VYVGART logo
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-AChR (acetylcholine receptor) antibody positive.
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-AChR (acetylcholine receptor) antibody positive.

Explore patient profiles

Find out which of your adult patients with anti-AChR antibody positive gMG may be right for VYVGART Hytrulo or VYVGART.

AChR=acetylcholine receptor; gMG=generalized myasthenia gravis.

Do you see patients like these in your practice?

Patient portrayals

Amber, 33

MG-ADL score: 5

Active professional uncontrolled on an AChE inhibitor and unwilling to consider IV treatment


Meet Amber

Diane, 53

MG-ADL score: 7

Busy office worker struggling with recurrence of symptoms with an NSIST and hesitant to change treatments

Meet Diane

Hector, 68

MG-ADL score: 8

Recently retired and experiencing symptom exacerbations when tapering prednisone and looking for HCP guidance

Meet Hector

Matthew, 37

MG-ADL score: 6

New father experiencing breakthrough symptoms despite periodic IVIG

Meet Matthew

Patient portrayals

AChE=acetylcholinesterase; gMG=generalized myasthenia gravis; HCP=healthcare professional; IV=intravenous; IVIG=intravenous immunoglobulin; MG-ADL=Myasthenia Gravis Activities of Daily Living; NSIST=nonsteroidal immunosuppressive therapy.

Use the MG-ADL scale to help assess the impact of gMG on your patients' daily life

Try the MG-ADL Builder

Amber,

 33 years old

Active professional uncontrolled on an AChE inhibitor and unwilling to consider IV treatment

MG-ADL score

Patient portrayal

BACKGROUND

Amber is a real estate agent in a busy firm who loves to travel and explore her city with friends. She was diagnosed with anti-AChR antibody positive gMG 2 years ago and is privately insured.

SYMPTOMS AND CONCERNS

Amber has been experiencing double vision, muscle weakness, and difficulty rising from a sitting position. These symptoms are causing her to miss showings at work, and she recently had to cancel dinner with a couple of friends. 

She is frustrated with the impact of her symptoms and eager to explore options to help better manage her gMG. She is resistant to restarting prednisone or considering an IV treatment.

AChE=acetylcholinesterase; AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; MG-ADL=Myasthenia Gravis Activities of Daily Living.

Amber is a real estate agent in a busy firm who loves to travel and explore her city with friends. She was diagnosed with anti-AChR antibody positive gMG 2 years ago and is privately insured.

Amber has been experiencing double vision, muscle weakness, and difficulty rising from a sitting position. These symptoms are causing her to miss showings at work, and she recently had to cancel dinner with a couple of friends. 

She is frustrated with the impact of her symptoms and eager to explore options to help better manage her gMG. She is resistant to restarting prednisone or considering an IV treatment.

AChE=acetylcholinesterase; AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; IV=intravenous; MG-ADL=Myasthenia Gravis Activities of Daily Living.

MEDICAL HISTORY
  • MG-ADL SCORE: 5
  • BMI: 24
  • Initially controlled with pyridostigmine and high-dose prednisone; weaned off prednisone without worsening of symptoms
  • Thymectomy
CURRENT TREATMENT
  • Pyridostigmine 90 mg 4 times a day

AChE=acetylcholinesterase; AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; MG-ADL=Myasthenia Gravis Activities of Daily Living.

  • MG-ADL SCORE: 5
  • BMI: 24
  • Initially controlled with pyridostigmine and high-dose prednisone; weaned off prednisone without worsening of symptoms
  • Thymectomy

  • Pyridostigmine 90 mg 4 times a day
See Amber’s MG-ADL Scale

Amber is a real estate agent in a busy firm who loves to travel and explore her city with friends. She was diagnosed with anti-AChR antibody positive gMG 2 years ago and is privately insured.

Amber has been experiencing double vision, muscle weakness, and difficulty rising from a sitting position. These symptoms are causing her to miss showings at work, and she recently had to cancel dinner with a couple of friends. 

She is frustrated with the impact of her symptoms and eager to explore options to help better manage her gMG. She is resistant to restarting prednisone or considering an IV treatment.

AChE=acetylcholinesterase; AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; IV=intravenous; MG-ADL=Myasthenia Gravis Activities of Daily Living.

  • MG-ADL SCORE: 5
  • BMI: 24
  • Initially controlled with pyridostigmine and high-dose prednisone; weaned off prednisone without worsening of symptoms
  • Thymectomy

  • Pyridostigmine 90 mg 4 times a day
See Amber’s MG-ADL Scale

Diane, 53 years old

Busy office worker struggling with recurrence of symptoms with an NSIST and hesitant to change treatments

MG-ADL score

Patient portrayal

BACKGROUND

Diane is a medical biller at a suburban practice. She and her husband are active volunteers and members of their church. She was diagnosed with anti-AChR antibody positive gMG 2 years ago and is privately insured.

SYMPTOMS AND CONCERNS

Diane is experiencing increased weakness in her neck, arms, and legs, which makes it hard to sit in front of a computer or attend services and events. She is also experiencing slurred speech and difficulty swallowing and has started to avoid eating lunch with her coworkers.

Diane is worried about the continued effect of her symptoms and is ready to discuss other options. She is concerned that will mean restarting prednisone.

AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; MG-ADL=Myasthenia Gravis Activities of Daily Living; NSIST=nonsteroidal immunosuppressive therapy.

Diane is a medical biller at a suburban practice. She and her husband are active volunteers and members of their church. She was diagnosed with anti-AChR antibody positive gMG 2 years ago and is privately insured.

Diane is experiencing increased weakness in her neck, arms, and legs, which makes it hard to sit in front of a computer or attend services and events. She is also experiencing slurred speech and difficulty swallowing and has started to avoid eating lunch with her coworkers.

Diane is worried about the continued effect of her symptoms and is ready to discuss additional options. She is concerned that will mean restarting prednisone.

AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; MG-ADL=Myasthenia Gravis Activities of Daily Living; NSIST=nonsteroidal immunosuppressive therapy.

MEDICAL HISTORY
  • MG-ADL SCORE: 7
  • BMI: 27
  • Initially controlled with pyridostigmine and high-dose prednisone, with an attempt to bridge to azathioprine; discontinued azathioprine after 1 year
  • Thymectomy
CURRENT TREATMENT
  • Pyridostigmine 60 mg 4 times a day
  • Mycophenolate mofetil 1.5 g 2 times a day

AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; MG-ADL=Myasthenia Gravis Activities of Daily Living; NSIST=nonsteroidal immunosuppressive therapy.

See Diane’s MG-ADL Scale

  • MG-ADL SCORE: 7
  • BMI: 27
  • Initially controlled with pyridostigmine and high-dose prednisone, with an attempt to bridge to azathioprine; discontinued azathioprine after 1 year
  • Thymectomy

  • Pyridostigmine 60 mg 4 times a day
  • Mycophenolate mofetil 1.5 g 2 times a day
See Diane’s MG-ADL Scale

Diane is a medical biller at a suburban practice. She and her husband are active volunteers and members of their church. She was diagnosed with anti-AChR antibody positive gMG 2 years ago and is privately insured.

Diane is experiencing increased weakness in her neck, arms, and legs, which makes it hard to sit in front of a computer or attend services and events. She is also experiencing slurred speech and difficulty swallowing and has started to avoid eating lunch with her coworkers.

Diane is worried about the continued effect of her symptoms and is ready to discuss additional options. She is concerned that will mean restarting prednisone.

AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; 
MG-ADL=Myasthenia Gravis Activities of Daily Living; NSIST=nonsteroidal immunosuppressive therapy.

  • MG-ADL SCORE: 7
  • BMI: 27
  • Initially controlled with pyridostigmine and high-dose prednisone, with an attempt to bridge to azathioprine; discontinued azathioprine after 1 year
  • Thymectomy

  • Pyridostigmine 60 mg 4 times a day
  • Mycophenolate mofetil 1.5 g 2 times a day
See Diane’s MG-ADL Scale

Hector, 68 years old

Recently retired and experiencing symptom exacerbations when tapering prednisone and looking for HCP guidance

MG-ADL score

Patient portrayal

BACKGROUND

Hector is retired from his job as an accountant and lives with his wife in a semi-suburban area. He was diagnosed with anti-AChR antibody positive gMG 4 years ago and is on Medicare.

SYMPTOMS AND CONCERNS

Hector is experiencing worsening muscle weakness, slurred speech, and occasional double vision after his most recent attempt to taper prednisone. His symptoms recently forced him to cancel some weekend trips with his wife, and he is having trouble keeping up with his usual yard work.

He is feeling increasingly frustrated and self-conscious about his symptoms and is looking to his HCP for guidance about another treatment option. He lives in close proximity to his HCP's office and an infusion center.

*Patients were excluded from the ADAPT clinical trials if they had IVIG or plasma 
 exchange within 1 month of screening.
AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; HCP=healthcare professional; MG-ADL=Myasthenia Gravis Activities of Daily Living.

Hector is retired from his job as an accountant and lives with his wife in a semi-suburban area. He was diagnosed with anti-AChR antibody positive gMG 4 years ago and is on Medicare.

Hector is experiencing worsening muscle weakness, slurred speech, and occasional double vision after his most recent attempt to taper prednisone. His symptoms recently forced him to cancel some weekend trips with his wife, and he is having trouble keeping up with his usual yard work.

He is feeling increasingly frustrated and self-conscious about his symptoms and is looking to his HCP for guidance about another treatment option. He lives in close proximity to his HCP's office and an infusion center.

AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; HCP=healthcare professional; MG-ADL=Myasthenia Gravis Activities of Daily Living.

MEDICAL HISTORY
  • MG-ADL SCORE: 8
  • BMI: 29
  • Most recent attempt to taper prednisone led to worsening of symptoms; high-dose prednisone was resumed
CURRENT TREATMENT
  • Pyridostigmine 60 mg 4 times a day
  • Prednisone 40 mg once daily

AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; HCP=healthcare professional; MG-ADL=Myasthenia Gravis Activities of Daily Living.

See Hector’s MG-ADL Scale

  • MG-ADL SCORE: 8
  • BMI: 29
  • Most recent attempt to taper prednisone led to worsening of symptoms; high-dose prednisone was resumed

  • Pyridostigmine 60 mg 4 times a day
  • Prednisone 40 mg once daily
See Hector's MG-ADL Scale

Hector is retired from his job as an accountant and lives with his wife in a semi-suburban area. He was diagnosed with anti-AChR antibody positive gMG 4 years ago and is on Medicare.

Hector is experiencing worsening muscle weakness, slurred speech, and occasional double vision after his most recent attempt to taper prednisone. His symptoms recently forced him to cancel some weekend trips with his wife, and he is having trouble keeping up with his usual yard work.

He is feeling increasingly frustrated and self-conscious about his symptoms and is looking to his HCP for guidance about another treatment option. He lives in close proximity to his HCP's office and an infusion center.

AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; HCP=healthcare professional; MG-ADL=Myasthenia Gravis Activities of Daily Living.

  • MG-ADL SCORE: 8
  • BMI: 29
  • Most recent attempt to taper prednisone led to worsening of symptoms; high-dose prednisone was resumed

  • Pyridostigmine 60 mg 4 times a day
  • Prednisone 40 mg once daily
See Diane’s MG-ADL Scale

Matthew, 37 years old

New father experiencing breakthrough symptoms despite periodic IVIG

MG-ADL score

Patient portrayal

BACKGROUND

Matthew is a high school teacher in a small city who recently became a father. He was diagnosed with anti-AChR antibody positive gMG 6 years ago and is privately insured.

SYMPTOMS AND CONCERNS

Matthew is experiencing facial weakness with difficulty smiling and nasality of speech, which makes it hard to interact with students. He is also experiencing limb weakness, which is frustrating to him as it impacts his ability to help his wife care for their daughter, especially in the evenings.

Matthew is concerned about the effect gMG is having on his ability to participate in family activities and the impact on his work from day to day. He is looking for additional options to help manage his symptoms.

AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; IVIG=intravenous immunoglobulin; MG-ADL=Myasthenia Gravis Activities of Daily Living.

Matthew is a high school teacher in a small city who recently became a father. He was diagnosed with anti-AChR antibody positive gMG 6 years ago and is privately insured.

Matthew is experiencing facial weakness with difficulty smiling and nasality of speech, which makes it hard to interact with students. He is also experiencing limb weakness, which is frustrating to him as it impacts his ability to help his wife care for their daughter, especially in the evenings.

Matthew is concerned about the effect gMG is having on his ability to participate in family activities and the impact on his work from day to day. He is looking for additional options to help manage his symptoms.

*Patients were excluded from the ADAPT clinical trials if they had IVIG or plasma exchange within 1 month of screening.

