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Emapalumab-lzsg Injection

Emapalumab-lzsg injection (Gamifant) is an interferon gamma-blocking antibody used to treat primary hemophagocytic lymphohistiocytosis (HLH) and HLH/macrophage activation syndrome in Still's disease when standard treatments have not worked.

Brand name Gamifant
Drug class Interferon Gamma Blocker
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Emapalumab-lzsg Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Gamifant (emapalumab-lzsg) is a specialist antibody, given by infusion into a vein, for HLH, a rare, life-threatening immune overreaction, and for macrophage activation syndrome in Still’s disease when standard therapy or steroids have not worked. It blocks interferon gamma, an immune signal these conditions overproduce, and has been available since about 2019, only as the brand. Infusion reactions (rash, fever, flushing, sweating) are what people notice most, sometimes at the first dose, and they usually ease when the drip is slowed. The real danger is serious, sometimes fatal infection, especially TB, shingles and fungal infections, so expect a TB test first, preventive medicines alongside and close monitoring throughout.

Clinical pearls

  • No live or live-attenuated vaccines during treatment or for at least 4 weeks after the last dose, so tell every provider.
  • Gamifant may speed the liver’s breakdown (CYP450 enzymes) of some other medicines, so their doses may need rechecking.
  • The preventive medicines for shingles, Pneumocystis pneumonia and fungal infections are part of the treatment, so do not skip them.
  • Expect blood pressure and potassium checks, since high blood pressure and low potassium are common side effects.
How you get itPrescription only
Comes asInjection
Earliest FDA record2018
Companies listing it with the FDA1
FDA label last updatedMar 26, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Emapalumab-lzsg Injection, written from its FDA label.

What Emapalumab-lzsg Injection is used for

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Emapalumab-lzsg (Gamifant) is approved for two serious immune conditions involving dangerous immune overactivation:

  • Primary hemophagocytic lymphohistiocytosis (HLH): Gamifant treats adults and children with primary HLH whose disease has not responded to, has come back during, or has worsened on standard HLH therapies, or who cannot tolerate those treatments.
  • HLH/macrophage activation syndrome (MAS) in Still's disease: Gamifant treats adults and children with HLH/MAS occurring in known or suspected Still's disease — including systemic Juvenile Idiopathic Arthritis (sJIA) — when glucocorticoids (steroid medicines) are not working well enough, cannot be tolerated, or when MAS keeps recurring.

How Emapalumab-lzsg Injection works

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Emapalumab-lzsg is a monoclonal antibody — a targeted, lab-designed protein — that latches onto and neutralizes interferon gamma (IFNγ), a key immune-signaling molecule. In HLH and related conditions, the body produces far too much IFNγ, which drives an out-of-control immune response that damages organs and tissues. By blocking IFNγ directly, Gamifant helps quiet this dangerous overactivation. As a measurable sign that it is working, Gamifant reduces blood levels of a marker called CXCL9, a chemokine (immune messenger) that is triggered by IFNγ.

Emapalumab-lzsg Injection dosage

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Gamifant is given only as an intravenous (IV) infusion in a clinical setting — never taken by mouth. It is infused over one hour through a central or peripheral IV line. The dosing schedule differs by condition:

  • Primary HLH: Treatment typically starts at a low dose given twice a week (every 3–4 days), with the possibility of stepwise dose increases if the response is not sufficient. Treatment continues until a stem cell transplant is performed or it is no longer needed.
  • HLH/MAS in Still's disease: Treatment begins with a higher initial dose on Day 1, followed by a different dose every 3 days for the next two weeks, then twice weekly thereafter. Doses may be adjusted based on response.

Dosing is based on body weight and adjusted by your care team based on lab results and clinical response. Always follow the schedule your prescriber sets — do not adjust it on your own.

