{ "query": "sacituzumab govitecan", "ingredient": "sacituzumab", "slug": "sacituzumab", "rxcui": "2360231", "brands": [ "Trodelvy" ], "names": [ "sacituzumab", "sacituzumab govitecan", "sacituzumab govitecan-hziy" ], "classes": [], "alternatives": [], "label": { "route_mode": "INTRAVENOUS", "route_counts": { "INTRAVENOUS": 1 }, "boxed_warning": "WARNING: NEUTROPENIA AND DIARRHEA TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm 3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia [see Dosage and Administration (2.4) ] . Initiate anti-infective treatment in patients with febrile neutropenia without delay [see Warnings and Precautions (5.1) ]. TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide [see Warnings and Precautions (5.2) ]. If severe diarrhea occurs, withhold TRODELVY until resolved to \u2264 Grade 1 and reduce subsequent doses [see Dosage and Administration (2.4) ]. WARNING: NEUTROPENIA AND DIARRHEA See full prescribing information for complete boxed warning . TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm 3 or neutropenic fever. Monitor blood cell counts periodically durin...", "indications_and_usage": "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. ( 1.1 , 14.1 ) In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS \u2265 10) as determined by an FDA-authorized test. ( 1.1 , 14.1 ) Second Line or Later For the treatment of adult patients with unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. ( 1.1 , 14.1 ) Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer For the treatment of adult patients with 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\u2013) breast cancer who have received endocrine-bas...", "contraindications": "is contraindicated in patients who have experienced a severe hypersensitivity reaction to TRODELVY [see Warnings and Precautions (5.3) ] . Severe hypersensitivity reaction to TRODELVY. ( 4 , 5.3 )", "warnings_and_cautions": "Hypersensitivity and Infusion-Related Reactions : Hypersensitivity reactions including severe anaphylactic reactions have been observed. Monitor patients for infusion-related reactions. Permanently discontinue TRODELVY if severe or life-threatening reactions occur. ( 5.3 ) Nausea/Vomiting : Use antiemetic preventive treatment and withhold TRODELVY for patients with Grade 3 nausea or Grade 3-4 vomiting at the time of scheduled treatment. ( 5.4 ) Patients with Reduced UGT1A1 Activity : Individuals who are homozygous for the UGT1A1*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia following initiation of TRODELVY. ( 5.5 ) Embryo-Fetal Toxicity : TRODELVY can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ( 5.6 , 8.1 , 8.3 ) 5.1 Neutropenia TRODELVY can cause severe, life-threatening, or fatal neutropenia as early as the first cycle of treatment. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 48% of patients. Febrile neutropenia occurred in 6% of patients. The median time to first onset of neutropenia (including febrile neutropenia) was 19 days (range: 1 ...", "warnings": "", "adverse_reactions": "The following adverse reactions are discussed in greater detail in other sections of the label: Neutropenia [see Warnings and Precautions (5.1) ] Diarrhea [see Warnings and Precautions (5.2) ] Hypersensitivity and Infusion-Related Reactions [see Warnings and Precautions (5.3) ] Nausea and Vomiting [see Warnings and Precautions (5.4) ] The most common adverse reactions including laboratory abnormalities: TRODELVY as a single agent (incidence \u2265 25%) were decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, nausea, diarrhea, decreased lymphocyte count, fatigue, alopecia, increased glucose, constipation, vomiting, decreased albumin, increased alkaline phosphatase, decreased appetite, abdominal pain, decreased creatinine clearance, decreased magnesium, and decreased potassium. ( 6.1 ) TRODELVY in combination with pembrolizumab (incidence \u226525%) were decreased neutrophil count, decreased hemoglobin, decreased leukocyte count, diarrhea, nausea, decreased lymphocyte count, fatigue, alopecia, increased alkaline phosphatase, increased glucose, increased alanine aminotransferase, constipation, increased aspartate aminotransferase, rash, decreased potassium, increased la...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "Indications and Usage ( 1.1 ) 06/2026 Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 ) 06/2026 Warnings and Precautions ( 5.3 ) 06/2026", "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Patient Information ) Neutropenia Advise patients of the risk of neutropenia. Instruct patients to immediately contact their healthcare provider if they experience fever, chills, or other signs of infection [see Warnings and Precautions (5.1) ] . Diarrhea Advise patients of the risk of diarrhea. Instruct patients to immediately contact their healthcare provider if they experience diarrhea for the first time during treatment; black or bloody stools; symptoms of dehydration such as lightheadedness, dizziness, or faintness; inability to take fluids by mouth due to nausea or vomiting; or inability to get diarrhea under control within 