Emapalumab injection

What is this medication?

EMAPALUMAB (EM a PAL ue mab) is a monoclonal antibody. It is used to treat the symptoms of primary hemophagocytic lymphohistiocytosis (HLH). This medicine is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Gamifant

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• infection
• recently received or are scheduled to receive a vaccine
• tuberculosis, a positive skin test for tuberculosis, or have recently been in close contact with someone who has tuberculosis
• an unusual or allergic reaction to emapalumab, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for infusion into a vein. It is given by a healthcare professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of the medicine in children. While this drug may be prescribed for children as young as newborns for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your doctor or healthcare professional if you are unable to keep an appointment.

What may interact with this medication?

• live virus vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medicine.

You will be tested for tuberculosis (TB) before you start this medicine. If your doctor prescribes any medicine for TB, you should start taking the TB medicine before starting this medicine. Make sure to finish the full course of TB medicine.

This medicine may increase your risk of getting an infection. Call your healthcare professional for advice if you get a fever, chills, or sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• fast heartbeat
• high blood pressure
• signs and symptoms of infection like fever; chills; cough; sore throat; pain or trouble passing urine

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• constipation
• cough
• diarrhea
• irritable
• pain, redness, or irritation at site where injected
• rash
• stomach pain
• vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medicine is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.