Efgartigimod alfa

Efgartigimod alfa

Efgartigimod alfa

What is Efgartigimod alfa?

Efgartigimod alfa may also be used for purposes not listed in this medication guide.

Side effects of efgartigimod alfa

If necessary, get emergency medical helpSigns of an allergic reaction:hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Efgartigimod alfa can cause serious side effects. Call your doctor immediately if you have:

• Signs of infection – fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding.

Common side effects of efgartigimod alfa may include:

• Cold symptoms such as stuffy nose, sneezing, sore throat;

• Headache; or

• Pain and burning when urinating, pain when urinating.

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

Warnings

Call your doctor immediately if you have fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising, or bleeding; or hives, difficulty breathing, swelling of the face, lips, tongue or throat.

Before you take this medicine

Tell your doctor if you currently have an infection or have recently had infections.

Tell your doctor if you are pregnant or planning to become pregnant, or are breast-feeding or plan to breast-feed.

How is efgartigimod alfa administered?

Follow all instructions on your prescription label and read any medication guides or instructions for use. Use the medicine exactly as directed.

Efgartigimod alfa is injected into a vein by a healthcare provider. Efgartigimod alfa will be administered over 1 hour once weekly for 4 weeks.

The dosage depends on weight. Your dose may change if you gain or lose weight.

You will be observed for a short time to make sure you do not have an allergic reaction.

Make sure you have received all vaccinations before you start using efgartigimod alfa.

Efgartigimod alfa dosage information

Usual Adult Dose for Myasthenia Gravis:

10 mg/kg i.v. once a week for 4 weeks
-Weight over 120 kg: 1200 mg i.v. once a week for 4 weeks

Comments:
– Subsequent treatment cycles should be based on clinical evaluation.
-The safety of starting a cycle earlier than 50 days from the start of the previous cycle has not been established.
-Assess the need for age-appropriate vaccinations before initiating therapy.

Use: For the treatment of generalized myasthenia gravis in patients positive for anti-acetylcholine receptor antibodies.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your efgartigimod alfa injection.

What happens if I overdose?

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

What should I avoid during treatment with efgartigimod alfa?

Avoid vaccination with a live vaccine while being treated with efgartigimod alfa.

What other medicines affect efgartigimod alfa?

Other medicines may affect efgartigimod alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are taking.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.