Side Effect Management Interactive Explorer

Management strategies

for select side effects associated with TRODELVY

This interactive resource is designed to guide you through the recommendations for developing a plan to help manage select side effects 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 treatment discontinuation of TRODELVY. Please see full Prescribing Information for guidance.

Most people spend about 3-5 minutes on this activity.
Please download the dose modification guide for more information.

Get started

Select a side effect

Neutropenia

Diarrhea

Hypersensitivity & Infusion-Related Reactions

Nausea & Vomiting

Next: Rates of occurrence

Neutropenia

Rates of occurrence

Neutropenia is common with TRODELVY and can sometimes be severe, life-threatening, or fatal as early as the first cycle of treatment¹

Among patients treated with TRODELVY in the clinical trials:

64% experienced neutropenia
49% experienced Grade 3-4 neutropenia
6% experienced febrile neutropenia
1.4% experienced neutropenic colitis
The median time to first onset of neutropenia (including febrile neutropenia) in patients receiving TRODELVY was 16 days (range: 1 to 435 days), but it has occurred earlier in patients with reduced UGT1A1 activity

TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

Next: Assess risk

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.

Older patients

Prior neutropenia

Poor performance status

Organ dysfunction

Multiple comorbidities

Other

TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

Next: G-CSF considerations

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

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

Be ready with G-CSF prophylaxis to help your patients receiving TRODELVY with risk of neutropenia

Treatment of neutropenia in an exploratory analysis of G-CSF use^3,a

In a pooled safety analysis of 1063 patients treated with TRODELVY^3,a:

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Primary Prophylaxis^b

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Secondary Prophylaxis^d

Rates of any-grade neutropenia were lower in patients who received primary or secondary G-CSF prophylaxis than in patients who did not receive prophylaxis³

Primary and secondary G-CSF prophylaxis were associated with a longer time to onset of Grade ≥3 neutropenia³

^aAnalysis of treatment-emergent AEs (starting on or after the first dose until ≤30 days after the last dose) from 4 clinical studies: ASCENT, TROPiCS-02, a phase 2 trial in another tumor type, and IMMU-132-01.³

^bPrimary prophylactic G-CSF use is defined as G-CSF use on or after cycle 1 Day 1 and prior to onset of first occurrence of neutropenia, regardless of grade, or G-CSF use when there is no event of neutropenia. For patients who received primary prophylaxis, neutropenia is subsequent to primary prophylaxis. For patients who did not receive primary prophylaxis, neutropenia is first occurrence since cycle 1 Day 1.³

^cNeutropenia includes preferred terms of neutropenia, neutrophil count decreased, and febrile neutropenia.³

^dSecondary prophylactic G-CSF use is defined as G-CSF use after resolution of Grade ≥2 neutropenia (to Grade ≤1) or occurrence of Grade ≥1 neutropenia, and prior to onset of any subsequent Grade ≥2 neutropenia or no occurrence of subsequent Grade ≥2 neutropenia. For patients who received secondary prophylaxis, neutropenia is subsequent to secondary prophylaxis. For patients who did not receive secondary prophylaxis, neutropenia is the first occurrence since Cycle 1 Day 1. Patients who received primary prophylactic G-CSF were excluded from the secondary prophylactic G-CSF use analysis.³

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?

G-CSF=granulocyte colony-stimulating factor; NCCN=National Comprehensive Cancer Network.

References: 1. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hematopoietic Growth Factors V.2.2026. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed December 1, 2025. To view the most recent and complete version of the guidelines, go online to NCCN.org. 3. Rugo HS, Tolaney SM, Bardia A, et al. Pooled safety analysis of sacituzumab govitecan in multiple solid tumor types. Poster presented at: American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2024; Chicago, IL. Poster 3029.

Next: TRODELVY initiation

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

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

Be ready with G-CSF prophylaxis to help your patients receiving TRODELVY with risk of neutropenia

Treatment of neutropenia in an exploratory analysis of G-CSF use^3,a

In a pooled safety analysis of 1063 patients treated with TRODELVY^3,a:

Scroll left to view

Primary Prophylaxis^b

Scroll left to view

Secondary Prophylaxis^d

Rates of any-grade neutropenia were lower in patients who received primary or secondary G-CSF prophylaxis than in patients who did not receive prophylaxis³

Primary and secondary G-CSF prophylaxis were associated with a longer time to onset of Grade ≥3 neutropenia³

^cNeutropenia includes preferred terms of neutropenia, neutrophil count decreased, and febrile neutropenia.³

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?

