Lifyorli (riprilecan) is a glucocorticoid receptor antagonist that has shown benefit in specific tumor populations, but is also subject to strict usage restrictions.

I. Indications

1. Applicable Cancer Types and Therapeutic Positioning

(1) Lifyorli is indicated in combination with nab-paclitaxel for the treatment of adult patients with platinum‑resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

(2) Patients must have received one to three prior systemic treatment regimens, and at least one of those regimens must have included bevacizumab.

2. Timing of Treatment and Dosing Cycle

(1) This medicinal product is administered once on the day before, the day of, and the day after each nab‑paclitaxel infusion, forming a 3‑day pulse dosing per cycle, and continued until disease progression or unacceptable toxicity occurs.

(2) Nab‑paclitaxel is given as an intravenous infusion on days 1, 8, and 15 of each 28‑day cycle; the dosing of Lifyorli is closely coordinated with this schedule.

3. Patient Population Characteristics

(1) The eligible population is adults with prior platinum‑resistant or no‑response disease, generally aged 26 years and older.

II. Contraindications

1. Absolute Contraindication: Use of Glucocorticoids as Life‑Saving Therapy

(1) Lifyorli is strictly contraindicated in patients receiving systemic glucocorticoids for life‑saving purposes, for example, maintenance immunosuppression after organ transplantation.

(2) The reason is that Lifyorli, by antagonising the glucocorticoid receptor, can significantly attenuate the efficacy of glucocorticoids, potentially endangering the patient's life support in such situations.

2. Relative Contraindication: Other Conditions Requiring Long‑Term or Frequent Glucocorticoid Use

(1) In patients who require frequent use of systemic glucocorticoids for other reasons, such as autoimmune diseases or chronic inflammatory conditions, co‑administration with Lifyorli should be avoided whenever possible.

(2) If avoidance is not possible, close monitoring is required for exacerbation of the underlying disease (due to reduced glucocorticoid efficacy) and for possible loss of Lifyorli effect (due to competitive antagonism by glucocorticoids).

(3) Patients requiring chronic or frequent glucocorticoid use were excluded from clinical studies, and safety data in this setting are limited.

III. Required Assessments Before Treatment

1. Hepatic Function Screening

(1) Hepatic function (total bilirubin, AST, etc.) must be measured before initiation; patients with moderate to severe hepatic impairment should avoid Lifyorli because of increased drug exposure and higher toxicity risk.

(2) No dose adjustment is required for patients with mild hepatic impairment at the start, but periodic monitoring during treatment is still recommended.

2. Pregnancy Status and Family Planning

(1) Pregnancy testing must be performed in women of childbearing potential before starting treatment, and a negative result must be confirmed before administration.

(2) During treatment and for 1 week after the last dose, both female and male patients (with female partners of childbearing potential) must use effective contraception.

3. Concomitant Medication History

(1) A detailed record is required of whether the patient is using strong CYP3A inducers, CYP2C8 inhibitors/inducers, or other drugs that may affect the exposure of Lifyorli or nab‑paclitaxel.

(2) If the patient is currently using glucocorticoids (for any indication), the physician must be clearly informed to allow risk assessment.