VYVGART Hytrulo efgartigimod alfa and hyaluronidase (human recombinant) 200 mg/mL; 2000 U/mL Injection, Solution — NDC 73475-1221-4 (Billing 73475-1221-04)
This is a package of VYVGART Hytrulo efgartigimod alfa and hyaluronidase (human recombinant) 200 mg/mL; 2000 U/mL Injection, Solution from argenx US, marketed since Apr 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 73475-1221-4 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 73475 labeler · 1221 product · 4 package
- Package marketed since
- Apr 10, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 7347512214 1
- Medicaid fills, this package
- 277 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 087572
- GCN: 57542
- HICL (First Databank): 049016
- AHFS class code: 90:08.04.00
- RxCUI (RxNorm): 2639951
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Neonatal Fc Receptor Blocker class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $3,353.05 | $67,060.92 / 20 ml |
| Medicare drug plans payPart D · Q2 2026 | $3,358.18 | $67,163.64 / 20 ml |
| Medicare Part B allowsASP · J9334 | $34.258 / J9334 unit | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Oct 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 73475-1221-01 73475-1221-1 | 1 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS | 2025-04-10 | — | Active |
| 73475-1221-04 You're viewing this Main listing | 4 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS | 2025-04-10 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 96% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of VYVGART Hytrulo efgartigimod alfa and hyaluronidase (human recombinant) 200 mg/mL; 2000 U/mL Injection, Solution?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| VYVGART Hytrulo 200 mg/mL; 2000 U/mLthis 73475-1221-04 | argenx | 4 syringes | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Jun 20, 2035 |
Is there a biosimilar for VYVGART HYTRULO 1,000MG-10,000?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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10.5 mg / 1 mL
UNII F7LTH1E20Y
Arginine hydrochloride is an amino acid salt used as a buffer and pH adjuster in medicines. It helps maintain the correct acidity level to keep the drug stable and effective.
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1.4 mg / 1 mL
UNII 4QD397987E
An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
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2.2 mg / 1 mL
UNII 1D5Q932XM6
An amino acid salt used in medicines as a buffer and pH regulator. It helps maintain the proper acidity level in liquid formulations to keep the drug stable and effective.
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1.5 mg / 1 mL
UNII AE28F7PNPL
Methionine is an amino acid used as a nutrient supplement and pH buffer in medicines. It helps stabilize the formulation and supports the product's overall composition.
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0.4 mg / 1 mL
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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4.1 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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20.5 mg / 1 mL
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
More NDCs from argenx US labeler code 73475
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE VYVGART HYTRULO is indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) chronic inflammatory demyelinating polyneuropathy (CIDP) VYVGART HYTRULO is a combination of efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) ( 1 ) chronic inflammatory demyelinating polyneuropathy (CIDP) ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for instructions on dosage, preparation, and administration. ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 ) Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART HYTRULO. ( 2.1 ) Important Administration Information VYVGART HYTRULO is for subcutaneous use only.
( 2.2 ) Prefilled syringe can be administered by patients and/or caregivers. ( 2.2 ) Vial to be administered with a winged infusion set by a healthcare professional only. ( 2.2 ) gMG: recommended dose and dose schedule Administer in cycles of once weekly injections for 4 weeks.
( 2.3 ) Prefilled syringe: 1,000 mg efgartigimod alfa and 10,000 units hyaluronidase administered over 20 to 30 seconds. ( 2.3 ) Vial: 1,008 mg efgartigimod alfa and 11,200 units hyaluronidase over 30 to 90 seconds. ( 2.3 ) Administer subsequent treatment cycles based on clinical evaluation.
( 2.3 ) CIDP: recommended dose and dose schedule Administer as once weekly injections. ( 2.4 ) Prefilled syringe: 1,000 mg efgartigimod alfa and 10,000 units hyaluronidase administered over approximately 20 to 30 seconds. ( 2.4 ) Vial: 1,008 mg efgartigimod alfa and 11,200 units hyaluronidase over 30 to 90 seconds.
( 2.4 )
2.1Recommended Vaccination Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART HYTRULO. Because VYVGART HYTRULO causes transient reduction in IgG levels, vaccination with live vaccines is not recommended during treatment with VYVGART HYTRULO [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ] .
2.2Important Dosage and Administration Instructions VYVGART HYTRULO is for subcutaneous use only. Do not administer intravenously. Do not dilute VYVGART HYTRULO.
Single-Dose Prefilled Syringe VYVGART HYTRULO prefilled syringe may be administered by patients and/or caregivers after proper instruction in subcutaneous injection technique [see Instructions for Use ] . Single-Dose Vial VYVGART HYTRULO vial is to be administered with a winged infusion set by a healthcare professional only [see Dosage and Administration (2.4) ].
2.3Recommended Dosage for gMG Single-Dose Prefilled Syringe The recommended dosage of VYVGART HYTRULO prefilled syringe is 1,000 mg / 10,000 units (1,000 mg efgartigimod alfa and 10,000 units hyaluronidase) administered subcutaneously over approximately 20 seconds to 30 seconds in cycles of once weekly injections for 4 weeks. Single-Dose Vial The recommended dosage of VYVGART HYTRULO vial is 1,008 mg / 11,200 units (1,008 mg efgartigimod alfa and 11,200 units hyaluronidase) administered subcutaneously over approximately 30 seconds to 90 seconds in cycles of once weekly injections for 4 weeks.
General Dosage Considerations Administer subsequent treatment cycles according to clinical evaluation. If a scheduled dose is missed, VYVGART HYTRULO may be administered up to 3 days after the scheduled time point. Thereafter, resume the original dosing schedule until the treatment cycle is completed.