G-CSF=granulocyte colony-stimulating factor; NCCN=National Comprehensive Cancer Network.

Next: TRODELVY initiation

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 side effects they experienced, potential side effects, 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 neutropenia:

Withhold TRODELVY¹:

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 discontinue according to Dosage Reduction Levels (or see table 1 in Prescribing Information).

See the TRODELVY Prescribing Information for recommendations for neutropenia management.

Continue to learn more about what you may expect with TRODELVY and the recommendations for neutropenia management

ANC=absolute neutrophil count; G-CSF=granulocyte colony-stimulating factor.

References: 1. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025. 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 28, 2025. https://www.cancer.gov/about-cancer/treatment/side-effects/infection 3. Rugo HS, Tolaney SM, Bardia A, et al. Pooled safety analysis of sacituzumab govitecan in multiple solid tumor types. Poster presented at: American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2024; Chicago, IL. Poster 3029.

Next: Time to onset

After initiating TRODELVY

Time to onset and duration of neutropenia

Understanding when you may expect neutropenia after TRODELVY initiation can help you and your patient be prepared and take appropriate next steps

Median time to first onset of neutropenia in patients receiving TRODELVY was 16 days (range: 1 to 435 days),^a but may occur earlier.¹

The median time to onset includes febrile neutropenia
Neutropenia did occur earlier in patients with reduced UGT1A1 activity

^aIncludes patients from 4 trials (IMMU-132-01, ASCENT, TROPiCS-02, and a phase 2 trial in another tumor type).¹

Median time to onset and duration for any grade
neutropenia related to TRODELVY^b

TROPiCS-02 study^c,e: HR+/HER2- mBC
(prespecified descriptive analysis)²

ASCENT study^d,e: 2L+ mTNBC (HR-/HER2-)
(post hoc descriptive analysis)³

^bEvents of "neutropenia" included the preferred terms "neutropenia" and "neutrophil count decreased" in both studies, as well as "febrile neutropenia" in TROPiCS-02.^2,3

^cTROPiCS-02 was a Phase 3, randomized, active-controlled, open label trial (N=543) that assessed patients with HR+/HER2- mBC who were previously treated with endocrine therapy, a CDK4/6i, and a taxane in any setting and who had received 2 to 4 lines of chemotherapy in the metastatic setting.⁴

^dASCENT was a Phase 3, randomized, active-controlled, open label trial (N=529) that assessed patients with unresectable locally advanced or mTNBC who had relapsed after at least 2 prior chemotherapies, at least one of them for metastatic disease.⁵

^ePatients were randomized (1:1) to receive TRODELVY 10 mg/kg as an IV infusion on Days 1 and 8 of a 21-day cycle or single-agent chemotherapy of investigator’s choice, which included eribulin, vinorelbine, gemcitabine, or capecitabine. Patients were treated until disease progression or unacceptable toxicity.¹

2L=second line; HER2-=human epidermal growth factor receptor 2-negative; HR+=hormone receptor-positive; mBC=metastatic breast cancer; mTNBC=metastatic triple-negative breast cancer.

References: 1. TRODELVY. Prescribing Information. Gilead Sciences, Inc; March 2025. 2. Rugo HS, Bardia A, Marme F, et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2022;40(29):3365-3376. 3. Rugo HS, Tolaney SM, Loirat D, et al. Safety analyses from the phase 3 ASCENT trial of sacituzumab govitecan in metastatic triple-negative breast cancer. NPJ Breast Cancer. 2022;8(1):98. 4. Rugo HS, Bardia A, Marmé F, et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2022;40(29):3365-3376. 5. Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021;384(16):1529-1541. doi:10.1056/NEJMoa2028485

Next: Monitoring and labs

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 side effects 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.

See NCI CTCAE
Neutropenia Grade Scale See NCI CTCAE Febrile
Neutropenia Grade Scale

Choose the patient's ANC level or indicate if febrile to review the recommended next steps

ANC <LLN to 1500/mm³ (Grade 1 neutropenia)³

ANC <1500/mm³ (Grade 2-4 neutropenia)³

Febrile neutropenia

NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.

