Efgartigimod alfa and Hyaluronidase (human recombinant)

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) chronic inflammatory demyelinating polyneuropathy (CIDP)

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.

See Full Prescribing Information for instructions on dosage, preparation, and administration. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART HYTRULO. Important Administration Information VYVGART HYTRULO is for subcutaneous use only. Prefilled syringe can be administered by patients and/or caregivers. Vial to be administered with a winged infusion set by a healthcare professional only. gMG: recommended dose and dose schedule Administer in cycles of once weekly injections for 4 weeks. Prefilled syringe: 1,000 mg efgartigimod alfa and 10,000 units hyaluronidase administered over 20 to 30 seconds. Vial: 1,008 mg efgartigimod alfa and 11,200 units hyaluronidase over 30 to 90 seconds. Administer subsequent treatment cycles based on clinical evaluation.

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.

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. 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. Infusion/injection-Related Reactions: If a severe infusion/injection-related reaction occurs, initiate appropriate therapy, consider the risks and benefits of readministering.

The following clinically significant adverse reactions are described elsewhere in the labeling: Infections Hypersensitivity Reactions Infusion/Injection-Related Reactions 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

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.

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. 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. Do not shake.