VYVGART logo
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.

Study design

Learn more about how the ADAPT, ADAPT-SERON, and ADAPT-SC pivotal trials were designed to include a range of patients.

The ADAPT Phase 3 clinical trial1,2

A 26-week, multicenter, randomized, double-blind, placebo-controlled trial that established efficacy in patients with anti–AChR-Ab positive gMG1

PRIMARY ENDPOINT
The percentage of anti–AChR-Ab positive patients who were MG-ADL responders, defined as a ≥2-point reduction in the 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

The majority of patients (n=65 for VYVGART; n=64 for placebo) were positive for AChR antibodies.1†

*All patients received an initial cycle, with subsequent cycles administered based on individual clinical evaluation when their MG-ADL total score was at least 5 (with >50% MG-ADL nonocular) and if the patient was an MG-ADL responder, when they no longer had a clinically meaningful decrease (defined as having a ≥2-point improvement in MG-ADL total score) compared with baseline. The minimum time to initiate a subsequent cycle, specified by study protocol, was 28 days from the last administration of the previous treatment cycle. A maximum of 3 cycles were possible in the 26-week study.1,2

†All patients received stable doses of their current gMG treatment.1,2
AChR=acetylcholine receptor; AChR-Ab=acetylcholine receptor antibody; gMG=generalized myasthenia gravis; IV=intravenous; MG-ADL=Myasthenia Gravis Activities of Daily Living; Tx=treatment.

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BASELINE PATIENT DEMOGRAPHICS

The pivotal trial population represented a range of adult patients with gMG1-4

167

patients
(overall)1,2

Mean age: 46

Female: 75%

Anti-AChR-Ab
positive: n=65/84

9

mean baseline
(MG-ADL TOTAL SCORE; BOTH ARMS)3*

MG-ADL 5-7: 24%

MG-ADL 8-9: 37%

MG-ADL ≥10: 39%

(0=normal; 24=most severe)

16

mean baseline
(QMG TOTAL SCORE; BOTH ARMS)3

Range: 4-28 (overall)

(0=normal; 39=most severe)

MGFA class at screening2

Class II (Mild): 40%

Class III (Moderate): 56%

Class IV (Severe): 4%

*MG-ADL total score of ≥5 required at screening with >50% of the total score attributed to nonocular symptoms.2
AChR-Ab=acetylcholine receptor antibody; gMG=generalized myasthenia gravis; IV=intravenous; MG-ADL=Myasthenia Gravis Activities of Daily Living; MGFA=Myasthenia Gravis Foundation of America; QMG=Quantitative Myasthenia Gravis.

167

patients
(overall)1,2

Mean age: 48

Female: 66%

Anti–AChR-Ab
positive: n=64/83

9

mean baseline
(MG-ADL TOTAL SCORE; both arms)3*

MG-ADL 5-7: 27%*

MG-ADL 8-9: 41%*

MG-ADL ≥10: 33%*

(0=normal; 24=most severe)

16

mean baseline
(QMG TOTAL SCORE; BOTH ARMS)3

Range: 4-28 (overall)

(0=normal; 39=most severe)

MGFA class at screening2

Class II (Mild): 37%

Class III (Moderate): 59%

Class IV (Severe): 4%

*MG-ADL total score of ≥5 required at screening with >50% of the total score attributed to nonocular symptoms.2
AChR-Ab=acetylcholine receptor antibody; gMG=generalized myasthenia gravis; MG-ADL=Myasthenia Gravis Activities of Daily Living; MGFA=Myasthenia Gravis Foundation of America; QMG=Quantitative Myasthenia Gravis.

Patients should be advised to complete age-appropriate vaccinations according to immunization guidelines prior to initiation of a new treatment cycle with VYVGART for IV infusion. Vaccination with live vaccines is not recommended during treatment with VYVGART for IV infusion. No specific vaccinations were required in the ADAPT clinical trial inclusion criteria.1,5

gMG treatments at study entry (in each arm): NSISTs (~60%), steroids (>70%), acetylcholinesterase inhibitors (>80%).1

The 5 most prevalent comorbidities identified at baseline (overall population)* were hypertension (28%), depression (13%), diabetes mellitus (10%), osteoporosis (9%), and gastroesophageal reflux disease (9%).4

Patients who had active hepatitis B, were seropositive for hepatitis C, were seropositive for HIV with low CD4 count, had severe infections, or had evidence of any significant serious malignant disease were not eligible to participate in the ADAPT trial.2

*Conditions shown represent the 5 most prevalent comorbidities reported by investigator at baseline in the ADAPT clinical trial (N=167).4
gMG=generalized myasthenia gravis; HIV=human immunodeficiency virus; IV=intravenous; NSIST=nonsteroidal immunosuppressive therapy.

The ADAPT-SERON Phase 3 clinical trial1,6

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



Part A was an 8-week, randomized, double-blind, placebo-controlled period establishing the efficacy of VYVGART for IV infusion in adults with anti–AChR-Ab negative gMG. Part B is an ongoing, up-to-2–year, open-label period being conducted to observe longer-term data.1,6

PRIMARY ENDPOINT
 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
compared to placebo.6

Triple seronegative=anti-AChR, anti-MuSK, and anti-LRP4 antibodies negative.1,5
AChR-Ab=acetylcholine receptor antibody; gMG=generalized myasthenia gravis; LRP4-Ab=low-density lipoprotein receptor-related protein 4 antibody; MG ADL=Myasthenia Gravis Activities of Daily Living; MuSK-Ab=muscle-specific tyrosine kinase antibody; Tx=treatment.

