Vutrisiran: Surgical Procedures

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Summary

 In the HELIOS-A study, patients who had a major surgery planned within 3 months or anticipated surgery during the study (through Month 18) were excluded from enrollment. Patients who had a liver transplant or were likely to undergo liver transplantation during the study were also excluded from enrollment.1

 In the HELIOS-B study, patients who had a prior or anticipated (during the first 12 months after randomization) heart, liver, or other organ transplant or implantation of left-ventricular assist device were excluded from enrollment. There were no additional exclusion criteria regarding surgical procedures.2

 A cumulative post-marketing review of Alnylam Pharmaceuticals’ global safety database did not identify any safety concerns involving surgical procedures related to the use of vutrisiran.3

 No additional information is available regarding the incidence of surgical procedures, including orthopedic procedures, in the HELIOS-A and HELIOS-B studies.

Updated 29 September 2025

References

1. Alnylam Pharmaceuticals. Data on file. MED-ALL-TTRSC02-2300015.

2. Protocol for: Fontana M, Berk JL, Gillmore JD, et al. Vutrisiran in patients with transthyretin amyloidosis with cardiomyopathy. N Engl J Med. 2025;392(1):33-44. doi:10.1056/NEJMoa2409134

3. Alnylam Pharmaceuticals. Data on file. MED-ALL-VUTRI-2500021.


MED-ALL-VUTRI-2500044 1.0 Approved through Oct 2027

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