Side Effects and Safety | About Gamifant®| Gamifant Cares™

What should I know about
the possible side effects of Gamifant?

Doctor and Girl

Risk of serious infections

Because Gamifant affects the immune system, it may lower a patient’s ability to fight infections.

Because Gamifant affects the immune system, it may lower a patient’s ability to
fight infections.

The most common adverse reactions reported in ≥10% of people in
the studies were:

Viral infection
Cytomegalovirus (CMV) infection or reactivation (a new herpes viral infection or one that restarts)
Rash
Anemia (low levels of red blood cells and hemoglobin, a protein in red blood cells)
Leukopenia (low white blood cell count)
Thrombosis (formation of a blood clot inside a blood vessel)

Bacterial infection
Headache
Hyperglycemia (too much sugar in
the blood)
Infusion-related reactions (side effects like fever, chills, or rash after receiving medication through a vein)
Abdominal pain
Hypertension (high blood pressure)
Pyrexia (fever)
Thrombocytopenia (low platelet levels in the blood)

Doctor and Girl

Twelve patients in the study experienced serious side effects, with pneumonia being most common. Two patients experienced serious health complications including multiple organ dysfunction and circulatory shock and passed away during the study.

See what the research
says about Gamifant

Explore how Gamifant
is given to patients

See what the research says  about Gamifant

Explore how Gamifant is given  to patients

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,

Important Safety Information

Gamifant can cause serious side effects including:

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

Gamifant can cause serious side effects including:

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

Before starting Gamifant, tell your doctor 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 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

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

Your healthcare provider may give you medicine to help prevent certain infections before you receive Gamifant and will monitor you closely for signs and symptoms of infections during treatment with Gamifant.

Infusion Reactions. These are common, can also be severe, and can happen during or shortly after treatment with Gamifant. Your healthcare provider may temporarily stop your infusion and treat your symptoms before continuing your infusion if you have severe infusion reactions. Tell your healthcare provider right away if you get any of the following symptoms:

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

Before starting Gamifant, tell your doctor about all of your medical conditions including if you:

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

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Gamifant in people with primary HLH include: infections, high blood pressure (hypertension), and fever.

The most common side effects of Gamifant in people with HLH/MAS in Still’s disease include: viral infection and rash.

These are not all the possible side effects of Gamifant. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see Patient Medication Guide for Gamifant.

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,

Important Safety Information

Gamifant can cause serious side effects including:

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

Gamifant can cause serious side effects including:

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

Before starting Gamifant, tell your doctor 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 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

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

Your healthcare provider may give you medicine to help prevent certain infections before you receive Gamifant and will monitor you closely for signs and symptoms of infections during treatment with Gamifant.

Infusion Reactions. These are common, can also be severe, and can happen during or shortly after treatment with Gamifant. Your healthcare provider may temporarily stop your infusion and treat your symptoms before continuing your infusion if you have severe infusion reactions. Tell your healthcare provider right away if you get any of the following symptoms:

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

Before starting Gamifant, tell your doctor about all of your medical conditions including if you:

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

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Gamifant in people with primary HLH include: infections, high blood pressure (hypertension), and fever.

The most common side effects of Gamifant in people with HLH/MAS in Still’s disease include: viral infection and rash.

These are not all the possible side effects of Gamifant. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see Patient Medication Guide for Gamifant.