IMAAVY - Management of Infusion-Related Reactions in Patients with Generalized Myasthenia Gravis or Warm Autoimmune Hemolytic Anemia

SUMMARY

• The company cannot recommend any practices, procedures, or usage of IMAAVY that deviate from the approved labeling.
• Please refer to the local labeling for relevant information regarding infusion-related reactions with IMAAVY.
• Summarized below is information regarding management of infusion-related reactions from the study protocols for the IMAAVY phase 2/3 clinical programs in generalized myasthenia gravis (gMG) and warm autoimmune hemolytic anemia (wAIHA).^1-6

PHASE 2/3 Studies

VIVACITY-MG3 Clinical Study

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.

Vibrance-mg Clinical Study

Ramchandren et al (2022)^2,7 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.

ENERGY Clinical Study

Fattizzo et al (2026)⁶ evaluated the efficacy and safety of IMAAVY in adults with wAIHA in a phase 2/3, randomized, double-blind, PBO-controlled study.

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.^3-5 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.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 12 August 2026.