Vyvgart Hytrulo

Vyvgart Hytrulo is used to treat generalized myasthenia gravis (gMG) or chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. It is a subcutaneous injection administered once a week.

Vyvgart Hytrulo combines efgartigimod alfa (an FcRn blocker that reduces harmful circulating IgG antibodies) with hyaluronidase (which temporarily breaks down skin tissue to allow larger subcutaneous injection volumes). Together, they treat CIDP and gMG, conditions where IgG autoantibodies damage nerves and muscles.

Vyvgart Hytrulo for subcutaneous injection first gained FDA approval on June 20, 2023, for gMG, and approval was extended on June 21, 2024, to cover CIDP. The intravenous formulation is called Vyvgart for IV infusion.

Administer Vyvgart Hytrulo exactly as your healthcare provider tells you to.

• Vyvgart Hytrulo is injected under your skin (subcutaneously) only. Do not inject into a vein (intravenously).
• It is administered under the skin of your abdominal area, but not within 2 inches of your navel.
• For gMG, Vyvgart Hytrulo is injected 1 time a week 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 a week.

Vyvgart Hytrulo comes in a single-dose prefilled syringe and a 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 the 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 come with the Vyvgart Hytrulo prefilled syringe.
• Monitor for signs and symptoms of an allergic reaction for at least 30 minutes after administration.

Do not receive Vyvgart Hytrulo if you are allergic to efgartigimod alfa, hyaluronidase, Vyvgart, Vyvgart Hytrulo, or any of the inactive ingredients in the preparation.

Before using Vyvgart Hytrulo, tell your healthcare provider about all 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
• Are breastfeeding or plan to breastfeed.

It is not known if Vyvgart Hytrulo is safe and effective in children.

Pregnancy

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

Breastfeeding

It is not known if Vyvgart Hytrulo passes into your breast milk.

Vyvgart Hytrulo combines efgartigimod alfa with hyaluronidase for subcutaneous administration. Efgartigimod alfa blocks the neonatal Fc receptor (FcRn), preventing it from binding circulating IgG antibodies. This allows more harmful IgG antibodies to be removed from the body, helping treat CIDP and gMG, where such antibodies damage nerves and muscles. Hyaluronidase temporarily increases skin permeability by breaking down hyaluronan, enabling larger subcutaneous injection volumes.

Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) belongs to the drug class called combination neonatal Fc receptor blockers and endoglycosidases.

Common side effects

The most common side effects of Vyvgart Hytrulo are:

• Respiratory tract infections
• Headache
• Urinary tract infections
• Injection site reactions.

Serious side effects

Vyvgart Hytrulo can cause side effects which can be serious, such as:

• Infection. Vyvgart Hytrulo may increase the risk of infection. If you have an active infection, your healthcare provider should delay treatment with Vyvgart Hytrulo until your infection is gone. Tell your healthcare provider right away if you get any of the following signs or symptoms of an infection: Fever Chills Frequent and painful urination Cough Pain and blockage of the 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 your Vyvgart Hytrulo injection. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction: Rash Swelling of the face, lips, throat, or tongue Shortness of breath Hives Trouble breathing Low blood pressure Fainting.
• Infusion or injection-related reactions. Vyvgart Hytrulo can cause infusion or injection-related reactions. These reactions can happen during or shortly after your Vyvgart Hytrulo injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction: High blood pressure Chills Shivering Chest, stomach, or back pain.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Dose of Vyvgart Hytrulo for gMG

• Prefilled syringe: 1 000 mg efgartigimod alfa and 10 000 units hyaluronidase subcutaneously over 20 to 30 seconds.
• Vial (Healthcare Provider only): 1 008 mg efgartigimod alfa and 11,200 units hyaluronidase subcutaneously over 30 to 90 seconds.

Administer once a week for 4 weeks.

• Subsequent treatment cycles may be administered based on clinical evaluation.
• It is unknown if it is safe to administer a subsequent treatment cycle within 50 days of the first treatment cycle.

Dose of Vyvgart Hytrulo for CIDP

• Prefilled syringe: 1 000 mg efgartigimod alfa and 10 000 units hyaluronidase subcutaneously over 20 to 30 seconds once a week.
• Vial (Healthcare Provider only): 1 008 mg efgartigimod alfa and 11,200 units hyaluronidase subcutaneously over 30 to 90 seconds once a week.

If you miss a dose, 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).

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

You should avoid receiving live vaccines, such as the chickenpox, measles, or mumps vaccines, while being treated with this medicine.

Vyvgart Hytrulo may interact with other prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use, and when you start, stop, or change a dose of any medicine.

Care should be taken when using Vyvgart Hytrulo with other medications that bind to the human neonatal Fc receptor (FcRn) (such as immunoglobulin products, monoclonal antibodies, or antibody derivatives containing the human Fc domain of the IgG subclass) because it may reduce the effectiveness of these medications.

Refrigerator

Store Vyvgart Hytrulo in the refrigerator between 36°F and 46°F (2°C and 8°C).

Only warm Vyvgart Hytrulo just before use by letting it sit on a flat surface for at least 30 minutes for the prefilled syringe and 15 minutes for the vial. Do not warm Vyvgart Hytrulo any other way (eg, with an external heat source).

• Store Vyvgart Hytrulo in the original carton to protect it from light until you are ready to use it.
• Do not freeze or shake.
• Do not use Vyvgart Hytrulo past the expiration date.
• Vygart Hytrulo is for one-time use only (single-dose).

Remove from the refrigerator only the dose you are preparing to inject. Future doses should remain refrigerated until ready to use.

Room temperature

If needed, Vyvgart Hytrulo may be stored at room temperature. Record the date you removed Vyvgart Hytrulo from the refrigerator.

• Single-dose prefilled syringe may be stored at room temperature (up to 86°F (30°C)) for up to 30 days. When removed from the refrigerator and brought to room temperature, Vyvgart Hytrulo must be used within 30 days or thrown away.
• Single-dose vial may be stored at room temperature (between 68°F and 77°F (20°C and 25°C)) for up to 3 days. When removed from the refrigerator and brought to room temperature, Vyvgart Hytrulo must be used within 3 days or thrown away.
• Do not put Vyvgart Hytruloback into the refrigerator after it has warmed to room temperature.

Keep Vyvgart Hytrulo and all medicines out of the reach of children.

Active ingredients: efgartigimod alfa and hyaluronidase (human recombinant)

Inactive ingredients:

• single-dose prefilled syringe: arginine hydrochloride, histidine, L-histidine hydrochloride monohydrate,methionine, polysorbate 80, sodium chloride, sucrose, and water for injection, USP
• single-dose vial: arginine hydrochloride, histidine, L-histidine hydrochloride monohydrate, methionine, polysorbate 80, sodium chloride, sucrose, and water for injection, USP

Vyvgart Hytrulo is available as:

• Single-dose prefilled syringe for injection: 1,000 mg efgartigimod alfa and 10,000 units of hyaluronidase per 5 mL (200 mg/2,000 units per mL)
• Single-dose vial for injection: 1,008 mg efgartigimod alfa and 11,200 units of hyaluronidase per 5.6 mL (180 mg/2,000 units per mL).

Preservative-free.

Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) is manufactured by:

• Argenx BV Industriepark 7, 9052 Zwijnaarde, Belgium, U.S. License No. 2217
• Halozyme, Inc. 12390 El Camino Real, San Diego, CA 92130, U.S. License No. 2187.

It is distributed by Argenx US, Inc., 33 Arch Street, Boston, MA 02110.