2.4Recommended Dosage for CIDP Single-Dose Prefilled Syringe The recommended dosage of VYVGART HYTRULO prefilled syringe is 1,000 mg / 10,000 units (1,000 mg efgartigimod alfa and 10,000 units hyaluronidase) administered subcutaneously over approximately 20 to 30 seconds as once weekly injections. Single-Dose Vial The recommended dosage of VYVGART HYTRULO vial is 1,008 mg / 11,200 units (1,008 mg efgartigimod alfa and 11,200 units hyaluronidase) administered subcutaneously over approximately 30 seconds to 90 seconds as once weekly injections.
General Dosage Considerations If a scheduled injection is missed, VYVGART HYTRULO may be administered up to 3 days after the scheduled time point. Thereafter, resume the original dosing schedule. Not all patients respond to VYVGART HYTRULO .
Consider the appropriateness of continuing treatment in p… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 1,000 mg efgartigimod alfa and 10,000 units hyaluronidase per 5 mL (200 mg/2,000 units per mL) as yellowish, clear to opalescent solution, in a single-dose prefilled syringe. Injection: 1,008 mg efgartigimod alfa and 11,200 units hyaluronidase per 5.6 mL (180 mg/2,000 units per mL) as yellowish, clear to opalescent solution, in a single-dose vial. Injection: 1,000 mg efgartigimod alfa and 10,000 units hyaluronidase per 5 mL (200 mg/2,000 units per mL) in a single-dose prefilled syringe.
( 3 ) Injection: 1,008 mg efgartigimod alfa and 11,200 units hyaluronidase per 5.6 mL (180 mg/2,000 units per mL) in a single-dose vial. ( 3 )
⛔ Contraindications ▾
4 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 [see Warnings and Precautions (5.2) ]. VYVGART HYTRULO is contraindicated in patients with serious hypersensitivity to efgartigimod alfa products, to hyaluronidase, or to any of the excipients of VYVGART HYTRULO.
( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Infections: Delay administration of VYVGART HYTRULO to patients with an active infection. Monitor for signs and symptoms of infection in patients treated with VYVGART HYTRULO. If serious infection occurs, administer appropriate treatment and consider withholding VYVGART HYTRULO until the infection has resolved.
( 5.1 ) Hypersensitivity Reactions: Anaphylaxis, hypotension leading to syncope, angioedema, dyspnea, rash, and urticaria have occurred in patients treated with VYVGART HYTRULO or intravenous efgartigimod alfa-fcab product. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention. ( 4 , 5.2 ) Infusion/injection-Related Reactions: If a severe infusion/injection-related reaction occurs, initiate appropriate therapy; consider the risks and benefits of readministering.
If a mild to moderate infusion/injection-related reaction occurs, consider rechallenging with close clinical observation, slower infusion/injection rates, and pre-medications. ( 5.3 )
5.1Infections 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 compared to 5% of placebo-treated patients) and respiratory tract infections (33% of efgartigimod alfa-fcab- treated patients compared to 29% of placebo-treated patients) [see Adverse Reactions (6.1) and Clinical Studies (14) ] . A higher frequency of patients who received efgartigimod alfa-fcab compared to placebo were observed to have below normal levels for white blood cell counts (12% versus 5%, respectively), lymphocyte counts (28% versus 19%, respectively), and neutrophil counts (13% versus 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 is resolved. During treatment with VYVGART HYTRULO, 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 IgG levels, vaccination with live vaccines is not recommended during treatment with VYVGART HYTRULO.
5.2Hypersensitivity 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 one hour to three 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 [see Dosage and Administration (2.4) ] .
If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention. VYVGART HYTRULO is contraindicated in patients with a history of serious hypersensitivity to efgartigimod alfa products, to hyaluronidase, or to any of the excipients of VYVGART HYTRULO [see Contraindications (4) ] .
5.3Infusion/Injection-Related Reactions Infusion-related reactions hav… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infections [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Infusion/Injection-Related Reactions [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥ 10%) in patients with gMG treated with efgartigimod alfa-fcab were respiratory tract infections, headache, and urinary tract infection. Injection site reactions were common (≥ 15%) in patients with gMG and CIDP who were treated with VYVGART HYTRULO ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact argenx at 1-833-argx411 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Experience in Patients with gMG The safety of efgartigimod alfa in adult patients with gMG was established in a double blinded placebo- controlled study with efgartigimod alfa-fcab administered intravenously (Study 1) and its open-label extension, and in an active-controlled study of VYVGART HYTRULO administered subcutaneously (Study 3) and its open-label extension [see Clinical Studies (14.1) ].
Adverse Reactions with Efgartigimod Alfa-fcab Intravenous in Adult Patients with gMG In clinical studies, the safety of efgartigimod alfa-fcab administered intravenously in adult patients with gMG has been evaluated in 364 patients who received at least one dose of efgartigimod alfa-fcab. In Study 1, 84 patients received efgartigimod alfa-fcab 10 mg/kg [see Clinical Studies (14) ] . Of these 84 patients, approximately 75% were female, 82% were White, 11% were Asian, and 8% were of Hispanic or Latino ethnicity.
The mean age at study entry was 46 years (range 19 to 78). The minimum time to initiate a subsequent cycle, specified by study protocol, was 28 days from the last administration of the previous treatment cycle. On average, efgartigimod alfa-fcab-treated patients received 2 cycles in Study 1.
