Emapalumab

What is Emapalumab?

• Emapalumab (Gamifant) is an anti interferon gamma antibody medication.

What are the uses of this medicine?

• Emapalumab (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.

How does this medicine work?

• It is a human monoclonal antibody against the cytokine interferon-gamma (IFN-gamma; IFNg), with potential immunomodulating activity.
• Upon administration, emapalumab binds to and neutralizes IFNg. This inhibits IFNg-mediated signaling pathways and suppresses the activation of the immune system.
• IFNg, a cell-signaling protein, plays a key role in the regulation and activation of the immune system; its upregulation is associated with certain auto-immune and auto-inflammatory diseases in which the immune system is abnormally activated.

Is this medicine FDA approved?

• It is approved by US FDA on November 20, 2018.

What are the brand names and dosage forms of this medicine?

• Brand name: Gamifant
• NDC Code(s): 72171-501-01, 72171-505-01
• Dosage forms: Gamifant is a clear to slightly opalescent, colorless to slightly yellow preservative-free solution available as injection:

1. 10 mg/2 mL (5 mg/mL) in a single-dose vial
2. 50 mg/10 mL (5 mg/mL) in a single-dose vial

How should this medicine be used?

• You will receive Gamifant through a vein by intravenous (IV) infusion over 1 hour.
• Your healthcare provider will monitor you during the infusion for side effects.
• Gamifant is given 2 times a week (every 3 to 4 days).
• Your healthcare provider will do blood tests during your treatment with Gamifant to see how well you respond to treatment.
• Gamifant is used with another prescription medicine called dexamethasone. You can ask your healthcare provider for information about dexamethasone.

What side effects can this medication cause?

• skin redness
• itching
• fever
• rash
• excessive sweating
• chills
• chest pain
• shortness of breath
• nausea or vomiting
• lightheadedness or dizziness
• High blood pressure
• infections
• hypokalemia
• lymphocytosis
• cytomegalovirus infection
• abdominal pain
• constipation

What special precautions should I follow?

• Inform patients and their caregivers of the risk of developing infections during treatment with Gamifant, and to report any symptoms of infection.
• Advise patients and their caregivers that the patient should not receive live or live attenuated vaccines during Gamifant treatment.
• Advise patients and their caregivers of the potential for developing infusion-related reactions during treatment with Gamifant.
• Emapalumab therapy is associated with mild and transient serum enzyme elevations during therapy, but has not been linked to instances of clinically apparent acute liver injury.
• 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.

What to do in case of emergency/overdose?

If Gamifant is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on Gamifant use in pregnant women to inform a drug-associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• Safety and effectiveness of Gamifant have been established in pediatric patients, newborn and older, with primary HLH that is reactivated or refractory to conventional therapies.

What should I know about storage and disposal of this medication?

• Store Gamifant in a refrigerator at 2°C to 8ºC (36°F to 46°F) in original carton to protect from light. Do not freeze or shake. This product contains no preservative.

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• Dailymed label info on Emapalumab
• FDA Emapalumab