emapalumab

What is the most important information I should know about emapalumab?

What is emapalumab?

Emapalumab is used together with a medicine called dexamethasone to treat hemophagocytic lymphohistiocytosis (HLH), a rare disease that is sometimes inherited. HLH causes your immune system to attack healthy blood cells, which can lead to serious or life-threatening side effects on your spleen or liver. Emapalumab is for use in adults and children as young as newborn.

Emapalumab is given after other treatments did not work or have stopped working.

Emapalumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving emapalumab?

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

Tell your doctor if you have ever had:

• a positive tuberculosis (TB) skin test;
• any type of infection (active or recent);
• histoplasmosis (a fungal infection);
• herpes zoster (shingles); or
• if you are scheduled to receive a vaccine.

Tell your doctor if you are pregnant or breastfeeding.

How is emapalumab given?

Before you start treatment with emapalumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Emapalumab is given as an infusion into a vein, usually once every 3 or 4 days. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take about 1 hour to complete.

Emapalumab affects your immune system. You may get infections more easily, even serious or fatal infections. You will need blood tests to help your doctor determine how long to treat you with this medicine.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving emapalumab?

Do not receive a "live" vaccine while using emapalumab and for at least 4 weeks after your last dose. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of emapalumab?

Some side effects may occur during the injection. Tell your caregiver if you feel feverish, chilled, sweaty, itchy, light-headed, nauseated, or if you have chest pain, shortness of breath, or skin rash or redness.

• fever, chills, night sweats;
• loss of appetite, weight loss;
• feeling very tired;
• warmth, redness, or painful sores on your skin;
• cough, trouble breathing;
• mouth and throat ulcers;
• cough with bloody mucus; or
• any other new or worsening signs of infection.

Common side effects may include:

• fever; or
• increased blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect emapalumab?

Other drugs may affect emapalumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about emapalumab.