The mean and median times to the second treatment cycle were 54 days and 50 days from the last administration of the first treatment cycle, respectively, for efgartigimod alfa-fcab-treated patients. Adverse reactions reported in at least 5% of patients treated with efgartigimod alfa-fcab and more frequently than placebo are summarized in Table 1. The most common adverse reactions (reported in at least 10% of efgartigimod alfa-fcab-treated patients) were respiratory tract infection, headache, and urinary tract infection.
Table 1: Adverse Reactions in at least 5% of Patients with gMG Treated with Efgartigimod Alfa-fcab Intravenously (EFG IV) and More Frequently than in Placebo-Treated Patients in Study 1 (Safety Population) Adverse reaction EFG IV (N=84) % Placebo (N=83) % Respiratory tract infection 33 29 Headache Headache includes migraine and procedural headache. 32 29 Urinary tract infection 10 5 Paraesthesia Paresthesia includes oral hypoesthesia, hypoesthesia, and hyperesthesia. 7 5 Myalgia 6 1 In a placebo-controlled study in patients with gMG who are anti-acetylcholine receptor (AChR) antibody negative (Study 2), 119 patients received one cycle of once-weekly administrations for 4 weeks of either efgartigimod alfa-fcab 10 mg/kg (n=58) or placebo (n=61).
The overall safety profile in Study 2 was consistent with the known safety profile of efgartigimod alfa-fcab in patients with gMG except for nausea, which occurred in 7% of anti-AChR antibody negative patients who received efgartigimod alfa-fcab compared to 5% of patients who received placebo. The safety of initiating subsequent cycles between 7 and 28 days from the last administration of the previous treatment cycle was assessed in another study in 60 patients (78% anti-AChR antibo… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing VYVGART HYTRULO and using alternative therapies. ( 7 )
7.1Effect of VYVGART HYTRULO on Other Drugs Concomitant use of VYVGART HYTRULO with medications that bind to the human neonatal Fc receptor (FcRn) (e.g., immunoglobulin products, monoclonal antibodies, or antibody derivates containing the human Fc domain of the IgG subclass) may lower systemic exposures and reduce effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing VYVGART HYTRULO and using alternative therapies.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYVGART HYTRULO during pregnancy. Healthcare providers and patients may call 1-855-272-6524 or go to https://www.Vyvgartpregnancy.com to enroll in or to obtain information about the registry. Risk Summary There are no available data on the use of VYVGART HYTRULO or efgartigimod alfa containing products during pregnancy.
There was no evidence of adverse developmental outcomes following the intravenous administration of efgartigimod alfa at up to 100 mg/kg/day in rats and rabbits (see Data ). The background rate of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Therefore, efgartigimod alfa may be transmitted from the mother to the developing fetus. 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 [see Warnings and Precautions (5.1) ]. Data Animal Data VYVGART HYTRULO for subcutaneous injection contains efgartigimod alfa and hyaluronidase [see Description (11) ] . Efgartigimod alfa: - Intravenous administration of efgartigimod alfa (0, 30, or 100 mg/kg/day) to pregnant rats and rabbits throughout organogenesis resulted in no adverse effects on embryofetal development in either species.
Maternal efgartigimod alfa exposures at the highest no-effect doses were approximately 8 and 62 times, respectively, that in humans at the recommended human dose (RHD) of 1008 mg. - Intravenous administration of efgartigimod alfa (0, 30, or 100 mg/kg/day) to rats throughout gestation and lactation resulted in no adverse effects on pre- or postnatal development. Maternal exposures at the highest no-effect dose were approximately 13 times that in humans at the RHD. Hyaluronidase: - In a study in which hyaluronidase (human recombinant) was administered by subcutaneous injection to pregnant mice throughout organogenesis, increased embryofetal mortality and decreased fetal body weights were observed at the highest doses tested.
The no-effect dose for adverse effects on embryofetal development in the mouse was approximately 1800 times the dose of hyaluronidase at the recommended human dose (RHD) of VYVGART HYTRULO (1,008 mg efgartigimod alfa and 11,200 U hyaluronidase), on a U/kg basis. - There were no adverse effects on pre- and postnatal development following subcutaneous administration of hyaluronidase (human recombinant) to mice throughout gestation and lactation at doses up to 5,000 times the dose of hyaluronidase at the RHD of VYVGART HYTRULO, on a U/kg basis.
8.2Lactation Risk Summary 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.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use Clinical studies of VYVGART HYTRULO did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger adul… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYVGART HYTRULO during pregnancy. Healthcare providers and patients may call 1-855-272-6524 or go to https://www.Vyvgartpregnancy.com to enroll in or to obtain information about the registry. Risk Summary There are no available data on the use of VYVGART HYTRULO or efgartigimod alfa containing products during pregnancy.
There was no evidence of adverse developmental outcomes following the intravenous administration of efgartigimod alfa at up to 100 mg/kg/day in rats and rabbits (see Data ). The background rate of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Therefore, efgartigimod alfa may be transmitted from the mother to the developing fetus. 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 [see Warnings and Precautions (5.1) ]. Data Animal Data VYVGART HYTRULO for subcutaneous injection contains efgartigimod alfa and hyaluronidase [see Description (11) ] . Efgartigimod alfa: - Intravenous administration of efgartigimod alfa (0, 30, or 100 mg/kg/day) to pregnant rats and rabbits throughout organogenesis resulted in no adverse effects on embryofetal development in either species.
Maternal efgartigimod alfa exposures at the highest no-effect doses were approximately 8 and 62 times, respectively, that in humans at the recommended human dose (RHD) of 1008 mg. - Intravenous administration of efgartigimod alfa (0, 30, or 100 mg/kg/day) to rats throughout gestation and lactation resulted in no adverse effects on pre- or postnatal development. Maternal exposures at the highest no-effect dose were approximately 13 times that in humans at the RHD. Hyaluronidase: - In a study in which hyaluronidase (human recombinant) was administered by subcutaneous injection to pregnant mice throughout organogenesis, increased embryofetal mortality and decreased fetal body weights were observed at the highest doses tested.