AChE=acetylcholinesterase; AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; IVIG=intravenous immunoglobulin; MG-ADL=Myasthenia Gravis Activities of Daily Living.

MEDICAL HISTORY
  • MG-ADL SCORE: 6
  • BMI: 26
  • Initially controlled with pyridostigmine and high-dose prednisone, which was successfully tapered
  • Thymectomy
CURRENT TREATMENT
  • Pyridostigmine 60 mg 4 times a day
  • Prednisone 20 mg once daily
  • Periodic IVIG, with the most recent infusion 4 weeks ago*

AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; IVIG=intravenous immunoglobulin; MG-ADL=Myasthenia Gravis Activities of Daily Living.

See Matthew’s MG-ADL Scale

  • MG-ADL SCORE: 6
  • BMI: 26
  • Initially controlled with pyridostigmine and high-dose prednisone, which was successfully tapered
  • Thymectomy

  • Pyridostigmine 60 mg 4 times a day
  • Prednisone 20 mg once daily
  • Periodic IVIG, with the most recent infusion 4 weeks ago*
See Matthew’s MG-ADL Scale

Matthew is a high school teacher in a small city who recently became a father. He was diagnosed with anti-AChR antibody positive gMG 6 years ago and is privately insured.

Matthew is experiencing facial weakness with difficulty smiling and nasality of speech, which makes it hard to interact with students. He is also experiencing limb weakness, which is frustrating to him as it impacts his ability to help his wife care for their daughter, especially in the evenings.

Matthew is concerned about the effect gMG is having on his ability to participate in family activities and the impact on his work from day to day. He is looking for additional options to help manage his symptoms.

*Patients were excluded from the ADAPT clinical trials if they had IVIG or plasma exchange within 1 month of screening.

AChE=acetylcholinesterase; AChR=acetylcholine receptor; gMG=generalized myasthenia 
 gravis; IVIG=intravenous immunoglobulin; MG-ADL=Myasthenia Gravis Activities of Daily Living.

  • MG-ADL SCORE: 6
  • BMI: 26
  • Initially controlled with pyridostigmine and high-dose prednisone, which was successfully tapered
  • Thymectomy

  • Pyridostigmine 60 mg 4 times a day
  • Prednisone 20 mg once daily
  • Periodic IVIG, with the most recent infusion 4 weeks ago*
See Matthew’s MG-ADL Scale

Do your patients know about the Myasthenia Gravis Patient Registry Survey?

Find out more about VYVGART Hytrulo and VYVGART

Learn about the clinical data of VYVGART Hytrulo and VYVGART

Explore clinical data

Discover how VYVGART Hytrulo or VYVGART may help 
your patients

Enroll now

Back to Top

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
 Infection

VYVGART HYTRULO may increase the risk of infection. The most common infections observed in Study 1 in patients with gMG 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, and did not lead to treatment discontinuation in gMG. 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. Healthcare professionals should 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-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-related reaction occurs, initiate appropriate therapy. Consider the risks and benefits of readministering VYVGART HYTRULO 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

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 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 in patients with gMG, 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 3 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 3, 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) who are anti-acetylcholine receptor (AChR) antibody positive.

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

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 were respiratory tract infection, headache, and urinary tract infection.

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 generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

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).

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
 Infection

VYVGART HYTRULO may increase the risk of infection. The most common infections observed in Study 1 in patients with gMG 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, and did not lead to treatment discontinuation in gMG. 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. Healthcare professionals should 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-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-related reaction occurs, initiate appropriate therapy. Consider the risks and benefits of readministering VYVGART HYTRULO 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

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 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 in patients with gMG, 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 3 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 3, 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) who are anti-acetylcholine receptor (AChR) antibody positive.

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

INDICATION

VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) is indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

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 were respiratory tract infection, headache, and urinary tract infection.

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 generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

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).

INDICATION

VYVGART® (efgartigimod alfa-fcab) is indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

References: 1. Wolfe GI et al. Neurology. 1999;52(7):1487-1489. doi:10.1212/wnl.52.7.1487 2. Howard JF Jr et al. Lancet Neurol. 2021;20(7):526-536. doi:10.1016/S1474-4422(21)00159-9 3. Cutter G et al. Muscle Nerve. 2019;60(6):707-715. https://doi.org/10.1002/mus.26695