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Trodelvy Sacituzumab Govitecan 180 mg Powder, For Solution, 1 vial — NDC 55135-132-01 (Billing 55135-0132-01)

by Gilead Sciences, Inc. · 1 VIAL in 1 BOX / 1 POWDER, FOR SOLUTION in 1 VIAL

This is a package of 1 vial of Trodelvy Sacituzumab Govitecan 180 mg Powder, For Solution from Gilead Sciences, Inc., marketed since Apr 2020 and currently FDA-listed. It is this product's only package size.

NDC 55135-0132-01
🏷️ FDA NDC (as labeled) 55135-132-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 55135-132-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
55135 labeler · 132 product · 01 package
Package marketed since
Apr 23, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
1 EA per package
Barcode (UPC-A, from the NDC)
3 5513513201 1
Medicaid fills, this package
7,565 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55135-132-01
Product NDC 55135-132
11-digit billing NDC 55135013201
NCPDP billing unit EA — each (per item)
RxCUI 2360534, 2360539
UNII M9BYU8XDQ6
Application # BLA761115
SPL Set ID 57a597d2-03f0-472e-b148-016d7169169d
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-04-22
Route INTRAVENOUS
Dosage form POWDER, FOR SOLUTION
Substance SACITUZUMAB GOVITECAN
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21551065402120
GCN Seq No 080965
GCN 47953
HICL code 046478
Ingredient (HICL) Sacituzumab Govitecan-Hziy
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1K
Therapeutic class — specific (HIC3) Antineoplastics Antibody/Antibody-Drug Complexes
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name TRODELVY 180 MG VIAL
FDB brand name Trodelvy
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 080965
  • GCN: 47953
  • GPI-14 (Medi-Span): 21551065402120
  • HICL (First Databank): 046478
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2360534
Why two NDCs? The FDA registers this code as 55135-132-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 55135-0132-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other monoclonal antibodies and antibody drug conjugates class.

Drug family (ATC) Other monoclonal antibodies and antibody drug conjugates
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name TRODELVY 180 MG VIAL Ingredient Sacituzumab Govitecan-Hziy

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $2,225.69 —
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9317 $37.640 / J9317 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)55135-132-01
11-digit billing NDC55135-0132-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9317
DescriptorINJECTION, SACITUZUMAB GOVITECAN-HZIY, 2.5 MG
Billing units / pkg72 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 2.5 mg, so one package = 72 billing units.
Medicare Part B spend (2026 (Q1))$66,915,389 · 6,486 claims · $10,316.90 per claim (all NDCs under J9317)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
55135-0132-01 You're viewing this Main listing 1 VIAL in 1 BOX / 1 POWDER, FOR SOLUTION in 1 VIAL 2020-04-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Trodelvy 180 mgthis 55135-0132-01 Gilead 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2020
First FDA approval
Apr 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2032
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2032. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 22, 2020 ⏳ ~5.5 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Trodelvysacituzumab govitecan-hziy
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2020 2022 2024 2026 2028 2030 2032
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateApr 22, 2032
Common questions
Is there a biosimilar for TRODELVY 180 MG VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2GNK67Q0C4
    A chemical buffer that helps maintain the pH (acidity level) of a medication. It keeps the drug stable and prevents it from breaking down in the stomach or bloodstream.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII B8WCK70T7I
    Trehalose is a natural sugar made from two glucose molecules linked together. It's used in medicines as a filler to add bulk, a sweetener for taste, and a stabilizer to help keep active ingredients effective during storage.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerGilead Sciences, Inc.
FDA applicationBLA761115 (BLA)
Labeler code55135
First marketedApr 2020
Product typeHuman Prescription Drug
Portfolio42 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

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 ≤ 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 during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.

( 2.1 , 2.4 , 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.

If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses. ( 2.4 , 5.2 )

🎯 Indications and Usage ~2 min read ▾

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. ( 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 ≥ 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–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

( 1.1 , 14.2 )

1.1Locally Advanced or Metastatic Triple-Negative Breast Cancer First Line TRODELVY as a single agent is indicated 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. TRODELVY, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 [Combined Positive Score (CPS ≥ 10)] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .

Second Line or Later TRODELVY is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.

1.2Locally Advanced or Metastatic HR-positive, HER2-negative Breast Cancer TRODELVY is indicated 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–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Do NOT substitute TRODELVY for or use with other drugs containing irinotecan or its active metabolite SN-38. ( 2 ) Premedication for prevention of infusion reactions and of chemotherapy-induced nausea and vomiting is recommended. ( 2.1 ) The recommended dosage as a single agent or in combination with pembrolizumab is 10 mg/kg on Days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity.

( 2.3 ) Monitor patients during the infusion and for at least 30 minutes after completion of infusion. Treatment interruption and/or dose reduction may be needed to manage adverse reactions. ( 2.4 , 2.5 ) See Full Prescribing Information for preparation and administration instructions.

