RECORLEV
Details
- Status
- Prescription
- First Approved
- 2021-12-30
- Routes
- ORAL
- Dosage Forms
- TABLET
RECORLEV Approval History
What RECORLEV Treats
3 indicationsRECORLEV is approved for 3 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypercortisolemia
- Cushing's Syndrome
- Fungal Infections
RECORLEV Boxed Warning
HEPATOTOXICITY AND QT PROLONGATION Hepatotoxicity • Cases of hepatotoxicity with a fatal outcome or requiring liver transplantation have been reported with use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Serious hepatotoxicity has been reported in patients receiving RECORLEV [see Warnings and Precautions ( 5.1 )]. • RECORLEV is contraindicated in patients with cirrhosis, acute liver disease or poorly controlled chronic liver disease, recurrent symptomatic c...
WARNING: HEPATOTOXICITY AND QT PROLONGATION Hepatotoxicity • Cases of hepatotoxicity with a fatal outcome or requiring liver transplantation have been reported with use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Serious hepatotoxicity has been reported in patients receiving RECORLEV [see Warnings and Precautions ( 5.1 )]. • RECORLEV is contraindicated in patients with cirrhosis, acute liver disease or poorly controlled chronic liver disease, recurrent symptomatic cholelithiasis, a prior history of drug induced liver injury due to ketoconazole or any azole antifungal therapy that required discontinuation of treatment, or extensive metastatic liver disease [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. • Evaluate liver enzymes prior to and during treatment. Interrupt RECORLEV treatment immediately if signs of hepatotoxicity occur [see Dosage and Administration ( 2.1 , 2.3 , 2.4 ), Warnings and Precautions ( 5.1 )]. QT Prolongation • RECORLEV is associated with dose-related QT interval prolongation. QT interval prolongation may lead to life-threatening ventricular dysrhythmias such as torsades de pointes [see Warnings and Precautions ( 5.2 )]. • Coadministration of RECORLEV with other drugs that prolong the QT interval associated with ventricular arrhythmias, including torsades de pointes, and use in patients with a prolonged QTcF interval of greater than 470 msec at baseline, history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or long QT syndrome (including first-degree family history) are contraindicated [see Contraindications ( 4 ), Drug Interactions ( 7.1 , 7.2 )]. • Perform an ECG and correct hypokalemia and hypomagnesemia prior to and during treatment. Temporarily discontinue RECORLEV if QTcF interval exceeds 500 msec [Dosage and Administration ( 2.1 , 2.3 , 2.4 )]. WARNING: HEPATOTOXICITY AND QT PROLONGATION See full prescribing information for complete boxed warning. Cases
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RECORLEV FDA Label Details
ProIndications & Usage
FDA Label (PDF)RECORLEV is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Limitations of Use RECORLEV is not approved for the treatment of fungal infections. The safety and effectiveness of RECORLEV for the treatment of fungal infections have not been established. RECORLEV is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative Limitations of Use RECORLEV is ...
WARNING: HEPATOTOXICITY AND QT PROLONGATION Hepatotoxicity • Cases of hepatotoxicity with a fatal outcome or requiring liver transplantation have been reported with use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Serious hepatotoxicity has been reported in pati...
RECORLEV Patents & Exclusivity
Patents (9 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.