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Gamifant Generic Name & Formulations
Legal Class
Rx
General Description
Emapalumab-lzsg 10mg/2mL, 50mg/10mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Interferon gamma blocking antibody.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Gamifant Indications
Indications
Primary hemophagocytic lymphohistiocytosis (HLH) in adults and children (newborn and older) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.
Gamifant Dosage and Administration
Adults and Children
Give prophylaxis for herpes zoster, Pneumocystis jirovecii, and fungal infections prior to infusion. Also, begin dexamethasone ≥5–10mg/m2 daily the day before starting Gamifant; dose can be tapered as appropriate. Give by IV infusion over 1hr. Initially 1mg/kg twice weekly (every 3–4 days) until HSCT performed or unacceptable toxicity. Subsequent doses may be increased based on response. Dose modification: see full labeling.
Gamifant Contraindications
Not Applicable
Gamifant Boxed Warnings
Not Applicable
Gamifant Warnings/Precautions
Warnings/Precautions
Monitor closely for serious infections (eg, sepsis, pneumonia, bacteremia); and those caused by specific pathogens favored by IFN-gamma neutralization (including mycobacteria, herpes zoster, histoplasma capsulatum). Evaluate for TB risk factors and test for latent TB prior to treatment start. Give TB prophylaxis if patient at risk, has (+) PPD test result or (+) IFN-gamma release assay. Monitor for TB, adenovirus, EBV, and CMV every 2 weeks and as clinically indicated. Monitor for infusion-related reactions. Pregnancy. Nursing mothers.
Gamifant Pharmacokinetics
See Literature
Gamifant Interactions
Interactions
Avoid concomitant live or live attenuated vaccines for at least 4 weeks after the last dose. May reduce efficacy of CYP450 substrates: monitor and adjust dose of these drugs.
Gamifant Adverse Reactions
Adverse Reactions
Infections, hypertension, infusion-related reactions, pyrexia, hypokalemia, constipation, rash, abdominal pain, diarrhea, lymphocytosis, cough, irritability, tachycardia, tachypnea.
Gamifant Clinical Trials
See Literature
Gamifant Note
Not Applicable
Gamifant Patient Counseling
See Literature
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