Recorlev® (levoketoconazole) | Official Patient Site

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Important Safety Information
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Prescribing Information
- English
- Spanish
Medication Guide
- English
- Spanish
Important Safety Information
Healthcare Professionals Site

Prescribing Information
- English
- Spanish
Medication Guide
- English
- Spanish
Healthcare Professionals Site

Prescribing Information
- English
- Spanish
Medication Guide
- English
- Spanish
Healthcare Professionals Site

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About Cushing’s Syndrome
What is Recorlev?
Tools and Resources
One-on-one support
- Meet your support team
- Sign up for support

About Cushing’s Syndrome
What is RECORLEV?
Tools and Resources
One-on-one support
- Meet your support team
- Sign up for support

About Cushing’s Syndrome
What is RECORLEV?
Tools and Resources
One-on-one support
- Meet your support team
- Sign up for support

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IMPORTANT SAFTY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION

RECORLEV can cause serious side effects, including:
- Liver damage (hepatotoxicity): Some people who were treated with ketoconazole, a medicine like the active ingredient in RECORLEV, had serious liver problems that required a liver transplant or led to death
  - Call your doctor right away if you have pain on the upper right side of your stomach area associated with nausea, unusual fatigue, yellowing of your skin or the whites of your eyes, or unusual bruising or bleeding
- Heart rhythm problems (QT prolongation): QT prolongation can cause irregular heartbeats that can be life-threatening
  - Call your doctor right away if you feel severe lightheadedness or if you faint
- Low cortisol levels (adrenal insufficiency): RECORLEV may cause adrenal insufficiency by excessively lowering production of cortisol
  - Call your doctor right away if you have nausea, vomiting, dizziness, unusual fatigue, low blood pressure, unexplained stomach pain, abnormal electrolyte levels, loss of appetite, low blood sugar, or body aches
Do not take RECORLEV if you:
- Have cirrhosis, active or poorly controlled liver disease, frequent stones in gallbladder, or history of liver problems due to use of a drug
- Take certain medicines that cause QT prolongation or may affect how your liver works, such as CYP3A4 inhibitors
- Have a history of certain heart problems, which may include one of the following conditions: torsades de pointes, ventricular tachycardia, ventricular fibrillation, or long QT syndrome
- Are allergic to levoketoconazole, ketoconazole, or any of the ingredients in RECORLEV
Serious allergic reactions can happen in people who take RECORLEV, including rash, itching, hives, fever, swelling of the lips or tongue, chest pain, or trouble breathing
RECORLEV may lower testosterone levels. For males, symptoms include breast enlargement and erectile dysfunction. For females, symptoms include low desire for sex and mood changes
The most common side effects of RECORLEV include nausea, vomiting, low potassium, easy bleeding or bruising, high blood pressure, headache, liver injury, abnormal uterine bleeding, redness of the skin, fatigue, abdominal pain or upset stomach, arthritis, upper respiratory infection, muscle pain, abnormal heart rhythm, back pain, sleep disturbances, and fluid retention
Before taking RECORLEV, tell your doctor about your medical conditions, medicines you take, and if you are breast feeding or plan to. RECORLEV may cause fertility problems in females and males, which may affect ability to have children
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

For more information, see Medication Guide and full Prescribing Information for RECORLEV.

INDICATION

RECORLEV (levoketoconazole) is a prescription medicine used to treat high cortisol levels in adult patients with Cushing’s syndrome who cannot have surgery or who have had surgery that did not cure their Cushing’s syndrome. RECORLEV is not to be used for treatment of fungal infections.

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