Management strategies
for select adverse reactions associated with TRODELVY
This interactive resource is designed to guide you through the recommendations for developing a plan to help manage select adverse reactions with TRODELVY.
As you answer the questions, consider reflecting on a patient you’ve treated with TRODELVY. If you haven’t yet treated a patient with TRODELVY, think about a hypothetical case to help ground the information in a clinical context.
Management of adverse reactions may require temporary interruption, dose reduction, or permanent discontinuation of TRODELVY. Please see full Prescribing Information for guidance.
Most people spend about 3-5 minutes on this activity.
Please download the dosing and adverse reaction management guide for more information.
Select an adverse reaction
Neutropenia
Rates of occurrence
TRODELVY can cause severe, life-threatening, or fatal neutropenia as early as the first cycle of treatment.
In TRODELVY monotherapy studies (pooled safety data)
Adverse reaction |
Occurrence in patients treated with TRODELVY |
|---|---|
| Neutropenia | 64% |
| Grade 3-4 neutropenia | 48% |
| Febrile neutropenia | 6% |
| Neutropenic colitis | 1.4% |
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.
TRODELVY as combination therapy with pembrolizumab (safety data)
Adverse reaction |
Occurrence in patients treated with TRODELVY + pembrolizumab |
|---|---|
| Any grade decreased neutrophil count | 86% |
| Grade 3-4 decreased neutrophil count | 50% |
UGT1A1=uridine diphosphate-glucuronosyl transferase 1A1.
Reference: TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
Prior to initiating TRODELVY
G-CSF is recommended for all patients at increased risk of febrile neutropenia
Which risk factors for febrile neutropenia do you see in patients you treat with TRODELVY?
Select all that apply or click Continue if none apply.
G-CSF=granulocyte colony-stimulating factor.
Reference: TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
Prior to initiating TRODELVY
G-CSF considerations
You did not select any risk factors. Here’s what you should know
Even if your patient did not have any of the risk factors listed, there may be additional factors to consider.
Plan for prophylaxis with G-CSF
Primary prophylaxis with G-CSF is recommended in the TRODELVY Prescribing Information starting in the first cycle of treatment for all patients at increased risk of febrile neutropenia, including1:
- Older patients
- Patients with previous neutropenia
- Poor performance status
- Organ dysfunction
- Multiple comorbidities
Prophylactic G-CSF is supported by NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).2
Be ready with G-CSF prophylaxis to help your patients receiving TRODELVY with risk of neutropenia
If patients do not receive primary prophylaxis with G-CSF and experience neutropenia, be ready with G-CSF support as clinically indicated to help appropriate patients stay on therapy.1
G-CSF=granulocyte colony-stimulating factor; NCCN=National Comprehensive Cancer Network.
References: 1. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hematopoietic Growth Factors V.3.2026. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed May 1, 2026. To view the most recent and complete version of the guideline, go to NCCN.org.
Prior to initiating TRODELVY
G-CSF considerations
You selected one or more risk factors
Plan for prophylaxis with G-CSF
Primary prophylaxis with G-CSF is recommended in the TRODELVY Prescribing Information starting in the first cycle of treatment for all patients at increased risk of febrile neutropenia, including1:
- Older patients
- Patients with previous neutropenia
- Poor performance status
- Organ dysfunction
- Multiple comorbidities
Prophylactic G-CSF is supported by NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).2
Be ready with G-CSF prophylaxis to help your patients receiving TRODELVY with risk of neutropenia
If patients do not receive primary prophylaxis with G-CSF and experience neutropenia, be ready with G-CSF support as clinically indicated to help appropriate patients stay on therapy.1
G-CSF=granulocyte colony-stimulating factor; NCCN=National Comprehensive Cancer Network.
References: 1. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hematopoietic Growth Factors V.3.2026. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed May 1, 2026. To view the most recent and complete version of the guideline, go to NCCN.org.
Prior to initiating TRODELVY
NCCN Guidelines for assessing risk for febrile neutropenia
Consider prophylaxis with G-CSF for patients with ≥1 risk factors
The NCCN Guidelines classify sacituzumab govitecan-hziy (TRODELVY®) as intermediate risk (10%-20%) for febrile neutropenia.
- Prophylactic G-CSF may be considered for patients with ≥1 risk factors for febrile neutropenia (shown below)
- If no risk factors, observe
Patient risk factorsa,b
- Prior chemotherapy or radiation therapy
- Persistent neutropenia
- Recent surgery and/or open wounds
- Age >65 years receiving full chemotherapy dose intensity
- Bone marrow involvement by tumor
- Liver dysfunction (ie, bilirubin >2.0 mg/dL)
- Renal dysfunction (ie, creatinine clearance <50 mL/min)
NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
There is currently no consensus nomogram for FN risk assessment. While the NCCN Panel outlines criteria to aid in the assessment of FN risk, independent clinical judgment should be exercised based on the individual patient’s situation.
aOther possible patient risk factors for febrile neutropenia may include poor performance status or HIV infection (in particular, patients with low CD4 counts). The listed patient risk factors are based on a multivariable risk model using a prospective cohort study of several thousand ambulatory patients with cancer receiving chemotherapy. This cohort did not include patients with HIV, acute leukemia, or hematopoietic cell transplant.
bOther factors may warrant the use of G-CSF (eg, chronic immunosuppression in the posttransplant setting, including organ transplant).
