Nipocalimab

Nipocalimab is used to treat myasthenia gravis in adults and in children who are at least 12 years old.

Your doctor will confirm that you have the correct antibody type to be treated with nipocalimab.

Nipocalimab may also be used for reasons not mentioned in this medication guide.

Nipocalimab is usually given once every 2 weeks as an infusion into a vein by a healthcare provider.

Your doctor will perform tests to ensure nipocalimab is the right treatment for you.

After receiving an injection, you will be monitored closely to make sure you do not have an allergic reaction or serious side effects.

Your healthcare provider may give other medications to help prevent an allergic reaction or serious side effects, or give nipocalimab more slowly or stop your infusion if you develop a reaction.

You may get infections more easily. You may need frequent medical tests.

Doses are based on weight. Your dose may change if you gain or lose weight.

You may get infections more easily. Call your doctor if you have flu symptoms, a cough, night sweats, neck stiffness, confusion, or vision problems.

You should not use nipocalimab if you are allergic to it.

Tell your doctor if you have or have ever had:

• if you recently received or are scheduled to receive a vaccine; or
• an active, chronic, or recent infection such as Epstein-Barr virus (EBV), herpes simplex or herpes zoster (shingles) virus.

Make sure you are current on all vaccines before you start receiving nipocalimab.

Tell your baby's doctor if you used nipocalimab during pregnancy. It could affect your baby's vaccination schedule.

It is not known if nipocalimab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, you may be enrolled in a pregnancy safety study to track the effects of nipocalimab on the baby.

Ask a doctor if it is safe to breastfeed while using nipocalimab.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Some side effects may happen during or after the injection. Tell your medical caregiver if you feel dizzy, nauseous, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

You may get infections more easily. Call your doctor right away if you have signs of infection such as:

• fever, chills, sore throat;
• mouth sores, red or swollen gums;
• pale skin, easy bruising, unusual bleeding; or
• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Your treatment may be delayed if you have certain side effects.

Common side effects of nipocalimab may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• swelling in your hands, ankles, or feet; or
• muscle spasms.

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 FDA at 1-800-FDA-1088.

Usual Adult Dose for Myasthenia Gravis:

Initial dose: 30 mg/kg IV once; infuse over at least 30 minutesMaintenance dose: 15 mg/kg IV 2 weeks after the initial dose, infused over at least 15 minutes; continue this dosage every 2 weeksComments:-Determine the need to administer age-appropriate vaccines before administering this drug.Use: For the treatment of generalized myasthenia gravis who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive

Usual Pediatric Dose for Myasthenia Gravis:

Initial dose: 30 mg/kg IV once; infuse over at least 30 minutesMaintenance dose: 15 mg/kg IV 2 weeks after the initial dose, infused over at least 15 minutes; continue this dosage every 2 weeksComments:-Determine the need to administer age-appropriate vaccines before administering this drug.Use: For the treatment of generalized myasthenia gravis who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive

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

In a medical setting, an overdose would be treated quickly.

Avoid getting a "live" vaccine. The vaccine may not be as effective while you are using nipocalimab. Live vaccines may include measles, mumps, rubella (MMR), varicella (chickenpox), nasal flu vaccine, and others.

Other drugs may affect nipocalimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.