Relacorilant: uses, dosing, side effects & brands

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 )]. 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. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Corcept Therapeutics at 1-855-844-3270 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of LIFYORLI in combination with nab-paclitaxel was evaluated in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in ROSELLA [see Clinical Studies ( 14 )] . Patients received LIFYORLI (150 mg orally on the day before, the day of, and the day after each administration of…

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 )] . Concurrent systemic glucocorticoid therapy for a lifesaving indication. ( 4 )

Strong CYP3A Inducers : Avoid coadministration with LIFYORLI in combination with nab-paclitaxel. ( 7.1 ) CYP2C8 Inducers and Moderate CYP3A Inducers : Monitor for reduced effectiveness for LIFYORLI in combination with nab-paclitaxel. ( 7.1 ) CYP2C8 Inhibitors : Monitor for increased adverse reactions and modify the dosage for adverse reactions as recommended. ( 7.1 ) CYP3A Substrates : Avoid coadministration unless otherwise recommended. ( 7.2 ) Certain CYP2C8 Substrates : Avoid coadministration unless otherwise recommended. ( 7.2 ) 7.1 Effect of Other Drugs on LIFYORLI in Combination with Nab-Paclitaxel Strong CYP3A Inducers Avoid coadministration of LIFYORLI plus nab-paclitaxel with strong CYP3A inducers. Both relacorilant and paclitaxel are CYP3A substrates. Coadministration of strong CYP3A inducers can decrease concentrations of relacorilant and paclitaxel, which may reduce their effectiveness [see Clinical Pharmacology ( 12.3 )] . CYP2C8 Inducers and Moderate CYP3A Inducers Monitor for reduced effectiveness of LIFYORLI plus nab-paclitaxel with CYP2C8 inducers and moderate CYP3A inducers. Paclitaxel is a substrate of CYP2C8 and CYP3A and relacorilant is a CYP3A substrate. Coadministration of CYP2C8 inducers and moderate CYP3A inducers can decrease concentrations of paclitaxel and relacorilant, which may reduce their effectiveness. CYP2C8 Inhibitors Monitor for increased adverse reactions and modify the dosage for adverse reactions as recommended [see Dosage and Administration ( 2.3 )] . Paclitaxel is a substrate of CYP2C8. Coadministration of CYP2C8 inhibitors may increase concentrations of paclitaxel, which may increase the risk of adverse reactions. 7.2 Effect of LIFYORLI on Other Drugs CYP3A Substrates Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A substrates. Relacorilant is a strong CYP3A inhibitor. Relacorilant increases exposure of CYP3A substrates [see Clinical Pharmacology ( 12.3 )], which may increase the risk for adverse reactions related to these substrates. Certain CYP2C8 Substrates Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP2C8 substrates where minimal concentration changes may lead to reduced effectiveness. Relacorilant is a weak CYP2C8 inducer. Relacorilant decreases exposure of CYP2C8 substrates [see Clinical Pharmacology ( 12.3 )] , which may decrease the effectiveness related to these substrates. 7.3 Potential for Reduced Effectiveness of Glucocorticoids or LIFYORLI with Coadministration LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression in organ transplantation) [see Contraindications ( 4 )]. Avoid coadministration in patients with other medical conditions requiring systemic glucocorticoids when possible. If coadministration cannot be avoided, monitor patients for reduced effectiveness of LIFYORLI and glucocorticoids. LIFYORLI is a glucocorticoid receptor antagonist, which may make systemic glucocorticoids less effective. Coadministration of systemic glucocorticoids may make LIFYORLI less effective.