If your patient needs G-CSF, don’t delay in submitting a prior authorization request, as it may be required
Ask the following when considering G-CSF:
- Is short-acting or long-acting G-CSF more appropriate for the patient?
- Which G-CSF products are covered by the patient’s insurance plan?
- When is it prudent to have G-CSF products on hand?
- For G-CSF use with the treatment of TRODELVY, what are other factors to consider?
CD4=cluster of differentiation 4; FN=febrile neutropenia; G-CSF=granulocyte colony-stimulating factor; NCCN=National Comprehensive Cancer Network.
Reference: Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hematopoietic Growth Factors V.3.2026. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed May 1, 2026. To view the most recent and complete version of the guideline, go to NCCN.org.
After assessing risk
TRODELVY initiation
You've assessed risk for febrile neutropenia and determined if prophylaxis with G-CSF is recommended
Next, work with your patient to develop a plan for neutropenia management.
Talk with your patient about any previous adverse reactions they experienced, potential adverse reactions, management strategies, and the importance of open and honest communication.
Be aware and prepare
Advise patients of the risk of neutropenia. Instruct and remind them to contact their healthcare provider immediately if they experience any of these signs of infections: fever, chills, cough, shortness of breath, or burning/pain when they urinate.1
Counsel patients about risk mitigation strategies such as2:
Avoiding
germs
Washing their
hands often
Maintaining
good hygiene
Have a conversation to set expectations and reinforce open and honest communication.
Withhold TRODELVY for neutropenic fever.1
Monitor and manage
Monitor blood cell counts periodically throughout treatment.1
To manage Grade 3-4 neutropenia (ANC <1000/mm3) or febrile neutropenia1:
Withhold TRODELVY:
- Until ANC ≥1500/mm3 for Day 1 dose
or - Until ANC ≥1000/mm3 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 dosage reduction levels for TRODELVY (or see table 1 in Prescribing Information).
See the TRODELVY Prescribing Information for recommendations for neutropenia management.
When administering TRODELVY in combination with pembrolizumab or pembrolizumab and berahyaluridase alfa-pmph, interrupt or discontinue one or both drugs of the combination or reduce the dose of TRODELVY to manage adverse reactions as appropriate. Refer to the Prescribing Information for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for recommendations on dosage interruption or discontinuation due to adverse reactions.
Continue to learn more about the recommendations for neutropenia management
ANC=absolute neutrophil count; G-CSF=granulocyte stimulating-colony factor.
References: 1. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026. 2. Infection and neutropenia during cancer treatment. National Cancer Institute. National Institutes of Health, US Department of Health and Human Services. Updated January 23, 2020. Accessed May 22, 2026. https://www.cancer.gov/about-cancer/treatment/side-effects/infection
After initiating TRODELVY
Monitor blood cell counts periodically throughout treatment1
Neutropenia is not always associated with symptoms that can easily be identified visually.2
Consider a patient’s comorbid conditions and adverse reactions with previous cancer treatments when monitoring for symptoms of neutropenia.
First, determine the severity or grade of neutropenia based on absolute neutrophil counts. Use the pop-ups below to review the grade scales.
Choose the patient's ANC level or indicate if febrile to review the recommended next steps.
ANC=absolute neutrophil count; LLN=lower limit of normal; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.
References: 1. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026. 2. Min K, Byeon S. Diagnosis and management of neutropenia. Blood Res. 2025;60(30):1-7. 3. 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 May 1, 2026.
After initiating TRODELVY
Manage
You selected Grade 1 neutropenia (ANC <LLN to 1500/mm3)1
- No dose modifications are recommended in the TRODELVY Prescribing Information.2 Follow your institutional protocols
- Continue to monitor blood cell counts2
When administering TRODELVY in combination with pembrolizumab or pembrolizumab and berahyaluridase alfa-pmph, interrupt or discontinue one or both drugs of the combination or reduce the dose of TRODELVY to manage adverse reactions as appropriate. Refer to the Prescribing Information for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for recommendations on dosage interruption or discontinuation due to adverse reactions.2
Reinforce open and honest communication with your patients.
Recommended for you
Here are some additional resources that you may find helpful to learn more about adverse reaction management or help support your patients:
You’ve reviewed the recommendations for Grade 1 neutropenia. Change the severity or select another adverse reaction to explore more management recommendations.
For full dose modifications for adverse reactions, please see Section 2 in the TRODELVY Prescribing Information.
