Bladder, kidney, and other urologic cancers:
Indications for: TRODELVY
Locally advanced or metastatic urothelial cancer (mUC) in adults who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
Adult Dosage:
Premedicate with antipyretics, H1 and H2 blockers prior to infusion; may use corticosteroids for those with prior infusion reactions. Also, can premedicate with a 2 or 3 drug combination regimen (eg, dexamethasone with either a 5-HT3 or NK1 receptor antagonist, others). Give by IV infusion over 3hrs for 1st infusion, then over 1–2hrs for subsequent infusions if tolerated. 10mg/kg (max dose) once weekly on Days 1 and 8 of 21-day cycles. Continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.
Children Dosage:
Not established.
Boxed Warning:
Neutropenia. Diarrhea.
TRODELVY Warnings/Precautions:
Not substitutable for or use with other drugs containing irinotecan or its active metabolite SN-38. Risk for severe neutropenia. Withhold therapy if ANC <1500/mm3 on Day 1 of any cycle, neutrophil count <1000/mm3 on Day 8 of any cycle, or neutropenic fever occurs. Monitor CBCs periodically during treatment. Consider G-CSF for secondary prophylaxis. Initiate anti-infective treatment without delay if febrile neutropenia occurs. Risk for severe diarrhea (monitor and evaluate for infectious causes if occurs), nausea, vomiting. Withhold dose for Grade 3/4 diarrhea, Grade 3 nausea, Grade 3/4 vomiting; resume when resolved to Grade ≤1; give loperamide, additional antiemetics, and other supportive measures as clinically indicated. Monitor closely for hypersensitivity and infusion-related reactions during and for at least 30mins after each infusion. Permanently discontinue if life-threatening infusion-related reactions occur. Patients homozygous for UGT1A1*28 allele. Monitor closely in those with reduced UGT1A1 activity for adverse reactions; withhold or permanently discontinue based on severity of reactions. Moderate (total bilirubin >1.5–3×ULN) or severe (total bilirubin >3×ULN) hepatic impairment: not established. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).
TRODELVY Classification:
Trop-2 directed antibody and topoisomerase inhibitor conjugate.
TRODELVY Interactions:
May be potentiated by UGT1A1 inhibitors; avoid. May be antagonized by UGT1A1 inducers; avoid.
Adverse Reactions:
Nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, rash, decreased appetite, abdominal pain; lab abnormalities, hypersensitivity reactions.
Drug Elimination:
Half-life: 15.3 hours (sacituzumab govitecan-hziy); 19.7 hours (free SN-38).
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1
Breast cancer:
Indications for: TRODELVY
Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) in adults who have received 2 or more prior systemic therapies, at least 1 of them for metastatic disease. Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in adults who have received endocrine-based therapy and at least 2 systemic therapies in the metastatic setting.
Adult Dosage:
Premedicate with antipyretics, H1 and H2 blockers prior to infusion; may use corticosteroids for those with prior infusion reactions. Also, can premedicate with a 2 or 3 drug combination regimen (eg, dexamethasone with either a 5-HT3 or NK1 receptor antagonist, others). Give by IV infusion over 3hrs for 1st infusion, then over 1–2hrs for subsequent infusions if tolerated. 10mg/kg (max dose) once weekly on Days 1 and 8 of 21-day cycles. Continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.
Children Dosage:
Not established.
Boxed Warning:
Neutropenia. Diarrhea.
TRODELVY Warnings/Precautions:
Not substitutable for or use with other drugs containing irinotecan or its active metabolite SN-38. Risk for severe neutropenia. Withhold therapy if ANC <1500/mm3 on Day 1 of any cycle, neutrophil count <1000/mm3 on Day 8 of any cycle, or neutropenic fever occurs. Monitor CBCs periodically during treatment. Consider G-CSF for secondary prophylaxis. Initiate anti-infective treatment without delay if febrile neutropenia occurs. Risk for severe diarrhea (monitor and evaluate for infectious causes if occurs), nausea, vomiting. Withhold dose for Grade 3/4 diarrhea, Grade 3 nausea, Grade 3/4 vomiting; resume when resolved to Grade ≤1; give loperamide, additional antiemetics, and other supportive measures as clinically indicated. Monitor closely for hypersensitivity and infusion-related reactions during and for at least 30mins after each infusion. Permanently discontinue if life-threatening infusion-related reactions occur. Patients homozygous for UGT1A1*28 allele. Monitor closely in those with reduced UGT1A1 activity for adverse reactions; withhold or permanently discontinue based on severity of reactions. Moderate (total bilirubin >1.5–3×ULN) or severe (total bilirubin >3×ULN) hepatic impairment: not established. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).
TRODELVY Classification:
Trop-2 directed antibody and topoisomerase inhibitor conjugate.
TRODELVY Interactions:
May be potentiated by UGT1A1 inhibitors; avoid. May be antagonized by UGT1A1 inducers; avoid.
Adverse Reactions:
Nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, rash, decreased appetite, abdominal pain; lab abnormalities, hypersensitivity reactions.
Drug Elimination:
Half-life: 15.3 hours (sacituzumab govitecan-hziy); 19.7 hours (free SN-38).
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1
