Efgartigimod alfa
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From MedlinePlus, U.S. National Library of Medicine
Neonatal Fc Receptor Blocker
Dosing in kidney impairment
Renal Impairment No dose adjustment of VYVGART is needed for patients with mild renal impairment. There are insufficient data to evaluate the impact of moderate renal impairment (eGFR 30-59 mL/min/1.73 m 2 ) and severe renal impairment (eGFR <30 mL/min/1.73 m 2 ) on pharmacokinetic parameters of efgartigimod alfa-fcab [see Clinical Pharmacology ].
Preparation and administration
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Recommended Dose and Dose Schedules Dilute VYVGART prior to administration. Administer via intravenous infusion only [see Dosage and Administration ] . The recommended dosage of VYVGART is 10 mg/kg administered as an intravenous infusion over one hour once weekly for 4 weeks. In patients weighing 120 kg or more, the recommended dose of VYVGART is 1,200 mg (3 vials) per infusion.
Administer subsequent treatment cycles based on clinical evaluation. If a scheduled infusion is missed, VYVGART may be administered up to 3 days after the scheduled time point. Thereafter, resume the original dosing schedule until the treatment cycle is completed.
Preparation and Administration Instructions Prior to administration, dilute VYVGART single-dose vials in 0.9% Sodium Chloride Injection to make a total volume to be administered of 125 mL (see Preparation ) . Check that the VYVGART solution is clear to slightly opalescent and colorless to slightly yellow. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not use if opaque particles, discoloration, or other foreign particles are present. Use aseptic technique when preparing the VYVGART diluted solution for intravenous infusion. Each vial is for single-dose only. Discard any unused portion. Preparation Calculate the dose (mg), total drug volume (mL) of VYVGART solution required, and the number of vials needed based on the recommended dose according to the patient's body weight [see Dosage and Administration ] .
Each vial contains a total of 400 mg of VYVGART at a concentration of 20 mg per mL. Gently withdraw the calculated dose of VYVGART from the vial(s) with a sterile syringe and needle. Discard any unused portion of the vials. Dilute the withdrawn VYVGART with 0.9% Sodium Chloride Injection to make a total volume of 125 mL for intravenous infusion.
Gently invert the infusion bag containing the diluted VYVGART without shaking to ensure thorough mixing of the product and the diluent. The diluted solution can be administered using polyethylene (PE), polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), or ethylene/polypropylene copolymer bags (polyolefins bags), and with PE, PVC, EVA, or polyurethane/polypropylene infusion lines.
Storage Conditions of the Diluted Solution VYVGART does not contain preservatives. Administer immediately after dilution and complete the infusion within 4 hours of dilution. If immediate use is not possible, the diluted solution may be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 8 hours. Do not freeze. Protect from light.
Allow the diluted drug to reach room temperature before administration. Complete the infusion within 4 hours of removal from the refrigerator. Do not heat the diluted drug in any manner other than via ambient air. Administration VYVGART should be administered via intravenous infusion by a healthcare professional. Visually inspect VYVGART diluted solution for particles or discoloration prior to administration.
Do not use if it is discolored, or if opaque or foreign particles are seen. Infuse the total 125 mL of diluted solution intravenously over one hour via a 0.2 micron in-line filter. After administration of VYVGART, flush the entire line with 0.9% Sodium Chloride Injection. Monitor patients during administration and for 1 hour thereafter for clinical signs and symptoms of hypersensitivity reactions.
If a hypersensitivity reaction occurs during administration, discontinue administration of VYVGART and institute appropriate supportive measures [see Warnings and Precautions ]. Do not inject other medications into infusion side ports or mix with VYVGART.
Drug interactions
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Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing VYVGART and using alternative therapies. ( 7 )
7.1 Effect of VYVGART on Other Drugs Concomitant use of VYVGART with medications that bind to the human neonatal Fc receptor (FcRn) (e.g., immunoglobulin products, monoclonal antibodies, or antibody derivates containing the human Fc domain of the IgG subclass) may lower systemic exposures and reduce effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing VYVGART and using alternative therapies.
Contraindications
4 CONTRAINDICATIONS VYVGART is contraindicated in patients with serious hypersensitivity to efgartigimod alfa products or to any of the excipients of VYVGART . Reactions have included anaphylaxis and hypotension leading to syncope [see Warnings and Precautions (5.2) ] . VYVGART is contraindicated in patients with serious hypersensitivity to efgartigimod alfa products or to any of the excipients of VYVGART. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYVGART during pregnancy. Healthcare providers and patients may call 1-855-272-6524 or go to https://www.Vyvgartpregnancy.com to enroll in or to obtain information about the registry. Risk Summary There are no available data on the use of VYVGART during pregnancy. There is no evidence of adverse developmental outcomes following the administration of VYVGART at up to 100 mg/kg/day in rats and rabbits (see Data ). The background rate of major birth defects and miscarriage in the indicated population is unknown. In the U.S.
general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Therefore, efgartigimod alfa-fcab may be transmitted from the mother to the developing fetus. As VYVGART is expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated.
Risk and benefits should be considered prior to administering live vaccines to infants exposed to VYVGART in utero [see Warnings and Precautions (5.1) ]. Data Animal Data Intravenous administration of efgartigimod alfa-fcab (0, 30, or 100 mg/kg/day) to pregnant rats and rabbits throughout organogenesis resulted in no adverse effects on embryofetal development in either species. The doses tested are 3 and 10 times the recommended human dose (RHD) of 10 mg/kg, on a body weight (mg/kg) basis. Intravenous administration of efgartigimod alfa-fcab (0, 30, or 100 mg/kg/day) to rats throughout gestation and lactation resulted in no adverse effects on pre- or postnatal development.
The doses tested are 3 and 10 times the recommended human dose (RHD) of 10 mg/kg, on a body weight (mg/kg) basis.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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