( 2.4 )

2.1Important Use Information and Premedication Do NOT substitute TRODELVY for or use with other drugs containing irinotecan or its active metabolite SN-38. Premedication Prior to each dose of TRODELVY, premedication for prevention of infusion reactions and of chemotherapy-induced nausea and vomiting (CINV) is recommended. Premedicate with antipyretics, H1 and H2 blockers prior to infusion, and corticosteroids may be used for patients who had prior infusion reactions.

Premedicate with a 2 or 3 drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK 1 receptor antagonist, as well as other drugs as indicated). Prophylaxis for Neutropenia Primary prophylaxis with granulocyte colony-stimulating factor (G-CSF) is recommended starting in the first cycle for all patients at increased risk of febrile neutropenia [see Warnings and Precautions (5.1) ] .

2.2Patient Selection for Combination Therapy Select patients for treatment of unresectable locally advanced or metastatic TNBC with TRODELVY in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, based on the tumor expression of PD-L1 as confirmed by an FDA-authorized test [see Clinical Studies (14.1) ] . Information on FDA-authorized tests is available at http://www.fda.gov/companiondiagnostics .

2.3Recommended Dosage The recommended dosage of TRODELVY as a single agent or in combination with pembrolizumab is 10 mg/kg administered as an intravenous infusion on Days 1 and 8 of each 21-day cycle. Continue TRODELVY until disease progression or unacceptable toxicity. Do not administer TRODELVY at doses greater than 10 mg/kg.

When TRODELVY is administered in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, discontinue pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, after approximately 24 months. Refer to the Prescribing Information for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the recommended dosing information.

2.4Dosage Modifications for Adverse Reactions Management of adverse reactions may require temporary interruption, dose reduction, or permanent discontinuation of TRODELVY as described in Tables 1 and 2. Do not re-escalate the TRODELVY dose after a dose reduction for adverse reactions has been made. Table 1: Dosage Reduction Levels Dose Reduction Permanently discontinue TRODELVY in patients unable to tolerate 5 mg/kg.

Dosage and Schedule First Reduce to 7.5 mg/kg Second Reduce to 5 mg/kg The recommended dosage modifications for adverse reactions are provided in Table 2. Table 2: Dosage Modifications for Adverse Reactions Adverse reactions Severity Dose Modification Neutropenia [see Warnings and Precautions (5.1) ] Grade 3-4 neutropenia (Absolute Neutrophil Count [ANC] <1,000/mm 3 ) or febrile neutropenia Withhold TRODELVY until ANC ≥1500/mm 3 for Day 1 dose or ANC ≥1000/mm 3 for Day 8 Dose Administer G-CSF during treatment as clinically indicated.

Reduce one dose level for each occurrence of febrile neutropenia or prolonged Grade 3-4 neutropenia, or permanently discontinue according to Table 1. Nausea/Vomiting/ Diarrhea [see Warnings and Precautions (5.2 , 5.4) ] Grade 3-4 nausea, vomiting or diarrhea that is not controll… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 32 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 180 mg off-white to yellowish lyophilized powder in a single-dose vial. For injection: 180 mg lyophilized powder in single-dose vials for reconstitution. ( 3 )

⛔ Contraindications 33 words ▾

4 CONTRAINDICATIONS TRODELVY 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 ~3 min read ▾

5 WARNINGS AND PRECAUTIONS 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 )

5.1Neutropenia 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 to 1022 days). Neutropenia occurred earlier in patients with reduced UGT1A1 activity [see Warnings and Precautions (5.5) ] .

Neutropenic colitis occurred in 1.4% of patients. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities [see Dosage and Administration (2.1) ] . Monitor absolute neutrophil count (ANC) during treatment.

Withheld TRODELVY for ANC below 1500/mm 3 on Day 1 of any cycle or below 1000/mm 3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Dose modifications may be required due to neutropenia.

Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 [see Dosage and Administration (2.4) ] .

5.2Diarrhea TRODELVY can cause severe diarrhea. Diarrhea occurred in 62% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 10% of all patients treated with TRODELVY.

One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.6% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea at the time of scheduled treatment administration and resume when resolved to ≤ Grade 1 [see Dosage and Administration (2.4) ].

At the onset of diarrhea, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte replacement) may also be employed as clinically indicated.

Patients who exhibit an excessive cholinergic response to treatment with TRODELVY (e.g., abdominal cramping, diarrhea, salivation, etc.) can receive appropriate premedication (e.g., atropine) for subsequent treatments.

5.3Hypersensitivity and Infusion-Related Reactions TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, and skin reactions [see Contraindications (4) ] . Hypersensitivity reactions occurred in 28% of patients treated with TRODELVY with 13% occurring within 24 hours of dosage.

Grade 3-4 hypersensitivity occurred in 1.5% of patients treated with TRODELVY with 0.4% of these occurring within 24 hours of dosage. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.4%. The incidence of anaphylactic reaction was <0.1%.

