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SELECT INDICATION: gMG
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-AChR (acetylcholine receptor) antibody positive.
SELECT INDICATION: gMG
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-AChR (acetylcholine receptor) antibody positive.

Efficacy

Explore the data behind VYVGART from the ADAPT pivotal trial, the ADAPT- SERON trial, as well as a pharmacodynamic (PD) endpoint for VYVGART Hytrulo from the ADAPT-SC pivotal trial.

The ADAPT trial established the effectiveness of VYVGART for IV infusion for the treatment of gMG in adults who are anti–AChR-Ab positive.1

AChR-Ab=acetylcholine receptor antibody; gMG=generalized myasthenia gravis; IV=intravenous.

ADAPT
PHASE 3 STUDY/PRIMARY ENDPOINT

Rapid, significant response within the first treatment cycle, sustained for ≥4 weeks1,2

The primary endpoint was the percentage of anti–AChR-Ab positive patients who were MG-ADL responders, defined as a patient who showed ≥2-point reduction in the MG-ADL total score compared with the treatment cycle baseline for at least 4 consecutive weeks during the first treatment cycle (by week 8), with the first reduction occurring no later than 1 week after the last infusion of the cycle.1

See study design

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

≥2

point reduction in MG-ADL total score from baseline for at least 4 consecutive weeks during the first treatment cycle (by week 8), with the first reduction occurring no later than 1 week after the last infusion of the cycle1

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

ADAPT
KEY SECONDARY ENDPOINT

Significantly more patients had reduction in muscle weakness sustained for ≥4 weeks1,2

The key secondary endpoint was the percentage of AChR-Ab positive patients who were QMG responders, defined as a patient with a ≥3-point reduction in the QMG total score compared with the treatment cycle baseline for at least 4 consecutive weeks during the first treatment cycle (by week 8), with the first reduction occurring no later than 1 week after the last infusion of the cycle.1

AChR-Ab=acetylcholine receptor antibody; IV=intravenous; QMG=Quantitative Myasthenia Gravis; Tx=treatment.

≥3

POINT REDUCTION IN QMG TOTAL SCORE from baseline for at least 4 consecutive weeks during the first treatment cycle (by week 8), with the first reduction occurring no later than 1 week after the last infusion of the cycle1

AChR=acetylcholine receptor; QMG=Quantitative Myasthenia Gravis; Tx=treatment.

ADAPT
PHASE 3 STUDY/POST HOC ANALYSIS

MG-ADL response data when adding VYVGART for IV infusion or placebo 
to current treatment1,3*†

Limitations: This post hoc analysis was not controlled for multiplicity and not powered; therefore, data should be interpreted with caution and conclusions cannot be drawn. The analysis was based on limited sample size and follow-up per patient duration. Patients might have been taking different treatments for gMG simultaneously; therefore, some patients might have been counted multiple times across subgroups.

*An MG-ADL responder was defined as a patient who showed a ≥2-point reduction in the MG-ADL total score compared to the treatment cycle baseline for at least 4 consecutive weeks during the first treatment cycle (by week 8), with the first reduction occurring no later than 1 week after the last infusion of the cycle.3

†Clinical trial data for anti–AChR-Ab positive patients. Patients were treated with VYVGART + current treatment or placebo + current treatment. Patients were required to be on a stable dose of at least 1 treatment for gMG (ie, AChEIs, corticosteroids, or NSISTs) before screening and throughout the trial.1,3
AChEI=acetylcholinesterase inhibitor; AChR-Ab=acetylcholine receptor antibody; gMG=generalized myasthenia gravis; MG-ADL=Myasthenia Gravis Activities of Daily Living; NSIST=nonsteroidal immunosuppressive therapy; Tx=treatment.

ADAPT
EXPLORATORY ENDPOINT

Data for MG-ADL total scores of 0 or 1 (MSE)2,4,5*

Observed during at least one visit in the first treatment cycle2:

MSE is characterized by an MG-ADL total score of 0 or 1 out of a maximum of 24. Patients were evaluated at any visit during the first treatment cycle.2,4,5†

Limitations: This was a prespecified descriptive exploratory analysis not controlled for multiplicity and not powered; therefore, data should be interpreted with caution and conclusions cannot be drawn.