Dosing details from the FDA-approved label

From the Emapalumab-lzsg Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Primary hemophagocytic lymphohistiocytosis (HLH)
    • Recommended starting dose 1 mg/kg given as a central or peripheral 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
    • Titration per Table 2: increase to 3 mg/kg from Day 4 onwards, to 6 mg/kg from Day 7 onwards, and to 10 mg/kg from Day 1
    • Maximum: 10 mg/kg
    • For patients not receiving baseline dexamethasone, begin dexamethasone at a daily dose of at least 5 mg/m2 to 10 mg/m2 the day before treatment begins.
  • Hemophagocytic lymphohistiocytosis/Macrophage activation syndrome (HLH/MAS) in Still's disease
    • Day 1: 6 mg/kg
    • Days 4 to 16: 3 mg/kg every 3 days for 5 doses
    • From Day 19 onward: 3 mg/kg twice per week (i.e., every 3 to 4 days)
    • Given as a central or peripheral intravenous infusion over 1 hour
    • If improvement is unsatisfactory, dose may be increased to a maximum cumulative dose of 10 mg/kg over 3 days and frequency increased to every 2 days or once da
    • Maximum: 10 mg/kg
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION For intravenous infusion only: Primary HLH recommended starting dosage: 1 mg/kg as an intravenous infusion over 1 hour twice per week. ( 2.1 ) 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. ( 2.2 ) For both indications, the dose may be titrated up to a maximum of 10 mg/kg. ( 2.5 , 2.6 ) 2.1 Recommended Dosage for Primary Hemophagocytic Lymphohistiocytosis The recommended starting dose of GAMIFANT is 1 mg/kg given as a central or peripheral 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 [see Dosage and Administration ( 2.5 )] . Administer GAMIFANT until hematopoietic stem cell transplantation (HSCT) is performed or unacceptable toxicity. Discontinue GAMIFANT when a patient no longer requires therapy for the treatment of HLH. 2.2 Recommended Dosage for Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome GAMIFANT is administered as a central or peripheral intravenous infusion over 1 hour according to the dosage schedule in Table 1. Doses may be increased based on clinical and laboratory criteria [see Dosage and Administration ( 2.6 )] . Discontinue GAMIFANT when a patient no longer requires therapy for the treatment of HLH/MAS. Table 1. GAMIFANT Dosage in Patients with HLH/MAS Treatment Day GAMIFANT Dosage Day 1 6 mg/kg Days 4 to 16 3 mg/kg every 3 days for 5 doses From Day 19 onward 3 mg/kg twice per week (i.e., every 3 to 4 days) 2.3 Monitoring to Assess Safety Before Initiating GAMIFANT Treatment 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 GAMIFANT. Administer tuberculosis prophylaxis to patients at risk for tuberculosis, or known to have a positive PPD test result, or positive IFNγ release assay. During GAMIFANT Treatment Monitor for herpes zoster infection, adenovirus, EBV and CMV as clinically indicated. 2.4 Prophylaxis and Concomitant Medication Information Prophylaxis Consider prophylaxis for herpes zoster, Pneumocystis jirovecii , and for fungal infections prior to GAMIFANT administration.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Emapalumab-lzsg Injection side effects

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Like all medicines, Gamifant can cause side effects. The most commonly reported ones include:

Common side effects

  • Infections (viral, bacterial, or fungal)
  • High blood pressure (hypertension)
  • Infusion-related reactions (rash, fever, flushing, sweating)
  • Fever (pyrexia)
  • Low potassium levels (hypokalemia)
  • Rash
  • Fast heart rate (tachycardia)
  • Abdominal pain
  • Constipation
  • Abdominal pain and diarrhea

When to get medical help

  • Call your doctor right away if you develop signs of infection — fever, chills, cough, difficulty breathing, or unusual wounds
  • Seek urgent care for signs of a serious infusion reaction — severe rash, difficulty breathing, or rapid heart rate during or within 24 hours of an infusion
  • Tell your doctor immediately if you have been exposed to or have symptoms of tuberculosis, herpes zoster (shingles), or a fungal infection
  • Do not receive live or live-attenuated vaccines while on Gamifant or for at least 4 weeks after the last dose — tell all your providers you are on this medicine
  • Contact your care team if you notice any worsening of your underlying condition or new, unexplained symptoms

Serious reactions — including severe infections (such as sepsis or pneumonia), gastrointestinal bleeding, and multiple organ problems — have occurred. Contact your care team immediately if you develop signs of infection, breathing problems, or any sudden worsening of your condition.

