sacituzumab govitecan
Trodelvy · ATC code L01FX06
Also known as: Sasituzumab govitekan
- Key facts
- Active substance
- sacituzumab govitecan
- ATC code
- L01FX06
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Trodelvy 200 mg powder for concentrate for solution for infusion.
- Marketing authorisation holder
- Gilead Sciences Ireland UC
- Information as of
- 2026-10-28
Key facts
Sacituzumab govitecan is a Trop-2-directed antibody-drug conjugate that delivers the topoisomerase inhibitor SN-38 to tumour cells. It is used for advanced triple-negative and HR-positive, HER2-negative breast cancer.
What it is used for
- Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) without prior systemic therapy for metastatic disease: with pembrolizumab if PD-L1 CPS ≥ 10, or as monotherapy if not candidates for PD-1/PD-L1 inhibitor therapy.
- TNBC as monotherapy after two or more prior systemic therapies, at least one for advanced disease.
- HR-positive, HER2-negative breast cancer as monotherapy after endocrine-based therapy and at least two additional systemic therapies in the advanced setting.
Dosing
- Trodelvy (powder for concentrate for infusion): 10 mg/kg body weight as an intravenous infusion once weekly on Day 1 and Day 8 of 21-day cycles, as monotherapy or with pembrolizumab (sacituzumab govitecan first).
- Before each dose, give premedication against infusion-related reactions and nausea and vomiting; consider primary G-CSF prophylaxis in patients at increased risk of febrile neutropenia.
- Dose reductions for adverse reactions to 7.5 mg/kg, then 5 mg/kg, then discontinue; no re-escalation after reduction.
- Do not administer if ANC is below 1500/mm3 on Day 1 or below 1000/mm3 on Day 8, or with neutropenic fever.
- Mild hepatic and mild to moderate renal impairment: no adjustment; avoid in greater hepatic impairment (e.g. bilirubin > 1.5 ULN).
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
Important warnings
- Severe or life-threatening neutropenia; fatal infections mainly in the first two cycles; monitor ANC.
- Diarrhoea, including severe: treat promptly at onset; excessive cholinergic responses can be treated, e.g. with atropine.
- Severe and life-threatening hypersensitivity including anaphylaxis; administer only where full resuscitation facilities are available.
- Nausea and vomiting; prophylaxis before each dose.
- Patients with reduced UGT1A1 activity (e.g. homozygous for UGT1A1*28) are at increased risk of neutropenia, febrile neutropenia and anaemia.
Side effects
- Monotherapy, most common: neutropenia (67.3%), nausea (62.1%), diarrhoea (59.9%), fatigue (57.4%), alopecia (48.3%), anaemia (40.1%), constipation (36.7%), vomiting (31.3%), decreased appetite (23.3%).
- Most frequent serious adverse reactions: febrile neutropenia (4.5%), diarrhoea (3.7%), neutropenia (2.9%), pneumonia (2.1%).
- With pembrolizumab, most frequent: diarrhoea (70.1%), nausea (67.9%), neutropenia (62.9%), fatigue (58.4%).
Interactions
- UGT1A1 inhibitors (e.g. propofol, ketoconazole, EGFR tyrosine kinase inhibitors) may increase SN-38 exposure and adverse reactions – use with caution.
- UGT1A1 inducers (e.g. carbamazepine, phenytoin, rifampicin, ritonavir) may reduce SN-38 exposure – use with caution.
Pregnancy and breastfeeding
- Can cause teratogenicity. Women: effective contraception during and for 6 months after the last dose; men with female partners of childbearing potential: during and for 3 months after.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- TrodelvyGilead Sciences Ireland UC · EMEA/H/C/005182
Source: European Medicines Agency (EMA), product information
Turkey
- TrodelvyTİC. LTD. ŞTİ. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Trodelvy
- Liechtenstein
- Trodelvy
- Norway
- Trodelvy
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
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Sources
- European Medicines Agency. Trodelvy – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/trodelvy-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.