Molecule

Emapalumab

Interferon gamma Blocker

Available on requestBiologicOrphanCold chainImmunology and transplant Multiple sclerosis

Presentations: 7
Brands: 1
Manufacturers: 1
Available from stock: 0

Emapalumab is an interferon gamma blocker indicated for the treatment of adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. MedsAcross supplies Emapalumab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class: Interferon gamma Blocker, Interferon gamma Antagonists
ATC classification: L04AG09 Emapalumab · Immunosuppressive drug, subgroup L04AG
US FDA first approval: 20 November 2018
EU status: Refused
Orphan designation: Yes
WHO essential medicine: Not recorded
India (CDSCO): Not yet confirmed against CDSCO approval lists
Routes: Intravenous
Dosage forms: Injection
Biologic: Yes
Identifiers: UNII 3S252O2Z4XCAS 1709815-23-5DrugBank DB14724Q28209889

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

GAMIFANT is indicated for the treatment of: adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. adult and pediatric patients with HLH/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.

Source: US FDA prescribing information

How it works

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.

Source: US FDA prescribing information

Dosing overview

For intravenous infusion only: Primary HLH recommended starting dosage: 1 mg/kg as an intravenous infusion over 1 hour twice per week. HLH/MAS in Still’s disease recommended dosage schedule: 6 mg/kg, followed by 3 mg/kg every 3 days for 5 doses, then 3 mg/kg twice per week. Given as an intravenous infusion over 1 hour. For both indications, the dose may be titrated up to a maximum of 10 mg/kg.

Source: US FDA prescribing information

Contraindications

None. None.

Source: US FDA prescribing information

Warnings and precautions

Infections: Monitor patients for signs and symptoms and treat promptly. Test for latent tuberculosis. Consider administering prophylactic treatment against herpes zoster, Pneumocystis jirovecii and fungal infections. Live Vaccines: Do not administer live or live attenuated vaccines to patients receiving GAMIFANT. Infusion-Related Reactions: Monitor patients for infusion-related reactions. Interrupt infusion for infusion reactions and institute appropriate medical management.

Source: US FDA prescribing information

Side effects

The following adverse reactions are described elsewhere in the labeling: Infections Increased Risk of Infection with Use of Live Vaccines Infusion-Related Reactions In patients with primary HLH, the most common adverse reactions (≥ 20%) were: infections, hypertension, infusion-related reactions, and pyrexia. In patients with HLH/MAS in Still’s disease, the most common adverse reactions (≥20%) were: viral infections, including cytomegalovirus infection or reactivation, and rash.

Source: US FDA prescribing information

Interactions

Effect of GAMIFANT on Cytochrome P450 Substrates The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (such as IFNγ) during chronic inflammation. By neutralizing IFNγ, use of GAMIFANT may normalize CYP450 activities which may reduce the efficacy of drugs that are CYP450 substrates due to increased metabolism. Upon initiation or discontinuation of concomitant GAMIFANT, monitor for reduced efficacy and adjust dosage of CYP450 substrate drugs as appropriate.

Source: US FDA prescribing information

Storage

Store GAMIFANT in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in original carton to protect from light. Do not freeze or shake.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

7 presentations of Emapalumab, sorted by availability.

Medicine	Manufacturer	Register	Availability
Gamifant 10 mg/2 mL injectionIntravenous Cold chain	Swedish Orphan Biovitrum AB (publ)	US FDA	Available on request
Gamifant 100 mg/20 mL injectionIntravenous Cold chain	Swedish Orphan Biovitrum AB (publ)	US FDA	Available on request
Gamifant 100 mg/4 mL injectionIntravenous Cold chain	Swedish Orphan Biovitrum AB (publ)	US FDA	Available on request
Gamifant 250 mg/10 mL injectionIntravenous Cold chain	Swedish Orphan Biovitrum AB (publ)	US FDA	Available on request
Gamifant 50 mg/10 mL injectionIntravenous Cold chain	Swedish Orphan Biovitrum AB (publ)	US FDA	Available on request
Gamifant 50 mg/2 mL injectionIntravenous Cold chain	Swedish Orphan Biovitrum AB (publ)	US FDA	Available on request
Gamifant 500 mg/20 mL injectionIntravenous Cold chain	Swedish Orphan Biovitrum AB (publ)	US FDA	Available on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Gamifant

Manufacturers

Swedish Orphan Biovitrum AB (publ)7 presentations

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

Register	Status	Source
US FDA	First approved 20 November 2018	Drugs@FDA
EU (EMA)	Refused	EMA medicines data
India (CDSCO)	Not yet confirmed against CDSCO approval lists	—
United States	Registered	US FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Emapalumab in public data. This is not a list of approved uses, see the clinical information.

Hemophagocytic lymphohistiocytosis

Questions and answers

Is Emapalumab available for export from India?

Yes, on request. MedsAcross lists 7 presentations of Emapalumab and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Emapalumab have?

The catalogue lists 1 brand names for Emapalumab, including Gamifant.

Is Emapalumab approved by the US FDA?

Yes. The US FDA first approved Emapalumab on 20 November 2018, according to Drugs@FDA.

Does Emapalumab need cold chain shipping?

At least one listed presentation of Emapalumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Emapalumab in?

Emapalumab is classified under ATC code L04AG09 (Emapalumab).

References

GAMIFANT prescribing information (Swedish Orphan Biovitrum AB (publ)). U.S. National Library of Medicine, DailyMed. Retrieved 26 March 2026

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