Sacituzumab govitecan-hziy (Elahere) is an antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα). It was approved by the U.S. FDA in 2022 for the treatment of adult patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
How to Use Sacituzumab Govitecan-hziy (Elahere)
Pre-Administration Preparation
Patient Screening: Tumor FRα-positive expression must be confirmed using an FDA-approved test (e.g., VENTANA FOLR1 RxDx Assay).
Ophthalmic Examinations: Before treatment, visual acuity and slit-lamp examinations are required; re-examinations should be conducted every 2 cycles (during the first 8 cycles) throughout the treatment period.
Dosage Form and Specification: The injection is supplied as a single-dose vial containing 100 mg/20 mL (5 mg/mL).
Dosing Regimen
Standard Dosage: 6 mg/kg (based on adjusted ideal body weight, AIBW), administered as an intravenous infusion once every 3 weeks, until disease progression or unacceptable toxicity occurs.
AIBW Calculation Formula: For females, Ideal Body Weight (IBW) in kg = 0.9 × height (cm) - 92.
AIBW Calculation: AIBW = IBW + 0.4 × (actual body weight - IBW).
Premedication
General Premedication: 30 minutes before infusion, administer glucocorticoids (e.g., dexamethasone 10 mg IV), antihistamines, antipyretics, and antiemetics.
Ocular Prophylaxis: From 1 day before infusion to Day 8, instill glucocorticoid eye drops into each eye (6 times daily for the first 4 days, then 4 times daily for the next 4 days); use lubricating eye drops at least 4 times daily.
Infusion Requirements
Diluent: Dilute only with 5% dextrose injection; normal saline is prohibited.
Infusion Rate: Initiate infusion at 1 mg/min; if tolerated, the rate can be gradually increased to a maximum of 5 mg/min.
Missed Doses
If an infusion is missed, administer the missed dose as soon as possible, with an interval of ≥21 days from the next scheduled dose.
Do not administer a double dose within a short period.
Dosage Adjustments for Sacituzumab Govitecan-hziy (Elahere)
Ocular Toxicity
Non-confluent Superficial Keratitis: Monitor only.
Confluent Keratitis or Visual Acuity Decrease ≥3 Lines: Withhold treatment; resume at the original dose or a reduced dose after improvement.
Corneal Ulcer or Visual Acuity ≤20/200: Withhold treatment until improvement, then resume at a 1-level dose reduction (e.g., 6 mg/kg → 5 mg/kg).
Corneal Perforation: Discontinue treatment permanently.
Pneumonitis
Grade 2 (Persistent or Recurrent): Withhold treatment until symptoms resolve to ≤Grade 1; consider dose reduction.
Grade 3-4: Discontinue treatment permanently.
Peripheral Neuropathy
Grade 2: Withhold treatment until symptoms resolve to ≤Grade 1, then resume at the original dose or a reduced dose.
Grade 3-4: Discontinue treatment permanently.
Use in Special Populations for Sacituzumab Govitecan-hziy (Elahere)
Hepatic Impairment
No dose adjustment is needed for mild to moderate hepatic impairment.
Avoid use in patients with moderate to severe hepatic impairment (total bilirubin >1.5 × upper limit of normal [ULN]).
Renal Impairment
No dose adjustment is needed for mild to moderate renal impairment (creatinine clearance [CLcr] 30-89 mL/min).
Data on use in patients with severe renal impairment (CLcr 15-30 mL/min) are insufficient; use with caution.
Pregnancy and Lactation
Pregnancy: Sacituzumab govitecan-hziy has embryo-fetal toxicity. Confirm negative pregnancy status before initiating treatment; effective contraception is required during treatment and for 7 months after discontinuing treatment.
Lactation: Breastfeeding is prohibited during treatment and for 1 month after the last dose.
