Nipocalimab
Generic name: nipocalimab [ NIP-oh-KAL-i-mab ]
Brand name: Imaavy
Dosage form: intravenous solution (aahu 185 mg/mL)
Drug class: Selective immunosuppressants
What is nipocalimab?
Nipocalimab is used to treat myasthenia gravis in adults and children at least 12 years old.
Your doctor will make sure you have the correct antibody type to be treated with nipocalimab.
Nipocalimab may also be used for purposes not listed in this medication guide.
Nipocalimab side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Some side effects may occur during or after the injection. Tell your medical caregiver if you feel dizzy, nauseated, 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.
Related/similar drugs
Warnings
You may get infections more easily. Call your doctor if you have flu symptoms, cough, night sweats, neck stiffness, confusion, or vision problems.
Before taking this medicine
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.
How is nipocalimab given?
Nipocalimab is usually given once every 2 weeks as an infusion into a vein by a healthcare provider.
Your doctor will perform tests to make sure nipocalimab is the right treatment for you.
After receiving an injection, you will be watched 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.
Nipocalimab dosing information
Usual Adult Dose for Myasthenia Gravis:
Initial dose: 30 mg/kg IV once; infuse over at least 30 minutes
Maintenance dose: 15 mg/kg IV 2 weeks after the initial dose, infused over at least 15 minutes; continue this dosage every 2 weeks
Comments:
-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 minutes
Maintenance dose: 15 mg/kg IV 2 weeks after the initial dose, infused over at least 15 minutes; continue this dosage every 2 weeks
Comments:
-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
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your nipocalimab injection.
What happens if I overdose?
In a medical setting an overdose would be treated quickly.
What should I avoid while receiving nipocalimab?
Avoid receiving a "live" vaccine. The vaccine may not work as well while you are using nipocalimab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).
What other drugs will affect nipocalimab?
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.
Nipocalimab Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for nipocalimab.
Imaavy (nipocalimab-aahu) - Janssen Biotech, Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 1,200 mg/6.5 mL (185 mg/mL) |
Single-Dose Vial | 300 mg/1.62 mL (185 mg/mL) |
View Imaavy information in detail.
More about nipocalimab
- Check interactions
- Compare alternatives
- Side effects
- Dosage information
- During pregnancy
- Drug class: selective immunosuppressants
- En español
Patient resources
Other brands
Professional resources
Other brands
Related treatment guides
Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2025 Cerner Multum, Inc. Version: 1.01.