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In the Phase 3 ASCENT trial of patients with metastatic triple-negative breast cancer:
Adverse events of special interest in the ASCENT trial1,2
This is not an exhaustive list. For full details of adverse events, please refer to the Trodelvy® Summary of Product Characteristics.3
Adapted from Bardia, et al. 2021.1
*Patients may report more than 1 event per preferred term. Adverse events were classified according to the MedDRA
systems of preferred terms and system organ class and according to severity by the National Cancer Institute Common
Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.2
**Combined preferred terms of “neutropenia” and “decreased neutrophil count”.2
†Combined preferred terms of “leukopenia” and “decreased white blood cell count”.2
‡IMMU-132-01, IMMU-132-05 [N=258; ASCENT] and IMMU-132-09 involving 688 patients who received Trodelvy® 10 mg/kg for the
treatment of mTNBC and HR+/HER2- breast cancer.2
Adverse events leading to discontinuation were infrequent in the ASCENT study1
Of the 529 patients enrolled in ASCENT, 482 patients (Trodelvy®, n=258; single-agent chemotherapy, n=224) were included in the safety population (all patients who received ≥1 dose of study treatment).1
In pooled data from three clinical studies in patients with breast cancer treated with Trodelvy®:*3
Most common adverse events reported in TNBC patients treated with Trodelvy®3
Neutropenia (67.6%), nausea (62.6%), diarrhoea (62.5%), fatigue (61.5%), alopecia (45.6%), anaemia (40.7%), constipation (36.2%), vomiting (33.6%), decreased appetite (25.7%), dyspnoea (22.1%) and abdominal pain (20.2%).
Most common serious adverse events in patients treated with Trodelvy®3
Febrile neutropenia (4.8%), diarrhoea (3.9%), neutropenia (2.6%), pneumonia (2%).
Fatal adverse events reported in patients treated with Trodelvy®3
Fatal adverse reactions occurred in 1.2% of patients who received Trodelvy®.
Trodelvy® can cause severe or life-threatening neutropenia, diarrhoea leading to dehydration and renal impairment and life-threatening infusion reactions. It is important to consult the Trodelvy® Summary of Product Characteristics before prescribing.
*The frequencies of adverse events are based on pooled data from three clinical studies involving 688 patients who received Trodelvy® 10 mg/kg body weight for the treatment of mTNBC and HR+/HER2- breast cancer. The median exposure to Trodelvy® in this data set was 4.63 months.3
The batch number of the administered Trodelvy® doses should be recorded.
Trodelvy® can cause severe or life-threatening neutropenia. Fatal infections in the setting of neutropenia have been observed in clinical studies with Trodelvy®, primarily in the first two cycles of treatment.
Primary prophylaxis with G-CSF should be considered starting in the first cycle of treatment in patients at increased risk of febrile neutropenia, e.g., older patients (in particular aged 65 years and older), patients with previous neutropenia, poor performance status, organ dysfunction (including renal, liver or cardiovascular dysfunction), or multiple comorbid conditions. Monitor absolute neutrophil count (ANC) during treatment.
Trodelvy® should not be administered if the ANC is below 1500/mm3 on Day 1 of any cycle or if the neutrophil count is below 1000/mm3 on Day 8 of any cycle. Trodelvy® should not be administered in case of neutropenic fever. Dose reductions are required due to neutropenia or febrile neutropenia. Consider treating neutropenia with G-CSF and consider prophylaxis in subsequent cycles as clinically indicated (see section 4.2 and 4.8).
Trodelvy® can cause severe and life-threatening hypersensitivity including anaphylaxis. It is contraindicated in patients with a known hypersensitivity to active drug, excipients or irinotecan.
Pre-medication is recommended to prevent infusion reactions. Patients should be closely observed for such reactions during, and for at least 30 minutes after completion of each infusion. Slow down or interrupt infusions if reactions occur. Permanently discontinue Trodelvy® in case of life-threatening infusion reactions.
Fatal adverse drug reactions have been reported in 1.2% of patients treated with Trodelvy®.
Trodelvy® can cause severe diarrhoea and can lead to dehydration and subsequent acute kidney damage. It should not be administered in case of Grade 3–4 diarrhoea at the time of scheduled treatment and treatment should be only continued when resolved to ≤Grade 1.
At the onset of diarrhoea, and if no infectious cause can be identified, treatment with loperamide should be initiated with additional supportive measures as clinically indicated.
Trodelvy® is emetogenic. Premedication is recommended.
Trodelvy® should not be administered in case of Grade 3 nausea or Grade 3–4 vomiting at the time of scheduled treatment and should be only continued with additional supportive measures when resolved to ≤Grade 1.
Individuals who are homozygous for UGT1A1*28 allele are potentially at increased risk of adverse reactions following initiation of Trodelvy® treatment.
UGT1A1 inhibitors/inducers may increase/reduce systemic exposure to the active SN-38 metabolite after Trodelvy® with potential increased toxicity/reduced exposure to SN-38.
Breast-feeding should be discontinued during and for 1 month after the last dose of Trodelvy®.
Based on findings in animals, Trodelvy® may impair fertility in females of reproductive potential.
Trodelvy® administration is not recommended during pregnancy. Based on its mechanism of action, Trodelvy® can cause teratogenicity and/or embryo-foetal lethality.
Inform female patients of the risk to the foetus and potential loss of the pregnancy and to immediately contact their doctor if they are pregnant or become pregnant.
Women of childbearing potential have to use effective contraception during treatment and for 6 months after the last dose.
Male patients with female partners of childbearing potential should have to use effective contraception during treatment with Trodelvy® and for 3 months after the last dose.Trodelvy® has not been studied in patients with moderate or severe hepatic or renal impairment. See Summary of Product Characteristics for prescribing restrictions.
Always consult the Trodelvy® Summary of Product Characteristics before prescribing.3
Adverse events in patients receiving Trodelvy® can usually be managed with dose modifications and routine management strategies.
*Please refer to the Summary of Product Characteristics for a full summary of the safety profile for Trodelvy®, premedication, recommended dose modifications, and management strategies.3
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May 2025 UKI-TRO-0278
Adverse events should be reported
Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or via the Yellow Card app (download from the Apple App Store or Google Play Store). Adverse events should also be reported to Gilead to [email protected] or +44 (0) 1223 897500.