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 May 13, 2025.

Next: Manage

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
Reinforce open and honest communication with your patients

Additional supportive measures such as fluid and electrolyte support may be employed as clinically indicated.²

Reinforce open and honest communication with your patients.

Recommended for you

Here are some resources that you may find helpful to learn more about side effect management or help support your patients:

You’ve reviewed the recommendations for Grade 1 neutropenia. Change the severity or select another side effect 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; 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 21, 2025. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

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.

For each occurrence of prolonged Grade 3-4 neutropenia, reduce 1 dose level or discontinue according to Dosage Reduction Levels below:

Dosage Reduction Levels²

Scroll left to view

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.

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 resources that you may find helpful to learn more about side effect management or help support your patients:

You’ve reviewed the recommendations for Grade 2-4 neutropenia. Change the severity or select another side effect 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.

Next: Time to onset

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 discontinue according to Dosage Reduction Levels below:

Dosage Reduction Levels²

Scroll left to view

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 resources that you may find helpful to learn more about side effect management or help support your patients:

You’ve reviewed the recommendations for febrile neutropenia. Change the severity or select another side effect 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 31, 2025. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

Next: Time to onset

Diarrhea

Rates of occurrence

TRODELVY can cause severe diarrhea

Among patients treated with TRODELVY in the clinical trials:

64% experienced diarrhea
11% experienced Grade 3-4 diarrhea
One patient had an intestinal perforation following diarrhea
0.7% experienced diarrhea that led to dehydration and subsequent acute kidney injury

TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

Next: Prepare

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

Prior excessive cholinergic response to treatment with TRODELVY (eg, abdominal cramping, diarrhea, salivation, etc)

Diarrhea with prior treatments

TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

Next: Premedication and counseling

Prior to initiating TRODELVY

Premedication and patient counseling

You selected no prior side effect 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 light-headedness, dizziness, or faintness
Inability to take fluids by mouth due to nausea or vomiting
Inability to control diarrhea within 24 hours

Work with your patient to develop a plan for diarrhea management

Talk with your patient about previous side effects they may have had, potential side effects, management strategies, and the importance of open and honest communication.

TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

Next: Time to onset

Prior to initiating TRODELVY

Premedication and patient counseling

You selected one or more prior side effect 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 future doses.

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 light-headedness, dizziness, or faintness
Inability to take fluids by mouth due to nausea or vomiting
Inability to control diarrhea within 24 hours

Work with your patient to develop a plan for diarrhea management

Talk with your patient about previous side effects they may have had, potential side effects, management strategies, and the importance of open and honest communication.

TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

Next: Time to onset

After initiating TRODELVY

Time to onset and duration of diarrhea

Understanding when you may expect diarrhea after TRODELVY initiation can help you and your patient be prepared and take appropriate next steps

Median time to onset and duration for any
grade diarrhea related to TRODELVY

TROPiCS-02 study^a,c: HR+/HER2- mBC
(prespecified descriptive analysis)¹

ASCENT study^b,c: 2L+ mTNBC (HR-/HER2-)
(post hoc descriptive analysis)²

^bASCENT was a Phase 3, randomized, active-controlled, open label trial (N=529) that assessed patients with unresectable locally advanced or mTNBC who had relapsed after at least 2 prior chemotherapies, at least one of them for metastatic disease.^3,5

^cPatients were randomized (1:1) to receive TRODELVY 10 mg/kg as an IV infusion on Days 1 and 8 of a 21-day cycle or single-agent chemotherapy of investigator’s choice, which included eribulin, vinorelbine, gemcitabine, or capecitabine. Patients were treated until disease progression or unacceptable toxicity.³

Understanding a time frame of when you may expect diarrhea after TRODELVY initiation can help you and your patient be prepared and take appropriate next steps

2L=second-line; CDK4/6i=cyclin-dependent kinase 4/6 inhibitor; HER2-=human epidermal growth factor receptor 2-negative; HR-=hormone receptor-negative; HR+=hormone receptor-positive; IV=intravenous; mBC=metastatic breast cancer; mTNBC=metastatic triple-negative breast cancer.

