Rx Item-GAMIFANT emapalumab-lzsg injection 10MG/20ML by NovImmune SA

Hemophagocytic Lymphohistiocytosis
Gamifant (emapalumab-lzsg) is an interferon gamma (IFN?) blocking antibody for the treatment of patients with primary hemophagocytic lymphohistiocytosis (HLH). GAMIFANT (emapalumab-lzsg) injection is a sterile, clear to slightly opalescent, colorless to slightly yellow solution supplied in the following packaging configuration:

NDC 72171-501-01 � containing one 10 mg/2 mL (5 mg/mL) single-dose vial

NDC 72171-505-01 � containing one 50 mg/10 mL (5 mg/mL) single-dose vial

Store GAMIFANT in a refrigerator at 2�C to 8�C (36�F to 46�F) in original carton to protect from light. Do not freeze or shake. This product contains no preservative. These highlights do not include all the information needed to use GAMIFANT safely and effectively. See full prescribing information for GAMIFANT.

GAMIFANT� (emapalumab-lzsg) injection, for intravenous use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE

GAMIFANT is an interferon gamma (IFN?) blocking antibody indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. (1)
DOSAGE AND ADMINISTRATION

For intravenous infusion only:

Recommended starting dosage: 1 mg/kg as an intravenous infusion over 1 hour twice per week. (2.1)
Administer dexamethasone concomitantly with GAMIFANT. (2.3)

DOSAGE FORMS AND STRENGTHS

Injection:

10 mg/2 mL (5 mg/mL) solution in a single-use vial (3)
50 mg/10 mL (5 mg/mL) solution in a single-use vial (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

Infections: Monitor patients for signs and symptoms and treat promptly. Test for latent tuberculosis. Administer prophylactic treatment against Herpes Zoster, Pneumocystis jiroveci and fungal infections. (5.1)
Live Vaccines: Do not administer live or live attenuated vaccines to patients receiving GAMIFANT. (5.2)
Infusion-Related Reactions: Monitor patients for infusion-related reactions. Interrupt infusion for severe infusion reactions and institute appropriate medical management. (5.3)

ADVERSE REACTIONS

The most common adverse reactions (? 20%) were: infections, hypertension, infusion-related reactions, and pyrexia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact 1-866-773-5274 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 11/2018

Rx Item-GAMIFANT emapalumab-lzsg injecti
RX72171-501-01

Rx Item-GAMIFANT emapalumab-lzsg injecti
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