Emapalumab

Generic Name/API:Emapalumab
Storage:Store the diluted solution of Emapalumab under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 4 hours from the time of dilution. If refrigerated, allow the diluted solution to come to room temperature, typically 20°C to 25°C (68°F to 77°F), prior to administration.
Dosage:For dosage information, please visit the General Information section.
Strength:Injection: 10 mg/2 mL (5 mg/mL) in a single-dose vial, 50 mg/10 mL (5 mg/mL) in a single-dose vial, 100 mg/20 mL (5 mg/mL) in a single-dose vial, 50 mg/2 mL (25 mg/mL) in a single-dose vial, 100 mg/4 mL (25 mg/mL) in a single-dose vial, 250 mg/10 mL (25 mg/mL) in a single-dose vial, 500 mg/20 mL (25 mg/mL) in a single-dose vial
Indication:Emapalumab is indicated for the treatment of: Adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Adult and pediatric patients with HLH/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.

Emapalumab is an anti-interferon-gamma (IFNγ) antibody medication used for the treatment of hemophagocytic lymphohistiocytosis (HLH) and is also approved for certain patients with HLH/macrophage activation syndrome (MAS) associated with Still’s disease.

Strength:

Injection:
10 mg/2 mL (5 mg/mL) in a single-dose vial
50 mg/10 mL (5 mg/mL) in a single-dose vial
100 mg/20 mL (5 mg/mL) in a single-dose vial
50 mg/2 mL (25 mg/mL) in a single-dose vial
100 mg/4 mL (25 mg/mL) in a single-dose vial
250 mg/10 mL (25 mg/mL) in a single-dose vial
500 mg/20 mL (25 mg/mL) in a single-dose vial

Dosage: 

For intravenous infusion only:

  • Primary HLH recommended starting dosage: 1 mg/kg as an intravenous infusion over 1 hour twice per week. 
  • HLH/MAS in Still’s disease recommended dosage schedule: 6 mg/kg, followed by 3 mg/kg every 3 days for 5 doses, then 3 mg/kg twice per week. Given as an intravenous infusion over 1 hour. 
  • For both indications, the dose may be titrated up to a maximum of 10 mg/kg

Adverse Reaction:

In patients with primary HLH, the most common adverse reactions (≥ 20%) were: infections, hypertension, infusion-related reactions, and pyrexia. (6.1) In patients with HLH/MAS in Still’s disease, the most common adverse reactions (≥20%) were: viral infections, including cytomegalovirus infection or reactivation, and rash.

Storage:

Store the diluted solution of Emapalumab under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 4 hours from the time of dilution. If refrigerated, allow the diluted solution to come to room temperature, typically 20°C to 25°C (68°F to 77°F), prior to administration.

  • Infections: Monitor patients for signs and symptoms and treat promptly. Test for latent tuberculosis. Consider administering prophylactic treatment against herpes zoster, Pneumocystis jirovecii and fungal infections. 
  • Live Vaccines: Do not administer live or live attenuated vaccines to patients receiving GAMIFANT.
  • Infusion-Related Reactions: Monitor patients for infusion-related reactions. Interrupt infusion for infusion reactions and institute appropriate medical management

Process to Import Medicine

FAQ

Emapalumab is approved for:

  • Primary (familial) HLH in adults and children (including newborns) with refractory, recurrent, or progressive disease, or intolerance to conventional HLH therapy. 
  • HLH/Macrophage Activation Syndrome (MAS) associated with Still’s disease in adults and pediatric patients with an inadequate response or intolerance to glucocorticoids, or recurrent MAS.

Emapalumab binds to interferon-gamma (IFN-γ) and prevents it from activating immune cells. This reduces macrophage and T-cell activation, decreases inflammatory cytokine production, and helps control the cytokine storm associated with HLH.

It is administered as an intravenous (IV) infusion over approximately 1 hour in a hospital or specialized infusion center.

The most significant risk is serious bacterial, viral, fungal or opportunistic infections due to suppression of IFN-γ-mediated immune responses.

Yes. It is approved for adults and pediatric patients, including newborns, with eligible forms of HLH.

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