sacituzumab govitecan: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
sacituzumab govitecan: clinical details
Prescribing considerations
- Restrict prescribing and administration to professionals experienced in anticancer therapy, with resuscitation facilities immediately available.
- Premedicate against infusion reactions and chemotherapy-induced nausea and vomiting.
- Consider primary G-CSF prophylaxis in patients at increased risk of febrile neutropenia.
- Use caution and close monitoring in known reduced UGT1A1 activity, particularly with unusually early or severe toxicity.
- Safety is not established in moderate or severe hepatic impairment or severe renal impairment/end-stage renal disease.
- Record the product name and batch number for biological-medicine traceability.
Contraindications and cautions
- Hypersensitivity to sacituzumab govitecan, any excipient or previous irinotecan therapy.
- Do not use in children or adolescents: safety and efficacy have not been established.
Monitoring
- Full blood count, particularly absolute neutrophil count, before and during treatment.
- Clinical evidence of infection, febrile neutropenia and neutropenic colitis.
- Frequency and severity of diarrhoea, hydration, renal function and electrolytes where indicated.
- Nausea, vomiting and adequacy of supportive medication.
- Infusion and hypersensitivity reactions during administration and for at least 30 minutes afterwards.
- Liver function and adverse effects in patients with hepatic impairment.
Clinical pharmacology
Sacituzumab govitecan is a humanised Trop-2-directed antibody–drug conjugate linked to SN-38. Following binding and internalisation, linker hydrolysis releases SN-38, which inhibits topoisomerase I and causes lethal DNA damage. SN-38 is primarily metabolised through UGT1A1.
Formulation and product differences
- Supplied as a single-use, off-white to yellowish powder for concentrate for intravenous infusion.
- Requires reconstitution and dilution by trained staff; only sodium chloride 0.9% solution should be used for preparation.
- Contains MES, polysorbate 80 and trehalose dihydrate; the prepared infusion must be protected from light and must not be frozen or shaken.
sacituzumab govitecan preparations and strengths
Solution for infusion
Route: Intravenous
Strengths: 180 mg
sacituzumab govitecan interactions
Tell the cancer team about all prescribed, non-prescribed and herbal products. Formal interaction studies are limited, but medicines affecting UGT1A1 may change exposure to SN-38.
UGT1A1 inhibitors, including ketoconazole, propofol and some EGFR tyrosine-kinase inhibitors
May increase SN-38 exposure and adverse effects, so caution and closer monitoring are required.
UGT1A1 inducers, including carbamazepine, phenytoin, rifampicin and protease inhibitors
May reduce SN-38 exposure, so caution and close monitoring are required.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.