ANC=absolute neutrophil count; AR=adverse reaction; G-CSF=granulocyte colony-stimulating factor; LLN=lower limit of normal.
References: 1. 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 May 1, 2026. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
After initiating TRODELVY
Manage
You selected Grade 2-4 neutropenia (ANC <1500/mm3)1
Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle.2
To manage Grade 3-4 neutropenia (ANC <1000/mm3)2:
Withhold TRODELVY2:
- Until ANC ≥1500/mm3 for Day 1 dose
or - Until ANC ≥1000/mm3 for Day 8 dose
Administer G-CSF during treatment as clinically indicated.2
For each occurrence of prolonged Grade 3-4 neutropenia, reduce 1 dose level or permanently discontinue according to dosage reduction levels below2:
Dosage reduction levels for TRODELVY2
Scroll left to view
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
In patients unable to tolerate 5 mg/kg
.svg)
PermanentlydiscontinueTRODELVY
NOTE: Do not reescalate the TRODELVY dose after a dose reduction for adverse reactions has been made.2 For more information on dose modifications for neutropenia, please refer to Section 2 of the TRODELVY Prescribing Information.
When administering TRODELVY in combination with pembrolizumab or pembrolizumab and berahyaluridase alfa-pmph, interrupt or discontinue one or both drugs of the combination or reduce the dose of TRODELVY to manage adverse reactions as appropriate. Refer to the Prescribing Information for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for recommendations on dosage interruption or discontinuation due to adverse reactions.2
Discussing dose modifications with patients
Patients may feel nervous, skeptical, or frustrated when hearing that they may have to reduce their treatment dose.
- Reinforce that dose modifications are part of finding a treatment plan that works for each person
- Connect the dose modification back to patient treatment goals
- Share next steps and additional resources with your patient
Recommended for you
Here are some additional resources that you may find helpful to learn more about adverse reaction management or help support your patients:
You’ve reviewed the recommendations for Grade 2-4 neutropenia. Change the severity or select another adverse reaction to explore more management recommendations.
For full dose modifications for adverse reactions, please see Section 2 in the TRODELVY Prescribing Information.
ANC=absolute neutrophil count; G-CSF=granulocyte colony-stimulating factor.
References: 1. 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 May 1, 2026. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
After initiating TRODELVY
Manage
You selected febrile neutropenia1
Withhold TRODELVY2:
- For neutropenic fever
- Until ANC ≥1500/mm3 for Day 1 dose or ANC ≥1000/mm3 for Day 8 dose
Initiate anti-infective treatment without delay.2
Administer G-CSF during treatment as clinically indicated.2
For each occurrence of febrile neutropenia, reduce 1 dose level or permanently discontinue according to dosage reduction levels below2:
Dosage reduction levels for TRODELVY2
Scroll left to view
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
In patients unable to tolerate 5 mg/kg
PermanentlydiscontinueTRODELVY
NOTE: Do not reescalate the TRODELVY dose after a dose reduction for adverse reactions has been made.2 For more information on dose modifications for neutropenia, please refer to Section 2 of the TRODELVY Prescribing Information.
When administering TRODELVY in combination with pembrolizumab or pembrolizumab and berahyaluridase alfa-pmph, interrupt or discontinue one or both drugs of the combination or reduce the dose of TRODELVY to manage adverse reactions as appropriate. Refer to the Prescribing Information for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for recommendations on dosage interruption or discontinuation due to adverse reactions.2
Discussing dose modifications with patients
Patients may feel nervous, skeptical, or frustrated when hearing that they may have to reduce their treatment dose.
- Reinforce that dose modifications are part of finding a treatment plan that works for each person
- Connect the dose modification back to patient treatment goals
- Share next steps and additional resources with your patient
Recommended for you
Here are some additional resources that you may find helpful to learn more about adverse reaction management or help support your patients:
You’ve reviewed the recommendations for febrile neutropenia. Change the severity or select another adverse reaction to explore more management recommendations.
For full dose modifications for adverse reactions, please see Section 2 in the TRODELVY Prescribing Information.
ANC=absolute neutrophil count; AR=adverse reaction; G-CSF=granulocyte colony-stimulating factor.
References: 1. 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 May 1, 2026. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
Diarrhea
Rates of occurrence
TRODELVY can cause severe diarrhea.
In TRODELVY monotherapy studies (pooled safety data)
Adverse reaction |
Occurrence in patients treated with TRODELVY |
|---|---|
| Diarrhea | 62% |
| Grade 3-4 diarrhea | 10% |
| Intestinal perforation following diarrhea | One patient |
| Diarrhea that led to dehydration and subsequent acute kidney failure | 0.6% |
TRODELVY as combination therapy with pembrolizumab (safety data)
Adverse reaction |
Occurrence in patients treated with TRODELVY + pembrolizumab |
|---|---|
| Diarrhea | 72% |
| Grade 3-4 diarrhea | 12% |
Reference: TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
Prior to initiating TRODELVY
Prepare for diarrhea management with TRODELVY
Has the patient experienced any of the following?