References: 1. Data on file. Gilead Sciences, Inc.; June 2022. 2. Rugo HS, Tolaney SM, Loirat D, et al. Safety analyses from the phase 3 ASCENT trial of sacituzumab govitecan in metastatic triple-negative breast cancer. NPJ Breast Cancer. 2022;8(1):98. 3. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025. 4. Rugo HS, Bardia A, Marmé F, et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2022;40(29):3365-3376. 5. Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021;384(16):1529-1541. doi:10.1056/NEJMoa2028485

Next: Monitor and manage

Prior to initiating TRODELVY

Monitor

Remind patients to monitor and report any diarrhea they experience

If the patient experiences diarrhea, determine the severity.

See NCI CTCAE Diarrhea Grade Scale

Choose a grade of diarrhea to review the recommended next steps

Grade 1

Grade 2

Grade 3

Grade 4

Next: Manage

Prior to 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 support may be employed as clinically indicated.²

Reinforce open and honest communication with your patients.

Premedication for subsequent treatments²

Recommended for you

Here are some resources that you may find helpful to learn more about side effect management or help support your patients:

You've reviewed the recommendations for Grade 1-2 diarrhea. Select another severity or side effect to explore more management recommendations.

For full dose modifications for adverse reactions, please see Section 2 in the TRODELVY Prescribing Information.

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 13, 2025. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

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 reduced, interrupted, or 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 discontinue according to Dosage Reduction Levels below:

Dosage Reduction Levels²

Scroll left to view

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.

Premedication for subsequent treatments²

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 resources that you may find helpful to learn more about side effect management or help support your patients:

You've reviewed the recommendations for Grade 3-4 diarrhea. Select another severity or side effect to explore more management recommendations.

For full dose modifications for adverse reactions, please see Section 2 in the TRODELVY Prescribing Information.

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 13, 2025. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

Hypersensitivity and infusion-related reactions

TRODELVY is contraindicated in patients who have experienced a severe hypersensitivity reaction to TRODELVY.

Rates of occurrence

TRODELVY can cause hypersensitivity and infusion-related reactions

Serious hypersensitivity reactions including life-threatening anaphylactic reactions have occurred with TRODELVY. Severe signs and symptoms include cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions.

Among patients treated with TRODELVY in the clinical trials:

35% experienced hypersensitivity reactions within 24 hours of dosing
2% experienced Grade 3-4 hypersensitivity
0.2% experienced hypersensitivity reactions leading to permanent discontinuation of TRODELVY
0.2% experienced anaphylactic reactions

Next: Prepare

TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

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?

Yes

Next: Premedication and counseling

Prior to initiating TRODELVY

Premedication and patient counseling

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.

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, or fever that occur during or within 24 hours following the 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 side effects.

H1=histamine receptor 1; H2=histamine receptor 2.

TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

Next: Time to onset

Prior to initiating TRODELVY

Premedication and patient counseling

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.

Patient counseling

Talk with your patients about previous hypersensitivity or infusion-related reactions they may have had, potential reactions, management strategies, and the importance of open and honest communication.

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 side effects.

H1=histamine receptor 1; H2=histamine receptor 2.

TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

Next: Time to onset

After initiating TRODELVY

Time to onset and duration of hypersensitivity

Understanding when you may expect hypersensitivity after TRODELVY initiation can help you and your patient be prepared and take appropriate next steps

Median time to onset and duration for
any grade hypersensitivity related to TRODELVY

TROPiCS-02 study^a: HR+/HER2- mBC
(prespecified descriptive analysis)¹

^aTROPiCS-02 was a Phase 3, randomized, active-controlled, open label trial (N=543) that assessed patients with HR+/HER2- mBC who were previously treated with endocrine therapy, a CDK4/6i, and a taxane in any setting and who had received 2 to 4 lines of chemotherapy in the metastatic setting. Patients were randomized (1:1) to receive TRODELVY 10 mg/kg as an IV infusion on Days 1 and 8 of a 21-day cycle or single-agent chemotherapy of investigator’s choice, which included eribulin, vinorelbine, gemcitabine, or capecitabine. Patients were treated until disease progression or unacceptable toxicity.^2,3

CDK4/6i=cyclin-dependent kinase 4/6 inhibitor; HER2-=human epidermal growth factor receptor 2-negative; HR+=hormone receptor-positive; IV=intravenous; mBC=metastatic breast cancer.

