Gamifant Dosage
Generic name: EMAPALUMAB 10mg in 2mL
Dosage form: injection
Drug class: Selective immunosuppressants
Medically reviewed by Drugs.com. Last updated on Jun 30, 2025.
2.1 Recommended Dosage for Primary Hemophagocytic Lymphohistiocytosis
The recommended starting dose of GAMIFANT is 1 mg/kg given as a central or peripheral 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.
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.
Recommended Dosage for Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome
GAMIFANT is administered as a central or peripheral intravenous infusion over 1 hour according to the dosage schedule in Table 1. Doses may be increased based on clinical and laboratory criteria. Discontinue GAMIFANT when a patient no longer requires therapy for the treatment of HLH/MAS.
Table 1. GAMIFANT Dosage in Patients with HLH/MAS
|
Treatment Day |
GAMIFANT Dosage |
|
Day 1 |
6 mg/kg |
|
Days 4 to 16 |
3 mg/kg every 3 days for 5 doses |
|
From Day 19 onward |
3 mg/kg twice per week (i.e., every 3 to 4 days) |
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 Herpes Zoster infection, adenovirus, EBV and CMV as clinically indicated.
Prophylaxis and Concomitant Medication Information
Prophylaxis
Consider prophylaxis for Herpes Zoster, Pneumocystis jirovecii, and for fungal infections prior to GAMIFANT administration.
Concomitant Medications
For primary HLH patients who are not receiving baseline dexamethasone treatment, begin dexamethasone at a daily dose of at least 5 mg/m2 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.
Dose Modification Based on Response for Primary Hemophagocytic Lymphohistiocytosis
The GAMIFANT dose may be titrated up if disease response is unsatisfactory (see Table 2) . After the patient's clinical condition is stabilized, decrease the dose to the previous level to maintain clinical response.
| Treatment Day | GAMIFANT Dose | Criteria for Dose Increase |
| Day 1 | Starting Dose of 1 mg/kg | N/A |
| From Day 4 onwards | 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 7 onwards | Increase to 6 mg/kg | |
| From Day 10 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 |
Dose Modification Based on Response for Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome
Table 3: Dosage Adjustment Criteria
|
Treatment Day |
GAMIFANT Dose |
Dose Adjustments |
|
Day 1 |
Initial dose of 6 mg/kg |
If unsatisfactory improvement in clinical condition, as assessed by a healthcare provider, the dose of GAMIFANT may be increased to:
AND the frequency may be increased to:
After the patient’s clinical condition has improved, consider decreasing the dose to the previous level and assess whether clinical response is maintained. If the clinical condition is not stabilized while receiving the maximum dosage, consider discontinuing GAMIFANT. |
|
Days 4 to 16 |
3 mg/kg every 3 days for 5 doses |
|
|
From Day 19 onwards |
3 mg/kg twice per week (i.e., every 3 to 4 days) |
Instructions for Preparation and Administration
Preparation
GAMIFANT vials are for single dose only.
Do not mix GAMIFANT 5 mg/mL and 25 mg/mL vials together.
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.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 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.
- For GAMIFANT 5 mg/mL vials:
- Dilute to a maximum concentration of 2.5 mg/mL. Do not dilute product to less than 0.25 mg/mL.
- The diluted solution can be placed in either a syringe or an infusion bag, depending on the volume needed.
- When using a syringe, use a gamma irradiated or ethylene oxide sterilized latex-free, polyvinyl chloride (PVC)-free syringe.
- When using an infusion bag, use a non-PVC polyolefin infusion bag.
- For GAMIFANT 25 mg/mL vials:
- Dilute to a maximum concentration of 12.5 mg/mL. Do not dilute product to less than 1.25 mg/mL.
- Use a non-PVC polyolefin infusion bag made from either polyethylene or ethylene/propylene copolymer.
- For GAMIFANT 5 mg/mL vials:
- Discard any unused portion left in the vial(s).
Administration
- Administer GAMIFANT diluted solution intravenously over 1 hour through a central or peripheral 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.
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