The no-effect dose for adverse effects on embryofetal development in the mouse was approximately 1800 times the dose of hyaluronidase at the recommended human dose (RHD) of VYVGART HYTRULO (1,008 mg efgartigimod alfa and 11,200 U hyaluronidase), on a U/kg basis. - There were no adverse effects on pre- and postnatal development following subcutaneous administration of hyaluronidase (human recombinant) to mice throughout gestation and lactation at doses up to 5,000 times the dose of hyaluronidase at the RHD of VYVGART HYTRULO, on a U/kg basis.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of VYVGART HYTRULO did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger adult patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action VYVGART HYTRULO is a coformulation of efgartigimod alfa and hyaluronidase. Efgartigimod alfa is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG. 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.
12.2Pharmacodynamics In Study 1 [see Clinical Studies (14) ], the pharmacological effect of efgartigimod alfa-fcab was assessed by measuring the decrease in serum IgG levels and anti-AChR autoantibody levels. In patients testing positive for anti-AChR antibodies and who were treated with efgartigimod alfa-fcab intravenous, there was a reduction in total IgG levels relative to baseline. Decrease in anti-AChR autoantibody levels followed a similar pattern.
A decrease in anti-AChR autoantibodies was associated with a clinical response in anti-AChR antibody positive patients, as measured by the change from baseline in MG- ADL total score. In Study 2 [see Clinical Studies (14) ], the pharmacological effect of efgartigimod alfa-fcab was assessed by measuring the decrease in serum IgG levels and anti-muscle-specific tyrosine kinase (MuSK) autoantibody levels. In patients testing negative for anti-AChR antibodies who were treated with efgartigimod alfa-fcab IV, there was a reduction in total IgG levels relative to baseline.
In patients testing positive for anti-MuSK antibodies, decreases in anti-MuSK autoantibodies levels followed a similar pattern as total IgG levels. In Study 3, the pharmacological effect of VYVGART HYTRULO administered subcutaneously (SC) at 1,008 mg / 11,200 Units was compared to efgartigimod alfa-fcab administered intravenously at 10 mg/kg (EFG IV) in gMG patients. The maximum mean reduction in anti-AChR autoantibody level was observed at week 4, with a mean reduction of 62.2% and 59.7% in the VYVGART HYTRULO SC and efgartigimod alfa-fcab IV arm, respectively.
The decrease in total IgG levels followed a similar pattern. The 90% confidence intervals for the geometric mean ratios of anti-AChR autoantibody reduction at day 29 and AUEC 0-4w (area under the effect-time curve from time 0 to 4 weeks post dose) were within the range of 80% to 125%, indicating no clinically significant difference between the two formulations.
12.3Pharmacokinetics Efgartigimod alfa exposures were approximately dose-proportional up to the highest subcutaneously tested dose of VYVGART HYTRULO (1750 mg, 1.75 times the recommended dosage). Absorption The rate and extent of absorption from a single-dose prefilled syringe and single-dose vial are similar. Distribution The volume of distribution is 15 to 20L.
Metabolism and Elimination Efgartigimod alfa and hyaluronidase are expected to be degraded by proteolytic enzymes into small peptides and amino acids. The terminal half-life is 80 to 120 hours (3 to 5 days). After a single intravenous dose of 10 mg/kg efgartigimod alfa-fcab in healthy subjects, less than 0.1% of the administered dose was recovered in urine.
Specific Populations Age, Sex and Race A population pharmacokinetics analysis assessing the effects of age, body weight, sex, and race did not suggest any clinically significant impact of these covariates on efgartigimod alfa exposures. Body Weight A population pharmacokinetics analysis suggests that the influence of body weight on efgartigimod alfa exposure after administration of VYVGART HYTRULO SC 1008 mg was limited and not clinically relevant. Patients with Renal Impairment No dedicated pharmacokinetic study has been performed in patients with renal impairment.
Population PK analyses of data from the VYVGART HYTRULO clinical studies indicated that patients with mild renal impairment (eGFR 60-89 mL/min/1.73 m 2 ) had 11 to 20% increase in exposure relative to the exposure in patients with normal renal function [see Use in… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action VYVGART HYTRULO is a coformulation of efgartigimod alfa and hyaluronidase. Efgartigimod alfa is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG. 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) injection is a preservative free, sterile, yellowish, clear to opalescent solution supplied as a single-dose prefilled syringe or vial. Single-Dose Prefilled Syringe Each single-dose prefilled syringe contains 1,000 mg efgartigimod alfa and 10,000 units hyaluronidase per 5 mL (200 mg/2,000 units per mL). It is available in cartons of one or four single-dose prefilled syringes (NDC 73475-1221-1 or NDC 73475-1221-4).
The safety needle that is 25G, 5/8 inches length, and thin wall type is not included in the carton. Store VYVGART HYTRULO prefilled syringe refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze.
Do not shake. If needed, prefilled syringes may be stored at room temperature at up to 30°C (86°F) in the original carton for a single period of up to 30 days after removing from refrigerator or until expiration date on the carton, whichever occurs first. Record the date removed from the refrigerator on the carton.
Single-Dose Vial Each single-dose vial contains 1,008 mg efgartigimod alfa and 11,200 units hyaluronidase per 5.6 mL (180 mg/2,000 units per mL). It is available in carton of one single-dose vial (NDC 73475-3102-3). Store VYVGART HYTRULO vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use.
