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Nausea and vomiting management strategy for TRODELVY
What to know when developing a nausea and vomiting adverse reaction plan
Patient Education
Educating patients about nausea and vomiting
It’s important to explain the risks of nausea and vomiting to your patients, including when they may occur, as well as steps that their healthcare team may take to support them, including premedications, other supportive measures, and take-home medications with clear instructions.
Instruct patients to immediately contact their healthcare provider if they experience uncontrolled nausea or vomiting.1
Be Aware and Prepare
TRODELVY is emetogenic and can cause severe nausea and vomiting.1
Among patients treated with TRODELVY in the clinical trials:
- 64% of all patients treated with TRODELVY experienced nausea
- 3% of patients experienced Grade 3-4 nausea
- 35% of all patients treated with TRODELVY experienced vomiting
- 2% of these patients experienced Grade 3-4 vomiting
Withhold TRODELVY doses for Grade 3-4 nausea or Grade 3-4 vomiting at the time of scheduled treatment administration, and resume with additional supportive measures when resolved to ≤Grade 1.
Premedication guidance1
Prior to each dose of TRODELVY, premedication for prevention of CINV is recommended
- Premedicate with a 2- or 3-drug combination (eg, dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist, as well as other drugs as needed)
- Additional antiemetics and other supportive measures may also be employed as clinically indicated
Note: All patients should be given take-home medications with clear instructions for prevention and treatment of delayed nausea and vomiting
- Be sure to advise patients of the risk of nausea and vomiting
- Instruct patients to immediately contact their healthcare provider if they experience uncontrolled nausea or vomiting
MANAGEMENT STRATEGIES
Strategies to help proactively monitor and manage nausea and vomiting
When a patient starts receiving TRODELVY, it is key to stay alert to any adverse reactions they may experience. This can help you tailor a plan to each patient.
Monitor
Remind patients to monitor and report any nausea or vomiting they experience1
If the patient experiences nausea or vomiting, first determine the severity.
NCI CTCAE Version 5.0 nausea grade scale2 |
|
|---|---|
|
Grade 1 |
Loss of appetite without alteration in eating habits |
|
Grade 2 |
Oral intake decreased without significant weight loss, dehydration, or malnutrition |
|
Grade 3 |
Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated |
|
Grade 4 |
- |
|
Grade 5 |
- |
NCI CTCAE Version 5.0 vomiting grade scale2 |
|
|---|---|
|
Grade 1 |
Intervention not indicated |
|
Grade 2 |
Outpatient IV hydration; medical intervention indicated |
|
Grade 3 |
Tube feeding, TPN, or hospitalization indicated |
|
Grade 4 |
Life-threatening consequences |
|
Grade 5 |
Death |
Manage1
To manage Grade 1-2 nausea or vomiting:
- Employ additional antiemetics. Other supportive measures may also be employed as clinically indicated
- Ensure all patients have been given take-home medications with clear instructions
- Reinforce open and honest communication with your patients
To manage Grade 3-4 nausea or vomiting that is not controlled with antiemetics:
- Withhold TRODELVY until resolved to ≤Grade 1
- Reduce 1 dose level for each occurrence or discontinue according to the dosage reduction level information below
- Employ additional antiemetics. Other supportive measures may also be employed as clinically indicated
- Ensure all patients have been given take-home medications with clear instructions
- Reinforce open and honest communication with your patients
Dosage reduction levels1
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Recommended starting dose
10
mg/kg
Once weekly on Days 1 and 8 of 21-day treatment cycles
First dose reduction
7.5
mg/kg
Second dose reduction
5
mg/kg
Requirement for further dose reduction
Permanently
discontinue
Do not reescalate the TRODELVY dose after a dose reduction for adverse reactions has been made.1
Schedule a visit with your Gilead Oncology Nurse Educator (ONE) or sign up to receive more information from your ONE
5-HT3=5-hydroxytryptamine type 3; IV=intravenous; NK1=neurokinin-1 receptor; TPN=total parenteral nutrition.
References: 1. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025. 2. National Cancer Institute, Division of Cancer Treatment & Diagnosis (DCTD). Common Terminology Criteria for Adverse Events (CTCAE). Version 5.0. National Institutes of Health. Published November 27, 2017. Accessed October 10, 2025.
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TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:
- Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
- 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.
Important Safety Information
Tap for Important Safety Information, including BOXED WARNING: Neutropenia and Diarrhea.
Boxed Warning: neutropenia and diarrhea
- TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 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.
- 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.
Contraindications
- Severe hypersensitivity reaction to TRODELVY.
Warnings and precautions
Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. 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. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.
Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, 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 substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.
Hypersensitivity 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, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.
Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.
Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.
Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. 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.
Adverse Reactions
In the pooled safety population, the most common (≥25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).
In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.
In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.
Drug Interactions
UGT1A1 Inhibitors: 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. Avoid administering UGT1A1 inhibitors with TRODELVY.
UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.
Please see full Prescribing Information, including BOXED WARNING.