Select all that apply or click Continue if none apply.
Reference: TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
Prior to initiating TRODELVY
Premedication and patient counseling
You selected no prior adverse reaction experiences
Patient counseling
Be sure to advise patients of the risk of diarrhea. Instruct your patients to contact their healthcare provider immediately if they experience any of the following symptoms:
- Diarrhea for the first time
- Black or bloody stools
- Symptoms of dehydration such as lightheadedness, dizziness, or faintness
- Cannot take fluids by mouth due to nausea or vomiting
- Cannot control diarrhea within 24 hours
Reference: TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
Prior to initiating TRODELVY
Premedication and patient counseling
You selected one or more adverse reaction experiences
Premedication
For patients who exhibit an excessive cholinergic response to treatment with TRODELVY (eg, abdominal cramping, diarrhea, salivation, etc), consider appropriate premedication (eg, atropine) before subsequent treatments.
Patient counseling
Be sure to advise patients of the risk of diarrhea. Instruct your patients to contact their healthcare provider immediately if they experience any of the following symptoms:
- Diarrhea for the first time
- Black or bloody stools
- Symptoms of dehydration such as lightheadedness, dizziness, or faintness
- Cannot take fluids by mouth due to nausea or vomiting
- Cannot control diarrhea within 24 hours
Reference: TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
Prior to initiating TRODELVY
Plan for diarrhea
Work with your patient to develop a plan for diarrhea management
Talk with your patient about previous adverse reactions they may have had, potential adverse reactions, management strategies, and the importance of open and honest communication.
Some patients may be hesitant to report adverse reactions, so it is important to remind them that diarrhea can be different for each person and to talk openly about any symptoms they may be experiencing.
Document your patient’s normal bowel movements to establish a baseline.
Considerations for diarrhea with TRODELVY in combination with pembrolizumab
For additional information on management strategies for diarrhea with TRODELVY in combination with pembrolizumab, see resource below.
For recommendations for management of adverse reactions of pembrolizumab, refer to the Prescribing Information for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph.
Proactively monitor for adverse reactions and educate patients about the importance of reporting certain symptoms promptly.
Reference: KEYTRUDA. Prescribing Information. Merck & Co., Inc.; June 2026.
After initiating TRODELVY
Monitor
Remind patients to monitor and report any diarrhea they experience
If the patient experiences diarrhea, determine the severity.
Next steps for management are based on the severity. Use the pop-up below to review the grade scale.
Choose a grade of diarrhea to review the recommended next steps.
NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.
Reference: 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 May 1, 2026.
After initiating TRODELVY
Manage
You selected Grade 1-2 diarrhea1
If your patient experiences diarrhea, first evaluate for infectious causes2
If no infectious cause is found, promptly initiate loperamide2:
- 4 mg of loperamide followed by 2 mg with each episode of diarrhea (up to 16 mg/day)
- Discontinue loperamide 12 hours after diarrhea resolves
Additional supportive measures such as fluid and electrolyte replacement may be employed as clinically indicated.2
Reinforce open and honest communication with your patients.
When administering TRODELVY in combination with pembrolizumab or pembrolizumab and berahyaluridase alfa-pmph, interrupt or discontinue one or both drugs of the combination or reduce the dose of TRODELVY to manage adverse reactions as appropriate. Refer to the Prescribing Information for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for recommendations on dosage interruption or discontinuation due to adverse reactions.2
Premedication for subsequent treatments2
For patients who exhibit an excessive cholinergic response to treatment with TRODELVY (eg, abdominal cramping, diarrhea, salivation, etc), consider appropriate premedication (eg, atropine) before subsequent treatments.
Recommended for you
Here are some additional resources that you may find helpful to learn more about adverse reaction management or help support your patients:
You've reviewed the recommendations for Grade 1-2 diarrhea. Select another severity or adverse reaction to explore more management recommendations.
For full dose modifications for adverse reactions, please see Section 2 in the TRODELVY Prescribing Information.
AR=adverse reaction.
References: 1. 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 May 1, 2026. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
Prior to initiating TRODELVY
Manage
You selected Grade 3-4 diarrhea1
If your patient experiences diarrhea, first evaluate for infectious causes2
If no infectious cause is found, promptly initiate loperamide2:
- 4 mg of loperamide followed by 2 mg with each episode of diarrhea (up to 16 mg/day)
- Discontinue loperamide 12 hours after diarrhea resolves
Doses of TRODELVY can be interrupted, reduced, or permanently discontinued to help manage diarrhea. Please refer to the Dose Modifications for Adverse Reactions section of the full Prescribing Information for guidance.
Additional supportive measures such as fluid and electrolyte support may be employed as clinically indicated.2
Reinforce open and honest communication with your patients.