Do not freeze. Do not shake. If needed, unopened vials may be stored in the original carton for up to 3 days at room temperature at 20°C to 25°C (68°F to 77°F) for a single period before administration or returned to refrigeration.
Do not store the vial at room temperature more than one time. Record the date removed from and the date returned to the refrigerator on the carton.
📦 Storage and Handling ▾
Store VYVGART HYTRULO vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze. Do not shake.
If needed, unopened vials may be stored in the original carton for up to 3 days at room temperature at 20°C to 25°C (68°F to 77°F) for a single period before administration or returned to refrigeration. Do not store the vial at room temperature more than one time. Record the date removed from and the date returned to the refrigerator on the carton.
📋 Description ▾
11 DESCRIPTION VYVGART HYTRULO is a fixed-combination drug product containing efgartigimod alfa and hyaluronidase (human recombinant). Efgartigimod alfa, a neonatal Fc receptor blocker, is a human immunoglobulin G1 (IgG1) -derived Fc fragment (fragment, crystallized) of the za allotype, produced in Chinese hamster ovary (CHO) cells. The efgartigimod alfa Fc fragment is a homodimer consisting of two identical peptide chains each consisting of 227 amino acids linked together by two interchain disulfide bonds with affinity for FcRn.
The molecular weight of efgartigimod alfa is approximately 54 kDa. Hyaluronidase (human recombinant) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. Hyaluronidase (human recombinant) is a glycosylated single-chain protein produced by Chinese hamster ovary cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20).
Hyaluronidase (human recombinant) has a molecular weight of approximately 61 kDa. VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) injection is a sterile, preservative free, yellowish, clear to opalescent solution supplied in a single-dose prefilled syringe or vial for subcutaneous injection. Each 5 mL single-dose prefilled syringe contains 1,000 mg of efgartigimod alfa and 10,000 units of hyaluronidase (human recombinant).
Each mL contains 200 mg of efgartigimod alfa, 2,000 units of hyaluronidase (human recombinant) and arginine hydrochloride (10.5 mg), histidine (1.4 mg), L-histidine hydrochloride monohydrate (2.2 mg), methionine (1.5 mg), polysorbate 80 (0.4 mg), sodium chloride (4.1 mg), sucrose (20.5 mg), and Water for Injection, USP, at a pH of 6.0. Each 5.6 mL single-dose vial contains 1,008 mg of efgartigimod alfa and 11,200 units of hyaluronidase (human recombinant). Each mL contains 180 mg of efgartigimod alfa, 2,000 units of hyaluronidase (human recombinant) and arginine hydrochloride (10.5 mg), histidine (1.4 mg), L- histidine hydrochloride monohydrate (2.2 mg), methionine (1.5 mg), polysorbate 80 (0.4 mg), sodium chloride (4.1 mg), sucrose (20.5 mg), and Water for Injection, USP, at a pH of 6.0.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read FDA-approved patient labeling (Patient Information and Instructions for Use). Infections Instruct patients to communicate any history of infections to the healthcare provider and to contact their healthcare provider if they develop any symptoms of an infection. Advise patients to complete age-appropriate vaccines according to immunization guidelines prior to initiation of a new treatment cycle with VYVGART HYTRULO.
Administration of live vaccines is not recommended during treatment with VYVGART HYTRULO [see Warnings and Precautions (5.1) ]. Hypersensitivity Reactions Inform patients that hypersensitivity reactions, including angioedema and anaphylaxis, have occurred in patients who were treated with efgartigimod alfa products. Inform patients about the signs and symptoms of these reactions, and advise patients to contact their healthcare provider immediately if these occur [see Warnings and Precautions (5.2) ].
Infusion/injection-Related Reactions Advise patients of the potential risk of infusion/injection-related reactions, which can include hypertension, chills, shivering, and chest, abdominal, and back pain [see Warnings and Precautions (5.3) ]. Neurological Symptoms Instruct patients to communicate any worsening of neurological symptoms to their prescriber. Symptom progression may indicate a lack of efficacy in these patients.
Instruction on Injection Technique If a patient or caregiver is to administer subcutaneous VYVGART HYTRULO prefilled syringe, instruct them in proper injection technique (e.g., site selection and duration of injection) [see Instructions for Use ] . Pregnancy Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYVGART HYTRULO during pregnancy. Encourage participation and advise patients about how they may enroll in the registry [see Use in Specific Populations (8.1) ] .
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Efgartigimod alfa exposures were approximately dose-proportional up to the highest subcutaneously tested dose of VYVGART HYTRULO (1750 mg, 1.75 times the recommended dosage). Absorption The rate and extent of absorption from a single-dose prefilled syringe and single-dose vial are similar. Distribution The volume of distribution is 15 to 20L.
Metabolism and Elimination Efgartigimod alfa and hyaluronidase are expected to be degraded by proteolytic enzymes into small peptides and amino acids. The terminal half-life is 80 to 120 hours (3 to 5 days). After a single intravenous dose of 10 mg/kg efgartigimod alfa-fcab in healthy subjects, less than 0.1% of the administered dose was recovered in urine.
Specific Populations Age, Sex and Race A population pharmacokinetics analysis assessing the effects of age, body weight, sex, and race did not suggest any clinically significant impact of these covariates on efgartigimod alfa exposures. Body Weight A population pharmacokinetics analysis suggests that the influence of body weight on efgartigimod alfa exposure after administration of VYVGART HYTRULO SC 1008 mg was limited and not clinically relevant. Patients with Renal Impairment No dedicated pharmacokinetic study has been performed in patients with renal impairment.