Premedication for infusion react… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 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 ≥ 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 ≥25%) 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 lactate dehydrogenase, vomiting, abdominal pain, headache, increased eosinophils, and decreased albumin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-888-983-4668 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The pooled safety population described in the Warnings and Precautions section reflect exposure to TRODELVY as a single agent in 1354 patients, which included 641 patients with mTNBC and 322 patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer from ASCENT-03, IMMU-132-01, ASCENT, and TROPiCS-02; and 391 patients with other tumor types.

TRODELVY was administered as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles at doses of 10 mg/kg until disease progression or unacceptable toxicity. Among the 1354 patients treated with TRODELVY, the median duration of treatment was 4.9 months (range: 0 to 63 months). In this pooled safety population, the most common (> 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (83%), decreased neutrophil count (77%), decreased hemoglobin (71%), nausea (63%), diarrhea (62%), decreased lymphocyte count (60%), fatigue (59%), alopecia (47%), increased glucose (40%), constipation (37%), vomiting (33%), decreased albumin (32%), increased alkaline phosphatase (30%) decreased appetite (28%), abdominal pain (27%), decreased creatinine clearance (27%), decreased magnesium (26%), and decreased potassium (26%).

The data described in the following section reflects exposure to TRODELVY in combination with intravenous pembrolizumab in 221 patients with PD-L1 positive TNBC from ASCENT-04. Among the 221 patients who received TRODELVY in combination with intravenous pembrolizumab, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased neutrophil count and decreased hemoglobin (86% each), decreased leukocyte count (84%), diarrhea (72%), nausea (68%), decreased lymphocyte count (61%), fatigue (58%), alopecia (52%), increased alkaline phosphatase and increased glucose (50% each), increased alanine aminotransferase (47%), constipation (41%), increased aspartate aminotransferase (40%), rash (37%), decreased potassium (35%), increased lactate dehydrogenase (34%), vomiting (29%), abdominal pain, headache, increased eosinophils (26% each) and decreased albumin (25%).

Locally Advanced or Metastatic Triple-Negative Breast C… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 109 words ▾

7 DRUG INTERACTIONS UGT1A1 Inhibitors or Inducers : Avoid concomitant use. ( 7 )

7.1Effect of Other Drugs on TRODELVY UGT1A1 Inhibitors Avoid administering UGT1A1 inhibitors with TRODELVY. SN-38 is a UGT1A1 substrate. Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38 [see Warnings and Precaution (5.5) and Clinical Pharmacology (12.3 , 12.5) ] .

UGT1A1 Inducers Avoid administering UGT1A1 inducers with TRODELVY. SN-38 is a UGT1A1 substrate. Concomitant administration of TRODELVY with inducers of UGT1A1may reduce exposure to SN-38 [see Warnings and Precaution (5.5) and Clinical Pharmacology (12.3 , 12.5) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. TRODELVY contains a genotoxic component, SN-38, and is toxic to rapidly dividing cells [see Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1) ] .

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 – 4% and 15 – 20%, respectively.

Data Animal data There were no reproductive and developmental toxicology studies conducted with sacituzumab govitecan-hziy.

8.2Lactation Risk Summary There is no information regarding the presence of sacituzumab govitecan-hziy or SN-38 in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 1 month after the last dose of TRODELVY.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to the initiation of TRODELVY. Contraception Females TRODELVY can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose.

Males Because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose. Infertility Females Based on findings in animals, TRODELVY may impair fertility in females of reproductive potential [see Nonclinical Toxicology (13.1) ] .

8.4Pediatric Use Safety and effectiveness of TRODELVY have not been established in pediatric patients.

8.5Geriatric Use As a Single Agent Of the 641 patients with TNBC who were treated with TRODELVY in clinical studies, 20% of patients were 65 years and older and 5% were 75 years and older. No overall differences in effectiveness were observed between patients ≥ 65 years of age and younger adult patients. Patients 65 and older had an increased incidence of neutropenia with fatal outcomes.

Of the 322 patients with HR+/HER2- breast cancer who were treated with TRODELVY, 26% of patients were 65 years and older and 6% were 75 years and older. No overall differences in effectiveness were observed between patients ≥ 65 years of age and younger patients. There was a higher discontinuation rate due to adverse reactions in patients aged 65 years or older (14%) compared with younger patients (3%).

In Combination with Pembrolizumab Of the 221 patients with TNBC who were treated with TRODELVY in combination with pembrolizumab in ASCENT-04, 26% of patients were 65 years and older and 5% were 75 years and older. No overall differences in effectiveness were observed between patients ≥ 65 years of age and younger adult patients. There was a higher rate of serious adverse reactions in patients aged 65 years or older (31%) compared with younger adult patients (26%).

8.6Hepatic Impairment The safety of TRODELVY in patients with moderate (total bilirubin > 1.5 to 3 × ULN) or severe (total bilirubin > 3 × ULN) hepatic impairment has not been established. TRODELVY has not been evaluated in patients with AST or ALT > 3 ULN without liver metastases, or AST or ALT > 5 ULN with liver metastases.