24 hours [see Warnings and Precautions (5.2) ]. Hypersensitivity and Infusion-Related Reactions Inform patients of the risk of serious infusion reactions and anaphylaxis. Instruct patients to immediately contact their healthcare provider if they experience facial, lip, tongue, or throat swelling, urticaria, difficulty breathing, lightheadedness, dizziness, chills, rigors, wheezing, pruritus, flushing, rash, hypotension, or fever that occur during or at any time following the infusion [see Warni...", "spl_medguide": "", "clinical_studies": "14.1 Locally Advanced or Metastatic Triple-Negative Breast Cancer (TNBC) Single Agent in Previously Untreated, Unresectable Locally Advanced or Metastatic TNBC ASCENT-03 The efficacy of TRODELVY was evaluated in ASCENT-03 (NCT05382299), a multicenter, open-label, randomized study that enrolled 558 patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who had not received previous systemic therapy for advanced disease and who were not candidates for PD-1 or PD-L1 inhibitor therapy. Patients were enrolled if: Their tumors were PD-L1 negative (defined as having a tumor CPS < 10 using the IHC 22C3 assay), or Their tumors were PD-L1 positive (defined as having a CPS \u2265 10 using the IHC 22C3 assay) and they had received a PD-1 or PD-L1 inhibitor in the (neo)adjuvant setting or if they had a comorbidity precluding treatment with a PD-1 or PD-L1 inhibitor. Patients were excluded if they had received anticancer treatment or surgery within the previous 6 months, had active central nervous system (CNS) metastases and ECOG performance status (PS) >1. Randomization was stratified by de novo metastatic disease vs recurrent disease within 6 to 12 months fro...", "brand_name": "TRODELVY", "manufacturer": "Gilead Sciences, Inc.", "application_number": "BLA761115", "pharm_class_epc": [], "route": [ "INTRAVENOUS" ], "effective_time": "20260624", "set_id": "57a597d2-03f0-472e-b148-016d7169169d", "has_boxed_warning": true, "controlled": false, "mentions_rems": false }, "faers": { "total": 5878, "serious": 5385, "death": 1345, "hospitalization": 1624, "primary_suspect": 5872, "top_reactions": [ [ "Disease Progression", 1648 ], [ "Death", 761 ], [ "Diarrhoea", 723 ], [ "Neutropenia", 641 ], [ "Inappropriate Schedule Of Product Administration", 369 ], [ "Fatigue", 352 ], [ "Nausea", 344 ], [ "Off Label Use", 322 ], [ "Asthenia", 296 ], [ "Febrile Neutropenia", 274 ], [ "Alopecia", 230 ], [ "Triple Negative Breast Cancer", 199 ], [ "Weight Fluctuation", 192 ], [ "Vomiting", 191 ], [ "Anaemia", 186 ] ], "by_year": { "2019": 2, "2020": 114, "2021": 405, "2022": 1413, "2023": 1132, "2024": 1061, "2025": 1235, "2026": 516 }, "by_year_primary": { "2019": 2, "2020": 114, "2021": 405, "2022": 1412, "2023": 1127, "2024": 1061, "2025": 1235, "2026": 516 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [], "recall_total": 0, "drugsfda": { "applications": 1, "nda": 0, "anda": 0, "first_approval": "20200422", "rems": false, "rems_last": "", "labeling_supplements": 0, "labeling_recent": 0, "sponsors": [ "IMMUNOMEDICS INC" ], "unapproved": false, "first_approval_fmt": "04/22/2020" }, "trials": { "total": 272, "completed": 15, "terminated": 17, "with_results": 20, "industry": 148, "phase3": 43, "results_share": 1.3333333333333333, "terminated_share": 0.0625 }, "pubmed": { "rct": 25, "meta": 14, "recent_rct": 24, "cochrane": [] }, "payments": { "year": "2024", "usd": 2797355.98, "records": 4216, "by_name": [ [ "Trodelvy", 2797355.98 ] ], "names_checked": [ "sacituzumab", "Trodelvy" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 319, "beneficiaries": 67, "spend": 6223469.74, "by_brand": [ { "brand": "Trodelvy", "claims": 319, "per_claim": 19509.30953, "is_generic": false } ], "per_claim": 19509.309529780567 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": null, "scores": { "safety": { "score": 58, "letter": "D", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "Death appears in 2.5x the share of reports seen across all of FAERS (-12)" ], "weight": 0.35 }, "evidence": { "score": 47, "letter": "F", "why": [ "25 randomized trials and 14 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)" ], "weight": 0.25 }, "regulatory": { "score": 95, "letter": "A", "why": [ "No recalls on record since 2016", "Label lists recent major changes to warnings or indications (-5)" ], "weight": 0.15 }, "conflict": { "score": 70, "letter": "C", "why": [ "Pharma paid doctors $2,797,356 tied to this drug last year (-30)", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 40, "letter": "F", "why": [ "No generic version approved: brand-only pricing (-30)", "No same-class alternatives found: little leverage to switch (-30)" ], "weight": 0.1 } }, "total": 61, "grade": "D", "questions": [ "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?", "The most-reported problems in FDA's adverse event data are disease progression, death, diarrhoea, neutropenia. How would we recognize and handle those?", "There is no generic. Is there an older generic in the same class that works as well for my situation?", "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }