Recorlev
Recorlev (levoketoconazole) is a cortisol synthesis inhibitor that's used to treat high cortisol levels in adults with Cushing's syndrome. This medication is taken by mouth twice per day. It has a lot of potential side effects, with flushing, bleeding, and fatigue as the most common.
What is Recorlev (levoketoconazole)?
What is Recorlev (levoketoconazole) used for?
High cortisol levels in adults with Cushing's syndrome who already tried surgery or who can't have surgery
How Recorlev (levoketoconazole) works
Recorlev (levoketoconazole) is a corticol synthesis inhibitor. It works by blocking certain essential steps in the production of cortisol (a hormone) in your body.
Drug Facts
What are the side effects of Recorlev (levoketoconazole)?
Common Side Effects
- Flushing of the skin (43%)
- Bleeding or bruising (40%)
- Fatigue (39%)
- Headache (38%)
- Nausea or vomiting (37%)
- Stomach pain or indigestion (33%)
- Back, muscle, or joint pain (up to 28%)
- Upper respiratory infection (28%)
- Abnormal vaginal bleeding (up to 24%)
- Abnormal heart rhythm (24%)
- Sleep problems (22%)
- High blood pressure (20%)
- Swelling in arms or legs (20%)
- Diarrhea (up to 19%)
Other Side Effects
- Dizziness
- Attention problems
- Mood changes (e.g., feeling irritated or depressed)
- Poor appetite
- Dry mouth
- Dry skin
- Itchiness
- Rash
- Hair loss
- Other infections (e.g., stomach, urinary tract infections)
- Lower sex drive
- Enlarged breasts in males
- Low potassium levels
Serious Side Effects
- Liver problems: yellowing of your skin or the whites of your eyes, dark or brown urine, swelling of your stomach, confusion
- Abnormal heart rhythm (QT prolongation): chest pounding, shortness of breath, chest pain, feeling faint or lightheaded
- Extremely low cortisol levels: feeling very weak or tired, dizziness, weight loss, no appetite
- Severe allergic reaction: hives; swelling of the lips, tongue, or face; difficulty breathing
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Recorlev (levoketoconazole)
Pros
Works well to lower cortisol levels
Can take with or without food
Support program and resources available to help you during treatment
Cons
Need to take twice per day
Can have a lot of side effects, such as fatigue, headache, and nausea
Has risks of liver failure, serious irregular heart rhythms, and fertility problems
Pharmacist tips for Recorlev (levoketoconazole)
Take Recorlev (levoketoconazole) with or without food. But if the medication starts to hurt your stomach, try taking it with food.
If you miss a dose of Recorlev (levoketoconazole), skip the missed dose. Then, take your next dose at your regularly scheduled time.
Avoid drinking alcohol while you're taking Recorlev (levoketoconazole) since this can raise your risk for liver damage.
Mark your calendar with your appointments to see your provider and have any lab tests done while you're taking Recorlev (levoketoconazole). It's important for your provider to follow up with you during treatment because the medication can cause heart, liver, and hormone-related side effects. Lab tests can include heart rhythm tests and blood tests.
Tell your providers and pharmacists about all the medications you're taking, including over-the-counter medications, vitamins, and supplements, before you start Recorlev (levoketoconazole). Also don't start any new medications while you're taking Recorlev (levoketoconazole) without talking to a provider first.
Your providers and pharmacists should check whether Recorlev (levoketoconazole) interacts with any of your other medications. They might need to adjust your treatment plan to keep you safe (e.g., dose adjustments, stop some medications altogether). Ask your providers to check your medication list for any dangerous drug interactions.
If you're pregnant or thinking of becoming pregnant, talk with your provider about the risks and benefits of taking Recorlev (levoketoconazole). It's not known whether this medication is safe to take during pregnancy because it hasn't been studied. But animal studies with ketoconazole (a similar medication) suggest that it might harm unborn babies.
Talk to your provider about family planning before you start Recorlev (levoketoconazole). Studies with ketoconazole (a similar medication) suggest that it can affect certain sex hormone levels. This can potentially cause fertility problems.
Frequently asked questions about Recorlev (levoketoconazole)
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What are the risks and warnings for Recorlev (levoketoconazole)?
Recorlev (levoketoconazole) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Worsening liver problems and liver failure
Risk factors: History of liver problems | Drinking a lot of alcohol | Taking medications that can cause liver damage
Some people who took Recorlev (levoketoconazole) had serious liver problems that have sometimes led to liver failure. For this reason, you can't take this medication if you have a history of liver problems.