🤰 Pregnancy 133 words ▾

8.1Pregnancy Risk Summary Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. TRODELVY contains a genotoxic component, SN-38, and is toxic to rapidly dividing cells [see Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1) ] .

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 – 4% and 15 – 20%, respectively.

Data Animal data There were no reproductive and developmental toxicology studies conducted with sacituzumab govitecan-hziy.

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and effectiveness of TRODELVY have not been established in pediatric patients.

🧓 Geriatric Use 212 words ▾

8.5Geriatric Use As a Single Agent Of the 641 patients with TNBC who were treated with TRODELVY in clinical studies, 20% of patients were 65 years and older and 5% were 75 years and older. No overall differences in effectiveness were observed between patients ≥ 65 years of age and younger adult patients. Patients 65 and older had an increased incidence of neutropenia with fatal outcomes.

Of the 322 patients with HR+/HER2- breast cancer who were treated with TRODELVY, 26% of patients were 65 years and older and 6% were 75 years and older. No overall differences in effectiveness were observed between patients ≥ 65 years of age and younger patients. There was a higher discontinuation rate due to adverse reactions in patients aged 65 years or older (14%) compared with younger patients (3%).

In Combination with Pembrolizumab Of the 221 patients with TNBC who were treated with TRODELVY in combination with pembrolizumab in ASCENT-04, 26% of patients were 65 years and older and 5% were 75 years and older. No overall differences in effectiveness were observed between patients ≥ 65 years of age and younger adult patients. There was a higher rate of serious adverse reactions in patients aged 65 years or older (31%) compared with younger adult patients (26%).

🆘 Overdosage 38 words ▾

10 OVERDOSAGE In a clinical trial, planned doses of up to 18 mg/kg (approximately 1.8 times the maximum recommended dose of 10 mg/kg) of TRODELVY were administered. In these patients, a higher incidence of severe neutropenia was observed.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism 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.

Sacituzumab govitecan-hziy decreased tumor growth in mouse xenograft models of triple-negative breast cancer.

12.2Pharmacodynamics The TRODELVY exposure-response relationships and pharmacodynamic time course for efficacy have not been fully characterized. Cardiac electrophysiology At the recommended dose, the maximum mean change from baseline was 9.7 msec (the upper bound of the two-sided 90% confidence interval is 16.8 msec). The increase in QTc was concentration dependent based on SN-38 concentrations.

12.3Pharmacokinetics The serum pharmacokinetics of sacituzumab govitecan-hziy and SN-38 were estimated in patients with mBC who received sacituzumab govitecan-hziy at the approved recommended dosage as a single agent or in combination with pembrolizumab and are presented as mean (%CV) unless otherwise specified. The pharmacokinetic parameters of sacituzumab govitecan-hziy and free SN-38 are presented in Table 13. No clinically significant differences in the pharmacokinetics of sacituzumab govitecan or SN-38 were observed when coadministered with pembrolizumab.

Table 13: Summary of Mean PK Parameters (CV%) of Sacituzumab Govitecan-hziy and Free SN-38 Parameters estimated based on population PK analyses as a single-agent Sacituzumab govitecan-hziy (N=827) Free SN-38 (N=827) C max : maximum serum concentration from 0-168 hours after the first dose AUC 0-168h : area under serum concentration curve through 168 hours after the first dose C max [ng/mL] 25,7107 (18%) 108 (39%) AUC 0-168h [ng*h/mL] 12,049,500 (18%) 3,510 (63%) Distribution Sacituzumab govitecan-hziy steady state volume of distribution is

4.6L. Elimination The median elimination half-life (t 1/2 ) of sacituzumab govitecan-hziy is 6.5 days and free SN-38 is 22 hours. The terminal half-life (t 1/2 ) of sacituzumab govitecan-hziy is 6.7 days (23%) and the apparent half-life (t 1/2 ) of free SN-38 is 24 hours (50%). The clearance of sacituzumab govitecan-hziy is

0.13L/h (20%). Renal elimination is known to contribute minimally to the excretion of SN-38, the small molecule moiety of sacituzumab govitecan-hziy. Metabolism No metabolism studies with sacituzumab govitecan-hziy were conducted.

SN-38 (the small molecule moiety of sacituzumab govitecan-hziy) is metabolized via UGT1A1. The glucuronide metabolite of SN-38 (SN-38G) was detectable in the serum of patients. Specific Populations No clinically significant differences in the pharmacokinetics of sacituzumab govitecan-hziy were observed based on: age (27 to 88 years), race (75% White, 8% Asian, or 5% Black), or CLcr 30 to 89 mL/min.

