Vutrisiran: Storage and Stability

Vutrisiran: Storage and Stability

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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.

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 Summary

Index

Label Information – Relevant Information – Abbreviations – References

 AMVUTTRA Prescribing Information – Relevant Content

The HOW SUPPLIED/STORAGE AND HANDLING section provides the following information1:

How Supplied

AMVUTTRA is a sterile, preservative-free, clear, colorless-to-yellow solution for subcutaneous injection. AMVUTTRA is supplied as 25 mg/0.5 mL solution in a single-dose 1‑mL prefilled syringe made from Type I glass with stainless steel 29-gauge needle with a needle shield. The prefilled syringe components are not made with natural rubber latex.

AMVUTTRA is available in cartons containing one single-dose prefilled syringe each.

Storage and Handling

Store at 2°C to 30°C (36°F to 86°F) in the original carton, until ready for use. Do not freeze.

 Relevant Information

The expiration date provided for each syringe should be used to determine if the product has expired. The shelf life of vutrisiran when stored at 2°C to 30°C (36°F to 86°F) is 36 months.2

Product Stability

The stability of vutrisiran finished product was assessed from three commercial scale batches stored for up to 9 months under long term conditions (2°C to 8°C, 25°C/60% RH, and 30°C/75% RH) and for 6 months under accelerated conditions (40°C/75% RH) following the ICH guidelines. Samples were stored horizontally, where horizontal position was considered as worst case due to maximal contact of the aqueous finished product with the plunger and tip cap.3

Samples were tested for appearance, purity, assay, pH, osmolality, particulate matter, volume in container, bacterial endotoxins, sterility, container closure integrity, and mechanism syringe performance. There were no significant changes observed in any of the attributes at either long-term or accelerated conditions.3

Photostability testing was conducted on one batch in accordance with the ICH guideline Q1B. The vutrisiran finished product was considered to be photostable.3

Exposure to thermal cycling for four times between -20°C to 40°C for three consecutive days at each condition showed no adverse effects on the quality of the vutrisiran finished product.3

 Abbreviations

C = Celsius; F = Fahrenheit; ICH = International Council for Harmonisation; RH = relative humidity.

Updated 2 June 2025

 References

1.  AMVUTTRA (vutrisiran) Prescribing Information. Cambridge, MA: Alnylam Pharmaceuticals, Inc.

2.  Alnylam Pharmaceuticals. Data on file. MED-US-TTRSC02-2200052.

3.  AMVUTTRA : EPAR – Public assessment report. European Medicines Agency. Published July 21, 2022. Accessed June 2, 2025. https://www.ema.europa.eu/en/documents/assessment-report/amvuttra-epar-public-assessment-report_en.pdf.