Active Ingredient: Sacituzumab govitecan
Sacituzumab govitecan as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 10 milligrams sacituzumab govitecan per kilogram of body weight, one dose, over the duration of 7 days. Afterwards, intravenous, 10 milligrams sacituzumab govitecan per kilogram of body weight, one dose, over the duration of 14 days.
The recommended dose of sacituzumab govitecan is 10 mg/kg body weight administered as an intravenous infusion once weekly on Day 1 and Day 8 of 21-day treatment cycles. Treatment should be continued until disease progression or unacceptable toxicity.
Prior to each dose of sacituzumab govitecan, treatment for prevention of infusion-related reactions and prevention of chemotherapy-induced nausea and vomiting (CINV) is recommended.
The infusion rate of sacituzumab govitecan should be slowed down or infusion interrupted if the patient develops an infusion-related reaction. Sacituzumab govitecan should be permanently discontinued if life-threatening infusion-related reactions occur.
Dose modifications to manage adverse reactions of sacituzumab govitecan are described in the table below. The sacituzumab govitecan dose should not be re-escalated after a dose reduction for adverse reactions has been made.
Recommended dose modifications for adverse reactions:
No dose adjustment is required in patients ≥65 years old. Data from sacituzumab govitecan in patients ≥75 years are limited.
Sacituzumab govitecan is for intravenous use only. It must be administered as an intravenous infusion, not as an intravenous push or bolus.
First infusion: the infusion should be administered over a period of 3 hours.
Subsequent infusions: the infusion should be administered over a period of 1 to 2 hours if prior infusions were tolerated.
Patients have to be observed during each infusion and for at least 30 minutes after each infusion for signs or symptoms of infusion-related reactions.
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