lifyorli (copackaged)
Lifyorli (Copackaged) (Relacorilant) is a medication used to treat Ovarian Epithelial Carcinoma, Fallopian Tube Neoplasms, Peritoneal Neoplasms.
Relacorilant · by Corcept Therap
Key facts
- Active ingredient
- Relacorilant
- Form
- Kit
- Strength
- Relacorilant 100MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Corcept Therap
- FDA application
- NDA220641
What is Lifyorli (Copackaged)?
From the FDA label:LIFYORLI (relacorilant) is a glucocorticoid receptor antagonist antineoplastic agent. Relacorilant chemical names: (R)-(1-(4-fluorophenyl)-6-((1-methyl-1H-pyrazol-4-yl)sulfonyl)-4,4a,5,6,7,8-hexahydro-1H-pyrazolo[3,4-g]isoquinolin-4a-yl)(4-trifluoromethyl)(pyridin-2-yl)methanone [(4a R )-1-(4-fluorophenyl)-6-(1-methyl-1 H -pyrazole-4-sulfonyl)-1,4,5,6,7,8-hexahydro-4a H -pyrazolo[3,4-g]isoquinolin-4a-yl][4-(trifluoromethyl)pyridin-2-yl]methanone The molecular formula is C 27 H 22 F 4 N 6 O 3 S and the molecular weight is 586.57 g/mol. The chemical structure of relacorilant is: Relacorilant is an off-white to light yellow solid that is practically insoluble in aqueous media. LIFYORLI capsules for oral use are supplied as immediate release, printed, soft gelatin capsules containing 25 mg or 100 mg of relacorilant. Each capsule contains the following excipients: butylated hydroxytoluene, lauroyl polyoxyl-32 glycerides, and propylene glycol caprylate. The capsule shell for the 25 mg strength contains black iron oxide, gelatin, red iron oxide, sorbitol special glycerin blend, titanium dioxide, and yellow iron oxide. The capsule shell for the 100 mg strength contains gelatin, sorbitol special glycerin blend, titanium dioxide, and yellow iron oxide. The printing ink contains ammonium hydroxide, black iron oxide, ethanol, ethyl acetate, isopropyl alcohol, macrogol/polyethylene glycol,…
How to use
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. ( 2 ) 2.1 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 [see Dosage and Administration ( 2.2 and 2.3 ) and Clinical Studies ( 14 )] . Do not substitute with other paclitaxel formulations. 2.2 Recommended Dosage and Administration 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 until disease progression or unacceptable toxicity. The recommended dosage for nab-paclitaxel is 80 mg/m 2 administered as an intravenous infusion on Days 1, 8 and 15 of each 28-day cycle…
Side effects
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…
Warnings
Important safety information
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. ( 2.3 , 5.1 ) Adrenal insufficiency: Monitor for signs and symptoms of adrenal insufficiency. ( 5.2 ) Exacerbation of Conditions Treated with Glucocorticoids: LIFYORLI makes systemic glucocorticoids less effective in patients who have an ongoing requirement for systemic glucocorticoids. ( 5.3 ) Embryo-Fetal Toxicity : LIFYORLI can cause fetal harm. Advise females of reproductive potential of the risk to a fetus and to use effective contraception. ( 5.4 ) 5.1 Neutropenia and Severe Infections LIFYORLI in combination with nab-paclitaxel can cause neutropenia, including febrile neutropenia and severe infections. In ROSELLA, decreased neutrophil count occurred in 74% of patients treated with LIFYORLI in combination with nab-paclitaxel, 30% Grade 3, 15% Grade 4, and 3.7% febrile neutropenia. The median time to onset of neutropenia was 15 days (range: 8 to 329). Instances of neutropenia were temporally associated with infection in 16% of patients. There was one fatal event of septic shock with febrile neutropenia. Thirty-eight percent of patients initiated granulocyte colony-stimulating factor (G-CSF) during the first or second cycle of therapy. Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated. Based on the severity of neutropenia, delay, reduce dose or permanently discontinue LIFYORLI in combination with nab-paclitaxel. Consider short-acting G-CSF administration as applicable [see Dosage and Administration ( 2.3 )] . Consider the possibility of concurrent adrenal insufficiency, particularly in the setting of serious infection [see Warnings and Precautions ( 5.2 )] . Inform patients to promptly report any episodes of fever to their healthcare provider. 