Population PK analyses of data from the VYVGART HYTRULO clinical studies indicated that patients with mild renal impairment (eGFR 60-89 mL/min/1.73 m 2 ) had 11 to 20% increase in exposure relative to the exposure in patients with normal renal function [see Use in Specific Populations (8.6) ]. Patients with Hepatic Impairment No dedicated pharmacokinetic study has been performed in patients with hepatic impairment. Hepatic impairment is not expected to affect the pharmacokinetics of efgartigimod alfa.
Drug Interaction Studies Clinical drug interactions studies have not been performed with efgartigimod alfa. P450 Enzymes Efgartigimod alfa is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely. Drug Interactions with Other Drugs or Biological Products Efgartigimod alfa may decrease concentrations of compounds that bind to the human FcRn [see Drug Interactions (7.1) ].
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics In Study 1 [see Clinical Studies (14) ], the pharmacological effect of efgartigimod alfa-fcab was assessed by measuring the decrease in serum IgG levels and anti-AChR autoantibody levels. In patients testing positive for anti-AChR antibodies and who were treated with efgartigimod alfa-fcab intravenous, there was a reduction in total IgG levels relative to baseline. Decrease in anti-AChR autoantibody levels followed a similar pattern.
A decrease in anti-AChR autoantibodies was associated with a clinical response in anti-AChR antibody positive patients, as measured by the change from baseline in MG- ADL total score. In Study 2 [see Clinical Studies (14) ], the pharmacological effect of efgartigimod alfa-fcab was assessed by measuring the decrease in serum IgG levels and anti-muscle-specific tyrosine kinase (MuSK) autoantibody levels. In patients testing negative for anti-AChR antibodies who were treated with efgartigimod alfa-fcab IV, there was a reduction in total IgG levels relative to baseline.
In patients testing positive for anti-MuSK antibodies, decreases in anti-MuSK autoantibodies levels followed a similar pattern as total IgG levels. In Study 3, the pharmacological effect of VYVGART HYTRULO administered subcutaneously (SC) at 1,008 mg / 11,200 Units was compared to efgartigimod alfa-fcab administered intravenously at 10 mg/kg (EFG IV) in gMG patients. The maximum mean reduction in anti-AChR autoantibody level was observed at week 4, with a mean reduction of 62.2% and 59.7% in the VYVGART HYTRULO SC and efgartigimod alfa-fcab IV arm, respectively.
The decrease in total IgG levels followed a similar pattern. The 90% confidence intervals for the geometric mean ratios of anti-AChR autoantibody reduction at day 29 and AUEC 0-4w (area under the effect-time curve from time 0 to 4 weeks post dose) were within the range of 80% to 125%, indicating no clinically significant difference between the two formulations.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Generalized Myasthenia Gravis The efficacy of efgartigimod alfa-fcab for the treatment of adult patients with generalized myasthenia gravis (gMG) was established in two multicenter, randomized, double-blind, placebo-controlled trials, one in adults who are anti-AChR antibody positive (Study 1) and one in adults who are anti-AChR antibody negative (Study 2). In Study 3, VYVGART HYTRULO demonstrated a comparable pharmacodynamic effect as compared to the efgartigimod alfa-fcab intravenous formulation, which established the efficacy of VYVGART HYTRULO [see Clinical Pharmacology (12.2) ].
Study 1 (Efgartigimod Alfa-fcab Intravenous) The efficacy of efgartigimod alfa-fcab intravenous (EFG IV) for the treatment of gMG in adults who are anti-AChR antibody positive was established in a 26-week, multicenter, randomized, double-blind, placebo-controlled trial (Study 1; NCT03669588). Study 1 enrolled patients who met the following criteria at screening: - Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IV - MG-Activities of Daily Living (MG-ADL) total score of ≥ 5 - On stable dose of MG therapy prior to screening, that included acetylcholinesterase (AChE) inhibitors, steroids, or non-steroidal immunosuppressive therapies (NSISTs), either in combination or alone - IgG levels of at least 6 g/L A total of 167 patients were enrolled in Study 1 and were randomized to receive either EFG IV 10 mg/kg (1,200 mg for those weighing 120 kg or more) (n=84) or placebo (n=83).
Baseline characteristics were similar between treatment groups. Patients had a median age of 46 years at screening (range: 19 to 81 years) and a median time since diagnosis of 7 years. Seventy-one percent were female, and 84% were White.
Median MG-ADL total score was 9, and median Quantitative Myasthenia Gravis (QMG) total score was 16. The majority of patients (n=65 for EFG IV; n=64 for placebo) were positive for anti-AChR antibodies. At baseline, over 80% of patients in each group received AChE inhibitors, over 70% in each treatment group received steroids, and approximately 60% in each treatment group received NSISTs, at stable doses.
Patients were treated with 10 mg/kg EFG IV administered as an intravenous infusion over one hour once weekly for 4 weeks. In patients weighing 120 kg or more, EFG IV was administered as 1200 mg per infusion. Subsequent treatment cycles were administered based on clinical evaluation, but no sooner than 28 days from the last administration of the previous treatment cycle.
The efficacy of EFG IV was measured using the Myasthenia Gravis-Specific Activities of Daily Living scale (MG-ADL) which assesses the impact of gMG on daily functions of 8 signs or symptoms that are typically affected in gMG. Each item is assessed on a 4-point scale where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. A total score ranges from 0 to 24, with the higher scores indicating more impairment.
