamifant

Classification

Therapeutic: Immunosuppressant, Antiviral

Pharmacological: Monoclonal Antibody, Anti-Interferon Gamma

FDA Approved Indications

Treatment of primary hemophagocytic lymphohistiocytosis (HLH) in pediatric and adult patients.

Mechanism of Action

Emapalumab-lzsg is a monoclonal antibody that binds to interferon gamma (IFN-γ), neutralizing its activity, thereby reducing immune system overactivation associated with HLH.

Dosage and Administration

Adult: Initial dose: 1 mg/kg IV bolus, then 0.50 mg/kg every 3 days, adjustable based on clinical response.

Pediatric: Dosing based on weight, with adjustments for body surface area; specific dosing regimen should be determined by clinician.

Geriatric: No specific dosage adjustments identified; use with caution due to limited data.

Renal Impairment: No specific dosage adjustments established; consider renal function monitoring.

Hepatic Impairment: No specific dosage adjustments; consider hepatic function.

Pharmacokinetics

Absorption: Administered intravenously; absorption not applicable.

Distribution: Distributes widely in vascular and extravascular compartments.

Metabolism: Metabolized via proteolytic degradation; specific pathways not well characterized.

Excretion: Cleared primarily through catabolic pathways.

Half Life: Approximately 25 days.

Contraindications

Known hypersensitivity to emapalumab or any component.
Active, serious infections that contraindicate immunosuppression.

Precautions

Use caution in patients with ongoing infections; monitor for infections, as immunosuppression can exacerbate these.

Adverse Reactions - Common

Infusion-related reactions (Common)
Elevated liver enzymes (Less common)

Adverse Reactions - Serious

Severe infections (Less common)
Hematologic abnormalities (e.g., neutropenia) (Less common)
Anaphylaxis (Rare)

Drug-Drug Interactions

Immunosuppressants increase infection risk.
Potential interactions with other biologics or immune modulating agents.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for signs of infection, infusion reactions, and liver function.

Diagnoses:

Risk for Infection
Impaired Skin Integrity

Implementation: Administer as per protocol; monitor vital signs and adverse reactions during infusion.

Evaluation: Assess clinical response and monitor for adverse effects; adjust treatment as needed.

Patient/Family Teaching

Report signs of infection immediately.
Notify healthcare provider before any new medications or vaccines.
Understand the importance of follow-up and laboratory tests.

Special Considerations

Black Box Warnings:

Serious infections leading to death; monitor closely.
Progression or reactivation of infections, including tuberculosis.

Genetic Factors: No specific genetic considerations noted.

Lab Test Interference: May alter laboratory tests related to immune function; interpret with caution.

Overdose Management

Signs/Symptoms: Potential for increased immunosuppression, infection symptoms.

Treatment: Supportive care; no specific antidote; consult poison control or applicable guidelines.

Storage and Handling

Storage: Store at 2°C to 8°C (36°F to 46°F); do not freeze.

Stability: Stable under recommended storage conditions; use within specified period after reconstitution.