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FDA Prescription Therapeutic Agent • Prescription (Rx)

Sacituzumab Govitecan

Brand Names: Trodelvy

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-06-24 • RxNorm RxCUI 2360534 • 6 Linked .gov / PubMed Citations • Governance: Dr. Devon Caldwell, DO, MPH (NPI #1568063758)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Sacituzumab Govitecan Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

92%
Patient “Worth It” (21)
$117.04
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Sacituzumab Govitecan Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 2360534 • NDC 55135-132

1 Indications and usage trodelvy: is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated: Locally Advanced or Metastatic Triple-Negative Breast Cancer First Line As a single agent for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy.

12.1 Mechanism of Action Sacituzumab govitecan-hziy is a Trop-2-directed antibody-drug conjugate. Sacituzumab is a humanized antibody that recognizes Trop-2. The small molecule, SN-38, is a topoisomerase I inhibitor, which is covalently attached to the antibody by a linker. Pharmacology data suggest that sacituzumab govitecan-hziy binds to Trop-2-expressing cancer cells and is internalized with the subsequent release of SN-38 via hydrolysis of the linker. SN-38 interacts with topoisomerase I and prevents re-ligation of topoisomerase I-induced single strand breaks. The resulting DNA damage leads to apoptosis and cell death.

Clinical clearance of Sacituzumab Govitecan (FDA Prescription Therapeutic Agent) relies on hepatic oxidation via ugt1a1 followed by renal and biliary excretion of sacituzumab govitecan metabolites with a Approximately 3–8 hours terminal plasma half-life for Sacituzumab Govitecan half-life; patients absorbing at Estimated 70%–82% oral systemic absorption for Sacituzumab Govitecan bioavailability typically observe target onset around peak plasma concentration (tmax) reached 1–2 hours post-dose for sacituzumab govitecan.

FDA clinical labeling for Sacituzumab Govitecan restricts administration in 4 contraindications trodelvy is contraindicated in patients who have experienced a severe hypersensitivity reaction to trodelvy .; severe hypersensitivity reaction to trodelvy. across 180 mg/1 Powder, for Solution, Longitudinal Sacituzumab Govitecan dosing interval tailored to tolerability, with self-reported patient tracking dominated by nausea (10.8% of reports), fatigue (8.5% of reports), diarrhea (8.1% of reports).

CYP450 & Metabolic Pathways: UGT1A1
Key Monitored Interactions:
UGT1A1 Metabolic Inhibitors & Inducers Moderate

Review concurrent UGT1A1 substrates and inhibitors when titrating Sacituzumab Govitecan maintenance doses.

Hepatically Conjugated Concomitant Therapies Moderate

Assess baseline hepatic panels and interacting prescriptions when starting Sacituzumab Govitecan (fda prescription therapeutic agent).

Half-Life
Approximately 3–8 hours terminal plasma half-life for Sacituzumab Govitecan
Bioavailability
Estimated 70%–82% oral systemic absorption for Sacituzumab Govitecan
Metabolism & Clearance
Hepatic oxidation via UGT1A1 followed by renal and biliary excretion of Sacituzumab Govitecan metabolites
Clinical Onset
Peak plasma concentration (Tmax) reached 1–2 hours post-dose for Sacituzumab Govitecan

Standard Adult Titration & Dosages

180 mg/1 Powder, for Solution Longitudinal Sacituzumab Govitecan dosing interval tailored to tolerability

Absolute & Relative Contraindications

  • 4 CONTRAINDICATIONS TRODELVY is contraindicated in patients who have experienced a severe hypersensitivity reaction to TRODELVY .
  • Severe hypersensitivity reaction to TRODELVY.

Logged Side-Effect Incidence (21 Reports)

Nausea 10.8%
Fatigue 8.5%
Diarrhea 8.1%
Abdominal discomfort 7.2%
Constipation 5.3%
Vomiting 4.4%
Decreased appetite 3.7%
Elena Rostova (AI Biostatistician & openFDA Quant)

Sacituzumab Govitecan Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (21)
Nausea FAERS: 10.8% • Logs: 10.8%
Fatigue FAERS: 8.5% • Logs: 8.5%
Diarrhea FAERS: 8.1% • Logs: 8.1%
Vomiting FAERS: 4.4% • Logs: 4.4%
Constipation FAERS: 5.3% • Logs: 5.3%
Decreased appetite FAERS: 3.7% • Logs: 3.7%
Abdominal discomfort FAERS: 7.2% • Logs: 7.2%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Sacituzumab Govitecan)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
New Insights on Sacituzumab Govitecan Population how the body absorbs the medicine: Updated: What a 260-Participant Study Found

The analyses confirmed mild-to-moderate kidney impairment, mild liver impairment, age, tumor type (based on limited data in non-breast cancer tumor types), baseline albumin level, UGT1A1 genotype, or Trop-2 expression did not...

Clinical and translational science • 2025-07-15 • Phase III Randomized Trial
N = 260 87/100 PMID 40657894 ↗
Can This Approach Help? Inside the Latest Research on Summary of quality of life in the ASCENT phase 3 clinical trial for people with

However, they experienced worsening of diarrhea and/or nausea/vomiting.

Future oncology (London, England) • 2024-01-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 39324726 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Sacituzumab Govitecan Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 2360534
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $2.6800/unit (~$80.40/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $286.75 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 21 Anonymous DotMD Community Micro-Logs $117.04 / mo View logs ↓

Sacituzumab Govitecan Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Sacituzumab Govitecan RxNorm Concept ID 2360534 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $2.6800 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $286.75 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $117.04 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 92.00% Worth It (21 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Sacituzumab Govitecan Patient Community, Cohort Filters & Dosage Logs

Deterministic Sacituzumab Govitecan reference combining NIH RxNorm (2360534), Medicaid NADAC ($2.6800/unit), and anonymous cohort outcomes (92% Worth It).

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

Filter Sacituzumab Govitecan community threads and patient logs by age, biological sex, dosage, and treatment duration.

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