You'll need to get blood tests done before and during treatment so your provider can check your liver health. Get medical attention right away if you notice yellowing of your skin or the whites of your eyes; stool changes (black, tarry, or bloody stools); dark or brown urine; swelling of your stomach; stomach pain; or confusion. You might need to stop taking Recorlev (levoketoconazole) to prevent further liver damage.
Life-threatening abnormal heart rhythm (QT prolongation)
Risk factors: Taking other medications that cause QT prolongation | Personal or family history of long QT syndrome | History of heart failure | History of abnormal heart rhythms (arrhythmias) | Slow heart rate | Low blood potassium or magnesium levels
Recorlev (levoketoconazole) can affect your heart rhythm by lengthening the time period from when the heart pumps and then relaxes. This is known as QT prolongation, or long QT syndrome, which can be life-threatening. Your risk for QT prolongation is higher in certain situations, such as having abnormal electrolyte levels or heart rhythm problems or taking other medications that can also cause QT prolongation, among others.
To lower your risk for QT prolongation, your provider will periodically check your heart and do certain tests to make sure your heart rhythm is normal. Call 911 right away if you feel your chest pounding; feel short of breath, faint, or lightheaded; or have chest pain while you're taking Recorlev (levoketoconazole).
Low cortisol levels
Recorlev (levoketoconazole) can lower your cortisol levels. Cortisol is a hormone your body makes that's involved in many things, such as controlling your blood sugar, maintaining your blood pressure, and lowering inflammation. Very low cortisol levels can put you at risk for low blood pressure, abnormal electrolyte levels, and low blood sugar, all of which can be dangerous.
Let your provider know if you experience symptoms of low cortisol, such as weakness, fatigue, dizziness, feeling faint, loss of appetite, or mood changes. You might need to have your Recorlev (levoketoconazole) dose lowered, stop your treatment, or be treated with corticosteroids to help restore your levels.
Allergic reactions
Severe allergic reactions to Recorlev (levoketoconazole) are possible, including life-threatening reactions like facial swelling, hives, and anaphylaxis (e.g., closing of the throat). Get medical attention right away if you notice difficulty breathing; a choking sensation; dizziness; fast heartbeat; nausea; or swelling around your eyes, lips, or tongue after you take this medication.
Low testosterone levels
Recorlev (levoketoconazole) might lower the levels of a sex hormone in the body called testosterone. This might cause side effects like erectile dysfunction, breast growth, and low sperm count in men and low sexual desire in women. Contact your provider if you notice any of these symptoms.
Recorlev (levoketoconazole) dosage forms
Typical dosing for Recorlev (levoketoconazole)
The typical starting dose is 150 mg by mouth twice per day with or without food. Your provider will then adjust the dose based on your cortisol levels, symptoms, and any side effects from the medication you might have. The maximum dose is 600 mg twice per day.
Recorlev (levoketoconazole) contraindications
Liver problems or liver failure
Recurrent gallstones
History of liver problems due to ketoconazole or a similar antifungal
History of QT prolongation or other severe irregular heart rhythms
Take certain medications that interact with Recorlev (levoketoconazole)
Known allergy to Recorlev (levoketoconazole) or ketoconazole
What are alternatives to Recorlev (levoketoconazole)?
High cortisol levels in adults with Cushing's syndrome who already tried surgery or who can't have surgery
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References
Best studies we foundAmerican Heart Association. (2022). What is an arrhythmia?
Farzam, K., et al. (2023). QT prolonging drugs. StatPearls.
Fleseriu, M., et al. (2022). Levoketoconazole treatment in endogenous Cushing's syndrome: Extended evaluation of clinical, biochemical, and radiologic outcomes. European Journal of Endocrinology.
Jose-Miller, A. B., et al. (2007). Infertility. American Family Physician.
National Heart, Lung, and Blood Institute. (2022). Long QT syndrome.
National Institute of Diabetes and Digestive and Kidney Diseases. (2018). Cushing’s syndrome.
National Institute of Diabetes and Digestive and Kidney Diseases. (2018). Definition & facts of adrenal insufficiency & Addison's disease.
Pivonello, R., et al. (2021). Levoketoconazole in the treatment of patients with Cushing's syndrome and diabetes mellitus: Results from the SONICS phase 3 study. Frontiers in Endocrinology.
Xeris Biopharma Holdings, Inc. (2021). Xeris Biopharma announces U.S. FDA approval of Recorlev® (levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome. Business Wire.
Xeris Pharmaceuticals, Inc. (2023). Recorlev- levoketoconazole tablet [package insert]. DailyMed.
You and Your Hormones. (2019). Cortisol.
You and Your Hormones. (2020). Testosterone.
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