Gamifant® (emapalumab-lzsg) is a
twice-weekly infusion1

Gamifant is administered by intravenous infusion over 1 hour twice a week (every 3 to 4 days) until HSCT is performed. Gamifant should be given concomitantly with dexamethasone at a starting daily dose (for the steroid) of at least 5 to 10 mg/m2.

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How to prepare and administer Gamifant

Calculate how much Gamifant your patient needs

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enter Patient Weight2

Enter your patient’s weight, ideally on the same day as the infusion.

weight in kg

Strength

select dose Strength

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GAMIFANT NEEDED

-- mg | -- mL

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ACCESS GAMIFANT1

Gamifant is available in 10 mg/2 mL and 50 mg/10 mL vials. Please note that vials are single-use only. Any remaining drug must be discarded.

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DETERMINE INFUSION VOLUME1

Patient Weight (kg)

Dose Infusion
Concentration
3 5 10 15 20 25 30 40 50 60 70 90
1
mg/kg
0.5
mg/mL
6
mL
10
mL
1
mg/kg
1
mg/mL
10
mL
15
mL
20
mL
25
mL
30
mL
40
mL
50
mL
60
mL
70
mL
90
mL
3
mg/kg
1
mg/mL
9
mL
15
mL
30
mL
45
mL
60
mL
75
mL
90
mL
3
mg/kg
2
mg/mL
60
mL
75
mL
90
mL
105
mL
135
mL
6
mg/kg
2
mg/mL
9
mL
15
mL
30
mL
45
mL
60
mL
75
mL
90
mL
6
mg/kg
2.5
mg/mL
96
mL
120
mL
144
mL
168
mL
216
mL
10
mg/kg
2
mg/mL
15
mL
25
mL
50
mL
75
mL
10
mg/kg
2.5
mg/mL
80
mL
100
mL
120
mL
160
mL
200
mL
240
mL
280
mL
360
mL

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Note: In cases where patient condition requires restriction of total infusion volume, higher concentrations of infusion solution than those recommended can be used as long as the final concentration of infusion solution remains ≤ 2.5 mg/mL. Do not dilute product to less than 0.25 mg/mL.

Select the appropriate bags or syringes2

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Depending on the patient’s weight and dose, the diluted sterile concentrate can be administered in a syringe or 0.9% sodium chloride for injection, USP infusion bag.

Note: Do not use with ethylene oxide-sterilized syringes.1

Infusion solution volume Administer in
≤ 16 mL 20 mL syringe
> 16 mL and ≤ 56 mL 60 mL syringe
≤ 80 mL 100 mL infusion bag
> 80 mL and ≤ 230 mL 250 mL infusion bag
> 230mL One 500 mL infusion bag or two 250 mL bags

Prepare the Gamifant dilution1

Remove Gamifant from the refrigerator and inspect vials for particulate matter and discoloration. Gamifant should be clear to slightly opalescent, and colorless to slightly yellow. Do not use if it is discolored or if 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). Gamifant vials are for single use only.1

Place the diluted solution in a syringe or infusion bag.

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Gently invert the infusion bag or syringe several times to ensure complete and homogenous distribution of Gamifant.2

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DO NOT SHAKE

Once the infusion solution is prepared, it should clearly be labeled for administration to the patient.2

  • Administer Gamifant diluted solution over 1 hour through an intravenous line containing sterile, non-pyrogenic, low protein binding 0.2 μm in-line filter.1
    • The duration of the infusion should be adapted when the volume to be infused is above the usual pediatric infusion recommendations.2
  • Do not infuse Gamifant concomitantly with other agents and do not add any other products to the infusion bag or syringe or infuse immediately through the same intravenous line.1,2
  • The infusion should preferably be performed through a central line, although peripheral infusions have been performed with no safety concern.2
  • 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.1
  • The volume to be infused will be administered through an infusion pump. To ensure the exact dose of Gamifant has been given, enter the volume to be administered into the pump, along with the rate at which it is to be infused. Also take into account the infusion process, whether priming or flushing.2
  • If you do not administer Gamifant immediately, download the Dosing and Administration Guide for storage information. Dosing and Administration Guide

Gamifant offers flexibility of dosing1

Gamifant can be incrementally titrated upward or downward according the clinician's assessment of patient response.

After the patient’s clinical condition is stabilized, decrease the dose to the previous level to maintain clinical response until HSCT.

Dexamethasone can also be tapered according to the judgment of the treating physician.

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Response criteria for dose increase1

Gamifant can be increased after 3 days, based on the clinician’s assessment of unsatisfactory improvement in clinical condition, AND at least one of the following:

Fever Persistence or recurrence
Platelet Count
  • If baseline < 50,000/mm3 and no improvement to > 50,000/mm3
  • If baseline > 50,000/mm3 and < 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
  • 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 or if baseline levels > 100 mg/dL and any decrease to <100 mg/dL
dosing & Administration guide