Vyvgart
(efgartigimod alfa-fcab)Dosage & Administration
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Vyvgart Prescribing Information
VYVGART is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
Recommended Vaccination
Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART. Because VYVGART causes transient reduction in IgG levels, vaccination with live vaccines is not recommended during treatment with VYVGART [see Dosage and Administration (2.2) and Warnings and Precautions (5.1)].
Recommended Dose and Dose Schedules
Dilute VYVGART prior to administration. Administer via intravenous infusion only [see Dosage and Administration (2.3)].
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 1200 mg (3 vials) per infusion.
Administer subsequent treatment cycles based on clinical evaluation. The safety of initiating subsequent cycles sooner than 50 days from the start of the previous treatment cycle has not been established.
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, VYVGART single-dose vials require dilution in 0.9% Sodium Chloride Injection, USP, 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 (2.2)]. 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, USP 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, USP.
- 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 (5.2)].
- Other medications should not be injected into infusion side ports or mixed with VYVGART.
Injection: 400 mg/20 mL (20 mg/mL) as a colorless to slightly yellow, clear to slightly opalescent solution, in a single-dose vial.
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.
Lactation
Risk Summary
There is no information regarding the presence of efgartigimod alfa-fcab in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VYVGART and any potential adverse effects on the breastfed infant from VYVGART or from the underlying maternal condition.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies of VYVGART did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger adult patients.
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 m2) and severe renal impairment (eGFR <30 mL/min/1.73 m2) on pharmacokinetic parameters of efgartigimod alfa-fcab [see Clinical Pharmacology (12.3)].
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)].
Infections
VYVGART may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% of VYVGART-treated patients compared to 5% of placebo-treated patients) and respiratory tract infections (33% of VYVGART-treated patients compared to 29% of placebo-treated patients) [see Adverse Reactions (6.1) and Clinical Studies (14)]. A higher frequency of patients who received VYVGART compared to placebo were observed to have below normal levels for white blood cell counts (12% versus 5%, respectively), lymphocyte counts (28% versus 19%, respectively), and neutrophil counts (13% versus 6%, respectively). The majority of infections and hematologic abnormalities were mild to moderate in severity. Delay VYVGART administration in patients with an active infection until the infection is resolved. During treatment with VYVGART, monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding VYVGART until the infection has resolved.
Immunization
Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART. The safety of immunization with live vaccines and the immune response to vaccination during treatment with VYVGART are unknown. Because VYVGART causes a reduction in IgG levels, vaccination with live vaccines is not recommended during treatment with VYVGART.
Hypersensitivity Reactions
In clinical trials, hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in VYVGART-treated patients. Hypersensitivity reactions were mild or moderate, occurred within one hour to three weeks of administration, and did not lead to treatment discontinuation.
Anaphylaxis and hypotension leading to syncope have been reported in postmarketing experience with VYVGART. Anaphylaxis and hypotension occurred during or within an hour of administration and led to infusion discontinuation and in some cases to permanent treatment discontinuation.
Monitor patients during administration and for 1 hour thereafter for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention. VYVGART is contraindicated in patients with a history of serious hypersensitivity to efgartigimod alfa products or to any of the excipients of VYVGART [see Contraindications (4)].
Infusion-Related Reactions
Infusion-related reactions have been reported with VYVGART in postmarketing experience. The most frequent symptoms and signs were hypertension, chills, shivering, and thoracic, abdominal, and back pain. Infusion-related reactions occurred during or within an hour of administration and led to infusion discontinuation. If a severe infusion-related reaction occurs during administration, discontinue VYVGART infusion and initiate appropriate therapy. Consider the risks and benefits of readministering VYVGART following a severe infusion-related reaction. If a mild to moderate infusion-related reaction occurs, patients may be rechallenged with close clinical observation, slower infusion rates, and pre-medications.