Givosiran: Temperature Excursions
Givosiran: Temperature Excursions
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
In the case of a minor excursion during the phase 3 ENVISION study, the investigational product could still be used. Excursions were considered minor if 2: o Temperatures were ≥ -20°C and < 2°C for ≥ 1 hour and ≤ 24 hours, or o Between > 8 °C and ≤ 40 °C for ≥ 1 hour and ≤ 24 hours. |
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
The ENVISION study was a phase 3, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of givosiran in patients with a documented diagnosis of AHP. Enrolled patients were randomized on a 1:1 basis to receive subcutaneous injections of givosiran 2.5 mg/kg (n=48) or placebo (n=46) once a month for 6 months, followed by an optional 30-month OLE. The primary endpoint was the annualized rate of composite porphyria attacks among patients with AIP at 6 months.3,4
During the ENVISION study, minimally acceptable standards pertaining to the receipt, storage, preparation, dispensing, administration, reconciliation, and return of the investigational product were provided to the trial sites.2
Minor excursions, including temperatures ≥ -20°C and < 2°C or between > 8 °C and ≤ 40 °C for ≥ 1 hour and ≤ 24 hours, were required to be documented and reported. In the case of a minor excursion, the investigational product could still be used.2
AHP = acute hepatic porphyria; AIP = acute intermittent porphyria; OLE = open-label extension
Updated 13 July 2026
1. GIVLAARI (givosiran) Prescribing Information. Cambridge, MA: Alnylam Pharmaceuticals, Inc.
2. Alnylam Pharmaceuticals. Data on file.
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MED-US-AS1-2000033 8.0 Approved through Jul 2028 |
