Why is this medicine prescribed?
Efgartigimod alfa and hyaluronidase-qvfc injection is used to treat a certain type of myasthenia gravis (MG; a disorder of the nervous system that causes muscle weakness) and to treat chronic inflammatory demyelinating polyneuropathy (CIDP; a disorder of the immune and nervous systems). Efgartigimod alfa-fcab is in a class of medications called immunomodulatory agents. 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 in a class of medications called endoglycosidases. 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) in a single-dose prefilled syringe and vial to be injected subcutaneously (just under the skin) into the abdomen (stomach) over 30 to 90 seconds. It is injected once a week. Try to inject on the same day each week. The length of your treatment depends on the condition being treated and how well your body responds to the medication and any side effects that you experience.
Efgartigimod alfa and hyaluronidase-qvfc injection may be given to you by a nurse or other healthcare provider, or you or a caregiver may inject the medication at home using a prefilled syringe. If you will be injecting efgartigimod alfa and hyaluronidase-qvfc at home, a healthcare provider will show you or your caregiver how to inject the medication. Carefully read the manufacturer's instructions for use that comes with the medication. Be sure to ask your pharmacist or doctor if you have any questions about how to inject this medication.
Before injecting, remove the prefilled syringe from the refrigerator. Place on a flat surface away from direct sunlight. Allow it to warm to room temperature away from direct sunlight for 30 minutes before you inject the medication. Do not try to warm the medication through any other method. Ask your doctor or pharmacist if you have any questions.
Efgartigimod alfa and hyaluronidase-qvfc injection may cause serious reactions, usually within 1 hour after you receive the injection. Watch carefully for symptoms 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 or get emergency care: 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 or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- 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.
- 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.
- 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?
Inject the missed dose as soon as you remember it, up to 3 days after the scheduled time. Then continue your regular schedule. Do not give a double dose to make up for a missed one.
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 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 know about storage and disposal of this medication?
Keep this medication in the package it came in, away from light, tightly closed, and out of reach of children. Store efgartigimod alfa and hyaluronidase-qvfc injection in the refrigerator in the original carton. Do not freeze. Discard any medication that is outdated or no longer needed. If necessary, efgartigimod alfa and hyaluronidase-qvfc prefilled syringes may be left at room temperature for up to 30 days. Discard unused pens or syringes left at room temperature after 30 days. Talk to your pharmacist about the proper disposal and storage of your medication.
Keep all medication out of sight and reach of children as many containers are not child resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach https://www.upandaway.org . Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.What other information should I know?
Keep all appointments with your doctor.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.