5.2 Adrenal Insufficiency LIFYORLI is a reversible glucocorticoid receptor antagonist and can cause adrenal insufficiency. Adrenal insufficiency can occur at any time during treatment with LIFYORLI. The risk of adrenal insufficiency is increased in situations of stress, such as acute illness, infection, or surgery. Consider whether supplemental glucocorticoids are required in the perioperative period in patients who have received LIFYORLI within 30 days of surgery. Monitor patients receiving LIFYORLI for signs and symptoms of adrenal insufficiency. Serum cortisol levels do not provide an accurate assessment of adrenal insufficiency in patients receiving LIFYORLI. Withhold LIFYORLI and administer glucocorticoid therapy if adrenal insufficiency is suspected. High doses of supplemental glucocorticoids may be needed to overcome the glucocorticoid receptor antagonism produced by LIFYORLI. When deciding on the duration of glucocorticoid treatment, consider the long half-life of relacorilant (27.5 hours) and that glucocorticoid receptor antagonism may occur for up to 6 days after the last dose of LIFYORLI [see Clinical Pharmacology ( 12.3 )] . After resolution of adrenal insufficiency, resume previous dose, reduce dose or permanently discontinue LIFYORLI based on severity [see Dosage and Administration ( 2.3 )] . Educate patients on the symptoms associated with adrenal insufficiency and advise them to contact a healthcare provider if they occur. 5.3 Exacerbation of Conditions Treated with Glucocorticoids Use of LIFYORLI in patients who are taking systemic glucocorticoids for other conditions (e.g., autoimmune disorders) may exacerbate these conditions. LIFYORLI is a glucocorticoid receptor antagonist which may make systemic glucocorticoids less effective. Similarly, coadministration of systemic glucocorticoids may make LIFYORLI less effective. Monitor patients for reduced effectiveness of LIFYORLI and glucocorticoids in patients receiving both [see Drug Interactions ( 7.3 )]. Patients who require chronic or frequent use of glucocorticoids were excluded from clinical trials of LIFYORLI in combination with nab-paclitaxel. LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes, [see Contraindications ( 4 )] . 5.4 Embryo-Fetal Toxicity Based on data from animal studies, LIFYORLI can cause fetal harm when administered to a pregnant woman. Oral administration of relacorilant to pregnant rabbits resulted in adverse developmental outcomes, including embryo-fetal mortality. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating LIFYORLI treatment. Advise females of reproductive potential to use effective contraception during treatment with LIFYORLI and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with LIFYORLI and for 1 week after the last dose [see Use in Specific Populations ( 8.1 , 8.3 )] .
Who should not take Lifyorli (Copackaged)
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 )
Interactions
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.
May treat (source: NIH RxClass)
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Lifyorli (Copackaged) treat?
- Lifyorli (Copackaged) (Relacorilant) may be used to treat ovarian epithelial carcinoma, fallopian tube neoplasms, peritoneal neoplasms, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Lifyorli (Copackaged)?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Lifyorli (Copackaged). To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Lifyorli (Copackaged)?
- Lifyorli (Copackaged) is marketed by Corcept Therap. You can see Corcept Therap's full profile, rating, and other products on pharmaranks.
- Is Lifyorli (Copackaged) a brand-name or generic drug?
- Lifyorli (Copackaged) is a brand-name product with the active ingredient Relacorilant.
- Is Lifyorli (Copackaged) available over the counter?
- No. Lifyorli (Copackaged) is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Lifyorli (Copackaged) come in?
- Lifyorli (Copackaged) is currently marketed as kit, per the FDA's National Drug Code Directory.
- Is Lifyorli (Copackaged) FDA-registered?
- Lifyorli (Copackaged) is on record with the U.S. FDA under application number NDA220641. You can verify this on its official FDA label.
- Is Lifyorli (Copackaged) safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Lifyorli (Copackaged). Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Lifyorli (Copackaged)?
- Lifyorli (Copackaged)'s side effects are taken directly from its FDA label. From the label: 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 )] .… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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