Dosing and administration

Find out how VYVGART can be tailored to your patient's individual needs based on clinical evaluation.

Patient portrayal

It may help to schedule subsequent cycles in advance.

You may find it helpful for your patients to track their gMG symptoms and any adverse reactions during treatment to assist you with determining their next treatment cycle.

The safety of initiating subsequent cycles sooner than 4 weeks from the last infusion of the previous treatment cycle has not been established.

*Clinical trial data from the anti-AChR antibody positive VYVGART-treated population.

†Based on ADAPT+ clinical trial.

‡Based on ADAPT clinical trial.

 AChR=acetylcholine receptor; gMG=generalized myasthenia gravis.

Based on time seen in the clinical trials2,3*

4 WEEKS

Shortest time observed between cycles 1 and 2†

7 WEEKS

Median time observed between cycles 1 and 2‡

Some patients in the ADAPT clinical trial went longer than 7 weeks before their second treatment cycle.

*Clinical trial data from the anti-AChR antibody positive VYVGART-treated population.

†Based on ADAPT+ clinical trial.

‡Based on ADAPT clinical trial.

 gMG=generalized myasthenia gravis.

Calculate your patient’s appropriate dose of VYVGART

In patients weighing 265 lbs (120 kg) or more, the recommended dose is 1200 mg (3 vials) per infusion. Please see the full Dosage and Administration section in the Prescribing Information.1

How is this calculated?

This tool is being provided for the purpose of convenience, and is intended to automate the dosing calculations provided in the VYVGART Prescribing Information (see Section 2.2 Recommended Dose and Dose Schedules and Section 2.3 Preparation and Administration Instructions).

lbs
Dose
--- mg
No. of vials per dose -
Drug volume
--- mL
NaCl 0.9%
--- mL

NaCl=sodium chloride. 

Mean change in MG-ADL from baseline over time in the ADAPT clinical trial (first treatment cycle)1*

Mean change in MG-ADL

*Clinical trial data from the anti-AChR antibody positive VYVGART-treated population.

AChR=acetylcholine receptor; MG-ADL=Myasthenia Gravis Activities of Daily Living; Tx=treatment.

REAL-WORLD DATA

Observational real-world data: distribution of time to the second treatment cycle for patients on VYVGART1,4

In the ADAPT clinical trial, the minimum time between treatment cycles, specified by study protocol, was 4 weeks from the last infusion.

argenx PSP patients (N=1108)

Study Limitations: This real-world data comes from a retrospective, observational study self-reported by patients who were enrolled in argenx's Patient Support Program from December 2021 to January 23, 2023, and was collected by argenx-employed Nurse Case Managers. Results were validated by comparison to actual dispense data reported by specialty pharmacies. The data, which looked at patients who completed 1 treatment cycle and initiated a second cycle, should not be extrapolated to apply to subsequent cycles. This data should not be used as a substitute for conducting a clinical evaluation of each individual patient.

*Most patients completed the first treatment cycle within 21 days (1 dose every week for 4 weeks).
PSP=Patient Support Program.

VYVGART may be administered in various infusion settings

In a healthcare professional's office

At an infusion center

At home, with assistance from a nurse*

At an outpatient hospital clinic

Find a center

*Home infusions may be available for patients with insurance coverage for this service. Please contact the patient's insurance provider directly to confirm.

Not actual size.

VYVGART Hytrulo: a new way to deliver individualized dosing for your adult patients

Discover VYVGART Hytrulo

Patient portrayal

Infection

VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% of efgartigimod alfa-fcab-treated patients vs 5% of placebo-treated patients) and respiratory tract infection (33% of efgartigimod alfa-fcab-treated patients vs 29% of placebo-treated patients). Patients on efgartigimod alfa-fcab vs placebo had below normal levels for white blood cell counts (12% vs 5%, respectively), lymphocyte counts (28% vs 19%, respectively), and neutrophil counts (13% vs 6%, respectively). The majority of infections and hematologic abnormalities were mild to moderate in severity. Delay the administration of VYVGART or VYVGART HYTRULO in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding treatment with VYVGART or VYVGART HYTRULO until the infection has resolved.

Immunization

Immunization with vaccines during treatment with VYVGART or VYVGART HYTRULO has not been studied; the safety with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because VYVGART and VYVGART HYTRULO cause a reduction in immunoglobulin G (IgG) levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with VYVGART or VYVGART HYTRULO. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART or VYVGART HYTRULO.

Hypersensitivity Reactions

Hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in patients treated with VYVGART or VYVGART HYTRULO. Urticaria was also observed in patients treated with VYVGART HYTRULO. In clinical trials, hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration, and did not lead to treatment discontinuation. Monitor patients during and for one hour after VYVGART administration, or for at least 30 minutes after VYVGART HYTRULO administration, for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs during VYVGART or VYVGART HYTRULO administration, discontinue use and institute appropriate supportive measures if needed.

