Educational Dinner sponsored by Johnson & Johnson/Janssen with Board Meeting following

INDICATION
IMAAVYTM (nipocalimab-aahu) is a neonatal Fc receptor (FcRn) 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.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
IMAAVYTM is contraindicated in patients with a history of serious hypersensitivity reaction to nipocalimab-aahu or
to any of the excipients in IMAAVYTM. Reactions have included anaphylaxis and angioedema.

WARNINGS AND PRECAUTIONS
Infections
IMAAVY™ may increase the risk of infection, including
serious and severe infections. The most common infections
observed in Study 1 and its extension study in patients
treated with IMAAVY™ for gMG were upper respiratory
tract infection (46%), respiratory tract infections (28%;
including pneumonia, bronchitis, COVID-19), urinary tract
infection (15%), herpes (8%; including herpes simplex, herpes
zoster, herpes zoster oticus), influenza (8%), oral infection
(8%; including candidiasis and dental infections), and skin
infection (7%; including cellulitis). Two cases of infections
(1%; including cellulitis and urinary tract infection) led to
discontinuation of IMAAVY™. Delay IMAAVY™ administration
in patients with an active infection until the infection is
resolved. During treatment with IMAAVY™, monitor for clinical
signs  and symptoms of infection. If serious infection occurs,
administer appropriate treatment and consider withholding
IMAAVY™ until the infection has resolved.
Patients treated with IMAAVY™ may be at an increased
risk of activation of latent viral infections. Follow standard
vaccination guidelines.
Immunization: Evaluate the need to administer ageappropriate vaccinations before initiation of treatment with
IMAAVY™. The safety of immunization with live vaccines and
the immune response to vaccination during treatment with
IMAAVY™ are unknown. Live vaccines are not recommended
during treatment with IMAAVY™.
Hypersensitivity Reactions
Administration of IMAAVY™ may result in hypersensitivity
reactions, including angioedema, anaphylaxis, rash, urticaria,
and eczema. Management of hypersensitivity reactions
depends on the type and severity of the reaction. Monitor
the patient during treatment and for 30 minutes after
administration. If a hypersensitivity reaction occurs during
administration, discontinue IMAAVY™ infusion and institute
appropriate supportive measures if needed.
Infusion-Related Reactions
Administration of IMAAVY™ may result in infusion-related
reactions, including headache, influenza-like illness, rash,
nausea, fatigue, dizziness, chills, and erythema. Monitor
the patient during treatment and for 30 minutes after
each infusion. If a severe infusion-related reaction occurs,
discontinue IMAAVY™ infusion and initiate appropriate
therapy. Consider the risks and benefits of readministering
IMAAVY™ following a severe infusion-related reaction. If a
mild to moderate infusion-related reaction occurs, patients
may be rechallenged with close clinical observation, slower
infusion rates, and pre-medication.
ADVERSE REACTIONS
Most common (≥10% of patients) adverse reactions
associated with IMAAVY™ include: respiratory tract infection,
peripheral edema, and muscle spasms.
Adverse reactions in ≥5% of patients taking IMAAVY™
include: urinary tract infection, herpes zoster and simplex
infection, oral infection, hypersensitivity reaction, abdominal
pain, back pain, pyrexia, diarrhea, cough, anemia, dizziness,
nausea, hypertension, and insomnia.