In this study, an MG-ADL responder was defined as a patient with a 2-point or greater reduction in the total MG-ADL score compared to the treatment cycle baseline for at least 4 consecutive weeks, with the first reduction occurring no later than 1 week after the last infusion of the cycle. The primary efficacy endpoint was the comparison of the percentage of MG-ADL responders during the first treatment cycle between treatment groups in the anti-AChR antibody positive population. A statistically significant difference favoring EFG IV was observed in the MG-ADL responder rate during the first treatment cycle (67.7% in the EFG IV-treated group vs 29.7% in the placebo-treated group [p <0.0001]).
The efficacy of EFG IV was also measured using the Quantitative Myasthenia Gravis (QMG) total score which is a 13-item categorical grading system that assesses muscle weakness. Each item is assessed on a 4-point scale where a score of 0 represents no weakness and a score of 3… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility VYVGART HYTRULO for subcutaneous injection contains efgartigimod alfa and hyaluronidase [see Description (11) ] . Carcinogenesis and Mutagenesis No studies have been conducted to assess the carcinogenic potential of efgartigimod alfa. No studies have been conducted to assess the genotoxic potential of efgartigimod alfa.
No carcinogenicity or genotoxicity studies were conducted for human recombinant hyaluronidase. Impairment of Fertility Intravenous administration of efgartigimod alfa (0, 30, or 100 mg/kg/day) to male and female rats prior to and during mating and continuing in females through gestation day 7 resulted in no adverse effects on fertility. Efgartigimod alfa exposures at the highest no-effect dose were approximately 12 times that in humans at the recommended human dose of 1008 mg.
There were no effects on reproductive tissues in monkeys following subcutaneous administration of hyaluronidase (human recombinant) doses up to approximately 1,200 times the dose of hyaluronidase at the recommended human dose (RHD) of VYVGART HYTRULO (1,008 mg efgartigimod alfa and 11,200 U hyaluronidase) on a U/kg basis for 39 weeks. No systemic exposure to hyaluronidase was observed at doses up to approximately 120 times the dose of hyaluronidase at the RHD of VYVGART HYTRULO, on a U/kg basis.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility VYVGART HYTRULO for subcutaneous injection contains efgartigimod alfa and hyaluronidase [see Description (11) ] . Carcinogenesis and Mutagenesis No studies have been conducted to assess the carcinogenic potential of efgartigimod alfa. No studies have been conducted to assess the genotoxic potential of efgartigimod alfa.
No carcinogenicity or genotoxicity studies were conducted for human recombinant hyaluronidase. Impairment of Fertility Intravenous administration of efgartigimod alfa (0, 30, or 100 mg/kg/day) to male and female rats prior to and during mating and continuing in females through gestation day 7 resulted in no adverse effects on fertility. Efgartigimod alfa exposures at the highest no-effect dose were approximately 12 times that in humans at the recommended human dose of 1008 mg.
There were no effects on reproductive tissues in monkeys following subcutaneous administration of hyaluronidase (human recombinant) doses up to approximately 1,200 times the dose of hyaluronidase at the recommended human dose (RHD) of VYVGART HYTRULO (1,008 mg efgartigimod alfa and 11,200 U hyaluronidase) on a U/kg basis for 39 weeks. No systemic exposure to hyaluronidase was observed at doses up to approximately 120 times the dose of hyaluronidase at the RHD of VYVGART HYTRULO, on a U/kg basis.
📄 Patient Package Insert ▾
PATIENT INFORMATION VYVGART HYTRULO ® [viv' gart hye troo' loe] (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 5/2026 What is VYVGART HYTRULO? VYVGART HYTRULO is a prescription medicine used to treat adults with: generalized myasthenia gravis (gMG). chronic inflammatory demyelinating polyneuropathy (CIDP).
It is not known if VYVGART HYTRULO is safe and effective in children. Do not take VYVGART HYTRULO if you: are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. See the end of this leaflet for a complete list of ingredients in VYVGART HYTRULO.
VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting. Before taking VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you: have an infection or fever. have recently received or are scheduled to receive any vaccinations. have any history of allergic reactions. have kidney (renal) problems. are pregnant or plan to become pregnant. It is not known whether VYVGART HYTRULO will harm your unborn baby.
Pregnancy Exposure Registry . There is a pregnancy exposure registry for women who use VYVGART HYTRULO during pregnancy. The purpose of this registry is to collect information about your health and your baby.
Your healthcare provider can enroll you in this registry. You may also enroll yourself or get more information about the registry by calling 1-855-272-6524 or going to https://www.Vyvgartpregnancy.com are breastfeeding or plan to breastfeed. It is not known if VYVGART HYTRULO passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I take VYVGART HYTRULO? Take VYVGART HYTRULO exactly as your healthcare provider tells you to take it.
VYVGART HYTRULO is injected under your skin (subcutaneously) only. Do not inject into a vein (intravenously). For gMG, VYVGART HYTRULO is injected 1 time weekly for 4 weeks (treatment cycle).Your healthcare provider will tell you when to administer your future treatment cycles.
For CIDP, VYVGART HYTRULO is injected 1 time weekly. VYVGART HYTRULO comes in a single-dose prefilled syringe and single-dose vial. Only a healthcare provider should inject VYVGART HYTRULO using the single-dose vial.
If you are prescribed the VYVGART HYTRULO prefilled syringe, you or your caregiver should receive training on the right way to prepare and inject VYVGART HYTRULO prefilled syringe. Do not try to inject VYVGART HYTRULO prefilled syringe until you have been shown the right way by a healthcare provider. See the detailed Instructions for Use that comes with VYVGART HYTRULO prefilled syringe.