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BASELINE PATIENT DEMOGRAPHICS

ADAPT-SERON represented a range of adult patients with anti–AChR-Ab negative gMG1,6

119

patients with
anti–AChR-Ab
negative gMG6

Mean age: 51

Female: 76%

VYVGART

10

mean baseline
MG-ADL
(TOTAL SCORE)6

VYVGART

14

mean baseline
(QMG TOTAL SCORE)7

MGFA class
at screening6

Class II (Mild): 29.3%

Class III (Moderate): 65.5%

Class IV (Severe): 5.2%

Additional characteristics

AChR-Ab=acetylcholine receptor antibody; gMG=generalized myasthenia gravis; MG-ADL=Myastenia Gravis Activities of Daily Living; MGFA=Myasthenia Gravis Foundation of America; QMG=Quantitative Myasthenia Gravis.

119

patients with
anti–AChR-Ab
negative gMG

Mean age: 52

Female: 75%

PLACEBO

9

mean baseline MG-ADL
(TOTAL SCORE)

PLACEBO

15

mean baseline
(QMG TOTAL SCORE)

MGFA class at screening2

Class II (Mild): 37.7%

Class III (Moderate): 57.4%

Class IV (Severe): 4.9%

Additional characteristics

AChR-Ab-acetylcholine receptor antibody; gMG=generalized myasthenia gravis; MG-ADL=Myastenia Gravis Activities of Daily Living; MGFA=Myasthenia Gravis Foundation of America; QMG=Quantitative Myasthenia Gravis.

The ADAPT-SC Phase 3 clinical trial5,7

A 10-week, multicenter, randomized, open-label, parallel-group trial7

PHARMACODYNAMIC (PD) ENDPOINT
The pharmacological effect of VYVGART Hytrulo administered subcutaneously was compared with VYVGART administered intravenously
in adult patients with gMG.5

  • Efficacy of VYVGART Hytrulo was based on this pharmacodynamic bridging study, which assessed the decrease in AChR-autoantibody levels5
  • The majority of patients (n=91) were positive for AChR antibodies7
  • In addition to pharmacodynamics, safety of VYVGART Hytrulo was also assessed5
  • Eligible patients entered the open-label extension ADAPT-SC+ trial7

*Patients were evaluated weekly from weeks 1-8, and then at week 10.7

†All patients received stable doses of their current gMG treatment.7
AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; Tx=treatment.

Back to efficacy
BASELINE PATIENT DEMOGRAPHICS

ADAPT-SC represented a range of adult patients with gMG7,8

110

patients
(overall)7

Mean age: 51

Female: 56%

Anti–AChR-Ab
positive: n=45/55

9

mean baseline
(MG-ADL TOTAL SCORE)7

MG-ADL 5-7*: 36%7†

MG-ADL 8-9*: 29%7†

MG-ADL ≥10*: 35%7†

(0=normal; 24=most severe)

15

mean baseline
(QMG TOTAL SCORE)7

QMG

(0=normal; 39=most severe)

MGFA class at screening7

Class II (Mild): 53%

Class III (Moderate): 44%

Class IV (Severe): 4%

110

patients
(overall)7

Mean age: 56

Female: 62%

Anti-AChR-ab positive: n=46/55

9

mean baseline
(MG-ADL TOTAL SCORE)7

MG-ADL 5-7*: 44%†

MG-ADL 8-9*: 22%†

MG-ADL ≥10*: 35%†

(0=normal; 24=most severe)

16

mean baseline
(QMG TOTAL SCORE)7

QMG

(0=normal; 39=most severe)

MGFA class at screening7

Class II (Mild): 40%

Class III (Moderate): 55%

Class IV (Severe): 5%

*MG-ADL total score of ≥5 required at screening with >50% of the total score attributed to nonocular symptoms.7

†Sum of the percentages is over 100% due to rounding.
AChR-Ab=acetylcholine receptor antibody; gMG=generalized myasthenia gravis; MG-ADL=Myasthenia Gravis Activities of Daily Living; MGFA=Myasthenia Gravis Foundation of America; QMG=Quantitative Myasthenia Gravis.

gMG treatments at study entry (in each arm) were acetylcholinesterase inhibitors (>85%), steroids (≥60%), and NSISTs (>40%).7

gMG=generalized myasthenia gravis; NSIST=nonsteroidal immunosuppressive therapy.

Find out more about VYVGART Hytrulo and VYVGART

VYVGART Hytrulo and VYVGART have 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. 3. Data on file. REF-00690. argenx US Inc. November 2021. 4. Data on file. REF-00692. argenx US Inc. October 2025. 5. VYVGART Hytrulo. Prescribing information. argenx US Inc; 2026. 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. Howard JF Jr et al. Neurotherapeutics. 2024;21(5):1-12. doi:10.1016/j.neurot.2024.e00378 
8. Data on file. REF-01893. argenx US Inc. October 2025.