Emapalumab-lzsg Injection warnings and precautions

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  • Serious and fatal infections: Gamifant suppresses an important immune defense signal (IFNγ), raising the risk of severe infections — especially tuberculosis, herpes zoster (shingles), and certain fungal infections. All patients must be screened for TB before starting, and preventive therapies for shingles, Pneumocystis jirovecii, and fungal infections are typically given alongside Gamifant. Monitor for any signs of infection throughout treatment.
  • Infusion-related reactions: Reactions including rash, fever, sweating, and in rare cases acute breathing problems can occur — sometimes during the very first infusion. Healthcare staff monitor patients during infusions and will slow or pause the drip if a reaction occurs.
  • Live vaccines are not safe during treatment: Do not receive any live or live-attenuated vaccine while on Gamifant or for at least 4 weeks after the last dose. Inform all healthcare providers that you are receiving this medicine.

Emapalumab-lzsg Injection interactions

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Gamifant can affect how your body processes certain other medications. The key interaction to know about:

  • CYP450 substrate drugs (medicines broken down by liver enzymes): High levels of IFNγ suppress these liver enzymes. When Gamifant lowers IFNγ, those enzymes can become more active again — which may speed up the breakdown of other medicines and make them less effective. Your doctor may need to monitor and adjust doses of any CYP450-metabolized drugs you take when starting or stopping Gamifant.

Interactions listed in the FDA-approved label

From the Emapalumab-lzsg Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Cytochrome P450 (CYP450) substrates: By neutralizing IFNγ, 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.
Read the label’s full interactions text

7 DRUG INTERACTIONS 7.1 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.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Emapalumab-lzsg Injection

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  • Active or latent tuberculosis: TB testing is required before starting Gamifant. Preventive TB treatment is given to anyone at risk or with a positive test.
  • Active serious infections: Gamifant should not be started in patients with active mycobacterial, herpes zoster, or Histoplasma infections until appropriate treatment has been initiated.
  • Pregnancy: There are no adequate human studies on Gamifant use during pregnancy. Animal studies did not show fetal harm, but risk in humans is unknown. Discuss the benefits and risks with your doctor.
  • Breastfeeding: It is not known whether emapalumab-lzsg passes into breast milk. The benefits of breastfeeding should be weighed against any potential risk. Talk to your doctor.
  • Children: Gamifant has been studied and is approved for use in pediatric patients, including very young infants. Dosing is weight-based.
  • Kidney or liver problems: No clinically significant differences in how the body handles Gamifant were seen in patients with kidney impairment (including those on dialysis) or with mild, moderate, or severe liver impairment.
  • All current medications: Tell your prescriber about every drug, supplement, or herbal product you take, especially anything metabolized by the liver.

Emapalumab-lzsg Injection overdose

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If you think too much Gamifant has been given, contact the Poison Help line at 1-800-222-1222 or seek emergency medical care. A medical toxicologist can provide additional guidance on management.

What Emapalumab-lzsg Injection does in the body

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Gamifant works by neutralizing interferon gamma (IFNγ), a signaling protein that is overproduced in HLH and drives the dangerous immune reaction. A measurable sign that it is working is a drop in blood levels of CXCL9, a chemokine (immune messenger) that IFNγ normally triggers — lower CXCL9 indicates that IFNγ is being blocked. At the doses used for HLH, Gamifant does not cause any meaningful change in the heart's electrical rhythm (QT interval).

How your body processes Emapalumab-lzsg Injection

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Gamifant's behavior in the body is closely linked to how much IFNγ a patient is producing. When IFNγ levels are high, the drug is cleared faster and has a shorter half-life (ranging from about 2.5 to nearly 19 days in HLH patients); in healthy adults with low IFNγ, the half-life is about 22 days. This means the drug builds up in the body differently depending on disease activity, which is why doses are adjusted based on lab results and clinical response. Gamifant does not appear to be significantly affected by age, sex, race, or kidney or liver function. Like other protein-based medicines, it is broken down into small peptides and amino acids by normal body processes rather than through liver drug-metabolizing enzymes.

How to store Emapalumab-lzsg Injection

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

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

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Supplements & herbs that interact with Emapalumab-lzsg Injection

53 supplements and herbal products have documented interactions with Emapalumab-lzsg Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Moderate · 52
  • Minor · 1
Every supplement checked against Emapalumab-lzsg Injection — ranked by severity The full interaction hub: 52 moderate · 1 minor · every one linked to its full report. Check Emapalumab-lzsg Injection against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Emapalumab-lzsg Injection: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Emapalumab-lzsg Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Gamifant being used for?

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Gamifant is used to treat a rare but life-threatening condition called hemophagocytic lymphohistiocytosis — HLH for short — where the immune system goes into dangerous overdrive and starts attacking the body's own organs. It is specifically for people whose HLH hasn't responded to standard treatments, has come back, or who can't tolerate those treatments. It's also used for a related condition called macrophage activation syndrome in people with Still's disease, including a form of juvenile arthritis. Both conditions involve the same kind of out-of-control immune reaction that Gamifant is designed to calm.

How is this medicine given — do I take a pill?

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No, Gamifant is not a pill. It's given as an IV infusion — a slow drip directly into a vein — and it takes about one hour each time. It's always given in a clinical setting by a healthcare professional, never at home on your own. How often you receive it depends on which condition you have and how you're responding. Your care team will set the schedule and adjust it based on your lab results and how you're feeling.

What side effects should I watch out for?

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The most common things people notice are infections, high blood pressure, fever, and reactions during or shortly after the infusion — like rash, flushing, or sweating. Most infusion reactions are mild to moderate and can be managed by slowing the drip. The more serious concern is infections, because Gamifant works by dialing down part of the immune system. Call your care team right away if you develop fever, chills, unusual pain, difficulty breathing, or any signs of infection. Serious infections like pneumonia or sepsis have occurred in some patients in clinical trials.

Is it safe to get vaccinated while I'm on Gamifant?

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Live or live-attenuated vaccines — like the nasal flu vaccine, shingles vaccine Zostavax, MMR, or chickenpox vaccine — are not safe to get while you're on Gamifant or for at least 4 weeks after your last dose. Because Gamifant affects your immune system, a live vaccine could cause a real infection. Make sure every doctor, nurse, or pharmacist who might give you a vaccine knows you are on this medicine.

Will I need any extra precautions or preventive medicines while on Gamifant?

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Yes, and this is really important. Before you start, you'll be tested for tuberculosis. If there's any risk of TB, you'll get a preventive antibiotic. Your team will also likely start preventive medicines against shingles, a lung infection called Pneumocystis jirovecii pneumonia, and fungal infections — all because Gamifant lowers one of your immune defenses. You'll also be monitored with regular tests for viruses like CMV and adenovirus. These precautions are standard with this drug and are there to keep you as safe as possible.

Is Gamifant safe during pregnancy or while breastfeeding?

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There isn't enough data from human pregnancies to know for certain what the risks are. Animal studies didn't show harm to the fetus, but those results don't always translate directly to humans. If you are pregnant, might become pregnant, or are breastfeeding, it's really important to have an honest conversation with your doctor. They'll help weigh the serious risks of untreated HLH against any potential concerns with using Gamifant during pregnancy or while nursing.

Is Emapalumab-lzsg Injection available over the counter?

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No. Emapalumab-lzsg Injection is a prescription medicine: every Emapalumab-lzsg Injection product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Emapalumab-lzsg Injection first available?

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The earliest FDA record we hold for Emapalumab-lzsg Injection is from 2018: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Emapalumab-lzsg Injection was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Emapalumab-lzsg Injection on HelloPharmacist

Detailed data & references for Emapalumab-lzsg Injection Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Emapalumab-lzsg Injection forms and strengths (how it comes)

Emapalumab-lzsg Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Emapalumab-lzsg Injection inactive ingredients by manufacturer.

Injection

Into a vein
Brands Gamifant
How this form is used
What it may be used for
  • Gamifant is used intravenously to treat primary HLH in adults and children when the disease is refractory, recurrent, progressive, or when conventional HLH therapy cannot be tolerated
  • Gamifant is used intravenously to treat HLH/macrophage activation syndrome (MAS) in adults and children with known or suspected Still's disease, including sJIA, when glucocorticoids are inadequate, not tolerated, or MAS recurs
Important instructions
  • Gamifant is administered only as an intravenous infusion over 1 hour through a central or peripheral IV line by a healthcare professional
  • Gamifant must be diluted before infusion and given through a sterile, low-protein-binding 0.2 micron in-line filter; do not mix with other agents in the same infusion bag or syringe
  • Gamifant vials are single-dose only; unused portions must be discarded and the diluted solution should not be stored for reuse beyond 4 hours under refrigeration
  • Gamifant dosing frequency varies by indication and patient response — follow the schedule set by your care team exactly
Available strengths 7 strengths
Show 1 more strength Show fewer strengths
14 FDA-listed product records ⓘ

