Prescribing Information
Important Safety Information
Medication Guide
For Healthcare Professionals
Gamifant
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  • Primary HLH
  • About Gamifant®
  • Support & Resources
  • For Healthcare Professionals

Gamifant® (emapalumab-lzsg) is the first and only FDA-approved treatment for patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy.

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Important Safety Information

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, Herpes zoster infection (shingles) and other infections caused by viruses, fungi or bacteria that can spread throughout the body.

INDICATION

GAMIFANT is a prescription medicine used for the treatment of adults and children (newborn and older) with primary hemophagocytic lymphohistiocytosis (HLH) whose disease has come back or progressed, or other medicines have not worked well enough or cannot be tolerated.

IMPORTANT SAFETY INFORMATION

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, 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 all of your medical conditions and 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 had a positive TB skin test (purified protein derivative test)
    • Currently have an infection or have 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 painful skin or sores on your body
    • Are pregnant or plan to become pregnant. It is not known if GAMIFANT can harm your unborn baby
    • Are breastfeeding or plan to breastfeed. It is not known if GAMIFANT passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with GAMIFANT
    • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
  • Your healthcare provider will 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

GAMIFANT can cause serious infusion reactions, including:

  • Infusion reactions are common with GAMIFANT and can also be severe. Infusion reactions 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
    • Chills
    • Chest pain
    • Shortness of breath
    • Nausea or vomiting
    • Lightheadedness or dizziness

The most common side effects of GAMIFANT include:

  • High blood pressure (hypertension) and fever. These are not all of the possible side effects of GAMIFANT

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800 FDA-1088.

Please see full Prescribing Information for Gamifant.

You may also contact Sobi at medinfo.us@sobi.com or 866-773-5274.

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Sobi is dedicated to providing access to innovative treatments that make a significant difference in the lives of individuals with ultra-rare diseases. We work closely with patients, caregivers and advocacy organizations to understand and address the challenges they face throughout their journey, from infancy to adulthood. And we keep innovating to meet their evolving needs, serving as a trusted partner for life.

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