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 infusion-related reactions with IMAAVY.

PHASE 2/3 CLINICAL PROTOCOLS

VIVACITY-MG3 and Vibrance-mg Clinical Trials

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

Ramchandren et al (2022)^2,3 is evaluating the safety, efficacy, PK, and 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 Infusion-Related Reactions

Per study protocols, an infusion reaction is defined as any adverse event (AE) that is reported by investigators to represent an infusion reaction. Minor infusion-related AEs may be managed by slowing the rate of the intravenous (IV) infusion and/or treating with antihistamines and/or acetaminophen as clinically indicated. If an IV infusion of the study intervention is interrupted because of an AE that, in the opinion of the investigator, is not severe or does not result in a serious AE, the infusion may be restarted with caution.^4,5

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 06 December 2024.