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    Stability of Unopened Vials after Temperature Excursion (Single and Multiple Excursions)

Trodelvy® (sacituzumab govitecan-hziy)
Stability of Unopened Vials after Temperature Excursion (Single and Multiple Excursions)

Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.

Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.

Trodelvy® (sacituzumab govitecan)

Stability of Unopened Vials After Single and Multiple Temperature Excursions

This document is in response to your request for extended storage and stability information of Trodelvy® (sacituzumab govitecan [SG]) unopened vials after single and multiple temperature excursions. This document does not intend to offer an opinion regarding the clinical relevance of these data or the advisability of storing or administering any drug in a manner inconsistent with its approved labeling. Trodelvy® (SG) should be stored according to the product label.

The full indication, important safety information, and boxed warnings for neutropenia and diarrhea are available at:
www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.

Relevant Product Labeling1

How Supplied/Storage and Handling

Store SG vials in a refrigerator at 2°C to 8°C (36–46°F) in the original carton to protect from light until time of reconstitution. Do not freeze.

Alternative Storage and Stability Information2

The tables below summarize available data from in-house studies regarding the storage of unopened SG vials in varying conditions after single (Table 1) and multiple (Table 2) temperature excursions. The “acceptable duration” refers to the stability of unopened SG vials in the specified packaging and storage conditions, but it does not endorse alternative packaging or use beyond the expiration date stated on the original packaging.

Table 1. Summary of Single Temperature Excursion and Duration for SG
Lyophilized Powder2

Storage Condition

Package Type

Acceptable Duration

25°±2°C (77°±3.6°F)/60±5% relative humidity

Unopened vial

22 days

-20°C (-4°F)

Unopened vial

72 hours

Table 2. Summary of Multiple Temperature Excursions and Durations for SG Lyophilized Powder2

Storage Condition

Package Type

Acceptable Duration

-20°C to 25°C (-4°F to 77°F)/
60±5% relative humidity

Unopened vial

Multiple Excursionsa:

  • Low extreme: Up to 3 excursions of 24 hours as low as -20°C (-4°F)

 

And/or

  • High extreme: Up to 3 excursions of 24 hours as high as 25°C (77°F)/ 60±5% relative humidity

aStability data support a total of 6 temperature excursions outside approved storage with a maximum of 3 excursions at each temperature extreme for the same vial. Excursions should not exceed a maximum of 72 hours at either the higher or lower temperature extreme.

Please note that in-house stability studies have not evaluated the stability of unopened SG vials that have been exposed to light.

References

  1. TRODELVY® Gilead Sciences Inc. Trodelvy (sacituzumab govitecan-hziy) for injection, for intravenous use. U.S. Prescribing Information. Foster City, CA.
  2. Gilead Sciences Inc. Data on File

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Product Label

For the full indication, important safety information, and boxed warning(s), please refer to the Trodelvy US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.

Follow-Up

For any additional questions, please contact Trodelvy Medical Information at:

☎1‐888-983-4668 or   www.askgileadmedical.com

Adverse Event Reporting

Please report all adverse events to:

Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
www.gilead.com/utility/contact/report-an-adverse-event

FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or   www.accessdata.fda.gov/scripts/medwatch

Data Privacy

The Medical Information service at Gilead Sciences may collect, store, and use your personal information to provide a response to your medical request. We may share your information with other Gilead Sciences colleagues to ensure that your request is addressed appropriately. If you report an adverse event or concern about the quality of a Gilead or Kite product, we will need to use the information you have given us in order to meet our regulatory requirements in relation to the safety of our medicines.

It may be necessary for us to share your information with Gilead’s affiliates, business partners, service providers, and regulatory authorities located in countries other than your own. Gilead Sciences has implemented measures to protect the personal information you provide. Please see the Gilead Privacy Statement (www.gilead.com/privacy-statements) for more information about how Gilead handles your personal information and your rights. If you have any further questions about the use of your personal information, please contact privacy@gilead.com.

TRODELVY, GILEAD, and the GILEAD logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
© 2025 Gilead Sciences, Inc.

 

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