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:
| Adverse reaction | Occurrence | Dose modification | |
|---|---|---|---|
| Severe neutropenia | |||
| Grade 4 | neutropenia ≥7 days or less if clinically indicated, OR Grade 3-4 febrile neutropenia, OR At time of scheduled treatment, Grade 3-4 neutropenia which delays dosing by 2 or 3 weeks for recovery to ≤ Grade 1 | First | Administer granulocyte- colony stimulating factor (GCSF) as soon as clinically indicated |
| Second | 25% dose reduction; administer G-CSF as soon as clinically indicated | ||
| Third | 50% dose reduction; administer G-CSF as soon as clinically indicated | ||
| Fourth | Discontinue treatment; administer G-CSF as soon as clinically indicated | ||
| At time of scheduled treatment, Grade 3-4 neutropenia which delays dosing beyond 3 weeks for recovery to ≤ Grade 1 | First | Discontinue treatment; administer G-CSF as soon as clinically indicated | |
| Severe non-neutropenic toxicity | |||
| Grade 4 | non-hematologic toxicity of any duration, OR Any Grade 3-4 nausea, vomiting or diarrhoea due to treatment that is not controlled with antiemetics and anti-diarrhoeal agents, OR Other Grade 3-4 non-hematologic toxicity persisting >48 hours despite optimal medical management, OR At time of scheduled treatment, Grade 3-4 non-neutropenic hematologic or non-hematologic toxicity, which delays dose by 2 or 3 weeks for recovery to ≤ Grade 1 | First | 25% dose reduction |
| Second | 50% dose reduction | ||
| Third | Discontinue treatment | ||
| In the event of Grade 3-4 non-neutropenic hematologic or non- hematologic toxicity, Grade 3 nausea or Grade 3-4 vomiting, which does not recover to ≤ Grade 1 within 3 weeks | First | Discontinue treatment | |
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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