SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Please refer to the local labeling for relevant information regarding hypersensitivity reactions with IMAAVY.
• Summarized below is information regarding management of hypersensitivity reactions from the study protocols for the IMAAVY phase 2/3 clinical programs in generalized myasthenia gravis (gMG).^1-5 

PHASE 2/3 CLINICAL PROTOCOLS

VIVACITY-MG3 and Vibrance-mg Clinical Trials

Antozzi et al (2025)¹ evaluated the efficacy and safety of IMAAVY in adults with gMG in a phase 3, randomized, multicenter, double-blind, placebo-controlled study (VIVACITY-MG3).

Ramchandren et al (2022)^2,3 is evaluating the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of IMAAVY in children and adolescents aged 2 to <18 years with gMG who have an insufficient response to ongoing, stable standard of care therapy in an ongoing, open-label, uncontrolled multicenter clinical trial (Vibrance-mg).

Management of Hypersensitivity Reactions^4,5 

• Per study protocols, before any administration of study intervention at the study site, appropriately trained personnel and medications (eg, antihistamines, injectable epinephrine) must be available to treat hypersensitivity reactions, including anaphylaxis. All patients must be observed carefully for signs and symptoms of a hypersensitivity reaction (eg, urticaria, pruritis, angioedema, wheezing, dyspnea, or hypotension).
• In the case of a severe allergic reaction (eg, anaphylaxis), subcutaneous aqueous epinephrine, corticosteroids, respiratory assistance, and other proper resuscitative measures are essential and must be available when study intervention is being administered. Patients who experience serious adverse reactions related to an injection or infusion should be discontinued from further study intervention administrations.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 04 February 2025.