Nipocalimab

What it is used for

IMAAVY is indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. IMAAVY is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Side effects, and when to stop

The following clinically significant adverse reactions are described elsewhere in the labeling

• Infections
• Hypersensitivity Reactions
• Infusion-related Reactions

Who should not take it

IMAAVY is contraindicated in patients with a history of serious hypersensitivity reaction to nipocalimab-aahu or any of the excipients in IMAAVY. Reactions have included anaphylaxis and angioedema.

Storing it

Storage and Handling

Unopened Vials

Store vials refrigerated at 2 ºC to 8 ºC (36 ºF to 46 ºF) in the original carton to protect from light until the time of use. Do not freeze. Do not shake.

Diluted Solution

For storage of the diluted IMAAVY solution, see Dosage and Administration.