Relacorilant (1 brand name, 1 dosage form, 1 route)
Available dosage forms: CAPSULE.
Routes of administration: ORAL.
Brand Names
- LIFYORLI (COPACKAGED)
Indications and Usage
LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab [see Clinical Studies (14)].
Contraindications
LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because LIFYORLI antagonizes the effect of glucocorticoids [see Warnings and Precautions (5.3)].
Adverse Reactions
The following adverse reactions are discussed in more detail in other sections of the labeling: Neutropenia and Severe Infections [see Warnings and Precautions (5.1)]. Adrenal Insufficiency [see Warnings and Precautions (5.2)] Exacerbation of Conditions Treated with Glucocorticoids [see Warnings and Precautions (5.3)].
Mechanism of Action
Relacorilant is a reversible glucocorticoid receptor (GR) antagonist. In functional in vitro assays with the mineralocorticoid receptor, relacorilant showed no agonist or antagonist activity. In human cell-line derived xenograft models, relacorilant enhanced apoptosis and antitumor activity when administered with paclitaxel. Cortisol binding to the GR is immunosuppressive, decreasing secretion of pro‑inflammatory cytokines. GR antagonism may indirectly activate the immune system; relacorilant inhibited the cortisol-induced reduction of tumor necrosis factor alpha and interferon gamma in stimulated peripheral blood mononuclear cells.