*Clinical trial data for anti–AChR-Ab positive patients. Patients were treated with VYVGART for IV infusion + current treatment or placebo + current treatment.2

†MSE evaluation occurred at any visit from week 1 through week 26.2
AChR-Ab=acetylcholine receptor antibody; IV=intravenous; MG-ADL=Myasthenia Gravis Activities of Daily Living; MSE=Minimal Symptom Expression; Tx=treatment.

What is MSE

NEW

ADAPT-SERON was designed to exclusively study adult patients with anti–AChR-Ab negative gMG (anti–AChR-Ab positive, anti–LRP4-Ab positive, and triple seronegative)6

Triple seronegative=anti-AChR, anti-MuSK, and anti-LRP4 antibodies negative.1,7

AChR-Ab=acetylcholine receptor antibody; gMG=generalized myasthenia gravis; LRP4-Ab=low-density lipoprotein receptor-related protein 4 antibody; MuSK-Ab=muscle-specific tyrosine kinase antibody.

ADAPT-SERON
PART A & PRIMARY ENDPOINT

Rapid, significant, and sustained efficacy in overall study population1,6,8

The primary endpoint was the mean change from baseline in MG-ADL total score at week 4 in adults with anti–AChR-Ab negative gMG treated with VYVGART IV infusion versus placebo.1

See study design See the sustained efficacy in Part A below

AChR-Ab=acetylcholine receptor antibody; CI=confidence interval; gMG=generalized myasthenia gravis; LS=least squares; MG-ADL=Myasthenia Gravis Activities of Daily Living.

Sustained Efficacy in Part A

Sustained efficacy in Part A in the overall study population1

Start of observation period no shorter than 7 days from the last administration.1

AChR-Ab=acetylcholine receptor antibody; MG-ADL=Myasthenia Gravis Activities of Daily Living; SE=standard error.

≥2

 

POINT REDUCTION in MG-ADL total score observed from weeks 2-8 in Part A1 

 

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

ADAPT-SERON SECONDARY ENDPOINT:
MG-ADL RESPONSE PART A & PART B

Interim analysis: October 28, 2025

Patients experienced continued improvement in the overall study population6*

In Part B, mean reduction in MG-ADL total score from week 8 through week 22 was observed in the overall population of anti–AChR-Ab negative patients (anti–MuSK-Ab positive, anti–LRP4-Ab positive, and triple seronegative) receiving consecutive cycles of VYVGART for IV infusion.6

Limitations: Part B of ADAPT-SERON is a single-arm, not placebo-controlled, open-label period designed to collect additional long-term data. Results are descriptive and therefore no conclusions or comparisons to Part A should be drawn.6

In Part A, start of observation period no shorter than 7 days from the last ( administration.
*The efficacy of VYVGART for IV infusion for the treatment of adult patients with ( gMG who are antiAChR antibody (AChR-Ab) negative was established (in a 4-( week, randomized, double-blind, placebo-controlled study (ADAPT-SERON, Part A).6
Triple seronegative=anti-AChR, anti-MuSK, and anti-LRP4 antibodies negative.6
AChR=acetylcholine receptor; AChR-Ab=acetylcholine receptor antibody; ( LRP4=low-density lipoprotein receptor-related protein 4; LRP4-Ab=low-( density lipoprotein receptor-related protein 4 antibody; MG-ADL=Myasthenia ( Gravis Activities of Daily Living; MuSK=muscle-specific tyrosine kinase; ( MuSK-Ab=muscle-specific tyrosine kinase antibody; SE=standard error.

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

The ADAPT-SC trial established that VYVGART Hytrulo and VYVGART showed a similar PD effect in the reduction of AChR-Ab levels in adult patients with gMG who are AChR-Ab positive, which established the efficacy of VYVGART Hytrulo.7,9

AChR-Ab=acetylcholine receptor antibody; gMG=generalized myasthenia gravis; PD=pharmacodynamic.

ADAPT-SC
PHASE 3 STUDY/PD ENDPOINT

Comparable pharmacodynamic effect of VYVGART Hytrulo SC7,9*†

Maximum mean reductions in AChR-Ab levels were
observed at week 4 (day 29) among AChR-Ab positive
patients receiving VYVGART Hytrulo SC + current Tx and
VYVGART IV + current Tx.7‡

See study design

*The 90% confidence interval for the geometric mean ratios of AChR-Ab reduction at day 29 and AUEC0-4w (area under the effect-time curve from time 0 to 4 weeks post dose) were within the range of 80% to 125%, indicating no clinically significant difference between the 2 formulations.7

†Clinical trial data for AChR-Ab positive patients.7

‡Seven days after the fourth IV or SC administration.7

AChR-Ab=acetylcholine receptor antibody; IgG=immunoglobulin G; IV=intravenous; SC=subcutaneous; Tx=treatment.

*The 90% confidence interval for the geometric mean ratios of AChR-Ab reduction at day 29 and AUEC0-4w (area under the effect-time curve from time 0 to 4 weeks post dose) were within the range of 80% to 125%, indicating no clinically significant difference between the two formulations.

†Clinical trial data for anti-AChR antibody positive patients.

‡Seven days after the fourth IV or SC administration.

 AChR=acetylcholine receptor; AChR-Ab=acetylcholine receptor antibody; IgG=immunoglobulin G; IV=intravenous; SC=subcutaneous; Tx=treatment.

Find out more about VYVGART Hytrulo and VYVGART

VYVGART Hytrulo and VYVGART
demonstrated safety profiles 

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IMPORTANT SAFETY INFORMATION AND INDICATION

CONTRAINDICATIONS

VYVGART HYTRULO is contraindicated in patients with serious hypersensitivity to efgartigimod alfa products, to hyaluronidase, or to any of the excipients of VYVGART HYTRULO. Reactions have included anaphylaxis and hypotension leading to syncope. 

WARNINGS AND PRECAUTIONS
 Infections

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 infections (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 VYVGART HYTRULO administration 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 VYVGART HYTRULO 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 HYTRULO. The safety of immunization with live vaccines and the immune response to vaccination during treatment with VYVGART HYTRULO are unknown. Because VYVGART HYTRULO causes a reduction in immunoglobulin G (IgG) levels, vaccination with live vaccines is not recommended during treatment with VYVGART HYTRULO.

Hypersensitivity Reactions

In clinical trials, hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in patients treated with VYVGART HYTRULO or intravenous efgartigimod alfa-fcab. Urticaria was also observed in patients treated with VYVGART HYTRULO. Hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration. Anaphylaxis and hypotension leading to syncope have been reported in postmarketing experience with intravenous efgartigimod alfa-fcab. 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 for clinical signs and symptoms of hypersensitivity reactions for at least 30 minutes after administration. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention.

Infusion/Injection-Related Reactions 

Infusion-related reactions have been reported with intravenous efgartigimod alfa-fcab 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/injection-related reaction occurs, initiate appropriate therapy. Consider the risks and benefits of readministering VYVGART HYTRULO following a severe infusion/injection-related reaction. If a mild to moderate infusion/injection-related reaction occurs, patients may be rechallenged with close clinical observation, slower infusion/injection rates, and pre-medications.

ADVERSE REACTIONS

Patients with gMG: 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 overall safety profile was consistent with the known safety profile of efgartigimod alfa-fcab in patients with gMG, except for nausea, which occurred in 7% of anti-acetylcholine receptor (AChR) antibody negative patients who received efgartigimod alfa-fcab compared to 5% of patients who received placebo. In Study 3, 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 3 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.

Patients with CIDP: In Study 4 stage B, the overall safety profile observed in patients with CIDP treated with VYVGART HYTRULO was consistent with the known safety profile of VYVGART HYTRULO and of efgartigimod alfa-fcab administered intravenously. In Study 4, injection site reactions occurred in 15% of patients treated with VYVGART HYTRULO compared to 6% of patients who received placebo. The most common of these injection site reactions were injection site bruising and injection site erythema. All injection site reactions were mild to moderate in severity. Most injection site reactions occurred during the first 3 months of treatment.

