GAMIFANT

GAMIFANT- emapalumab injection
NovImmune SA

1 INDICATIONS AND USAGE

GAMIFANT is 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.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

The recommended starting dose of GAMIFANT is 1 mg/kg given as an intravenous infusion over 1 hour twice per week (every three to four days). Doses subsequent to the initial dose may be increased based on clinical and laboratory criteria [see Dosage and Administration (2.4)].

Administer GAMIFANT until hematopoietic stem cell transplantation (HSCT) is performed or unacceptable toxicity. Discontinue GAMIFANT when a patient no longer requires therapy for the treatment of HLH.

2.2 Monitoring to Assess Safety

Before Initiating GAMIFANT Treatment

Conduct testing for latent tuberculosis infections using the purified protein derivative (PPD) or IFNγ release assay and evaluate patients for tuberculosis risk factors prior to initiating GAMIFANT. Administer tuberculosis prophylaxis to patients at risk for tuberculosis, or known to have a positive PPD test result, or positive IFNγ release assay.

During GAMIFANT Treatment

Monitor for tuberculosis, adenovirus, EBV and CMV every 2 weeks and as clinically indicated.

2.3 Pre-Medications and Concomitant Medication Information

Pre-Medications

Administer prophylaxis for Herpes Zoster, Pneumocystis jirovecii , and for fungal infections prior to GAMIFANT administration.

Concomitant Medications

For patients who are not receiving baseline dexamethasone treatment, begin dexamethasone at a daily dose of at least 5 to 10 mg/m2 the day before GAMIFANT treatment begins. For patients who were receiving baseline dexamethasone, they may continue their regular dose provided the dose is at least 5 mg/m2. Dexamethasone can be tapered according to the judgment of the treating physician [see Clinical Studies (14)].

2.4 Dose Modification Based on Response

The GAMIFANT dose may be titrated up if disease response is unsatisfactory (see Table 1) [see Clinical Pharmacology (12.3)]. After the patient’s clinical condition is stabilized, decrease the dose to the previous level to maintain clinical response.

Table 1: Dose Titration Criteria
TreatmentDay GAMIFANT Dose Criteria for Dose Increase
Day 1 Starting Dose of 1 mg/kg N/A
On Day 3 Increase to 3 mg/kg Unsatisfactory improvement in clinical condition, as assessed by a healthcare provider AND at least one of the following:
From Day 6 onwards Increase to 6 mg/kg
  • Fever – persistence or recurrence
  • Platelet count
    • If baseline < 50,000/mm3 and no improvement to >50,000/mm3
    • If baseline > 50,000/mm3 and less than 30% improvement
    • If baseline > 100,000/mm3 and decrease to < 100,000/mm3
  • Neutrophil count
    • If baseline < 500/mm3 and no improvement to > 500/mm3
    • If baseline > 500 -1000/mm3 and decrease to < 500/mm3
    • If baseline 1000-1500/mm3 and decrease to < 1000/ mm3
  • Ferritin (ng/mL)
    • If baseline ≥ 3000 ng/mL and < 20% decrease
    • If baseline < 3000 ng/mL and any increase to > 3000 ng/mL
  • Splenomegaly – any worsening
  • Coagulopathy (both D-Dimer and Fibrinogen must apply)
    • D-Dimer
      • If abnormal at baseline and no improvement
    • Fibrinogen (mg/dL)
      • If baseline levels ≤ 100 mg/dL and no improvement
      • If baseline levels > 100 mg/dL) and any decrease to < 100 mg/dL
From Day 9 onwards Increase to 10 mg/kg Assessment by a healthcare provider that based on initial signs of response, a further increase in GAMIFANT dose can be of benefit

2.5 Instructions for Preparation and Administration

Preparation

GAMIFANT vials are for single-use only.

Prepare the solution for infusion as follows:

  • Calculate the dose (mg/kg), total volume (mL) of GAMIFANT required and the number of GAMIFANT vials needed based on patient actual body weight [see Dosage and Administration (2.1)].
  • Inspect GAMIFANT vials visually for particulate matter and discoloration prior to dilution. GAMIFANT is a clear to slightly opalescent, colorless to slightly yellow liquid. Do not administer if discolored or foreign particulate matter is present.
  • Withdraw the necessary amount of GAMIFANT solution and dilute with 0.9% Sodium Chloride Injection, USP to a maximum concentration of 2.5 mg/mL. Do not dilute product to less than 0.25 mg/mL.
  • Discard any unused portion left in the vial(s).
  • The diluted solution can be placed in either a syringe or an infusion bag, depending on the volume needed.
  • Use a gamma irradiated latex-free, polyvinyl chloride (PVC)-free syringe. Do not use with ethylene oxide-sterilized syringes.
  • Use a non-PVC polyolefin infusion bag.

Administration

  • Administer GAMIFANT diluted solution intravenously over 1 hour through an intravenous line containing a sterile, non-pyrogenic, low-protein binding 0.2 micron in-line filter.
  • Do not infuse GAMIFANT concomitantly with other agents and do not add any other product to the infusion bag or syringe.
  • Do not store any unused portion of the infusion solution for reuse. Any unused product or waste material should be disposed of in accordance with local requirements.

Storage of Diluted Solution

This product does not contain a preservative.

If not administered immediately:

  • Store the diluted solution of GAMIFANT 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 prior to administration.
  • Do not freeze. Do not shake.

3 DOSAGE FORMS AND STRENGTHS

GAMIFANT is a clear to slightly opalescent, colorless to slightly yellow preservative-free solution available as:

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

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Infections

GAMIFANT may increase the risk of fatal and serious infections to include specific pathogens favored by IFNγ neutralization, including mycobacteria, Herpes Zoster virus, and Histoplasma Capsulatum.

Do not administer GAMIFANT in patients with infections caused by these pathogens until appropriate treatment has been initiated.

In 32% of patients receiving GAMIFANT in clinical trials, serious infections such as sepsis, pneumonia, bacteremia, disseminated histoplasmosis, necrotizing fasciitis, viral infections, and perforated appendicitis were observed. The reported infections were viral (41%), bacterial (35%), fungal (9%), and the pathogen was not identified in 15% of cases.

Evaluate patients for tuberculosis risk factors and test for latent infection (PPD testing, PCR, or IFNγ release assay) prior to initiating GAMIFANT. Administer tuberculosis prophylaxis to patients at risk for tuberculosis or known to have a positive purified protein derivative (PPD) test result [see Dosage and Administration (2.2)].

Administer prophylaxis for Herpes Zoster, Pneumocystis jirovecii , and fungal infection to mitigate the risk to patients while receiving GAMIFANT. Employ surveillance testing during treatment with GAMIFANT.

Closely monitor patients receiving GAMIFANT for signs or symptoms of infection, promptly initiate a complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.

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