Vyvgart Hytrulo Dosage

​Single-Dose Prefilled Syringe

​VYVGART HYTRULO prefilled syringe may be administered by patients and/or caregivers after proper instruction in subcutaneous injection technique.

​Single-Dose Vial

​VYVGART HYTRULO vial is to be administered with a winged infusion set by a healthcare professional only.

​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 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 to 90 seconds in cycles of once weekly injections for 4 weeks.

General Dosage Considerations

Administer subsequent treatment cycles according to clinical evaluation. The safety of initiating subsequent cycles sooner than 50 days from the start of the previous treatment cycle has not been established.

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.

​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 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.

​Single-Dose Prefilled Syringe

• ​Take the VYVGART HYTRULO prefilled syringe out of the refrigerator at least 30 minutes before injecting to allow it to reach room temperature. Do not use external heat sources to bring the syringe to room temperature.
• ​Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Visually inspect that the prefilled syringe solution is yellowish, clear to opalescent and devoid of particulate matter. Do not use if visible particles are present.
• ​Each prefilled syringe is for one-time use only.
• ​To administer VYVGART HYTRULO prefilled syringe, use a safety needle that is 25G, 5/8 inches in length, and thin wall type. The safety needle is not included in the carton.
• ​Choose an injection site on the abdomen (at least 2 inches away from the navel).
  • ​Do not inject on areas where the skin is irritated, red, bruised, infected, tender, hard, or into areas where there are moles or scars.
  • ​Rotate injection sites for subsequent administrations.
• ​Inject VYVGART HYTRULO prefilled syringe subcutaneously into a pinched skin area at an angle of 45 to 90 degrees for approximately 20 to 30 seconds.
• ​Discard any unused portions of medicine remaining in the syringe.
• ​Localized injection site reactions may occur after VYVGART HYTRULO is administered.
• ​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 and the healthcare professional should institute appropriate measures, if needed.

​For detailed instructions on the preparation and administration of VYVGART HYTRULO prefilled syringe see INSTRUCTIONS FOR USE.

Single-Dose Vial

Use aseptic technique when preparing and administering VYVGART HYTRULO vial. Do not shake the vial. Each vial is for one-time use only. Avoid exposure to direct sunlight.