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What is GAMIFANT?
- primary HLH whose disease has come back or progressed,
Important Safety Information
- Infections. GAMIFANT affects your immune system and may lower the ability of your immune system to fight infections. Gamifant may increase your risk of serious
What is GAMIFANT?
Gamifant (emapalumab-lzsg) is a prescription medicine used for the treatment of hemophagocytic lymphohistiocytosis (HLH) in adults and children (newborn and older) with:
- primary HLH whose disease has come back or progressed, other medicines have not worked well enough or cannot be tolerated.
- HLH/macrophage activation syndrome (MAS) in Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), when glucocorticoids have not worked well enough or cannot be tolerated, or with MAS that has come back.
Important Safety Information
- Infections. GAMIFANT 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, herpes zoster infection (shingles), and other infections caused by viruses, fungi, or bacteria that can spread throughout the body. Infections are common in people treated with Gamifant. Your healthcare provider will:
- Test you for TB before you start Gamifant
- Treat you with a medicine for TB if you are at risk for TB or if you have a known positive TB test
- 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 a history of infections, including histoplasmosis 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), or warm, red, or painful skin or sores on your body
- 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
- skin redness
- itching
- fever
- rash
- excessive sweating
- headache
- bone pain
- chills
- chest pain
- shortness of breath
- nausea or vomiting
- lightheadedness or dizziness
- tingling, burning, or numbness
- cold hands, arms, legs, or feet
- have an infection
- have received or are scheduled to receive an immunization (vaccine). You should not receive live or live attenuated vaccines while taking Gamifant and for at least 4 weeks after your last dose of Gamifant
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed
What is GAMIFANT?
- primary HLH whose disease has come back or progressed,
Important Safety Information
- Infections. GAMIFANT affects your immune system and may lower the ability of your immune system to fight infections. Gamifant may increase your risk of serious
What is GAMIFANT?
Gamifant (emapalumab-lzsg) is a prescription medicine used for the treatment of hemophagocytic lymphohistiocytosis (HLH) in adults and children (newborn and older) with:
- primary HLH whose disease has come back or progressed, other medicines have not worked well enough or cannot be tolerated.
- HLH/macrophage activation syndrome (MAS) in Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), when glucocorticoids have not worked well enough or cannot be tolerated, or with MAS that has come back.
Important Safety Information
- Infections. GAMIFANT 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, herpes zoster infection (shingles), and other infections caused by viruses, fungi, or bacteria that can spread throughout the body. Infections are common in people treated with Gamifant. Your healthcare provider will:
- Test you for TB before you start Gamifant
- Treat you with a medicine for TB if you are at risk for TB or if you have a known positive TB test
- 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 a history of infections, including histoplasmosis 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), or warm, red, or painful skin or sores on your body
- 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
- skin redness
- itching
- fever
- rash
- excessive sweating
- headache
- bone pain
- chills
- chest pain
- shortness of breath
- nausea or vomiting
- lightheadedness or dizziness
- tingling, burning, or numbness
- cold hands, arms, legs, or feet
- have an infection
- have received or are scheduled to receive an immunization (vaccine). You should not receive live or live attenuated vaccines while taking Gamifant and for at least 4 weeks after your last dose of Gamifant
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed
NOW APPROVED
Gamifant is now approved for HLH/MAS in Still’s disease.
We are excited to announce that Gamifant® (emapalumab-lzsg) has received FDA approval for the treatment of adults and children (newborn and older) with HLH/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), when glucocorticoids have not worked well enough or cannot be tolerated, or with MAS that has come back.
Please see Important Safety Information and Med Guide for more information.
PP-27769 06/25