Emapalumab-lzsg Injection on the U.S. market: products, makers and brands

How Emapalumab-lzsg Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 7 Emapalumab-lzsg Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2018. Brand names on the directory include Gamifant; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
7
FDA-listed product records ⓘ
2018
Earliest FDA record ⓘ

How widely Emapalumab-lzsg Injection is used (Medicaid data)

A general measure of how commonly Emapalumab-lzsg Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Emapalumab-lzsg Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

29
Medicaid prescriptions filled (Q1–Q4 2025)
$94,377 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Emapalumab-lzsg Injection prescribed? Of the 1,601 medications we measure, Emapalumab-lzsg Injection ranks #1,565 by Medicaid prescriptions — more than 2% of them.

Where Emapalumab-lzsg Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Emapalumab-lzsg Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mL / 5 mg/mL injection is the most-dispensed Emapalumab-lzsg Injection product — about 52% of these Medicaid prescriptions.

10 ML emapalumab-lzsg 5 MG/ML Injection Most dispensed

15 Medicaid prescriptions (Q1–Q4 2025) 52% of Emapalumab-lzsg Injection prescriptions shown

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2104621

2 ML emapalumab-lzsg 5 MG/ML Injection

14 Medicaid prescriptions (Q1–Q3 2025) 48% of Emapalumab-lzsg Injection prescriptions shown $94,377 gross reimbursement (before rebates) ≈ $6,741 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2104611

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Emapalumab-lzsg Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 2 listed Emapalumab-lzsg Injection NDCs with Medicaid activity.

Compare Emapalumab-lzsg Injection products

A representative set of FDA-listed product records for Emapalumab-lzsg Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Injection
10 mg/2 mL Intravenous Swedish Orphan Biovitrum AB (publ) BLA View NDC →
50 mg/2 mL Intravenous Swedish Orphan Biovitrum AB (publ) BLA View NDC →
50 mg/10 mL Intravenous Swedish Orphan Biovitrum AB (publ) BLA View NDC →
100 mg/4 mL Intravenous Swedish Orphan Biovitrum AB (publ) BLA View NDC →
100 mg/20 mL Intravenous Swedish Orphan Biovitrum AB (publ) BLA View NDC →
250 mg/10 mL Intravenous Swedish Orphan Biovitrum AB (publ) BLA View NDC →
500 mg/20 mL Intravenous Swedish Orphan Biovitrum AB (publ) BLA View NDC →

Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Emapalumab-lzsg Injection NDCs →

Emapalumab-lzsg Injection recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Emapalumab-lzsg recalls since July 2021.

✅No Emapalumab-lzsg recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Emapalumab-lzsg Injection RxCUI 2104604 1 dose form · 7 strengths

Look up RxCUI 2104604 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Emapalumab-lzsg Injection brand names

Emapalumab-lzsg Injection is sold under one brand name in the FDA directory — Gamifant. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Gamifant

Who makes Emapalumab-lzsg Injection: manufacturers and labelers

One company lists Emapalumab-lzsg Injection products with the FDA. By number of product records, the largest are Swedish Orphan Biovitrum AB (publ). Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Swedish Orphan Biovitrum AB (publ) 7

Emapalumab-lzsg Injection drug class (RxNorm)

Emapalumab-lzsg Injection belongs to the Interferon gamma Blocker class.

Pharmacologic class Interferon gamma Blocker
Drug family (ATC) Monoclonal antibodies
How it works Interferon gamma Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Emapalumab-lzsg Injection page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 26, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Emapalumab-lzsg Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Emapalumab-lzsg Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
7
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Swedish Orphan Biovitrum AB (publ)
Linked label effective
Mar 26, 2026
Composite sections available
22
Linked SPL Set ID
a865e0ef-8685-4f69-8838-648c4f3bab47
Linked SPL Document ID
58d52c0a-08fe-40f4-86ba-752dd079ec91
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Swedish Orphan Biovitrum AB (publ) is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →