LIFYORLI (relacorilant)

There are 2 contraindications. Absolute contraindication.

Contraindication List
Child-pugh class B hepatic impairment
Lactation

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Disease of liver
Neutropenic disorder

There are 2 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Adrenocortical insufficiency
Infection

There are 14 severe adverse reactions.

More Frequent	Less Frequent
Anemia Leukopenia Neutropenic disorder Thrombocytopenic disorder	Acute kidney injury Adrenocortical insufficiency Hypertension Hypotension Infection Pleural effusions Pneumonia

Rare/Very Rare
Cerebrovascular accident Gastrointestinal obstruction Septic shock

There are 14 less severe adverse reactions.

More Frequent	Less Frequent
Anorexia Diarrhea Fatigue Nausea Skin rash	Acute abdominal pain Cough Dizziness Dysgeusia Edema Fever Nail disorders Stomatitis Syncope

Rare/Very Rare
None.

Relacorilant is used in combination with nab-paclitaxel. Refer to the Prescribing Information of nab-paclitaxel for pregnancy information. Based on findings in animals, relacorilant can cause fetal harm when administered to a pregnant woman.

There are no available data on relacorilant use in pregnant women to inform drug-associated risk. In animal embryo-fetal development studies, oral administration of relacorilant to pregnant rabbits during the period of organogenesis resulted in embryo-fetal mortality and structural abnormalities at maternal doses of >= 10 mg/kg/day (0.6 times the human exposure based on AUC at the recommended dose). Oral administration of relacorilant to pregnant rats during the period of organogenesis did not result in fetal malformations.

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is between 2 to 4% and 15 to 20%, respectively.

Relacorilant is used in combination with nab-paclitaxel. Refer to the Prescribing Information of nab-paclitaxel for lactation information. There are no data on the presence of relacorilant or its metabolites in animal or human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with relacorilant and for 1 week after the last dose.

Of the 188 patients with platinum-resistant epithelial ovarian cancer who received relacorilant, 38% were 65 years of age or older and 9.6% were 75 years of age or older. A higher incidence of grade 3-4 adverse events and dosage modification occurred in patients 65 years of age or older when compared to younger adult patients. No overall differences in effectiveness were observed between patients >=65 years of age and younger patients.