Emapalumab-lzsg

Class: Immunosuppressive Agents
Chemical Name: Immunoglobulin G1, anti-(human interferon γ) (human monoclonal NI-0501 heavy chain), disulfide with human monoclonal NI-0501 light chain, dimer
Molecular Formula: C₆₄₃₀H₉₈₉₈N₁₇₁₈O₂₀₃₈S₄₆
CAS Number: 1709815-23-5
Brands: Gamifant

Medically reviewed by Drugs.com on Nov 30, 2021. Written by ASHP.

Introduction

Emapalumab-lzsg, an interferon gamma (IFNγ) blocking antibody, is an immunosuppressive agent.

Uses for Emapalumab-lzsg

Emapalumab-lzsg has the following uses:

Emapalumab-lzsg is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.

Emapalumab-lzsg Dosage and Administration

General

Emapalumab-lzsg is available in the following dosage form(s) and strength(s):

Injection:

• 10 mg/2 mL (5 mg/mL) solution in a single-use vial.

• 50 mg/10 mL (5 mg/mL) solution in a single-use vial.

Dosage

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

Conduct testing for latent tuberculosis infections using the purified protein derivative (PPD) or IFNγ release assay and evaluate patients for tuberculosis risk factors prior to initiating emapalumab-lzsg. Administer tuberculosis prophylaxis to patients at risk for tuberculosis, or known to have a positive PPD test result, or positive IFNγ release assay.

Monitor for tuberculosis, adenovirus, Epstein-Barr virus, and cytomegalovirus every 2 weeks and as clinically indicated.

Administer prophylaxis for Herpes Zoster, Pneumocystis jirovecii, and for fungal infections prior to emapalumab-lzsg administration.

Pediatric Patients

Dosage and Administration

The recommended starting dose of emapalumab-lzsg in pediatric patients (newborn and older) is 1 mg/kg given as an intravenous infusion over 1 hour twice per week (every three to four days). Doses subsequent to the initial dose may be increased based on clinical and laboratory criteria.

Administer emapalumab-lzsg until hematopoietic stem cell transplantation (HSCT) is performed or unacceptable toxicity. Discontinue emapalumab-lzsg when a patient no longer requires therapy for the treatment of HLH.

For patients who are not receiving baseline dexamethasone treatment, begin dexamethasone at a daily dose of at least 5 to 10 mg/m² the day before emapalumab-lzsg treatment begins. For patients who were receiving baseline dexamethasone, they may continue their regular dose provided the dose is at least 5 mg/m². Dexamethasone can be tapered according to the judgment of the treating physician.

The emapalumab-lzsg dose may be titrated up if disease response is unsatisfactory. After the patient’s clinical condition is stabilized, decrease the dose to the previous level to maintain clinical response.

Adults

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