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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).

Frequently asked questions

Find answers to some of your most frequently asked questions.

About VYVGART Hytrulo

VYVGART Hytrulo contains efgartigimod alfa, the first and only targeted IgG Fc-antibody fragment in CIDP. This is the first novel mechanism for CIDP treatment in 30+ years.1-4

Efgartigimod alfa targets FcRn, which plays a key role in recycling IgG antibodies. By binding to and blocking FcRn, VYVGART Hytrulo results in the reduction of circulating IgG.1,2,5-7

VYVGART Hytrulo is a coformulation of efgartigimod alfa and hyaluronidase. Hyaluronidase increases permeability of the subcutaneous tissue by depolymerizing hyaluronan. This effect is transient, and permeability of the subcutaneous tissue is restored within 24 to 48 hours.1

Learn more about the mechanism of action for VYVGART Hytrulo.

No. VYVGART Hytrulo is approved as a once-weekly, subcutaneous treatment for adults with CIDP. The ADHERE trial enrolled patients treated with standard-of-care therapy as well as those off treatment for ≥6 months, including patients who were treatment naive.1

Learn more about the ADHERE clinical trial.

Efficacy and safety

The efficacy of VYVGART Hytrulo for the treatment of adults with CIDP was established in a 2-stage, prospective, multicenter study. It included an open-label period to identify VYVGART Hytrulo responders (Stage A), who then entered a randomized, double-blind, placebo-controlled withdrawal period (Stage B).1

The primary endpoint for the randomized withdrawal period (double blind, Stage B) was defined as time to first clinical deterioration (relapse), defined as a 1-point increase in aINCAT score at 2 consecutive visits or a >1-point increase in aINCAT score at 1 visit.1 

The adjusted INCAT (aINCAT) disability score, which is identical to the INCAT disability score but excludes changes in upper limb function from 0 (normal function) to 1 (minor symptoms), was used to assess the efficacy of VYVGART Hytrulo for the treatment of CIDP.1

See the ADHERE clinical data.

There are no recommended routine lab monitoring requirements for patients during treatment with VYVGART Hytrulo. Continue to evaluate patient response and monitor patients for possible side effects using your clinical judgment.

Read the full Important Safety Information.

Dosing and administration

VYVGART Hytrulo is injected subcutaneously, with 2 administration options: the prefilled syringe for at-home administration by patients or caregivers after proper instruction on subcutaneous injection technique, and the single-dose vial, which may be a viable option if self-injection is not appropriate.1

Learn more about the 2 dosing options.

The VYVGART Hytrulo prefilled syringe is a 1,000 mg efgartigimod alfa and 10,000 units hyaluronidase dose per 5 mL subcutaneous injection that can be administered by a patient or caregiver after proper instruction on subcutaneous injection technique. It contains the same active ingredients as the VYVGART Hytrulo single-dose vial. The injection takes approximately 20-30 seconds.1

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 Please see the Prescribing Information and Instructions for use for full administration guidance.

Watch a video on how to administer the prefilled syringe.

The injection takes approximately 20-30 seconds. It should be injected subcutaneously in the abdomen, at least 2 inches away from the navel. It can be administered by patients or caregivers after proper instruction on subcutaneous injection technique.1

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 Please see the Prescribing Information and Instructions for use for full administration guidance.

Watch the administration video for the prefilled syringe.

Download the PFS Instructions for use to learn more.

VYVGART Hytrulo vials and prefilled syringes should be stored under refrigeration at 36 °F to 46 °F (2 °C to 8 °C) in the original carton to protect from light. Do not freeze and do not shake the vials or prefilled syringes.1

If needed, unopened prefilled syringes may be stored at room temperature up to 86 °F (30 °C) in the original carton for a single period of up to 1 month after removing from the refrigerator or until the expiration date on the carton, whichever occurs first.1

If needed, unopened vials may be stored in the original carton for up to 3 days at room temperature at 68 °F to 77 °F  (20 °C to 25 °C) for a single period before administering or returning to refrigeration. Do not store the vial at room temperature more than one time. Record the dates the carton is removed from and returned to the refrigerator on the carton.1

Watch the administration video for the prefilled syringe.

Download the Dosing and Administration Guide to learn more.

Patients and/or caregivers will receive in-person injection training until ready to inject.1 argenx has engaged with a network of specialty pharmacies to deliver a robust suite of services to support the patient journey and ensure seamless coordination of care.

  • Training includes education on self-administration, storage, handling, and disposal of the prefilled syringe

Additionally, every patient enrolled in My VYVGARTⓇ Path will be connected to a Nurse Case Manager (NCM). NCMs can provide dosing and administration education and ongoing support.

Watch the administration video for the prefilled syringe.

Download the PFS Instructions for use to learn more.

Once you submit a prescription for the VYVGART Hytrulo prefilled syringe and the patient completes the prior authorization process, they can switch at their next scheduled injection.

Visit the dosing page to learn more about the prefilled syringe.

The My VYVGARTⓇ Path program provides ongoing patient support with regular adherence calls, check-ins, and reminders. Nurse Case Managers (NCMs) can also provide support for at-home administration options.

Learn more about the My VYVGART Path Patient Support Program.

Access

There are 2 ways to enroll your patients and get them started with the VYVGART Hytrulo prefilled syringe. Fill out and submit the My VYVGART Path enrollment form online, or download the enrollment form and fax the completed form to 1-833-698-7284. If patients are switching from VYVGART Hytrulo vials to the VYVGART Hytrulo prefilled syringe, they will still need to fill out a new enrollment form.

If a patient is already enrolled in My VYVGART Path, they may be eligible for the Quick Start Program. 

Eligible commercially insured patients may pay as little as $0 for VYVGART Hytrulo and may receive a maximum benefit of $25,000 per calendar year for their eligible out-of-pocket costs for the drug and drug administration. Persons residing in MA and RI are not eligible for financial assistance related to administration costs.

Learn more about patient access.

aINCAT=adjusted Inflammatory Neuropathy Cause and Treatment; CIDP=chronic inflammatory demyelinating polyneuropathy; Fc=fragment, crystallized; FcRn=neonatal Fc receptor; IgG=immunoglobulin G; PFS=prefilled syringe.

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.

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).

References: 1. VYVGART Hytrulo. Prescribing information. argenx US Inc; 2025. 2. Wolfe GI et al. J Neurol Sci. 2021;430:118074. doi:10.1016/j.jns.2021.118074 3. Brun S et al. Immuno. 2022;2:118-131. doi:10.3390/immuno2010009 4. Vermeulen M et al. J Neurol Sci. 1985;70(3):317-326. doi:10.1016/0022-510x(85)90173-x 5. Mathey EK et al. J Neurol Neurosurg Psychiatry. 2015;86(9):973-985. doi:10.1136/jnnp-2014-309697 
6. Vaccaro C et al. Nat Biotechnol. 2005;23(10):1283-1288. doi:10.1038/nbt1143 7. Ulrichts P et al. J Clin Invest. 2018;128(10):4372-4386. doi:10.1172/JCI97911

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VYVGART Hytrulo is a registered trademark of argenx.

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