NEW PRODUCT SLIDESHOW

Gamifant (emapalumab-lzsg)

Introduction

Brand name: Gamifant

Generic name: Emapalumab-lzsg

Pharmacological class: Interferon gamma

blocking antibody

Strength and Formulation: Emapalumab-lzsg

10mg/2mL, 50mg/10mL; soln for IV infusion

after dilution; preservative-free

Manufacturer: Sobi, Inc.

How supplied: Single-dose vial—1

Legal Classification: Rx

Gamifant

Indication

Primary hemophagocytic

lymphohistiocytosis (HLH) in adults and

children (newborn and older) with

refractory, recurrent or progressive

disease or intolerance with conventional

HLH therapy

Dosage & Administration

Give prophylaxis for herpes zoster,

Pneumocystis jirovecii, and fungal

infections prior to infusion

Begin dexamethasone ≥5–10mg/m2 daily

the day before starting Gamifant; dose can

be tapered as appropriate

Dosage & Administration

Give by IV infusion over 1hr

Initially 1mg/kg twice weekly (every 3–4

days) until HSCT performed or

unacceptable toxicity

Subsequent doses may be increased

based on response

Dose modification: see full labeling

Considerations for Special

Populations

Pregnancy: No available data to inform

drug-associated risk

Nursing mothers: Consider benefits of

breastfeeding with potential adverse effects

on child

Elderly: Insufficient number studied

Warnings/Precautions

Monitor closely for serious infections (eg,

sepsis, pneumonia, bacteremia); and those

caused by specific pathogens favored by IFN-

gamma neutralization (including

mycobacteria, herpes zoster, histoplasma

capsulatum)

Warnings/Precautions

Evaluate for TB risk factors and test for

latent TB prior to treatment start

Give TB prophylaxis if patient at risk, has (+)

PPD test result or (+) IFN-gamma release

assay

Monitor for TB, adenovirus, EBV, and CMV

every 2 weeks and as clinically indicated

Monitor for infusion-related reactions

Interactions

Avoid concomitant live or live attenuated

vaccines for at least 4 weeks after the last

dose

May reduce efficacy of CYP450

substrates: monitor and adjust dose of

these drugs

Adverse Reactions

Infections

Hypertension

Infusion-related

reactions

Pyrexia

Hypokalemia

Constipation

Rash

Abdominal pain

Diarrhea

Lymphocytosis

Cough

Irritability

Tachycardia

Tachypnea

Mechanism of Action

Emapalumab-lzsg is a monoclonal antibody

that binds to and neutralizes interferon

gamma (IFNγ)

Nonclinical data suggest that IFNγ plays a

pivotal role in the pathogenesis of HLH by

being hypersecreted

Clinical Studies

Gamifant was evaluated in a multicenter,

open-label, single-arm trial (NI-0501-04) in 27

pediatric patients with suspected or confirmed

primary HLH with either refractory, recurrent,

or progressive disease during conventional

HLH therapy or who were intolerant of

conventional HLH therapy

Clinical Studies

Study treatment duration was up to 8 weeks

after which patients could continue

treatment on the extension study

Of the 27 patients, 22 enrolled onto the

open-label extension study which monitored

patients for up to 1 year after HSCT or after

the last infusion (NI-0501-05)

All patients received background

dexamethasone

Clinical Studies

Efficacy was based upon overall response

rate (ORR) at the end of treatment, defined

as achievement of either a complete or

partial response or HLH improvement

HLH improvement was defined as ≥3 HLH

abnormalities improved by ≥50% from

baseline

Clinical Studies

The data showed an ORR of 63% (95% CI,

0.42, 0.81; P =.013)

Complete response was seen in 26% of

patients

Partial response was seen in 30% of patients

HLH improvement was seen in 7.4% of

patients

Clinical Studies

Median duration of first response (defined as time from achievement of first response to loss of first response) was not reached

Range: 4 to 56+ days

70% of patients proceeded to HSCT

For more clinical trial data, see full labeling

New Product Monograph

For more information view the product

monograph available at:

https://www.empr.com/drug/gamifant/