Trodelvy

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).

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).