USE IN SPECIFIC POPULATIONS
Pregnancy
As VYVGART HYTRULO 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 HYTRULO in utero.

 

Lactation
There is no information regarding the presence of efgartigimod alfa or hyaluronidase, from administration of VYVGART HYTRULO, 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 HYTRULO and any potential adverse effects on the breastfed infant from VYVGART HYTRULO or from the underlying maternal condition.

 

INDICATION
VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) is indicated for the treatment of adult patients with:

  • generalized myasthenia gravis (gMG)
  • chronic inflammatory demyelinating polyneuropathy (CIDP)

 

Please see the full Prescribing Information.

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).

Dosage Forms and Strengths: VYVGART Hytrulo is available as a single-dose subcutaneous injection containing: 200 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per prefilled syringe, or 180 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per vial.

IMPORTANT SAFETY INFORMATION AND INDICATION
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.

WARNINGS AND PRECAUTIONS
Infection

VYVGART may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% for VYVGART vs 5% for placebo) and respiratory tract infections (33% for VYVGART vs 29% for placebo). Patients on VYVGART 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 VYVGART administration 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 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 immunoglobulin G (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 1 hour to 3 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.

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.

ADVERSE REACTIONS

In Study 1, the most common (≥10%) adverse reactions with VYVGART-treated patients were respiratory tract infection, headache, and urinary tract infection. In Study 2, the overall safety profile was consistent with the known safety profile of VYVGART in patients with gMG, except for nausea, which occurred in 7% of anti-acetylcholine receptor (AChR) antibody negative patients who received VYVGART compared to 5% of patients who received placebo.

USE IN SPECIFIC POPULATIONS
Pregnancy

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.

Lactation

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.

INDICATION

VYVGART® (efgartigimod alfa-fcab) is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG).

Please see the full Prescribing Information.

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).

Dosage Form and Strength: VYVGART is available as a single-dose injection for intravenous use containing 400 mg/20 mL of efgartigimod alfa-fcab per vial.

IMPORTANT SAFETY INFORMATION AND INDICATION

CONTRAINDICATIONS

VYVGART HYTRULO is contraindicated in patients with serious hypersensitivity to efgartigimod alfa products, to hyaluronidase, or to any of the excipients of VYVGART HYTRULO. Reactions have included anaphylaxis and hypotension leading to syncope. 

WARNINGS AND PRECAUTIONS
 Infections

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 infections (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 VYVGART HYTRULO administration 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 VYVGART HYTRULO 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 HYTRULO. The safety of immunization with live vaccines and the immune response to vaccination during treatment with VYVGART HYTRULO are unknown. Because VYVGART HYTRULO causes a reduction in immunoglobulin G (IgG) levels, vaccination with live vaccines is not recommended during treatment with VYVGART HYTRULO.

Hypersensitivity Reactions

In clinical trials, hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in patients treated with VYVGART HYTRULO or intravenous efgartigimod alfa-fcab. Urticaria was also observed in patients treated with VYVGART HYTRULO. Hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration. Anaphylaxis and hypotension leading to syncope have been reported in postmarketing experience with intravenous efgartigimod alfa-fcab. 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 for clinical signs and symptoms of hypersensitivity reactions for at least 30 minutes after administration. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention.

Infusion/Injection-Related Reactions 

Infusion-related reactions have been reported with intravenous efgartigimod alfa-fcab 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/injection-related reaction occurs, initiate appropriate therapy. Consider the risks and benefits of readministering VYVGART HYTRULO following a severe infusion/injection-related reaction. If a mild to moderate infusion/injection-related reaction occurs, patients may be rechallenged with close clinical observation, slower infusion/injection rates, and pre-medications.

ADVERSE REACTIONS

Patients with gMG: 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 overall safety profile was consistent with the known safety profile of efgartigimod alfa-fcab in patients with gMG, except for nausea, which occurred in 7% of anti-acetylcholine receptor (AChR) antibody negative patients who received efgartigimod alfa-fcab compared to 5% of patients who received placebo. In Study 3, 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 3 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.

