Vutrisiran: Vaccines
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The full Prescribing Information for AMVUTTRA® (vutrisiran) is provided here. Alnylam Pharmaceuticals does not recommend the use of its products in any manner that is inconsistent with the approved Prescribing Information. This resource may contain information that is not in the approved Prescribing Information.
If you are seeking additional scientific information related to Alnylam medicines, you may visit the Alnylam US Medical Affairs website at RNAiScience.com.
Summary
In the vutrisiran phase 3 studies, patients were permitted to receive vaccines as concomitant medications2,3: o In HELIOS-A, 60 of 122 patients (49.2%) in the vutrisiran group received viral vaccines, the majority of which were COVID-19 vaccines and influenza vaccines.4 o In HELIOS-B, 202 of 326 patients (62.0%) in the vutrisiran group received viral vaccines, including 118 COVID-19 vaccines and 84 influenza vaccines.5 The safety or efficacy of vutrisiran with regard to vaccine administration was not evaluated as part of the HELIOS-A and HELIOS-B studies.6,7 Information regarding the timing of vaccine administration in relation to vutrisiran administration is not available. The timing of vaccine administration for patients receiving vutrisiran is at the clinical discretion of the healthcare professional. |
Updated 24 September 2025
1. AMVUTTRA (vutrisiran) Prescribing Information. Cambridge, MA: Alnylam Pharmaceuticals, Inc.
2. Alnylam Pharmaceuticals. Data on file. MED-ALL-TTRSC02-2300015.
4. Alnylam Pharmaceuticals. Data on file. MED-ALL-TTRSC02-2200006.
5. Alnylam Pharmaceuticals. Data on file. MED-ALL-VUTRI-2500043.
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MED-ALL-TTRSC02-2200052 3.0 Approved through Oct 2027 |