Gamifant - Emapalumab Injection

What is this medication?

EMAPALUMAB (EM a PAL ue mab) treats hemophagocytic lymphohistiocytosis (HLH), a condition that can cause severe inflammation and tissue injury in the body. It works by slowing down an overactive immune system. This decreases inflammation. It is a monoclonal antibody.

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 recent close contact with someone who has tuberculosis
• An unusual or allergic reaction to emapalumab, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is infused into a vein. It is given by a care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. While this medication 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 care team 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 medication.

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

This medication may increase your risk of getting an infection. Call your care team 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 care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
• Stomach pain, unusual weakness or fatigue, nausea, vomiting, diarrhea, or fever that lasts longer than expected

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

• Constipation
• Cough
• Diarrhea
• Stomach pain

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 medication is given in a hospital or clinic. It 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.