There are no data on the pharmacokinetics of sacituzumab govitecan-hziy in patients with CLcr 15 to 29 mL/min, or end-stage renal disease (CLcr < 15 mL/min). Patients with Hepatic Impairment The exposure of sacituzumab govitecan-hziy for patients with mild hepatic impairment (total bilirubin ≤ ULN with AST > ULN, or bilirubin > 1 to ≤

1.5ULN with any AST) is within range of that of patients with normal hepatic function (total bilirubin and AST < ULN). Sacituzumab govitecan-hziy and free SN-38 exposures are unknown in patients with moderate (total bilirubin > 1.5 to 3 × ULN) or severe (total bilirubin > 3 × ULN) hepatic impairment. Drug Interaction Studies No drug-drug interaction studies were conducted with sacituzumab govitecan-hziy or its compon… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 100 words ▾

12.1Mechanism 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.

Sacituzumab govitecan-hziy decreased tumor growth in mouse xenograft models of triple-negative breast cancer.

📦 How Supplied / Storage and Handling 79 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING TRODELVY (sacituzumab govitecan-hziy) for injection is a sterile, off-white to yellowish lyophilized powder in a single-dose vial. Each TRODELVY vial is individually boxed in a carton: NDC 55135-132-01 contains one 180 mg vial Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of reconstitution. Do not freeze.

TRODELVY is a hazardous drug. Follow applicable special handling and disposal procedures 1 .

📦 Storage and Handling 41 words ▾

Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of reconstitution. Do not freeze. TRODELVY is a hazardous drug. Follow applicable special handling and disposal procedures 1 .

📋 Description 195 words ▾

11 DESCRIPTION Sacituzumab govitecan-hziy is a Trop-2 directed antibody and topoisomerase inhibitor conjugate, composed of the following three components: the humanized monoclonal antibody, hRS7 IgG1κ (also called sacituzumab), which binds to Trop-2 (the trophoblast cell-surface antigen-2); the drug SN-38, a topoisomerase inhibitor; a hydrolysable linker (called CL2A), which links the humanized monoclonal antibody to SN-38. The recombinant monoclonal antibody is produced by mammalian (murine myeloma) cells, while the small molecule components SN-38 and CL2A are produced by chemical synthesis.

Sacituzumab govitecan-hziy contains on average 7 to 8 molecules of SN-38 per antibody molecule. Sacituzumab govitecan-hziy has a molecular weight of approximately 160 kilodaltons. Sacituzumab govitecan-hziy has the following chemical structure.

TRODELVY (sacituzumab govitecan-hziy) for injection is a sterile, preservative-free, off-white to yellowish lyophilized powder for intravenous use in a 50 mL clear glass single-dose vial, with a rubber stopper and crimp-sealed with an aluminum flip-off cap. Each single-dose vial of TRODELVY delivers 180 mg sacituzumab govitecan-hziy, 71.7 mg 2-(N-morpholino) ethane sulfonic acid (MES), 1.8 mg polysorbate 80 and 153.99 mg trehalose. Reconstitution with 20 mL of 0.9% Sodium Chloride Injection, USP, results in a concentration of 10 mg/mL with a pH of 6.5.

Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION 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 Warnings and Precautions (5.3) ] .

Nausea/Vomiting Advise patients of the risk of nausea and vomiting. Premedication according to established guidelines with a two or three drug regimen for prevention of chemotherapy-induced nausea and vomiting (CINV) is also recommended. Additional antiemetics, sedatives, and other supportive measures may also be employed as clinically indicated.

All patients should receive take-home medications for preventing and treating delayed nausea and vomiting, with clear instructions. Instruct patients to immediately contact their healthcare provider if they experience uncontrolled nausea or vomiting [see Warnings and Precautions (5.4) ] . Embryo-Fetal Toxicity Advise female patients to contact their healthcare provider if they are pregnant or become pregnant.

Inform female patients of the risk to a fetus and potential loss of the pregnancy [see Use in Specific Populations (8.1) ]. Contraception Advise female patients of reproductive potential to use effective contraception during treatment and for 6 months after the last dose of TRODELVY [see Use in Specific Populations (8.3) ] . Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of TRODELVY [see Use in Specific Populations (8.3) ] .

Lactation Advise women not to breastfeed during treatment and for 1 month after the last dose of TRODELVY [see Use in Specific Populations (8.2) ]. Infertility Advise females of reproductive potential that TRODELVY may impair fertility [see Use in Specific Populations (8.3) ].

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics The serum pharmacokinetics of sacituzumab govitecan-hziy and SN-38 were estimated in patients with mBC who received sacituzumab govitecan-hziy at the approved recommended dosage as a single agent or in combination with pembrolizumab and are presented as mean (%CV) unless otherwise specified. The pharmacokinetic parameters of sacituzumab govitecan-hziy and free SN-38 are presented in Table 13. No clinically significant differences in the pharmacokinetics of sacituzumab govitecan or SN-38 were observed when coadministered with pembrolizumab.

