Gamifant

What is Gamifant used for?

Gamifant is a prescription medicine that is used to treat an immune system problem called primary hemophagocytic lymphohistiocytosis (HLH).

Description

Emapalumab-lzsg is an interferon gamma (IFNγ) blocking antibody. Emapalumab-lzsg is produced in Chinese Hamster Ovary cells by recombinant DNA technology. Emapalumab-lzsg is an IgG1 immunoglobulin with a molecular weight of approximately 148 kDa.

GAMIFANT (emapalumab-lzsg) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution provided in single-dose vials that require dilution prior to intravenous infusion.

Each vial contains 10 mg/2 mL, 50 mg/10 mL, or 100 mg/20 mL emapalumab-lzsg at a concentration of 5 mg/mL. Each mL also contains the following inactive ingredients: L-Histidine (1.55 mg), L-Histidine monohydrochloride, monohydrate (3.14 mg), Polysorbate 80 (0.05 mg), sodium chloride (7.30 mg), and Water for Injection, USP.

Mechanism of Action

Emapalumab-lzsg is a monoclonal antibody that binds to and neutralizes interferon gamma (IFNγ). Nonclinical data suggest that IFNγ plays a pivotal role in the pathogenesis of HLH by being hypersecreted.

Before taking Gamifant, tell your doctor:

• If you are allergic to Gamifant; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have an infection.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Gamifant with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Gamifant?

• Tell all of your health care providers that you take Gamifant. This includes your doctors, nurses, pharmacists, and dentists.
• You will need a TB (tuberculosis) test before starting Gamifant.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• Talk with your doctor before getting any vaccines while using Gamifant and for at least 4 weeks after stopping it. Use with Gamifant may either raise the chance of an infection or make the vaccine not work as well.
• Some people have had side effects during the infusion or a short time after treatment. Tell the doctor if you have a rash, redness, fever, chills, chest pain, shortness of breath, upset stomach, throwing up, or if you sweat a lot while getting Gamifant.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Gamifant while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Gamifant best taken?

Use Gamifant as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• You will need to take Gamifant with certain other drugs to prevent side effects. Talk with your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Gamifant that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Fast or slow heartbeat.
• Fast breathing.
• Stomach or bowel bleeding has happened with Gamifant. Rarely, this has been deadly. Call your doctor or get medical help right away if you have black, tarry, or bloody stools; throwing up blood or throw up that looks like coffee grounds; very bad stomach pain; or very upset stomach or throwing up.

What are some other side effects of Gamifant?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Constipation.
• Diarrhea.
• Stomach pain.
• Feeling tired or weak.
• Feeling irritable.
• Nosebleed.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Gamifant?

• If you need to store Gamifant at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

Principal Display Panel – 50mg/10mL Carton Label

• NDC 66658-505-01
• Gamifant®
  (emapalumab-lzsg)
  Injection
• 50 mg/10 mL
  (5 mg/mL)
• For intravenous infusion only.
• Requires dilution prior to administration.
• Single-dose vial. Discard unused portion.
• Rx only
• Dispense the enclosed Medication Guide
  to each patient.