Relacorilant

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. LIFYORLI is a glucocorticoid receptor antagonist 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.

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.

The recommended dosage of LIFYORLI is 150 mg orally once on the day before, the day of, and the day after each nab-paclitaxel infusion. Important Dosage and Administration Information LIFYORLI Follow LIFYORLI dosing instructions provided on the blister card. Take LIFYORLI with food. Swallow capsules whole. Do not crush, chew, dissolve, or split the capsules. If a dose of LIFYORLI is missed by less than 12 hours, take the missed dose. If a dose of LIFYORLI is missed by 12 hours or more, skip the missed dose and take the next dose at the regularly scheduled time. Do not take 2 doses at the same time to make up for a missed dose. If vomiting occurs after taking LIFYORLI, do not take an additional dose. Nab-Paclitaxel The recommended dosage and dosage modifications for nab-paclitaxel when administered in combination with LIFYORLI differ from those for other nab-paclitaxel indications.

LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because LIFYORLI antagonizes the effect of glucocorticoids. Concurrent systemic glucocorticoid therapy for a lifesaving indication.

Neutropenia and Severe Infections: Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated. Withhold, reduce the dose, or permanently discontinue LIFYORLI based on severity. Adrenal insufficiency: Monitor for signs and symptoms of adrenal insufficiency. Exacerbation of Conditions Treated with Glucocorticoids: LIFYORLI makes systemic glucocorticoids less effective in patients who have an ongoing requirement for systemic glucocorticoids. Embryo-Fetal Toxicity: LIFYORLI can cause fetal harm. Advise females of reproductive potential of the risk to a fetus and to use effective contraception.

The following adverse reactions are discussed in more detail in other sections of the labeling: Neutropenia and Severe Infections. Adrenal Insufficiency Exacerbation of Conditions Treated with Glucocorticoids. Most common adverse reactions (incidence > 20%), including laboratory abnormalities, that occurred in patients treated with LIFYORLI in combination with nab-paclitaxel were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.

Strong CYP3A Inducers: Avoid coadministration with LIFYORLI in combination with nab-paclitaxel. CYP2C8 Inducers and Moderate CYP3A Inducers: Monitor for reduced effectiveness for LIFYORLI in combination with nab-paclitaxel. CYP2C8 Inhibitors: Monitor for increased adverse reactions and modify the dosage for adverse reactions as recommended. CYP3A Substrates: Avoid coadministration unless otherwise recommended. Certain CYP2C8 Substrates: Avoid coadministration unless otherwise recommended.

Store LIFYORLI at 20°C to 25°C (68°F to 77°F), excursions are permitted from 15°C to 30°C (59°F to 86°F). Store and dispense LIFYORLI in their original carton.