Givosiran: Temperature Excursions
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Givosiran: Temperature Excursions
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The full Prescribing Information for GIVLAARI® (givosiran) 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
Stability data results from 6 batches of finished product were within specification for the samples stored under long-term conditions. Based on the available stability data, the proposed shelf-life is 36 months, not to exceed 25ºC.2 |
Label Information – Additional Stability Information – Abbreviations – References
givlaari prescribing information – Relevant content
The HOW SUPPLIED/STORAGE AND HANDLING provides the following information1:
Storage and Handling
Store at 2°C to 25°C (36°F to 77°F).
Store GIVLAARI in its original container until ready for use.
ADDITIONAL STABILITY INFORMATION
Stability data from 6 batches of finished product, some at full commercial scale, stored for up to 48 months under long term conditions (2-8ºC) and (25ºC/60% RH) and for up to 6 months under accelerated conditions (40ºC/75% RH) according to the ICH guidelines were provided. Samples were stored in the up-right and inverted position to increase the contact time with the stopper. The registration stability batches of medicinal product were identical to those proposed for marketing and were packed in the primary packaging proposed for marketing.2
Samples were tested for the parameters listed in the release specifications, including appearance, assay, purity and impurity, pH, osmolality, particulate matter, bacterial endotoxins, sterility, extractable volume, and container closure integrity, with the exception of identity. The analytical procedures used were stability indicating. All results were within specification for the samples stored under long-term conditions. No significant changes have been observed under the named conditions.2
Based on the available stability data, the proposed shelf-life is 36 months, not to exceed 25ºC. Keep vial in the outer carton to protect from light.2
ICH = International Council for Harmonisation; RH = relative humidity.
Updated 21 August 2024
1. GIVLAARI (givosiran) Prescribing Information. Cambridge, MA: Alnylam Pharmaceuticals, Inc.
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MED-US-AS1-2000033 7.0 Approved through Aug 2026 |
