VYVGART logo
SELECT INDICATION: CIDP (VYVGART Hytrulo only)
VYVGART Hytrulo® (efgartigimod alfa and hyaluronidase-qvfc) is indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
SELECT INDICATION: CIDP (VYVGART Hytrulo only)
VYVGART Hytrulo® (efgartigimod alfa and hyaluronidase-qvfc) is indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Dosing and administration

VYVGART Hytrulo offers fast and streamlined treatment administration1

2 administration options for use at home, in office, or at the infusion center1

Prefilled syringe for self-injection1

  • Administered subcutaneously via a single-dose prefilled syringe by a patient or a caregiver*
  • Fast, 20-30–second subcutaneous self-injection†
  • Fixed, weekly, low-volume dose (5 mL)
    • 1,000 mg efgartigimod alfa/10,000 units hyaluronidase

Covered under Pharmacy Benefit and Medicare Part D2

                 SC injection by an HCP1           

SC injection by an HCP1

  • Administered subcutaneously via a single-dose vial using a winged infusion set only by a healthcare professional
  • Fast, ~30-90–second subcutaneous injection†
  • Fixed, weekly, low-volume dose (5.6 mL)
    • 1,008 mg efgartigimod alfa/11,200 units hyaluronidase

Covered under Medical Benefit and Medicare Part B3

*After proper instruction on subcutaneous injection technique, a patient or caregiver may inject VYVGART Hytrulo prefilled syringe.1 See full Prescribing Information.

†Refers to actual subcutaneous injection time of VYVGART Hytrulo. 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.1
HCP=healthcare professional; SC=subcutaneous.

Which administration option is right for your patients?

The prefilled syringe may be appropriate for patients who:

  • Are able to self-inject
  • Have access to a trained caregiver
  • Prefer to self-inject at home

The subcutaneous injection with the vial may be appropriate for patients who:

  • Are unable to self-inject
  • Do not have access to a trained caregiver
  • Prefer administration from a healthcare professional

Open up their world to VYVGART Hytrulo prefilled syringe for self-injection1

Fast ~20-30–second self-injection
Refers to actual subcutaneous injection time of VYVGART Hytrulo. Monitor for clinical signs and symptoms of hypersensitivity reactions for at least 30 minutes after administration. If a hypersensitivity reaction occurs, the patient should seek medical attention.1

100% of patients with CIDP and caregivers successfully used the prefilled syringe and interacted with the associated labeling, packaging, and instructional materials across 2 human factors studies (15 patients and 15 caregivers of patients with CIDP or gMG). All participants were able to follow the Instructions for use and prepare and administer the dose into the simulated injection pad unaided.4*

Patients and/or caregivers will receive in-person injection training until ready to inject.1†

*Human factors studies evaluated participants’ ability to follow injection instructions and successfully prepare the product in a simulated-use environment. During the unaided injection, 2 use errors and one close call occurred. The use errors were participants not putting the product back into the original packaging before putting into the refrigerator, and the close call was a participant removing the needle cap at the incorrect time. ​Performance of critical tasks did not result in any patterns of use errors, close calls, or difficulties that would lead to patient harm (including compromised medical care). ​Findings were based on performance, observed behaviors, subjective feedback, and human factors analyses, and therefore were not traditionally statistically analyzed​.4

†After proper instruction on subcutaneous injection technique, a patient or caregiver may inject VYVGART Hytrulo prefilled syringe.1 See full Prescribing Information.
CIDP=chronic inflammatory demyelinating polyneuropathy; gMG=generalized myasthenia gravis.

An example approach to prescribing VYVGART Hytrulo

Prescribing the prefilled syringe 

Order the 4-pack for 4 weeks of treatment and fewer deliveries from the specialty pharmacy.1

12 refills of VYVGART Hytrulo will cover 12 months of treatment.1 Use your clinical judgment to determine the appropriate amount of refills for your patient.

Prescribing the single-dose vial

Each carton contains 1 vial administered with a winged infusion set.1 Use your clinical judgment to determine the appropriate amount of refills for your patient.

Example prescriptions only. Please refer to the full Prescribing Information for complete dosing information. 

PFS=prefilled syringe; QW=once weekly.

Starting treatment with VYVGART Hytrulo

Patient counseling information: Discuss the risk of infections, hypersensitivity reactions, and infusion/injection-related reactions associated with treatment, as well as exposure to VYVGART Hytrulo during pregnancy*

No infusion pump or venous access required: Review full dosing and administration information before treating patients

No treatment-specific vaccinations required: Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiating treatment

no boxes warning

No Boxed Warning: Please see the full Prescribing Information for VYVGART Hytrulo and safety information before starting patients on treatment

*Please also see the Patient Counseling Information in Section 17 of the Prescribing Information.

 Patient portrayal. Individual results may vary.

Receive more information about
VYVGART Hytrulo and CIDP

Contact a rep

CIDP=chronic inflammatory demyelinating polyneuropathy.

Discover what VYVGART Hytrulo has to offer

Help your patients save on their treatment with VYVGART Hytrulo

Explore access

Ready to start your patients on treatment?

Enroll today

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 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. 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 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).

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 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 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. 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 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).

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.

 

References: 1. VYVGART Hytrulo. Prescribing information. argenx US Inc; 2025. 2. Centers for Medicare & Medicaid Services. Fact sheet: Medicare Prescription Payment Plan. August 2023. Accessed April 9, 2025. https://www.cms.gov/files/document/medicare-prescription-payment-plan-fact-sheet.pdf 3. Medicare.gov. Learn how Medigap works. Accessed April 9, 2025. https://www.medicare.gov/health-drug-plans/medigap/basics/how-medigap-works 4. Data on file. REF-03778. argenx US Inc. January 2025.

For US audiences only.

VYVGART Hytrulo is a registered trademark of argenx.
© 2025 argenx US-VYV_HYT-24-00177 V5 05/2025. All Rights Reserved.