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Sacituzumab Govitecan Dosage

Medically reviewed by Drugs.com. Last updated on Aug 13, 2020.

Applies to the following strengths: 180 mg

Usual Adult Dose for Breast Cancer

10 mg/kg IV over 3 hours on Days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity
Maximum dose: 10 mg/kg

Recommended premedications:
-Premedicate with antipyretics, H1 and H2 blockers prior to infusion, and corticosteroids may be used for patients who had prior infusion reactions.
-Premedicate with a 2 or 3 drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist, and other drugs if needed).

Comments:
-The initial infusion should be given over 3 hours; if tolerated, subsequent infusions may be given over 1 to 2 hours.
-Observe patients during the infusion and for at least 30 minutes after for infusion-related reactions.
-Prior to each dose, premedication for prevention of infusion reactions and chemotherapy-induced nausea and vomiting (CINV) is recommended.
-Premedicate with antipyretics, H1 and H2 blockers prior to infusion, and corticosteroids may be used for patients who had prior infusion reactions.
-Premedicate with a 2 or 3 drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist, as well as other drugs as indicated).

Use: For the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (mTNBC) who have received 2 or more prior systemic therapies, at least one of them for metastatic disease

Usual Adult Dose for Urothelial Carcinoma

10 mg/kg IV over 3 hours on Days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity
Maximum dose: 10 mg/kg

Recommended premedications:
-Premedicate with antipyretics, H1 and H2 blockers prior to infusion, and corticosteroids may be used for patients who had prior infusion reactions.
-Premedicate with a 2 or 3 drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist, and other drugs if needed).

Comments:
-The initial infusion should be given over 3 hours; if tolerated, subsequent infusions may be given over 1 to 2 hours.
-Observe patients during the infusion and for at least 30 minutes after for infusion-related reactions.
-Prior to each dose, premedication for prevention of infusion reactions and chemotherapy-induced nausea and vomiting (CINV) is recommended.
-Premedicate with antipyretics, H1 and H2 blockers prior to infusion, and corticosteroids may be used for patients who had prior infusion reactions.
-Premedicate with a 2 or 3 drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist, as well as other drugs as indicated).

Use: For the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild hepatic impairment: No adjustment recommended.
Severe hepatic impairment: Data not available

Dose Adjustments

DOSE MODIFICATIONS FOR ADVERSE REACTIONS:
INFUSION-RELATED REACTIONS:
-Slow or interrupt the infusion rate for infusion-related reactions.
-Permanently discontinue therapy for life-threatening infusion-related reactions.
-Do not re-escalate the dose after a reduction for adverse reactions has been made.
SEVERE NEUTROPENIA:
-Grade 4 neutropenia for 7 days or more OR Grade 3 febrile neutropenia (absolute neutrophil count less than 1000/mm3 and fever 38.5C or higher), OR at time of scheduled therapy, Grade 3 or 4 neutropenia which delays dosing by 2 or 3 weeks for recovery to Grade 1 or less:
1) First occurrence: Reduce dose by 25% and administer granulocyte-colony stimulation factor (G-CSF)
2) Second occurrence: Reduce dose by 50%
3) Third occurrence: Discontinue therapy
-At time of scheduled therapy, Grade 3 to 4 neutropenia which delays dosing beyond 3 weeks for recovery to Grade 1 or less:
1) First occurrence: Discontinue therapy
SEVERE NONNEUTROPENIC TOXICITY:
-Grade 4 non-hematologic toxicity of any duration, OR any Grade 3 or 4 nausea, vomiting or diarrhea due to therapy that is not controlled with antiemetics and anti-diarrheal agents, OR other Grade 3 or 4 non-hematologic toxicity persisting for 48 hours or longer despite optimal medical management, OR at time of scheduled therapy, Grade 3 or 4 nonneutropenic hematologic or nonhematologic toxicity, which delays dose by 2 or 3 weeks for recovery to Grade 1 or less:
1) First occurrence: Reduce dose by 25%
2) Second occurrence: Reduce dose by 50%
3) Third occurrence: Discontinue therapy
-In the event of Grade 3 or 4 nonneutropenic hematologic or nonhematologic toxicity, which does not recover to Grade 1 or less within 3 weeks:
1) First occurrence: Discontinue therapy

Precautions

US BOXED WARNINGS:
NEUTROPENIA:
-Severe neutropenia may occur.
Recommendations:
-Withhold this drug for absolute neutrophil count below 1500/mm3 or neutropenic fever.
-Monitor blood cell counts periodically during therapy.
-Consider G-CSF for secondary prophylaxis.
-Initiate anti-infective treatment in patients with febrile neutropenia.
DIARRHEA:
-Severe diarrhea may occur.
Recommendations:
-Monitor patients with diarrhea and give fluid and electrolytes as needed.
-Administer atropine, if not contraindicated, for early diarrhea of any severity.
-At the onset of late diarrhea, evaluate for infectious causes and, if negative, initiate loperamide.
-If severe diarrhea occurs, withhold this drug until resolved to Grade 1 or less and reduce subsequent doses.

CONTRAINDICATIONS:
-Hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Administer this drug as an IV infusion only; do not administer as an IV push or bolus.
-Do not substitute this drug for or use with other drugs containing irinotecan or its active metabolite SN-38.
-Administer this drug as an IV infusion.
-Protect infusion bag from light.
-An infusion pump may be used.
-Do not mix this drug, or administer as an infusion, with other medicinal products.
-When the infusion is complete, flush the IV line with 20 mL 0.9% sodium chloride injection.

Storage requirements:
-Do not freeze or shake.
-Protect from light.
-Store unopened vials in a refrigerator at 2C to 8C (36F to 46F) in the original carton to protect from light until time of reconstitution.

Reconstitution/preparation techniques:
-The manufacturer product information should be consulted.

IV compatibility:
-Compatible with 0.9% sodium chloride injection.

General:
-This drug is cytotoxic; follow applicable special handling and disposal procedures.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.