Dosing, Administration, Reconstitution, and Storage Information for Sacituzumab Govitecan-hziy

Sacituzumab govitecan-hziy is indicated for the treatment of adult patients with metastatic triple-negative breast cancer who have received ≥2 prior systemic therapies, with ≥1 previous systemic therapies being for metastatic disease.¹

The recommended dose of sacituzumab govitecan-hziy is 10 mg/kg administered as an intravenous (IV) infusion once weekly on days 1 and 8 of 21-day treatment cycles.² Treatment is continued until disease progression or unacceptable toxicity.² Sacituzumab govitecan-hziy is administered as an IV infusion only. It should never be administered as an IV push or bolus.¹

The first infusion should be administered over 3 hours. The patient should be observed during the infusion and for ≥30 minutes following the initial dose for any signs or symptoms of infusion-related reactions.² Subsequent infusions can be administered over 1 to 2 hours if prior infusions were tolerated, with reduced chair time resulting in shorter patient waiting times and reducing patient exposure during the current COVID-19 pandemic. The patient should always be observed during and after infusions for ≥30 minutes.²

Prior to each dose of sacituzumab govitecan-hziy, premedications for prevention of infusion reactions and prevention of chemotherapy-induced nausea and vomiting are recommended.² Premedicate patients with antipyretics such as acetaminophen or ibuprofen, and H1 blockers such as cyclizine along with H2 blockers such as cimetidine, prior to infusion.² Corticosteroids may be used for patients who had prior infusion reactions.² Premedicate patients with a 2- or 3-drug combination regimen (eg, dexamethasone with either a 5-HT₃ receptor antagonist, such as ondansetron or an NK1 receptor antagonist, as well as other drugs as indicated).²

Sacituzumab govitecan-hziy for injection is a sterile, off-white to yellowish lyophilized powder in a single-dose vial containing 180 mg of drug, individually boxed in a carton.¹ The vials should be stored in a refrigerator at 2°C to 8°C (36°F-46°F) in the original carton to protect from light until time of reconstitution.¹ Trodelvy diluted solution, if not given immediately, should be refrigerated and administered within 4 hours of reconstitution, including infusion time.¹

The required dose in milligrams is calculated based on the patient’s body weight. Inject 20 mL 0.9% sodium chloride into each 180-mg vial, forming a 10-mg/mL solution. Gently swirl the vials and allow 15 minutes to dissolve, do not shake, and use the solution immediately to prepare a diluted sacituzumab govitecan-hziy infusion solution.¹

Sacituzumab govitecan-hziy is a cytotoxic drug and so all applicable special handling and disposal procedures should be followed as per the sacituzumab govitecan-hziy official prescribing information.¹

Always follow the sacituzumab govitecan-hziy product information to ensure correct steps are taken when storing, reconstituting, and administering sacituzumab govitecan-hziy.¹

References

1. Trodelvy (sacituzumab govitecan-hziy) [package insert]. Foster City, CA: Gilead Sciences, Inc; April 2021.
2. Trodelvy (sacituzumab govitecan-hziy) dosing, reconstitution and administration guide. www.trodelvyhcp.com/-/media/project/trodelvy/trodelvyhcp/files/dosing-reconstitution-admin-booklet.pdf. Accessed November 28, 2021.