IMAAVY – Concomitant Use of Vaccines in Patients with 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 the concomitant use of vaccines and IMAAVY in patients with warm autoimmune hemolytic anemia (wAIHA).

Company core data sheet

Immunizations

• Patients treated with IMAAVY may receive non-live vaccines as needed, according to immunization guidelines.¹
• The safety of immunization with live or live-attenuated vaccines and the response to immunization with these vaccines during treatment with IMAAVY are unknown.
• Immunization with live or live attenuated vaccines is not recommended during treatment with IMAAVY.
• Evaluate the need to administer age-appropriate live and live attenuated immunizations according to immunization guidelines prior to initiation of treatment with IMAAVY.

RELEVANT INCLUSION/EXCLUSION CRITERIA FROM CLINICAL TRIAL

ENERGY Study

Fattizzo et al (2026)¹ conducted a phase 3, randomized, multicenter, double-blind (DB), placebo (PBO)-controlled study to evaluate the safety and efficacy of IMAAVY in adults with wAIHA.

Inclusion Criteria

• Patients who participated in the trial should be up to date on all appropriate vaccinations prior to screening as per routine local medical guidelines.²
  • It was strongly recommended that patients must have completed a locally approved (or emergency use–authorized) coronavirus disease (COVID-19) vaccination regimen ≥2 weeks prior to study-related visits or procedures.
  • Patients should follow applicable local vaccine labeling, guidelines, and standards-of-care for patients receiving immune-targeted therapy when determining an appropriate interval between vaccination and study enrollment.

Exclusion Criteria

• Patients should not have received a live viral or bacterial vaccine within 4 weeks prior to the first dose of study drug or have a known need to receive a live viral or bacterial vaccine during the study or within ≥8 weeks after the last dose of study drug.²
• Patients participating in the trial should not have had a Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to the first dose of study drug and must agree not to receive a BCG vaccination during the study and within 8 weeks after receiving the last dose of study drug.²

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 31 August 2026.