Drug Detail:Vyvgart hytrulo (Efgartigimod alfa and hyaluronidase-qvfc)
Generic Name: Immune globulins
Dosage Form: injection, solution
Drug Class: Immune globulins
Recommended Vaccination
Because VYVGART HYTRULO causes transient reduction in IgG levels, immunization with live-attenuated or live vaccines is not recommended during treatment with VYVGART HYTRULO. Evaluate the need to administer age-appropriate immunizations according to immunization guidelines before initiation of a new treatment cycle with VYVGART HYTRULO [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)].
Important Dosage and Administration Instructions
VYVGART HYTRULO is to be administered by a healthcare professional only.
VYVGART HYTRULO is for subcutaneous use only and administered with a winged infusion set [see Dosage and Administration (2.4)]. Do not administer intravenously.
Do not dilute VYVGART HYTRULO.
Recommended Dose and Dose Schedules
The recommended dosage of VYVGART HYTRULO 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.
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.
Preparation and Administration Instructions
Use aseptic technique when preparing and administering VYVGART HYTRULO. Do not shake the vial. Each vial is for one time use only. Avoid exposure to direct sunlight.
Preparation
- Take the VYVGART HYTRULO vial out of the refrigerator at least 15 minutes before injecting to allow it to reach room temperature [see How Supplied/Storage and Handling (16)]. Do not use external heat sources.
- Check that the VYVGART HYTRULO solution is yellowish, clear to opalescent.
- Parenteral medicine products should be inspected visually for particulate matter prior to administration, whenever solution and container permit. Do not use if opaque particles or other foreign particles are present.
- Withdraw the entire content of VYVGART HYTRULO from the vial using a polypropylene syringe and an 18G stainless steel transfer needle.
- Remove large air bubbles, if present.
- Each vial contains overfill to compensate for liquid loss during preparation and to compensate for the priming volume of the winged infusion set.
- VYVGART HYTRULO does not contain preservatives. Administer immediately after preparation.
Administration
- To administer VYVGART HYTRULO use a winged infusion set made of polyvinyl chloride (PVC), 25G, 12 inches tubing, maximum priming volume of 0.4 mL.
- Remove the transfer needle from the syringe and connect the syringe to the winged infusion set.
- Prior to administration, fill the tubing of the winged infusion set by gently pressing the syringe plunger until the plunger is at 5.6 mL. There should be solution at the end of the winged infusion set needle.
- Choose an injection site on the abdomen (at least 2 to 3 inches away from the navel).
- Do not inject on areas where the skin is red, bruised, tender, hard, or into areas where there are moles or scars.
- Rotate injection sites for subsequent administrations.
- Inject VYVGART HYTRULO subcutaneously into a pinched skin area at an angle of about 45 degrees over 30 to 90 seconds.
- Localized injection site reactions may occur after VYVGART HYTRULO is administered. [see Adverse Reactions (6.1)].
- Discard any unused portions of medicine remaining in the vial, the syringe and the winged infusion set.
- Healthcare professionals should 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 [see Warnings and Precautions (5.2)].
