Efgartigimod alfa/Hyaluronidase-qvfc (By injection)

Efgartigimod Alfa (ef-gar-TIG-i-mod AL-fa), Hyaluronidase-qvfc (hye-al-ure-ON-i-dase - qvfc)

Treats generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.

Brand Name(s):

Vyvgart Hytrulo, Vyvgart Hytrulo PFS

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the stomach area.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are irritated, tender, red, bruised, infected, scarred, or has moles.
• This medicine is available in 2 forms: a vial and prefilled syringe.
• Prefilled syringe:
  • Wash your hands with soap and water before and after using this medicine.
  • Allow the medicine to warm to room temperature for 30 minutes before using it. Do not warm it by using a heat source or in any other way.
  • Check the liquid in the syringe. It should be clear to yellowish. Do not use if it is frozen, discolored, or has particles in it. Do not use the syringe if it is cracked, broken, damaged, or if the cap is missing.
  • Remove 1 prefilled syringe from the carton and place the remaining prefilled syringes back into the refrigerator for later use.
  • Carefully open the safety needle package and remove the needle. Bend the prefilled syringe cap to one side to snap it off. Do not touch the tip of the prefilled syringe.
  • Hold the body of the prefilled syringe with one hand and attach the safety needle by twisting it to the right.
  • Hold the body of the syringe and pull the cap straight off. Do not recap.
  • Pinch the skin. Insert the needle at a 45 to 90 degree angle into the pinched skin.
  • Slowly press the thumb pad down all the way until it stops. It will take about 20 to 30 seconds to inject all of the medicine. Pull the needle straight out.
• Use a new needle and syringe each time you inject your medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose. If you miss a dose of this medicine, you may inject for up to 3 days after the missed dose and go back to regular dosing schedule.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. If needed, you may store the prefilled syringe at room temperature for up to 30 days. Do not put it back in the refrigerator. Throw away unused medicine after 30 days of room temperature storage.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how efgartigimod alfa/hyaluronidase-qvfc works. Tell your doctor if you are using a medicine that can weaken the immune system.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive live virus vaccines during treatment with this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease or any type of infection.
• This medicine may cause the following problems:
  • Increased risk of serious infections
  • Infusion-related reactions
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, lower back or side pain, difficult or painful urination
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Lightheadedness or fainting
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice these less serious side effects, talk with your doctor:

• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 6/4/2025