References: 1. Data on file. Gilead Sciences, Inc.; June 2022. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025. 3. Rugo HS, Bardia A, Marmé F, et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2022;40(29):3365-3376.

Next: Monitor

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 a hypersensitivity or 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.

See NCI CTCAE Infusion-Related Reaction Grade Scale

Choose a grade of infusion-related reaction to review the recommended next steps

Grade 1-3

Grade 4

NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.

Next: Manage

After initiating TRODELVY

Manage

You selected Grade 1-3
infusion-related reactions²

Slow or interrupt the infusion rate of TRODELVY²

Have medications and emergency equipment immediately available to treat infusion-related reactions, including anaphylaxis.²

Recommended for you

Here are some resources that you may find helpful to learn more about side effect management or help support your patients:

You've reviewed the recommendations for Grade 1-3 infusion-related reactions. Select another severity or side effect to explore more management recommendations.

For full dose modifications for adverse reactions, please see Section 2 in the TRODELVY Prescribing Information.

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 13, 2025. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

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.²

Recommended for you

Here are some resources that you may find helpful to learn more about side effect management or help support your patients:

You've reviewed the recommendations for Grade 4 infusion-related reactions. Select another severity or side effect to explore more management recommendations.

For full dose modifications for adverse reactions, please see Section 2 in the TRODELVY Prescribing Information.

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 13, 2025. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

Nausea and Vomiting

Rates of occurrence

TRODELVY is emetogenic and can cause severe nausea and vomiting

Among patients treated with TRODELVY in the clinical trials:

64% and 35% experienced nausea and vomiting, respectively
3% experienced Grade 3-4 nausea
2% experienced Grade 3-4 vomiting

TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

Next: Premedication and counseling

Prior to initiating TRODELVY

Premedication and patient counseling

Premedication

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)

Ongoing supportive care

All patients should be given take-home medications with clear instructions for prevention and treatment of delayed nausea and vomiting.

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 side effects they may have had, potential side effects, management strategies, and the importance of open and honest communication.

5-HT3=5-hydroxytryptamine 3 receptor; CINV=chemotherapy-induced nausea and vomiting; NK₁=neurokinin 1.

TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

Next: Time to onset

After initiating TRODELVY

Time to onset and duration of nausea and vomiting

Understanding when you may expect nausea and vomiting reactions after TRODELVY initiation can help you and your patient be prepared and take appropriate next steps

Median time to onset and duration for any
grade nausea related to TRODELVY

ASCENT study^a: 2L+ mTNBC (HR-/HER2-)
(post hoc descriptive analysis)¹

Median time to onset and duration for any
grade vomiting related to TRODELVY

ASCENT study^a: 2L+ mTNBC (HR-/HER2-)
(post hoc descriptive analysis)¹

^aASCENT was a Phase 3, randomized, active-controlled, open label trial (N=529) that assessed patients with unresectable locally advanced or mTNBC who had relapsed after at least 2 prior chemotherapies, at least one of them for metastatic disease. Patients were randomized (1:1) to receive TRODELVY 10 mg/kg as an IV infusion on Days 1 and 8 of a 21-day cycle or single-agent chemotherapy of investigator’s choice, which included eribulin, vinorelbine, gemcitabine, or capecitabine. Patients were treated until disease progression or unacceptable toxicity.^2,3

2L=second-line; HER2-=human epidermal growth factor receptor 2-negative; HR-=hormone receptor-negative; mTNBC=metastatic triple-negative breast cancer.

References: 1. Rugo HS, Tolaney SM, Loirat D, et al. Safety analyses from the phase 3 ASCENT trial of sacituzumab govitecan in metastatic triple-negative breast cancer. NPJ Breast Cancer. 2022;8(1):98. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025. 3. Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021;384(16):1529-1541. doi:10.1056/NEJMoa2028485

Next: Monitor

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.

See NCI CTCAE Nausea Grade Scale

See NCI CTCAE Vomiting Grade Scale

Choose a grade to review the recommended next steps

Grade 1-2

Grade 3-4

NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.

Next: Manage

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

Recommended for you

Here are some resources that you may find helpful to learn more about side effect management or help support your patients:

You've reviewed the recommendations for Grade 1-2 nausea or vomiting. Select another severity or side effect to explore more management recommendations.

