TM Owner Gilead Sciences
Trodelvy 180mg Injection
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Indications & Clinical Uses
- Trodelvy 180mg (sacituzumab govitecan-hziy), made by Gilead Sciences (USA), is a Trop-2-directed antibody-drug conjugate given only by intravenous infusion in a hospital or clinic - it is never self-injected at home.
- In the US it is approved for adults with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC), as first-line treatment (alone, or with pembrolizumab if the tumour is PD-L1-positive) or after two or more prior systemic therapies, and for previously treated hormone-receptor-positive/HER2-negative metastatic breast cancer after endocrine therapy and at least two further treatment lines.
- Trodelvy also held an accelerated approval for metastatic urothelial (bladder) cancer from 2021, but Gilead voluntarily withdrew that indication in the US after a confirmatory trial did not meet its endpoint, and it was removed from the label in November 2024 - Trodelvy is no longer indicated for bladder cancer, only for the breast cancer uses above.
- The EU authorisation covers the same breast cancer indications.
Side Effects
- Trodelvy carries a boxed warning for severe, life-threatening or fatal neutropenia (low white blood cell count) and for severe diarrhoea; blood counts are checked before every dose, growth-factor support may be given to high-risk patients, and diarrhoea is treated promptly with loperamide and, if needed, fluids.
- Very common side effects, in more than 1 in 10 patients, include nausea, fatigue, hair loss, vomiting, constipation, decreased appetite and abdominal pain, along with laboratory changes such as raised blood sugar and low neutrophil, white cell or red cell counts.
- Severe hypersensitivity and infusion-related reactions can occur during or shortly after infusion, so patients are premedicated and monitored on the infusion unit.
- Report fever, signs of infection, diarrhoea that does not settle, or severe nausea and vomiting to the care team straight away, since these can become dangerous quickly without prompt treatment.
Precautions & Warnings
- Trodelvy must only be given as an intravenous infusion under the supervision of a healthcare professional experienced in cancer therapy - it is never given by rapid injection or used at home.
- Complete blood counts are checked at baseline and before each dose, and treatment is delayed, reduced or stopped for significant neutropenia, diarrhoea, or other serious toxicity.
- Patients with a reduced-function UGT1A1 genotype may be at higher risk of severe neutropenia; genotype testing can guide dose decisions.
- Trodelvy can cause severe hypersensitivity reactions, including anaphylaxis, and severe skin reactions, so patients are monitored closely during infusion, especially the first two cycles.
- It can cause fetal harm, so effective contraception is required during treatment and for a period afterward in patients of reproductive potential, and breastfeeding should be avoided during treatment and for a month after the last dose.
- Interrupt or stop treatment for interstitial lung disease/pneumonitis.
Avoid Interactions
- Strong or moderate UGT1A1 inhibitors, such as certain antivirals and antifungals, can raise SN-38 (the active metabolite) exposure and worsen Trodelvy's side effects, so these are used with caution and closer monitoring.
- UGT1A1 inducers can lower drug exposure and reduce effectiveness.
- Trodelvy must not be combined with other irinotecan-containing medicines, since it shares the same active metabolite, SN-38, which would increase toxicity risk.
- There is no established interaction with the routine anti-nausea or anti-diarrhoeal medicines used to manage its side effects, but patients should tell their oncology team about every prescription, herbal and over-the-counter medicine, including antifungals, antivirals and HIV medicines, before each infusion.
References
Frequently Asked Questions
Trodelvy (sacituzumab govitecan) treats adults with triple-negative breast cancer, either as an early-line option or after prior chemotherapy, and hormone-receptor-positive, HER2-negative breast cancer after endocrine therapy and further treatment lines. An earlier bladder cancer approval was withdrawn in the US in 2024.
Trodelvy is given only by intravenous infusion in a hospital or clinic, usually once weekly for two weeks of every three-week cycle. The first infusion takes about 3 hours; later infusions can be shortened to 1 to 2 hours if well tolerated.
Trodelvy's boxed warning covers severe or life-threatening low white blood cell counts (neutropenia) and severe diarrhoea. Very common effects include nausea, tiredness, hair loss and vomiting. Tell your care team immediately about fever, persistent diarrhoea, or signs of infection.
Avoid other irinotecan-containing medicines, since Trodelvy shares the same active breakdown product, SN-38. Tell your oncology team about all antifungal, antiviral and HIV medicines you take, as some can raise Trodelvy's side effects. Effective contraception is needed during treatment.
You will have blood counts checked before each dose, then receive Trodelvy through a vein, with staff monitoring for infusion reactions, especially during the first two cycles. You may be given anti-nausea medicine beforehand. Doses can be delayed or reduced if side effects occur.
No. Trodelvy can harm an unborn baby, so effective contraception is required during treatment for patients who could become pregnant, and breastfeeding should be avoided during treatment and for one month after the last dose. Discuss family planning with your oncologist beforehand.
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