< 100 mg/dL
From Day 9
onwards
Increase to 10 mg/kg Assessment by a healthcare provider that based oninitial signs of response, a further increase inGAMIFANT 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 numberof 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 todilution. 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% SodiumChloride 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 onthe volume needed.
Use a gamma irradiated latex-free, polyvinyl chloride (PVC)-free syringe. Do not usewith ethylene oxide-sterilized syringes.
Use a non-PVC polyolefin infusion bag.
Administration
Administer GAMIFANT diluted solution intravenously over 1 hour through anintravenous line containing a sterile, non-pyrogenic, low-protein binding 0.2 micron inline
filter.
Do not infuse GAMIFANT concomitantly with other agents and do not add any otherproduct to the infusion bag or syringe.
Do not store any unused portion of the infusion solution for reuse. Any unused product orwaste 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 to46°F) for no more than 4 hours from the time of dilution.
If refrigerated, allow the diluted solution to come to room temperature prior toadministration.
Do not freeze. Do not shake.
3 DOSAGE FORMS AND STRENGTHS
GAMIFANT is a clear to slightly opalescent, colorless to slightly yellow preservative-freesolution 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 pathogensfavored by IFNγ neutralization, including mycobacteria, Herpes Zoster virus, and HistoplasmaCapsulatum.
Do not administer GAMIFANT in patients with infections caused by these pathogens untilappropriate 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, andperforated appendicitis were observed. The reported infections were viral (41%), bacterial(35%), fungal (9%), and the pathogen was not identified in 15% of cases.
eva luate patients for tuberculosis risk factors and test for latent infection (PPD testing, PCR, orIFNγ release assay) prior to initiating GAMIFANT. Administer tuberculosis prophylaxis topatients at risk for tuberculosis or known to h |