For full dose modifications for adverse reactions, please see Section 2 in the TRODELVY Prescribing Information.

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 13, 2025. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

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 discontinue according to Dosage Reduction Levels below:

Dosage Reduction Levels²

Scroll left to view

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.

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 resources that you may find helpful to learn more about side effect management or help support your patients:

You've reviewed the recommendations for Grade 3-4 nausea or vomiting. Select another severity or side effect to explore more management recommendations.

For full dose modifications for adverse reactions, please see Section 2 in the TRODELVY Prescribing Information.

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 13, 2025. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

Back Continue

Change Grade Select another side effect

Consider prophylaxis with G-CSF for patients with ≥1 risk factors²

The NCCN Guidelines classify sacituzumab govitecan-hziy (TRODELVY®) as intermediate risk (10%-20%) for febrile neutropenia.²

Prophylactic G-CSF may be considered for patients with ≥1 risk factors for febrile neutropenia (shown below)
If no risk factors, observe

Patient risk factors^2,a,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.²

^bOther factors may warrant the use of G-CSF (eg, chronic immunosuppression in the posttransplant setting, including organ transplant).²

CD4=cluster of differentiation 4; FN=febrile neutropenia; G-CSF=granulocyte colony-stimulating factor; NCCN=National Comprehensive Cancer Network.

Febrile Neutropenia NCI-CTCAE Version 5.0 Grade Scale³
Grade 1	—
Grade 2	—
Grade 3	ANC <1000/mm³ with a single temperature of >38.3 °C (101 °F) or a sustained temperature of ≥38 °C (100.4 °F) for more than 1 hour
Grade 4	Life-threatening consequences; urgent intervention indicated
Grade 5	Death

ANC=absolute neutrophil count.

Diarrhea NCI CTCAE Version 5.0 Grade Scale²
Grade 1	Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline
Grade 2	Increase of 4 to 6 stools per day over baseline; moderate increase in ostomy output compared to baseline; limiting instrumental activities of daily living
Grade 3	Increase of ≥7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care activities of daily living
Grade 4	Life-threatening consequences; urgent intervention indicated
Grade 5	Death

Neutropenia NCI-CTCAE Version 5.0 Grade Scale³
Grade 1	ANC <LLN to 1500/mm³
Grade 2	ANC <1500 to 1000/mm³
Grade 3	ANC <1000 to 500/mm³
Grade 4	ANC <500/mm³

ANC=absolute neutrophil count; LLN=lower limit of normal.

Infusion-Related Reaction NCI CTCAE Version 5.0 Grade Scale²
Grade 1	Mild transient reaction; infusion interruption not indicated; intervention not indicated
Grade 2	Therapy or infusion interruption indicated but responds promptly to symptomatic treatment (eg, antihistamines, NSAIDs, narcotics, IV fluids); prophylactic medications indicated for ≤24 hrs
Grade 3	Prolonged (eg, not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae
Grade 4	Life-threatening consequences; urgent intervention indicated
Grade 5	Death

IV=intravenous; NSAIDs=non-steroidal anti-inflammatory drugs.

Nausea NCI CTCAE Version 5.0 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	—

TPN=total parenteral nutrition.

Vomiting NCI CTCAE Version 5.0 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

IV=intravenous; TPN=total parenteral nutrition.

Top

Indications

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.

This website is intended for US healthcare professionals

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Management strategies

for select side effects associated with TRODELVY

Most people spend about 3-5 minutes on this activity. Please download the dose modification guide for more information.

Select a side effect

Next: Rates of occurrence

Neutropenia

Rates of occurrence

Neutropenia is common with TRODELVY and can sometimes be severe, life-threatening, or fatal as early as the first cycle of treatment1

Next: Assess risk

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?

