Prescription medicine
Emapalumab Brand names: Gamifant
Emapalumab (Gamifant) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the emapalumab FDA label on DailyMed (effective March 26, 2026); every emapalumab label on DailyMed.
Highlights of the record
FDA label of March 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageGAMIFANT 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.
Forms and strengths
- 10 mg/2ml
- 50 mg/10ml
- 50 mg/2ml
- 100 mg/4ml
- 100 mg/20ml
- 250 mg/10ml
- 500 mg/20ml
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 208 through July 30, 2026
What is emapalumab used for?
From the label: indications and usageGAMIFANT 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. […]
FDA pharmacologic class: Interferon gamma Blocker.
Source: FDA drug label (GAMIFANT), Swedish Orphan Biovitrum AB (publ), effective March 26, 2026 (SPL set a865e0ef-8685-4f69-8838-648c4f3bab47), via openFDA; the full label on DailyMed
What does the patient leaflet for emapalumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about GAMIFANT?GAMIFANT can cause serious side effects including: Infections. GAMIFANT is a medicine that affects your immune system and may lower the ability of your immune system to fight infections. GAMIFANT may increase your risk of serious infections that can lead to death. These infections include tuberculosis (TB), histoplasmosis, pneumonia, cytomegalovirus infection or reactivation of infection, sepsis, herpes zoster infection (shingles) and other infections caused by viruses, fungi or bacteria that can spread throughout the body. Your healthcare provider will: test you for TB before you start treatment with GAMIFANT. treat you with a medicine for TB if you are at risk for TB or if you have a known positive TB test. Infections are common in people treated with GAMIFANT. Before starting GAMIFANT, tell your healthcare provider if you: had TB in the past, or if you or a member of your family have been in recent close contact with someone with TB. have ever had a positive TB skin test (PPD). currently have or have had history of infections, including histoplasmosis, cytomegalovirus, or herpes zoster (shingles). are being treated for an active infection. have symptoms of an infection, such as fever, sweat and chills, cough, breathing problems, blood in mucus (phlegm), warm, red, or painful skin or sores on your body. Your healthcare provider may give you medicine to help prevent certain infections before you receive GAMIFANT. After starting GAMIFANT , tell your healthcare provider if: new symptoms of an infection appear. symptoms of an infection that you already had when starting GAMIFANT worsen. Your healthcare provider will monitor you closely for signs and symptoms of infections during treatment with GAMIFANT. […]
Source: FDA drug label (GAMIFANT), Swedish Orphan Biovitrum AB (publ), effective March 26, 2026 (SPL set a865e0ef-8685-4f69-8838-648c4f3bab47), via openFDA; the full label on DailyMed
Is there a generic for emapalumab (Gamifant)?
No generic emapalumab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for emapalumab?
The FDA Adverse Event Reporting System holds 208 reports that list emapalumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 87 are coded as a death and 55 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Emapalumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other