Patients with CIDP: In Study 4 stage B, the overall safety profile observed in patients with CIDP treated with VYVGART HYTRULO was consistent with the known safety profile of VYVGART HYTRULO and of efgartigimod alfa-fcab administered intravenously. In Study 4, injection site reactions occurred in 15% of patients treated with VYVGART HYTRULO compared to 6% of patients who received placebo. The most common of these injection site reactions were injection site bruising and injection site erythema. All injection site reactions were mild to moderate in severity. Most injection site reactions occurred during the first 3 months of treatment.

USE IN SPECIFIC POPULATIONS
Pregnancy
As VYVGART HYTRULO 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 HYTRULO in utero.

 

Lactation
There is no information regarding the presence of efgartigimod alfa or hyaluronidase, from administration of VYVGART HYTRULO, 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 HYTRULO and any potential adverse effects on the breastfed infant from VYVGART HYTRULO or from the underlying maternal condition.

 

INDICATION
VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) is indicated for the treatment of adult patients with:

  • generalized myasthenia gravis (gMG)
  • chronic inflammatory demyelinating polyneuropathy (CIDP)

 

Please see the full Prescribing Information.

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).

Dosage Forms and Strengths: VYVGART Hytrulo is available as a single-dose subcutaneous injection containing: 200 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per prefilled syringe, or 180 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per vial.

IMPORTANT SAFETY INFORMATION AND INDICATION

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.

WARNINGS AND PRECAUTIONS
Infection

VYVGART may increase the risk of infection. The most common infections observed in Study 1 were urinary tract infection (10% for VYVGART vs 5% for placebo) and respiratory tract infections (33% for VYVGART vs 29% for placebo). Patients on VYVGART 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 VYVGART administration 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 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 immunoglobulin G (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 1 hour to 3 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.

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.

ADVERSE REACTIONS

In Study 1, the most common (≥10%) adverse reactions with VYVGART-treated patients were respiratory tract infection, headache, and urinary tract infection. In Study 2, the overall safety profile was consistent with the known safety profile of VYVGART in patients with gMG, except for nausea, which occurred in 7% of anti-acetylcholine receptor (AChR) antibody negative patients who received VYVGART compared to 5% of patients who received placebo.

USE IN SPECIFIC POPULATIONS
Pregnancy

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.

Lactation

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.

INDICATION

VYVGART® (efgartigimod alfa-fcab) is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG).

Please see the full Prescribing Information.

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).

Dosage Form and Strength: VYVGART is available as a single-dose injection for intravenous use containing 400 mg/20 mL of efgartigimod alfa-fcab per vial.

References: 1. VYVGART. Prescribing information. argenx US Inc; 2026. 2. Howard JF Jr et al. Lancet Neurol. 2021;20(7):526-536. doi:10.1016/S1474-4422(21)00159-9 3. Karam C et al. Presented at: Myasthenia Gravis Foundation of America (MGFA) National Conference; April 11-13, 2021. Canada. Virtual. 4. Uzawa A et al. Acta Neurol Belg. 2023;123(3):979-982. doi:10.1007/s13760-022-02162-1 5. ClinicalTrials.gov. An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness (ADAPT). Updated February 8, 2022. Accessed April 13, 2026. https://www.clinicaltrials.gov/study/NCT03669588 6. Howard JF Jr et al. Presented (ADAPT-SERON) at: The American Academy of Neurology (AAN) 2026 Annual Meeting; April 18-22, 2026. Chicago, IL. 7. VYVGART Hytrulo. Prescribing information. argenx US Inc; 2026. 8. Muppidi S et al. Muscle Nerve. 2011;44(5):727-731. doi:10.1002/mus.22140 9. Data on file. REF-01900. argenx US Inc. October 2025. 10. Wolfe GI et al. Neurology. 1999;52(7):1487-1489. doi:10.1212/wnl.52.7.1487 11. Burns TM et al. Neurology. 2010;74(18):1434-1440. doi:10.1212/wnl.0b013e3181dc1b1e 12. Barohn RJ et al. Ann NY Acad Sci. 1998;841:769-772. doi:10.1111/j.1749-6632.1998.tb11015.x