Next: G-CSF considerations

Prior to initiating TRODELVY

G-CSF Considerations

You did not select any risk factors. Here’s what you should know

Plan for prophylaxis with G-CSF

Be ready with G-CSF prophylaxis to help your patients receiving TRODELVY with risk of neutropenia

Treatment of neutropenia in an exploratory analysis of G-CSF use3,a

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Primary Prophylaxisb

Scroll left to view

Secondary Prophylaxisd

Rates of any-grade neutropenia were lower in patients who received primary or secondary G-CSF prophylaxis than in patients who did not receive prophylaxis3

Primary and secondary G-CSF prophylaxis were associated with a longer time to onset of Grade ≥3 neutropenia3

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:

Next: TRODELVY initiation

Prior to initiating TRODELVY

G-CSF Considerations

You selected one or more risk factors

Plan for prophylaxis with G-CSF

Be ready with G-CSF prophylaxis to help your patients receiving TRODELVY with risk of neutropenia

Treatment of neutropenia in an exploratory analysis of G-CSF use3,a

Scroll left to view

Primary Prophylaxisb

Scroll left to view

Secondary Prophylaxisd

Rates of any-grade neutropenia were lower in patients who received primary or secondary G-CSF prophylaxis than in patients who did not receive prophylaxis3

Primary and secondary G-CSF prophylaxis were associated with a longer time to onset of Grade ≥3 neutropenia3

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:

Next: TRODELVY initiation

After assessing risk

TRODELVY initiation

You've assessed risk for febrile neutropenia and determined if prophylaxis with G-CSF is recommended

Be aware and prepare

Monitor and manage

Continue to learn more about what you may expect with TRODELVY and the recommendations for neutropenia management

Next: Time to onset

After initiating TRODELVY

Time to onset and duration of neutropenia

Understanding when you may expect neutropenia after TRODELVY initiation can help you and your patient be prepared and take appropriate next steps

Median time to onset and duration for any grade neutropenia related to TRODELVYb

Next: Monitoring and labs

After initiating TRODELVY

Monitor blood cell counts periodically throughout treatment1

Next: Manage

After initiating TRODELVY

Manage

You selected Grade 1 neutropenia (ANC <LLN to 1500/mm3)1

Recommended for you

After initiating TRODELVY

Manage

You selected Grade 2-4 neutropenia (ANC <1500/mm3)1

To manage Grade 3-4 neutropenia (ANC <1000/mm3)2:

Withhold TRODELVY2:

Dosage Reduction Levels2

Scroll left to view

Discussing dose modifications with patients

Recommended for you

Next: Time to onset

After initiating TRODELVY

Manage

You selected febrile neutropenia1

Dosage Reduction Levels2

Scroll left to view

This website is intended for
US healthcare professionals

Are you sure you
want to leave?

Most people spend about 3-5 minutes on this activity.
Please download the dose modification guide for more information.

Neutropenia is common with TRODELVY and can sometimes be severe, life-threatening, or fatal as early as the first cycle of treatment¹

Treatment of neutropenia in an exploratory analysis of G-CSF use^3,a

Primary Prophylaxis^b

Secondary Prophylaxis^d

Rates of any-grade neutropenia were lower in patients who received primary or secondary G-CSF prophylaxis than in patients who did not receive prophylaxis³

Primary and secondary G-CSF prophylaxis were associated with a longer time to onset of Grade ≥3 neutropenia³

Treatment of neutropenia in an exploratory analysis of G-CSF use^3,a

Primary Prophylaxis^b

Secondary Prophylaxis^d

Rates of any-grade neutropenia were lower in patients who received primary or secondary G-CSF prophylaxis than in patients who did not receive prophylaxis³

Primary and secondary G-CSF prophylaxis were associated with a longer time to onset of Grade ≥3 neutropenia³

Median time to onset and duration for any grade
neutropenia related to TRODELVY^b

Monitor blood cell counts periodically throughout treatment¹

You selected Grade 1 neutropenia (ANC <LLN to 1500/mm³)¹

You selected Grade 2-4 neutropenia (ANC <1500/mm³)¹

To manage Grade 3-4 neutropenia (ANC <1000/mm³)²:

Withhold TRODELVY²:

Dosage Reduction Levels²

You selected febrile neutropenia¹

Dosage Reduction Levels²

Median time to onset and duration for any
grade diarrhea related to TRODELVY

You selected Grade 1-2 diarrhea¹

If your patient experiences diarrhea, first evaluate for infectious causes²

Premedication for subsequent treatments²

You selected Grade 3-4 diarrhea¹

If your patient experiences diarrhea, first evaluate for infectious causes²

For Grade 3-4 diarrhea that is not controlled with antidiarrheal agents²:

Dosage Reduction Levels²

Premedication for subsequent treatments²

You selected no prior
infusion-related reactions

You selected prior
infusion-related reactions