Emapalumab
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From MedlinePlus, U.S. National Library of Medicine
Interferon gamma Blocker
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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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 [see Dosage and Administration] .
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 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, typically 20°C to 25°C (68°F to 77°F), prior to administration. Do not freeze. Do not shake.
Drug interactions
Check emapalumab against a medication listLabel text (2 paragraphs)
7 DRUG INTERACTIONS
7.1 Effect of GAMIFANT on Cytochrome P450 Substrates The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (such as IFNγ) during chronic inflammation. By neutralizing IFNγ, use of GAMIFANT may normalize CYP450 activities which may reduce the efficacy of drugs that are CYP450 substrates due to increased metabolism. Upon initiation or discontinuation of concomitant GAMIFANT, monitor for reduced efficacy and adjust dosage of CYP450 substrate drugs as appropriate.
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on GAMIFANT use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In an animal reproduction study, a murine surrogate anti-mouse IFNγ antibody administered to pregnant mice throughout gestation crossed the placental barrier, and no fetal harm was observed (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In a mouse embryo-fetal development study, a murine surrogate anti-mouse IFNγ antibody was administered every 3-4 days throughout organogenesis and late gestation at doses of 0, 30, 75 or 150 mg/kg/occasion. The surrogate antibody was detected in the plasma of all treated pregnant mice and their corresponding fetuses. No maternal toxicity occurred and there was no evidence of teratogenicity or effects on embryo-fetal survival or growth.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.