For Grade 3-4 diarrhea that is not controlled with antidiarrheal agents2:
Withhold TRODELVY until resolved to ≤Grade 1
For each occurrence of diarrhea, reduce 1 dose level or permanently discontinue according to dosage reduction levels below:
Dosage reduction levels for TRODLEVY2
Scroll left to view
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
In patients unable to tolerate 5 mg/kg
PermanentlydiscontinueTRODELVY
NOTE: Do not reescalate the TRODELVY dose after a dose reduction for adverse reactions has been made.2 For more information on dose modifications, please refer to section 2 of the TRODELVY Prescribing Information.
When administering TRODELVY in combination with pembrolizumab or pembrolizumab and berahyaluridase alfa-pmph, interrupt or discontinue one or both drugs of the combination or reduce the dose of TRODELVY to manage adverse reactions as appropriate. Refer to the Prescribing Information for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for recommendations on dosage interruption or discontinuation due to adverse reactions.2
Premedication for subsequent treatments2
For patients who exhibit an excessive cholinergic response to treatment with TRODELVY (eg, abdominal cramping, diarrhea, salivation, etc), consider appropriate premedication (eg, atropine) before subsequent treatments.
Discussing dose modifications with patients
Patients may feel nervous, skeptical, or frustrated when hearing that they may have to reduce their treatment dose
- Reinforce that dose modifications are a normal part of finding a treatment plan that works for each person
- Connect the dose modification back to patient treatment goals
- Share next steps and additional resources with your patient
Recommended for you
Here are some additional resources that you may find helpful to learn more about adverse reaction management or help support your patients:
You've reviewed the recommendations for Grade 3-4 diarrhea. Select another severity or adverse reaction to explore more management recommendations.
For full dose modifications for adverse reactions, please see Section 2 in the TRODELVY Prescribing Information.
AR=adverse reaction.
References: 1. 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 May 1, 2026. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
Hypersensitivity and infusion-related reactions
Rates of occurrence
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.
TRODELVY is contraindicated in patients who have experienced a severe hypersensitivity reaction to TRODELVY.
In TRODELVY monotherapy studies (pooled safety data)
Adverse reaction |
Occurrence in patients treated with TRODELVY |
|---|---|
| Hypersensitivity reactions | 28% |
| Occurring within 24 hours of dosing | 13% |
| Grade 3-4 hypersensitivity | 1.5% |
| Occurring within 24 hours of dosing | 0.4% |
| Permanent discontinuation due to hypersensitivity reactions | 0.4% |
| Anaphylactic reactions | <0.1% |
Reference: TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
Prior to initiating TRODELVY
Prepare for managing hypersensitivity and infusion-related reactions
Prior to each dose of TRODELVY, premedication for prevention of infusion reactions is recommended. Determine which premedications may be appropriate for your patients.
Has the patient experienced prior infusion-related reactions?
Reference: TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
Prior to initiating TRODELVY
Premedication
You selected no prior
infusion-related reactions
Premedication
Premedicate with antipyretics, H1 and H2 blockers prior to infusion.
Have medications and emergency equipment immediately available to treat infusion-related reactions, including anaphylaxis, when administering TRODELVY.
H1=histamine receptor 1; H2=histamine receptor 2.
Reference: TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
Prior to initiating TRODELVY
Premedication
You selected prior
infusion-related reactions
Premedication
- Premedicate with antipyretics, H1 and H2 blockers prior to infusion
- Corticosteroids may be used for patients who had prior infusion reactions
Have medications and emergency equipment immediately available to treat infusion-related reactions, including anaphylaxis, when administering TRODELVY.
H1=histamine receptor 1; H2=histamine receptor 2.
Reference: TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
Prior to initiating TRODELVY
Patient counseling
Patient counseling
Talk with your patients about potential reactions, management strategies, and the importance of open and honest communication.
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, fever, or chest pain that occur during or at any time after their infusion.
Inform patients that they will be monitored during each infusion and for 30 minutes after infusion for hypersensitivity and infusion-related reactions.
Work with your patients to develop a plan for management of hypersensitivity and infusion-related reactions
Prepare your patients with the support and management strategies they need to address potential adverse reactions.
Reference: TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
After initiating TRODELVY
Monitor
Closely monitor patients for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after the infusion is complete1
Have medications and emergency equipment to treat infusion-related reactions, including anaphylaxis, available for immediate use when administering TRODELVY.
If the patient experiences an infusion-related reaction, first determine the severity
Next steps for management are based on the severity. Use the pop-up below to review the grade scale.
Choose a grade of infusion-related reaction to review the recommended next steps.
NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.
References: 1. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026. 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 May 1, 2026.