Table 13: Summary of Mean PK Parameters (CV%) of Sacituzumab Govitecan-hziy and Free SN-38 Parameters estimated based on population PK analyses as a single-agent Sacituzumab govitecan-hziy (N=827) Free SN-38 (N=827) C max : maximum serum concentration from 0-168 hours after the first dose AUC 0-168h : area under serum concentration curve through 168 hours after the first dose C max [ng/mL] 25,7107 (18%) 108 (39%) AUC 0-168h [ng*h/mL] 12,049,500 (18%) 3,510 (63%) Distribution Sacituzumab govitecan-hziy steady state volume of distribution is

4.6L. Elimination The median elimination half-life (t 1/2 ) of sacituzumab govitecan-hziy is 6.5 days and free SN-38 is 22 hours. The terminal half-life (t 1/2 ) of sacituzumab govitecan-hziy is 6.7 days (23%) and the apparent half-life (t 1/2 ) of free SN-38 is 24 hours (50%). The clearance of sacituzumab govitecan-hziy is

0.13L/h (20%). Renal elimination is known to contribute minimally to the excretion of SN-38, the small molecule moiety of sacituzumab govitecan-hziy. Metabolism No metabolism studies with sacituzumab govitecan-hziy were conducted.

SN-38 (the small molecule moiety of sacituzumab govitecan-hziy) is metabolized via UGT1A1. The glucuronide metabolite of SN-38 (SN-38G) was detectable in the serum of patients. Specific Populations No clinically significant differences in the pharmacokinetics of sacituzumab govitecan-hziy were observed based on: age (27 to 88 years), race (75% White, 8% Asian, or 5% Black), or CLcr 30 to 89 mL/min.

There are no data on the pharmacokinetics of sacituzumab govitecan-hziy in patients with CLcr 15 to 29 mL/min, or end-stage renal disease (CLcr < 15 mL/min). Patients with Hepatic Impairment The exposure of sacituzumab govitecan-hziy for patients with mild hepatic impairment (total bilirubin ≤ ULN with AST > ULN, or bilirubin > 1 to ≤

1.5ULN with any AST) is within range of that of patients with normal hepatic function (total bilirubin and AST < ULN). Sacituzumab govitecan-hziy and free SN-38 exposures are unknown in patients with moderate (total bilirubin > 1.5 to 3 × ULN) or severe (total bilirubin > 3 × ULN) hepatic impairment. Drug Interaction Studies No drug-drug interaction studies were conducted with sacituzumab govitecan-hziy or its components.

Inhibitors or inducers of UGT1A1 may increase or decrease SN-38 exposure, respectively.

🧬 Pharmacodynamics 55 words ▾

12.2Pharmacodynamics The TRODELVY exposure-response relationships and pharmacodynamic time course for efficacy have not been fully characterized. Cardiac electrophysiology At the recommended dose, the maximum mean change from baseline was 9.7 msec (the upper bound of the two-sided 90% confidence interval is 16.8 msec). The increase in QTc was concentration dependent based on SN-38 concentrations.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Locally 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 ≥ 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 from completion of treatment in the curative setting versus recurrent disease > 12 months from completion of treatment in the curative setting, and by geographic region (United States/Canada/Western Europe vs. Rest of World). Patients were randomized (1:1) to one of the following treatment arms; all study medications were administered via intravenous infusion: TRODELVY 10 mg/kg on Days 1 and 8 of a 21-day cycle (n=279) nab-paclitaxel 100mg/m 3 on Days 1, 8, and 15 of a 28-day cycle (n=110), paclitaxel 90 mg/m 2 on days 1, 8, and 15 of a 28-day cycle (n=45), or gemcitabine 1000 mg/m 2 and carboplatin AUC2 on Days 1 and 8 of a 21-day cycle (n=124) Assessment of tumor status was performed every 6 weeks for the first year followed by every 12 weeks thereafter.

Crossover to TRODELVY monotherapy was allowed at the time of disease progression and study treatment discontinuation. The primary efficacy outcome was progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Additional efficacy outcomes measures included overall survival (OS) and objective response rate (ORR).

The median age was 55 years (range: 23-86 years), 26% age 65 or older; 99.5% female; 64% White, 23% Asian, 4.5% American Indian or Alaskan Native, 3.0% Black; and 5.2% not specified , 72% non-Hispanic/non-Latino, 27% Hispanic/Latino, and 0.9% not reported; and 66% ECOG PS of 0 and 34% ECOG PS of 1. Of patients enrolled 31% had de novo disease, 21% had recurrent disease with a disease-free interval (DFI) of 6 to 12 months and 48% had recurrent disease with a DFI of > 12 months. Seventy-six percent of patients had visceral metastasis at baseline; and 5% had previously treated brain metastases.

The majority of patients (99.5%) had tumor CPS < 10, and 0.4% had tumor CPS ≥ 10. The trial demonstrated a statistically significant improvement in PFS. The OS data were immature and a total of 283 (51%) patients had died across both study arms.

