Gamifant

— THERAPEUTIC DISORDERS TREATED —
  • Miscellaneous immune disorders

Gamifant Generic Name & Formulations

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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