Efgartigimod alfa and Hyaluronidase-qvfc Injection

WHY is this medicine prescribed?

Efgartigimod alfa and hyaluronidase-qvfc injection is used to treat a certain form of myasthenia gravis (MG; a disorder of the nervous system that causes muscle weakness). Efgartigimod alfa and hyaluronidase-qvfc injection is also used to treat chronic inflammatory demyelinating polyneuropathy (CIDP; a disorder of the immune and nervous systems). Efgartigimod alfa-fcab is in a group of medications called monoclonal antibodies. It works by reducing a certain natural substance in the body that causes symptoms of myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. Hyaluronidase-qvfc is an endoglycosidase. It helps to keep efgartigimod alfa in the body longer so that the medication will have a greater effect.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Efgartigimod alfa and hyaluronidase-qvfc injection comes as a solution (liquid) to be injected subcutaneously (just under the skin) into the abdomen (stomach) over 30 to 90 seconds by a healthcare provider. When efgartigimod alfa and hyaluronidase-qvfc injection is given to treat myasthenia gravis, is usually injected once a week for 4 weeks. This cycle may be repeated as recommended by your doctor, but no sooner than at least 50 days after your last weekly dose. When efgartigimod alfa and hyaluronidase-qvfc injection is given to treat chronic inflammatory demyelinating polyneuropathy, it is usually given once a week. The length of your treatment depends on how well your body responds to the medication and any side effects that you experience.

Efgartigimod alfa and hyaluronidase-qvfc injection may cause serious reactions, usually within 1 hour after your receive the injection. Your healthcare provider will watch you carefully while you are receiving efgartigimod alfa and hyaluronidase-qvfc injection and for at least 30 minutes after you receive the medication. If you experience any of the following symptoms, tell your doctor immediately: chest pain; feeling dizzy, lightheaded, or faint; rash; hives; swelling of the eyes, face, lips, tongue, or throat; hoarseness; difficulty breathing or swallowing; chills; shivering; or stomach or back pain.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving efgartigimod alfa and hyaluronidase-qvfc injection,

• tell your doctor and pharmacist if you are allergic to efgartigimod alfa, hyaluronidase, any other medications, or any of the ingredients in efgartigimod alfa and hyaluronidase-qvfc injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have an infection or have ever had an infection that keeps coming back or if you have or ever had kidney disease or any other medical conditions.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving efgartigimod alfa and hyaluronidase-qvfc injection, call your doctor.

• if you received efgartigimod alfa and hyaluronidase-qvfc injection while you were pregnant and have given birth, tell your baby's doctor that you received efgartigimod alfa and hyaluronidase-qvfc injection. Efgartigimod alfa-fcab may interfere with your baby's immune response to vaccines. Talk to your baby's doctor about vaccinations for your baby.

• check with the doctor to see if you need to receive any vaccinations. It is important to have all vaccines appropriate for your age before beginning treatment with efgartigimod alfa and hyaluronidase-qvfc injection. Do not have any vaccinations without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive a dose of efgartigimod alfa and hyaluronidase-qvfc injection, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Efgartigimod alfa and hyaluronidase-qvfc injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• pain, burning, numbness, or tingling in the hands, feet, or mouth
• muscle pain
• itching, swelling, bruising, or redness of the skin at the injection site

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fever, sore throat, chills, cough, or other signs of infection
• pain or burning on urination or frequent urination
• rash; hives; difficulty breathing or swallowing; or swelling of the eyes, face, lips, tongue, or throat

Efgartigimod alfa and hyaluronidase-qvfc injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.