After initiating TRODELVY
Manage
You selected Grade 1-3
infusion-related reactions1
Slow or interrupt the infusion rate of TRODELVY2
Have medications and emergency equipment immediately available to treat infusion-related reactions, including anaphylaxis, when administering TRODELVY.2
When administering TRODELVY in combination with pembrolizumab or pembrolizumab and berahyaluridase alfa-pmph, interrupt or discontinue one or both drugs of the combination or reduce the dose of TRODELVY to manage adverse reactions as appropriate. Refer to the Prescribing Information for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for recommendations on dosage interruption or discontinuation due to adverse reactions.2
Recommended for you
Here are some additional resources that you may find helpful to learn more about adverse reaction management or help support your patients:
You've reviewed the recommendations for Grade 1-3 infusion-related reactions. Select another severity or adverse reaction to explore more management recommendations.
For full dose modifications for adverse reactions, please see Section 2 in the TRODELVY Prescribing Information.
AR=adverse reaction.
References: 1. 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 May 1, 2026. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
After initiating TRODELVY
Manage
You selected Grade 4
infusion-related reactions1
Permanently discontinue TRODELVY2
Have medications and emergency equipment immediately available to treat infusion-related reactions, including anaphylaxis, when administering TRODELVY.2
When administering TRODELVY in combination with pembrolizumab or pembrolizumab and berahyaluridase alfa-pmph, interrupt or discontinue one or both drugs of the combination or reduce the dose of TRODELVY to manage adverse reactions as appropriate. Refer to the Prescribing Information for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for recommendations on dosage interruption or discontinuation due to adverse reactions.2
Recommended for you
Here are some additional resources that you may find helpful to learn more about adverse reaction management or help support your patients:
You've reviewed the recommendations for Grade 4 infusion-related reactions. Select another severity or adverse reaction to explore more management recommendations.
For full dose modifications for adverse reactions, please see Section 2 in the TRODELVY Prescribing Information.
AR=adverse reaction.
References: 1. 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 May 1, 2026. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
Nausea and Vomiting
Rates of occurrence
TRODELVY is emetogenic and can cause severe nausea and vomiting.
In TRODELVY monotherapy studies (pooled safety data)
Adverse reaction |
Occurrence in patients treated with TRODELVY |
|---|---|
| Nausea | 63% |
| Grade 3-4 nausea | 3% |
| Vomiting | 33% |
| Grade 3-4 vomiting | 2% |
TRODELVY as combination therapy with pembrolizumab (safety data)
Adverse reaction |
Occurrence in patients treated with TRODELVY + pembrolizumab |
|---|---|
| Nausea | 68% |
| Grade 3-4 nausea | 3.2% |
| Vomiting | 29% |
| Grade 3-4 vomiting | 0.9% |
Reference: TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
Prior to initiating TRODELVY
Premedication
Premedication
Prior to each dose of TRODELVY, premedication for prevention of CINV is recommended.
- Premedicate with a 2- or 3-drug combination regimen (eg, dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as needed)
Ongoing supportive care
All patients should be given take-home medications with clear instructions for prevention and treatment of delayed nausea and vomiting.
5-HT3=5-hydroxytryptamine 3 receptor; CINV=chemotherapy-induced nausea and vomiting; NK1=neurokinin 1.
Reference: TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
Prior to initiating TRODELVY
Patient counseling
Patient counseling
- 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
Work with your patient to develop a plan for managing nausea and vomiting
Talk with your patient about previous adverse reactions they may have had, potential adverse reactions, management strategies, and the importance of open and honest communication.
Reference: TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
After initiating TRODELVY
Monitor
Remind patients to monitor and report any nausea or vomiting they experience1
If the patient experiences nausea or vomiting, first determine the severity.
Next steps for management are based on the severity. Use the pop-ups below to review the grade scales.
Choose a grade to review the recommended next steps.
NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events
References: 1. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026. 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 May 1, 2026.
After initiating TRODELVY
Manage
You selected Grade 1-2 nausea or vomiting1
Antiemetics and supportive measures2
- Additional antiemetics and other supportive measures may also be employed as clinically indicated
- Make sure all patients have been given take-home medications with clear instructions for prevention and treatment of nausea and vomiting
- Ensure your patients are taking antiemetics as prescribed
- Reinforce open and honest communication with your patients
When administering TRODELVY in combination with pembrolizumab or pembrolizumab and berahyaluridase alfa-pmph, interrupt or discontinue one or both drugs of the combination or reduce the dose of TRODELVY to manage adverse reactions as appropriate. Refer to the Prescribing Information for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for recommendations on dosage interruption or discontinuation due to adverse reactions.2
Recommended for you
Here are some additional resources that you may find helpful to learn more about adverse reaction management or help support your patients:
You've reviewed the recommendations for Grade 1-2 nausea or vomiting. Select another severity or adverse reaction to explore more management recommendations.
For full dose modifications for adverse reactions, please see Section 2 in the TRODELVY Prescribing Information.
AR=adverse reaction.
