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
Side effects of Recorlev (levoketoconazole)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
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%)
Less Common 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
Recorlev (levoketoconazole) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- 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
The following Recorlev (levoketoconazole) 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.
Common questions about Recorlev (levoketoconazole)
Yes, Recorlev (levoketoconazole) was approved by the FDA in 2021 for the treatment of Cushing's syndrome in adults.
Yes, Recorlev (levoketoconazole) is available as 150 mg tablets. The tablets are taken by mouth twice per day with or without food.
No. Recorlev (levoketoconazole) and ketoconazole have similar chemical structures. Other than that, Recorlev (levoketoconazole) and ketoconazole are completely different from each other. Ketoconazole is an antifungal medication that's used to treat fungal infections. On the other hand, Recorlev (levoketoconazole) isn't an antifungal and should never be used to fight against fungal infections because it hasn't been studied this way. Recorlev (levoketoconazole) is only approved for treating high cortisol levels in adults with Cushing's syndrome.
It's not completely clear how long it takes for Recorlev (levoketoconazole) to work because it can take some time for your provider to figure out what dose works best for you. Your provider will see how well you're responding to Recorlev (levoketoconazole) by collecting a couple of urine samples to measure your cortisol levels no sooner than 2 to 3 weeks after you start the medication. Your provider will adjust your dose if your levels aren't where they should be and collect urine samples again a few weeks later. Keep in mind everyone responds differently to medication. Talk to your provider if you're concerned about how well the medication is working for you.
In one study, about 30% of people who were taking a stable dose of Recorlev (levoketoconazole) had cortisol levels that returned to normal after 6 months of treatment. After a total of 12 months of therapy with Recorlev (levoketoconazole), 19% of people who took the medication had normal cortisol levels. Make sure to follow your provider's instructions to collect urine samples on time to check how well Recorlev (levoketoconazole) is working to lower your cortisol levels.
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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
Typical dosage 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
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Recorlev (levoketoconazole) will not be safe for you to take.
- 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 medications that cause QT prolongation
- Take certain medications that interact with Recorlev (levoketoconazole)
- Known allergy to Recorlev (levoketoconazole) or ketoconazole
What are alternatives to Recorlev (levoketoconazole)?
Pasireotide can be used in adults to treat these conditions if surgery isn't an option or haven't worked well: