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Trop-2 Antibody-Drug Conjugate Pregnancy: Contraindicated — cytotoxic payload; effective contraception required during and for 6 months (female) or 3 months (male) after treatment

Sacituzumab Govitecan

Brand names: Trodelvy

Adult dose

Dose: 10 mg/kg IV on days 1 and 8 of each 21-day cycle
Route: Intravenous infusion over 3 hours (first dose); 1–2 hours (subsequent doses if tolerated)
Frequency: Days 1 and 8 of every 21 days
Max: 10 mg/kg per dose
Metastatic urothelial carcinoma after platinum-based chemotherapy and PD-1/L1 inhibitor; also triple-negative breast cancer (TNBC); G-CSF primary prophylaxis recommended due to high neutropenia rate; UGT1A1*28 genotyping optional but informs toxicity risk

Paediatric dose

Dose: Not established N/A/kg
Route: N/A
Frequency: N/A
Max: N/A
Not licensed in paediatrics

Dose adjustments

Renal

No dose adjustment for CrCl ≥30 mL/min; limited data below

Hepatic

Avoid in moderate-severe hepatic impairment — SN-38 (active metabolite) clearance impaired

Paediatric weight-based calculator

Not licensed in paediatrics

Clinical pearls

  • TROPHY-U-01 (Tagawa et al. JCO 2021): sacituzumab govitecan achieved 27.7% ORR in platinum- and checkpoint inhibitor-refractory metastatic UC — MHRA 2023 approved; NICE TA958 (2024); addresses major unmet need in post-platinum/post-IO urothelial cancer
  • Trop-2 targeting: TACSTD2 (Trop-2) is a transmembrane glycoprotein overexpressed in >80% of urothelial carcinomas — SN-38 (active irinotecan metabolite) is the cytotoxic payload; high drug-to-antibody ratio (DAR ~7.6) and bystander effect contribute to efficacy
  • Diarrhoea management: two patterns — early (cholinergic, within 24h of infusion, managed with atropine) and late (SN-38-mediated secretory, >24h, managed with loperamide); both require prompt intervention; severe late diarrhoea is the main reason for treatment delay/dose reduction
  • UGT1A1*28 homozygotes (Gilbert's syndrome phenotype): impaired SN-38 glucuronidation → increased SN-38 levels → higher neutropenia and diarrhoea risk; consider starting at 7.5 mg/kg if *28/*28 genotype confirmed; test available but not mandated
  • Positioning in bladder cancer: after enfortumab vedotin approval as earlier-line therapy (EV+pembrolizumab first-line), sacituzumab govitecan fills the third-line slot in patients progressed on EV; distinct Trop-2 target vs Nectin-4 (enfortumab) means no cross-resistance expected

Contraindications

  • Severe hepatic impairment
  • Known hypersensitivity to sacituzumab govitecan

Side effects

  • Neutropenia (dose-limiting — grade 3-4 in ~35%; G-CSF prophylaxis recommended)
  • Diarrhoea (SN-38 irinotecan metabolite — can be severe; early vs late onset patterns)
  • Nausea/vomiting
  • Alopecia
  • Fatigue
  • Anaemia
  • Mucositis

Interactions

  • UGT1A1 inhibitors — increase SN-38 exposure; increased toxicity risk
  • Strong CYP3A4 inhibitors — may affect SN-38 levels
  • G-CSF — use as primary prophylaxis to mitigate neutropenia

Monitoring

  • FBC before each dose (hold if ANC <1.5 or platelets <100)
  • G-CSF administration (primary prophylaxis from cycle 1)
  • Diarrhoea scoring (each visit — NCI-CTCAE grade)
  • LFTs
  • UGT1A1 genotyping (optional, informs dose)

Reference: BNFc; BNF 90; TROPHY-U-01 (Tagawa et al. JCO 2021); MHRA SPC Trodelvy 2023; NICE TA958; EAU Bladder Cancer Guidelines 2024; Goldenberg et al. Oncologist 2021. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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