Gamifant Dosage

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.

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/m 2the 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/m 2. Dexamethasone can be tapered according to the judgment of the treating physician .

Preparation

GAMIFANT vials are for single-use 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.
• Discard any unused portion left in the vial(s).

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.