Table 14 and Figure 1 summarize the efficacy results for ASCENT-03. Table 14: Efficacy Results from ASCENT-03 TRODELVY N=279 TPC N=279 BICR = Blinded Independent Central Review; CI = Confidence Interval; TPC = Treatment of physician’s choice (gemcitabine and carboplatin, paclitaxel, or nab-paclitaxel) Progression-Free Survival by BICR Number of patients with events (%) 161 (58) 188 (67) Median PFS in months (95% CI) 9.7 (8.1, 11.1) 6.9 (5.6, 8.2) Hazard ratio (95% CI) Hazard ratio based on the stratified Cox proportional hazards model 0.62 (0.50, 0.77) p-value 2-sided p-value based on stratified log-rank test <0.0001 Objective Response Rate by BICR Patients with Measurable Disease at Baseline, N 266 264 ORR (95% CI) 50% (44, 56) 47% (41, 53) Complete re… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 113 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been conducted with sacituzumab govitecan-hziy. SN-38 was clastogenic in an in vitro mammalian cell micronucleus test in Chinese hamster ovary cells and was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay. Fertility studies with sacituzumab govitecan-hziy have not been conducted.

In a repeat-dose toxicity study in cynomolgus monkeys, intravenous administration of sacituzumab govitecan-hziy on Day 1 and Day 4 resulted in endometrial atrophy, uterine hemorrhage, increased follicular atresia of the ovary, and atrophy of vaginal epithelial cells at doses ≥ 60 mg/kg ( ³ 6 times the human recommended dose of 10 mg/kg based on body weight).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 110 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been conducted with sacituzumab govitecan-hziy. SN-38 was clastogenic in an in vitro mammalian cell micronucleus test in Chinese hamster ovary cells and was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay. Fertility studies with sacituzumab govitecan-hziy have not been conducted.

In a repeat-dose toxicity study in cynomolgus monkeys, intravenous administration of sacituzumab govitecan-hziy on Day 1 and Day 4 resulted in endometrial atrophy, uterine hemorrhage, increased follicular atresia of the ovary, and atrophy of vaginal epithelial cells at doses ≥ 60 mg/kg ( ³ 6 times the human recommended dose of 10 mg/kg based on body weight).

📚 References 9 words ▾

15 REFERENCES 1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html .

📄 Patient Package Insert ~3 min read ▾

The Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 06/2026 Patient Information TRODELVY ® (troh-DELL-vee) (sacituzumab govitecan-hziy) for injection, for intravenous use What is the most important information I should know about TRODELVY?

TRODELVY can cause serious side effects, including: Low white blood cell count (neutropenia). Low white blood cell counts can be severe and lead to infections that can be life-threatening or cause death as early as the first cycle of treatment. Your healthcare provider should check your blood cell counts during treatment with TRODELVY and may give a medicine to help prevent low white blood cell count starting in the first cycle of treatment if you have an increased risk for developing low white blood cell count with a fever (febrile neutropenia).

Tell your healthcare provider right away if you develop any of the following signs of infection during treatment with TRODELVY : fever chills cough shortness of breath burning or pain when you urinate Severe diarrhea. Severe diarrhea can lead to loss of too much body fluid (dehydration) and kidney problems. Your healthcare provider should monitor you for diarrhea and give you medicine as needed to help control your diarrhea.

If you lose too much body fluid, your healthcare provider may need to give you fluids and electrolytes to replace body salts. If you develop diarrhea during treatment with TRODELVY, your healthcare provider should check to see if diarrhea may be caused by an infection. Tell your healthcare provider right away: the first time that you get diarrhea during treatment with TRODELVY if you develop black or bloody stools if you develop symptoms of losing too much body fluid and body salts, such as lightheadedness, dizziness or faintness if you cannot take fluids by mouth due to nausea or vomiting if you cannot get your diarrhea under control within 24 hours If you develop serious side effects, your healthcare provider may treat you with certain medicines, delay treatment, lower your dose, or permanently stop treatment with TRODELVY.

See “ What are the possible side effects of TRODELVY? ” for more information about side effects. What is TRODELVY? TRODELVY is a prescription medicine used in adults to treat: Triple-Negative Breast Cancer (TNBC) that has spread to nearby tissues (locally advanced) or other parts of the body (metastatic) As the first treatment: alone when your TNBC cannot be removed by surgery and you are not a candidate for PD-1 or PD-L1 inhibitor-based therapy. with the medicine pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph when your TNBC cannot be removed by surgery and the tumors test positive for PD-L1.

As the second or later treatment: after you have received 2 or more prior therapies throughout the body (systemic) for TNBC that cannot be removed by surgery and at least 1 of the therapies was for metastatic TNBC. Hormone Receptor (HR) positive, Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer that has spread to nearby tissues (locally advanced) or other parts of the body (metastatic) when your HR-positive, HER2-negative breast cancer cannot be removed by surgery and you have received hormonal-based therapy and at least 2 more therapies throughout the body (systemic) for metastatic breast cancer.

It is not known if TRODELVY is safe and effective in children. Who should not receive TRODELVY? Do not receive TRODELVY if you have had a severe allergic reaction to TRODELVY.