References: 1. 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 May 1, 2026. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
After initiating TRODELVY
Manage
You selected Grade 3-4 nausea or vomiting1
Antiemetics and supportive measures2
- Additional antiemetics and other supportive measures may also be employed as clinically indicated
- Make sure all patients have been given take-home medications with clear instructions for prevention and treatment of nausea and vomiting
- Ensure your patients are taking antiemetics as prescribed
- Reinforce open and honest communication with your patients
For Grade 3-4 nausea or vomiting that is not controlled with antiemetics2:
Withhold TRODELVY until resolved to ≤Grade 1
For each occurrence of nausea or vomiting, reduce 1 dose level or permanently discontinue according to dosage reduction levels below:
Dosage reduction levels for TRODELVY2
Scroll left to view
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
In patients unable to tolerate 5 mg/kg
PermanentlydiscontinueTRODELVY
NOTE: Do not reescalate the TRODELVY dose after a dose reduction for adverse reactions has been made. For more information on dose modifications for nausea and vomiting, please refer to Section 2 of the TRODELVY Prescribing Information.
When administering TRODELVY in combination with pembrolizumab or pembrolizumab and berahyaluridase alfa-pmph, interrupt or discontinue one or both drugs of the combination or reduce the dose of TRODELVY to manage adverse reactions as appropriate. Refer to the Prescribing Information for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for recommendations on dosage interruption or discontinuation due to adverse reactions.2
Discussing dose modifications with patients
Patients may feel nervous, skeptical, or frustrated when hearing that they may have to reduce their treatment dose.
- Reinforce that dose modifications are a part of finding a treatment plan that works for each person
- Connect the dose modification back to patient treatment goals
- Share next steps and additional resources with your patient
Recommended for you
Here are some additional resources that you may find helpful to learn more about adverse reaction management or help support your patients:
You've reviewed the recommendations for Grade 3-4 nausea or vomiting. Select another severity or adverse reaction to explore more management recommendations.
For full dose modifications for adverse reactions, please see Section 2 in the TRODELVY Prescribing Information.
AR=adverse reaction.
References: 1. 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 May 1, 2026. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; 2026.
TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2–directed antibody and topoisomerase inhibitor conjugate indicated in adult patients:
Locally Advanced or Metastatic Triple-Negative Breast Cancer
First Line
- As a single agent for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy
- In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of unresectable locally advanced or mTNBC whose tumors express PD-L1 [Combined Positive Score (CPS ≥10)] as determined by an FDA-authorized test
Second Line or Later
- For the treatment of unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Locally Advanced or Metastatic HR-positive, HER2-negative Breast Cancer
- For the treatment of 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 48% 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 62% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 10% of patients. 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 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 (eg, fluid and electrolyte replacement) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (eg, 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, and skin reactions. Hypersensitivity reactions occurred in 28% of patients with 13% occurring within 24 hours of dosage. Grade 3-4 hypersensitivity occurred in 1.5% of patients 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%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Closely monitor patients 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 63% of all patients treated with TRODELVY, and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 33% of patients, and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two- or three-drug combination regimen (eg, 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. 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 57% in patients homozygous for the UGT1A1*28 allele, 48% in patients heterozygous for the UGT1A1*28 allele, and 41% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 17% in patients homozygous for the UGT1A1*28 allele, 9% in patients heterozygous for the UGT1A1*28 allele, and 8% 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 of TRODELVY as a single agent, 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 and potassium (26% each).
In the safety population of TRODELVY in combination with pembrolizumab, the most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased neutrophil count and hemoglobin (86% each), decreased leukocyte count (84%), diarrhea (72%), nausea (68%), decreased lymphocyte count (61%), fatigue (58%), alopecia (52%), increased alkaline phosphatase and 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, and increased eosinophils (26% each), and decreased albumin (25%).
In the ASCENT-03 study (single agent in previously untreated, unresectable locally advanced or mTNBC), the most common adverse reactions (incidence ≥25%) were nausea, diarrhea, alopecia, fatigue, constipation, and vomiting. The most frequent serious adverse reactions (SAR) (>2%) were diarrhea, febrile neutropenia, and neutropenia (3.6% each), and pneumonia (2.9%). SAR occurred in 26% of patients, and 3.6% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 2.5% of patients and included sepsis (1.1%), and acute respiratory failure, neutropenic colitis, pneumonia, and septic shock (0.4% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
In the ASCENT-04 study (in combination with pembrolizumab in previously untreated, unresectable locally advanced or mTNBC whose tumors express PD-L1), the most common adverse reactions (incidence ≥25%) were diarrhea, nausea, fatigue, alopecia, constipation, rash, vomiting, abdominal pain, and headache. The most frequent SAR (≥2%) were febrile neutropenia (7%), neutropenia (6%), diarrhea (5%), and fatigue and pneumonia (2.3% each). SAR occurred in 38% of patients, and 7% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 3.2% of patients and included death (unknown cause) (0.9%) and completed suicide, neutropenic sepsis, sepsis, pneumonia, and pulmonary embolism (0.5% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
In the ASCENT study (previously treated locally advanced or mTNBC), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent SAR (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR occurred in 27% of patients, and 5% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 1.2% of patients and included respiratory failure (0.8%) and pneumonia (0.4%). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils, leukocytes, and lymphocytes.
In the TROPiCS-02 study (locally advanced or metastatic HR+/HER2– breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent SAR (>1%) were diarrhea (5%), febrile neutropenia (4.1%), neutropenia (3%), abdominal pain (2.2%), neutropenic colitis and vomiting (1.9% each), and colitis and pneumonia (1.5% each). SAR occurred in 28% of patients, and 6% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 2.2% of patients and included arrhythmia, COVID-19 pneumonia, pneumonia, nervous system disorder, pulmonary embolism, and septic shock (0.4% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
Drug Interactions
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.
UGT1A1 Inducers: Avoid administering UGT1A1 inducers with TRODELVY. SN-38 is a UGT1A1 substrate. Concomitant administration of TRODELVY with inducers of UGT1A1 may reduce exposure to SN-38.
Please see full Prescribing Information, including BOXED WARNING.
TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2–directed antibody and topoisomerase inhibitor conjugate indicated in adult patients:
Locally Advanced or Metastatic Triple-Negative Breast Cancer
First Line
- As a single agent for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy
- In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of unresectable locally advanced or mTNBC whose tumors express PD-L1 [Combined Positive Score (CPS ≥10)] as determined by an FDA-authorized test
Second Line or Later
- For the treatment of unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Locally Advanced or Metastatic HR-positive, HER2-negative Breast Cancer
- For the treatment of 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 48% 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 62% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 10% of patients. 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 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 (eg, fluid and electrolyte replacement) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (eg, 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, and skin reactions. Hypersensitivity reactions occurred in 28% of patients with 13% occurring within 24 hours of dosage. Grade 3-4 hypersensitivity occurred in 1.5% of patients 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%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Closely monitor patients 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 63% of all patients treated with TRODELVY, and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 33% of patients, and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two- or three-drug combination regimen (eg, 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. 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 57% in patients homozygous for the UGT1A1*28 allele, 48% in patients heterozygous for the UGT1A1*28 allele, and 41% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 17% in patients homozygous for the UGT1A1*28 allele, 9% in patients heterozygous for the UGT1A1*28 allele, and 8% 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 of TRODELVY as a single agent, 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 and potassium (26% each).
In the safety population of TRODELVY in combination with pembrolizumab, the most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased neutrophil count and hemoglobin (86% each), decreased leukocyte count (84%), diarrhea (72%), nausea (68%), decreased lymphocyte count (61%), fatigue (58%), alopecia (52%), increased alkaline phosphatase and 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, and increased eosinophils (26% each), and decreased albumin (25%).
In the ASCENT-03 study (single agent in previously untreated, unresectable locally advanced or mTNBC), the most common adverse reactions (incidence ≥25%) were nausea, diarrhea, alopecia, fatigue, constipation, and vomiting. The most frequent serious adverse reactions (SAR) (>2%) were diarrhea, febrile neutropenia, and neutropenia (3.6% each), and pneumonia (2.9%). SAR occurred in 26% of patients, and 3.6% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 2.5% of patients and included sepsis (1.1%), and acute respiratory failure, neutropenic colitis, pneumonia, and septic shock (0.4% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
In the ASCENT-04 study (in combination with pembrolizumab in previously untreated, unresectable locally advanced or mTNBC whose tumors express PD-L1), the most common adverse reactions (incidence ≥25%) were diarrhea, nausea, fatigue, alopecia, constipation, rash, vomiting, abdominal pain, and headache. The most frequent SAR (≥2%) were febrile neutropenia (7%), neutropenia (6%), diarrhea (5%), and fatigue and pneumonia (2.3% each). SAR occurred in 38% of patients, and 7% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 3.2% of patients and included death (unknown cause) (0.9%) and completed suicide, neutropenic sepsis, sepsis, pneumonia, and pulmonary embolism (0.5% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
In the ASCENT study (previously treated locally advanced or mTNBC), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent SAR (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR occurred in 27% of patients, and 5% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 1.2% of patients and included respiratory failure (0.8%) and pneumonia (0.4%). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils, leukocytes, and lymphocytes.
In the TROPiCS-02 study (locally advanced or metastatic HR+/HER2– breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent SAR (>1%) were diarrhea (5%), febrile neutropenia (4.1%), neutropenia (3%), abdominal pain (2.2%), neutropenic colitis and vomiting (1.9% each), and colitis and pneumonia (1.5% each). SAR occurred in 28% of patients, and 6% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 2.2% of patients and included arrhythmia, COVID-19 pneumonia, pneumonia, nervous system disorder, pulmonary embolism, and septic shock (0.4% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
Drug Interactions
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.
UGT1A1 Inducers: Avoid administering UGT1A1 inducers with TRODELVY. SN-38 is a UGT1A1 substrate. Concomitant administration of TRODELVY with inducers of UGT1A1 may reduce exposure to SN-38.
Please see full Prescribing Information, including BOXED WARNING.