Trodelvy® (sacituzumab govitecan-hziy)

Density and Specific Gravity

This document is in response to your unsolicited request for information regarding the density and specific gravity of Trodelvy® (sacituzumab govitecan-hziy [SG]).

Some data may be outside of the US FDA-approved Prescribing Information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA approved prescribing information.

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.

Density1

During the manufacturing process, SG is provided as a frozen aqueous solution which is thawed prior to lyophilization. The density of the SG solution prior to lyophilization is 1.0057 g/mL.

The density of the reconstituted SG (reconstituted with 0.9% sodium chloride) at 20°C is 1.012 g/mL. The density of the 0.9% sodium chloride diluent used for reconstitution at 20°C is 1.005 g/mL.

Specific Gravity

Gilead is unable to provide information pertaining to the specific gravity of SG.

Please refer to and follow institutional guidelines when considering use of formulas or calculations.

References

1. Gilead Sciences Inc. Data on File.

Product Label

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

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 Pharmacovigilance and Epidemiology ☎ 1-800-445-3235, option 3 or
 https://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

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