Ask your healthcare provider if you are not sure. Before receiving TRODELVY, tell your healthcare provider about all of your medical conditions, including if you: have been told that you carry a gene for uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28. People who carry this gene have an increased risk of getting side effects with TRODELVY, especially low white blood cell counts, a fever while your white blood cell count is low, and low red blood cell counts.

See… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 27 words ▾

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

📄 Package Label / Principal Display Panel 94 words ▾

PRINCIPAL DISPLAY PANEL - 180 mg Vial Label NDC 55135-132-01 Rx only TRODELVY ® sacituzumab govitecan-hziy For injection 180 mg per vial For intravenous infusion only Warning: Hazardous Drug Single-dose vial Discard unused portion 90370103 PRINCIPAL DISPLAY PANEL - 180 mg Vial Label

PRINCIPAL DISPLAY PANEL - 180 mg Vial Box NDC 55135-132-01 Rx only TRODELVY ® sacituzumab govitecan-hziy For injection 180 mg per vial For intravenous infusion only Warning: Hazardous Drug Reconstitute and dilute immediately prior to use Single-dose vial Discard unused portion 1 Vial PRINCIPAL DISPLAY PANEL - 180 mg Vial Box

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
7.6K
Units reimbursed last 4 qtrs
21.1K
Gross reimbursed last 4 qtrs
$46.91M
Avg / prescription
$6,201.34
Avg / unit
$2,225.66
Latest quarter Q4 2025
1.4KRx
Fee-for-service vs managed care ⓘ
29% FFS 71% MCO
Fee-for-service · 2,214 Rx Managed care · 5,351 Rx
State Medicaid map
Alaska: no data reported AK Maine: 47 units · 3.4 per 100k residents ME Washington: 114 units · 1.5 per 100k residents WA Idaho: no data reported ID Montana: 44 units · 3.9 per 100k residents MT North Dakota: no data reported ND Minnesota: 212 units · 3.7 per 100k residents MN Wisconsin: 441 units · 7.5 per 100k residents WI Michigan: 574 units · 5.7 per 100k residents MI New York: 2,222 units · 11.4 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 191 units · 4.5 per 100k residents OR Nevada: 990 units · 31.0 per 100k residents NV Wyoming: 66 units · 11.3 per 100k residents WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,330 units · 10.6 per 100k residents IL Indiana: 720 units · 10.5 per 100k residents IN Ohio: 1,303 units · 11.1 per 100k residents OH Pennsylvania: 559 units · 4.3 per 100k residents PA New Jersey: 692 units · 7.4 per 100k residents NJ Massachusetts: 487 units · 7.0 per 100k residents MA California: 2,347 units · 6.0 per 100k residents CA Utah: no data reported UT Colorado: 115 units · 2.0 per 100k residents CO Nebraska: 42 units · 2.1 per 100k residents NE Missouri: 268 units · 4.3 per 100k residents MO Kentucky: 354 units · 7.8 per 100k residents KY West Virginia: no data reported WV Virginia: 706 units · 8.1 per 100k residents VA Maryland: 684 units · 11.1 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 472 units · 6.4 per 100k residents AZ New Mexico: 83 units · 3.9 per 100k residents NM Kansas: 115 units · 3.9 per 100k residents KS Arkansas: 218 units · 7.1 per 100k residents AR Tennessee: 757 units · 10.6 per 100k residents TN North Carolina: 427 units · 3.9 per 100k residents NC South Carolina: 54 units · 1.0 per 100k residents SC Delaware: 32 units · 3.1 per 100k residents DE Oklahoma: 58 units · 1.4 per 100k residents OK Louisiana: 190 units · 4.2 per 100k residents LA Mississippi: 59 units · 2.0 per 100k residents MS Alabama: 308 units · 6.0 per 100k residents AL Georgia: 368 units · 3.3 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,373 units · 4.5 per 100k residents TX Florida: 1,046 units · 4.6 per 100k residents FL
Units reimbursed · per 100k residents
1.031.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Nevada 31.0 /100k
2 New York 11.4 /100k
3 Wyoming 11.3 /100k
4 Maryland 11.1 /100k
5 Ohio 11.1 /100k
6 Tennessee 10.6 /100k
7 Illinois 10.6 /100k
8 Indiana 10.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Trodelvy — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Trodelvy. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.78M
Claims incl. refills
100
Beneficiaries
38
Spend / beneficiary
$46,905.16
Spend / claim
$17,823.96
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for SACITUZUMAB GOVITECAN — the ingredient across all brands.

Top reported reactions

Disease Progression1,294
Diarrhoea561
Neutropenia510
Death462
Fatigue265
Nausea265
Asthenia206

Age at onset

Infant1
Adult1,832
Elderly743

Reporter sex

0 reports
Male · 6%
Female · 94%

Serious outcomes

Hospitalization1,231
Life-threatening186
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Gilead Sciences, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Gilead Sciences, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9317 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 55132-0038-15 · TRUECARE 55147-0001-00 · Minneapolis →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.