Breast cancer:

Indications for TRODELVY:

Treatment of adults with metastatic triple-negative breast cancer (mTNBC) who have received at least 2 prior therapies for metastatic disease.

Adult:

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:

Not established.

Boxed Warning:

Neutropenia. Diarrhea.

Warnings/Precautions:

Do not substitute Trodelvy 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 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 severe neutropenia. Moderate to severe hepatic impairment. 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).

Pharmacologic Class:

Trop-2 directed antibody and topoisomerase inhibitor conjugate.

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.

Elimination:

Half-life: 16hrs (sacituzumab govitecan-hziy) and 18hrs (free SN-38).

Generic Availability:

NO

How Supplied:

Single-dose vial—1

Pricing for TRODELVY

180mg vial (Qty: 1)
Appx. price $2062
GoodRx