ADVERSE REACTIONS

In Study 1, the most common (≥10%) adverse reactions in efgartigimod alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. In Study 2, the most common (≥10%) adverse reactions in VYVGART HYTRULO-treated patients were injection site reactions and headache. Injection site reactions occurred in 38% of VYVGART HYTRULO-treated patients, including injection site rash, erythema, pruritus, bruising, pain, and urticaria. In Study 2 and its open-label extension, all injection site reactions were mild to moderate in severity and did not lead to treatment discontinuation. The majority occurred within 24 hours after administration and resolved spontaneously. Most injection site reactions occurred during the first treatment cycle, and the incidence decreased with each subsequent cycle.

USE IN SPECIFIC POPULATIONS

Pregnancy

As VYVGART and VYVGART HYTRULO are expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated. Risks and benefits should be considered prior to administering live or live attenuated vaccines to infants exposed to VYVGART or VYVGART HYTRULO in utero.

Lactation

There is no information regarding the presence of efgartigimod alfa-fcab from administration of VYVGART, or efgartigimod alfa or hyaluronidase from administration of VYVGART HYTRULO, in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYVGART or VYVGART HYTRULO, and any potential adverse effects on the breastfed infant from VYVGART or VYVGART HYTRULO or from the underlying maternal condition.

INDICATION

VYVGART® (efgartigimod alfa-fcab) for intravenous infusion and VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection are each indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO.

You may report side effects to the US Food and Drug Administration by visiting http://www.fda.gov/medwatch or calling 1-800-FDA-1088. You may also report side effects to argenx US, Inc, at 1-833-argx411 (1-833-274-9411).

Infection

VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% of efgartigimod alfa-fcab-treated patients vs 5% of placebo-treated patients) and respiratory tract infection (33% of efgartigimod alfa-fcab-treated patients vs 29% of placebo-treated patients). Patients on efgartigimod alfa-fcab vs placebo had below normal levels for white blood cell counts (12% vs 5%, respectively), lymphocyte counts (28% vs 19%, respectively), and neutrophil counts (13% vs 6%, respectively). The majority of infections and hematologic abnormalities were mild to moderate in severity. Delay the administration of VYVGART or VYVGART HYTRULO in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding treatment with VYVGART or VYVGART HYTRULO until the infection has resolved.

Immunization

Immunization with vaccines during treatment with VYVGART or VYVGART HYTRULO has not been studied; the safety with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because VYVGART and VYVGART HYTRULO cause a reduction in immunoglobulin G (IgG) levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with VYVGART or VYVGART HYTRULO. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART or VYVGART HYTRULO.

Hypersensitivity Reactions

Hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in patients treated with VYVGART or VYVGART HYTRULO. Urticaria was also observed in patients treated with VYVGART HYTRULO. In clinical trials, hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration, and did not lead to treatment discontinuation. Monitor patients during and for one hour after VYVGART administration, or for at least 30 minutes after VYVGART HYTRULO administration, for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs during VYVGART or VYVGART HYTRULO administration, discontinue use and institute appropriate supportive measures if needed.

ADVERSE REACTIONS

In Study 1, the most common (≥10%) adverse reactions in efgartigimod alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. In Study 2, the most common (≥10%) adverse reactions in VYVGART HYTRULO-treated patients were injection site reactions and headache. Injection site reactions occurred in 38% of VYVGART HYTRULO-treated patients, including injection site rash, erythema, pruritus, bruising, pain, and urticaria. In Study 2 and its open-label extension, all injection site reactions were mild to moderate in severity and did not lead to treatment discontinuation. The majority occurred within 24 hours after administration and resolved spontaneously. Most injection site reactions occurred during the first treatment cycle, and the incidence decreased with each subsequent cycle.

USE IN SPECIFIC POPULATIONS

Pregnancy

As VYVGART and VYVGART HYTRULO are expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated. Risks and benefits should be considered prior to administering live or live attenuated vaccines to infants exposed to VYVGART or VYVGART HYTRULO in utero.

Lactation

There is no information regarding the presence of efgartigimod alfa-fcab from administration of VYVGART, or efgartigimod alfa or hyaluronidase from administration of VYVGART HYTRULO, in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYVGART or VYVGART HYTRULO, and any potential adverse effects on the breastfed infant from VYVGART or VYVGART HYTRULO or from the underlying maternal condition.

INDICATION

VYVGART® (efgartigimod alfa-fcab) for intravenous infusion and VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection are each indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO.

You may report side effects to the US Food and Drug Administration by visiting http://www.fda.gov/medwatch or calling 1-800-FDA-1088. You may also report side effects to argenx US, Inc, at 1-833-argx411 (1-833-274-9411).

References: 1. VYVGART. Prescribing information. argenx US Inc; 2022. 2. Pasnoor M et al. Presented at: American Academy of Neurology (AAN) Annual Meeting; April 22-27, 2023. Boston, MA. 3. Howard JF Jr et al. Lancet Neurol. 2021;20(7):526-536. doi:10.1016/S1474-4422(21)00159-9 4. Qi C et al. Poster presented at: 45th Annual Carrell-Krusel Neuromuscular Symposium; February 23-24, 2023. Dallas, TX.