Monitor for signs and symptoms of an allergic reaction for at least 30 minutes after administration. See " What are the possible side effects of VYVGART HYTRULO? " If you miss a dose of VYVGART HYTRULO, you may give the injection for up to 3 days after the missed dose. After that, continue with the normal time between doses (dosing schedule).
What are the possible side effects of VYVGART HYTRULO? VYVGART HYTRULO can cause side effects which can be serious, including: Infection. VYVGART HYTRULO may increase the risk of infection.
If you have an active infection, your healthcare provider should delay your treatment with VYVGART HYTRULO until your infection is gone. Tell your healthcare provider right away if you get any of the following signs and symptoms of an infection: fever chills frequent and painful urination cough pain and blockage of nasal passages wheezing shortness of breath sore throat excess phlegm nasal discharge Allergic reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions that can be severe.
These reactions can happen during, shortly after, or weeks after… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
INSTRUCTIONS FOR USE VYVGART HYTRULO [viv' gart hye troo' loe] (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use 1,000 mg and 10,000 units/5 mL This Instructions for Use contains information on how to inject VYVGART HYTRULO. Important Information You Need to Know Before Injecting VYVGART HYTRULO VYVGART HYTRULO is for under the skin (subcutaneous) injection only. Be sure to read and understand this Instructions for Use before injecting VYVGART HYTRULO .
Your healthcare provider should show you or your caregiver how to prepare and inject VYVGART HYTRULO the correct way before using it for the first time. Ask your healthcare provider if you have any questions. The prefilled syringe is for one-time-use only and cannot be reused.
Do not use VYVGART HYTRULO if it has been at room temperature for longer than 30 days. Do not use the prefilled syringe if it is expired. Do not use the prefilled syringe if it is cracked, broken, or damaged.
Return damaged prefilled syringes to the specialty pharmacy. Do not use a prefilled syringe if the liquid medicine is discolored or contains particles. The liquid medicine should look clear to yellowish in color.
A little cloudiness is normal. Do not shake the prefilled syringe. You will need supplies that are not provided with VYVGART HYTRULO (see Figure J ).
Storing VYVGART HYTRULO Prefilled Syringe Store VYVGART HYTRULO in the refrigerator between 36°F to 46°F (2°C to 8°C) (see Figure A ). Keep the prefilled syringes in the original carton to protect them from light until ready to use. Keep VYVGART HYTRULO and all medicines out of the reach of children.
Do not freeze the prefilled syringes or store them in direct sunlight. Do not use a prefilled syringe that has been frozen or left in direct sunlight. Prefilled Syringe Parts Safety Needle (not provided with VYVGART HYTRULO prefilled syringe) that is 25G, 5/8 inch length, thin wall Gather and Check the Prefilled Syringe 1 Remove the carton from the refrigerator
1.1Remove the carton containing the prefilled syringe from the refrigerator (see Figure C ).
1.2Remove 1 prefilled syringe from the carton (see Figure D ) and place any remaining prefilled syringes back into the refrigerator for later use.
1.3Remove the prefilled syringe from the tray (see Figure E ). 2 Check the prefilled syringe before use
2.1Check the expiration date on the prefilled syringe label (see Figure F ). Do not use the prefilled syringe if the expiration date has passed.
2.2Check the condition of the prefilled syringe and the prefilled syringe cap (see Figure G ). Do not use the prefilled syringe if it is cracked, broken, damaged, or if the prefilled syringe cap is missing.
2.3Check the appearance of the liquid medicine in the prefilled syringe (see Figure H ). The liquid medicine should look clear to yellowish in color. A little cloudiness is normal. Do not use the prefilled syringe if the liquid medicine is discolored or contains particles. Prepare for the Injection 3 Allow the prefilled syringe to warm to room temperature
3.1Place the prefilled syringe on a clean flat surface and let it sit for at least 30 minutes, to allow it to warm to room temperature (see Figure I ). Do not attempt to warm the prefilled syringe in any other way. Do not use the VYVGART HYTRULO prefilled syringe if it has been at room temperature for longer than 30 days. 4 Gather supplies and wash your hands
4.1Gather the following supplies that are not provided with the prefilled syringe (see Figure J ).
4.2Wash your hands with soap and water (see Figure K ). 5 Snap off the prefilled syringe cap and attach the safety needle
5.1Carefully open the safety needle package and remove the needle (see Figure L ). Throw away the packaging into household trash.
5.2Bend the prefilled syringe cap to one side to snap it off and remove it from the prefilled syringe (see Figure M ). Throw away the prefilled syringe cap into the household trash. Do not touch the tip of the prefilled syr… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Indications and Usage ( 1 ) 5/2026 Dosage and Administration ( 2.3 ) 10/2025 Dosage and Administration ( 2.4 ) 2/2026
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 1,008 mg and 11,2000 units/5.6 mL Vial Carton NDC 73475-3102-3 VYVGART ® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) INJECTION 1,008 mg and 11,200 units/5.6 mL (180 mg and 2,000 units/mL) For subcutaneous injection over 30 to 90 seconds One single-dose vial Discard unused portion Must be administered by a healthcare provider Rx only PRINCIPAL DISPLAY PANEL - 1,008 mg and 11,2000 units/5.6 mL Vial Carton
PRINCIPAL DISPLAY PANEL - 5 mL Syringe Carton NDC 73475-1221-1 VYVGART Hytrulo ® (efgartigimod alfa and hyaluronidase-qvfc) INJECTION 1,000 mg and 10,000 units/5 mL (200 mg and 2,000 units/mL) For subcutaneous injection over 20 to 30 seconds One single-dose prefilled syringe Rx only PRINCIPAL DISPLAY PANEL - 5 mL Syringe Carton
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| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |