Key takeaways

  • Recorlev is a brand-name medication that’s prescribed for certain adults with Cushing syndrome. The drug comes as an oral tablet.
  • Common side effects of Recorlev include abdominal pain, dizziness, and fatigue, while serious side effects may include adrenal insufficiency, liver damage, and QT prolongation.
  • Recorlev can interact with several medications, including certain antibiotics, statins, and proton pump inhibitors. Before starting Recorlev treatment, it’s important to tell your doctor about any medications, vitamins, or supplements you take.

Specifically, the Food and Drug Administration (FDA) has approved Recorlev to lower cortisol levels in certain adults with Cushing syndrome. It’s prescribed when surgery has not worked or is not an option for treating this condition.

Drug details

The following is key information about Recorlev:

  • Drug class: cortisol synthesis inhibitors
  • Drug form: oral tablet
  • Generic available? no
  • Prescription required? yes
  • Controlled substance? no

Recorlev has boxed warnings. A boxed warning is the most serious warning from the FDA. For details, see the “Recorlev precautions” section.

Recorlev is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics usually cost less than brand-name drugs.

The Recorlev dosage your doctor prescribes will depend on several factors. These include:

  • the severity of the condition you’re taking Recorlev to treat
  • the results of your 24-hour cortisol urine test
  • certain side effects you may have

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug form and strength

Recorlev comes as an oral tablet. It’s available in one strength of 150 milligrams (mg).

Dosage for Cushing syndrome

Recorlev is prescribed to lower cortisol levels in certain adults with Cushing syndrome.

The typical starting dosage of Recorlev is 150 mg taken twice daily. If needed, your doctor may slowly increase your dosage by 150 mg every 2 to 3 weeks until your cortisol levels reach the desired range.

The maximum recommended dosage of Recorlev is 600 mg taken twice daily.

About taking Recorlev

Key dosage information for Recorlev includes the following:

  • When to take: You should take Recorlev twice daily, typically every 12 hours.Taking the medication around the same time of day helps keep a steady level of the drug in your body. This helps Recorlev work effectively.
  • If you miss a dose: If you miss a dose of Recorlev, skip your missed dose and take your next dose at the regular time.
  • Taking Recorlev with food: You can take Recorlev with or without food.
  • Crushing, splitting, or chewing Recorlev: The manufacturer of Recorlev doesn’t specify whether the tablets can be crushed, split, or chewed. If you have difficulty swallowing Recorlev tablets, talk with your doctor or pharmacist.
  • Length of use: Recorlev is meant to be a long-term treatment. If you and your doctor determine that Recorlev is safe and effective, you’ll likely take it long term.
  • Length of time Recorlev starts to work: Recorlev starts working right after you take your first dose of the drug. Your doctor will give you 24-hour cortisol urine tests to help monitor how well the drug is working. In clinical trials, many people had their cortisol levels reach the desired range after 3 to 4 months of Recorlev treatment.

Overdose

Do not take more Recorlev than your doctor prescribes, as this can lead to harmful effects.

Call your doctor if you think you’ve taken too much Recorlev. You can also call 800-222-1222 to reach America’s Poison Centers or use its online resource. But if you have severe symptoms, immediately call 911 or your local emergency number. Or go to the nearest emergency room.

Recorlev can cause mild or serious side effects. The following lists contain some key side effects that may occur while taking Recorlev. These lists do not include all possible side effects.

For more information about the possible side effects of Recorlev, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect while taking Recorlev and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

Mild side effects

The following is a partial list of mild side effects of Recorlev. To learn about other mild side effects, talk with your doctor or pharmacist, or view Recorlev’s prescribing information.

Mild side effects of Recorlev can include:

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Recorlev aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency phone number if your symptoms feel life threatening or you’re having a medical emergency.

Serious side effects can include:

* Recorlev has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Recorlev precautions” section.

ALLERGIC REACTION

For some people, Recorlev can cause an allergic reaction. In general, symptoms of an allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Recorlev, your doctor may recommend a different medication instead.

The following information describes Recorlev’s FDA-approved use.

Recorlev for Cushing syndrome

Recorlev is approved to lower cortisol levels in adults with Cushing syndrome. It’s prescribed when surgery has not worked or is not an option for treating this condition.

Cushing syndrome occurs when the body makes too much cortisol. This may be caused by several factors, including long-term use of corticosteroids or having certain health conditions.

Doctors prescribe Recorlev when excess cortisol originates from inside the body. For example, certain tumors can cause the adrenal glands to release too much cortisol. Symptoms of Cushing syndrome vary but may include weight gain, rounding of the face, and thinning of the skin.

To learn more about Recorlev’s use for Cushing syndrome, talk with your doctor.

Recorlev and children

Recorlev is not FDA approved for use in children. It’s not known for sure whether the drug is safe or effective for children.

Recorlev can interact with several other medications. However, the drug isn’t known to interact with any supplements or foods.

Before taking Recorlev, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Interactions with medications

The following is a list of medications that can interact with Recorlev. This list does not contain all drugs that may interact with Recorlev. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Medications that can interact with Recorlev include:

  • certain antibiotics, such as clarithromycin and rifampin (Rifadin, Rimactane)
  • certain statin drugs, such as simvastatin (FloLipid, Zocor) and atorvastatin (Lipitor)
  • certain benzodiazepines, such as triazolam (Halcion) and midazolam (Nayzilam)
  • certain immunosuppressants, such as tacrolimus (Astagraf XL, Prograf, others) and sirolimus (Fyarro, Hyftor)
  • certain antiseizure drugs, such as carbamazepine (Carbatrol, Tegretol, others) and phenytoin (Dilantin, Phenytek)
  • antivirals, such as ritonavir (Norvir) and darunavir (Prezista)
  • irregular heart rhythm drugs, such as dofetilide (Tikosyn) and dronedarone (Multaq)
  • proton pump inhibitors, such as omeprazole (Prilosec) and pantoprazole (Protonix)
  • H2 blockers, such as famotidine and nizatidine (Axid AR)
  • antacids, such as calcium carbonate (TUMS) and aluminum hydroxide/magnesium carbonate (Gaviscon)
  • metformin (Fortamet, Glumetza)
  • sucralfate (Carafate)
  • dabigatran (Pradaxa)

Alcohol interaction

It may not be safe to consume alcohol while taking Recorlev. Combining the two can cause symptoms such as nausea, headache, flushing, or skin rash.

Drinking excessive amounts of alcohol may also cause liver damage. Recorlev has a boxed warning about the risk of liver damage (see the “Recorlev precautions” section). So drinking large amounts of alcohol while taking the drug may raise this risk even further.

If you have questions about the safety of drinking alcohol while taking Recorlev, talk with your doctor or pharmacist.

As with all medications, the cost of Recorlev can vary. The actual price you’ll pay depends on your insurance plan (if you have one) and your location.

Financial and insurance assistance: If you need financial support to pay for Recorlev or help understanding your insurance coverage, help is available. A program called Xeris CareConnection is available for Recorlev. For more information and to find out if you’re eligible for support, call 844-444-7258 or visit the program website.

Generic version: Recorlev is not available in a generic form. A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics tend to cost less than brand-name drugs.

Other drugs are available that can treat Cushing syndrome. Some may be a better fit for you than others. If you’re interested in finding an alternative to Recorlev, talk with your doctor. They can tell you about other medications that may work well for you.

Examples of drugs that are alternatives to Recorlev include:

If you can become pregnant, consider the following information about pregnancy, fertility, and breastfeeding.

Note: The use of binary terms such as “males” and “females” in this article reflects the language of the sources we’ve used. Unless otherwise noted, it’s unclear whether the research we reference included participants with expansive gender identities.

Recorlev and pregnancy

It’s not known whether Recorlev should be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.

Recorlev and fertility

Recorlev may cause infertility (an inability to conceive) in males and females. This effect may be temporary and reverse after Recorlev treatment is stopped.

If you have questions about Recorlev and fertility, talk with your doctor.

Recorlev and breastfeeding

It’s not known whether Recorlev should be taken while breastfeeding. The drug may pass into breast milk, which could cause side effects in a child who is breastfed.

To be safe, your doctor may advise you to avoid breastfeeding while taking the drug and for at least 1 day after your final dose.

If you’re currently breastfeeding or planning to do so, talk with your doctor before taking Recorlev.

Here are answers to some frequently asked questions about Recorlev.

Does Recorlev cause weight loss?

Recorlev is not known to directly cause weight loss. Weight loss was not reported as a side effect in clinical trials of the drug.

However, Recorlev may cause a loss of appetite as a side effect. This could lead to weight loss over time.

Recorlev is also used to lower cortisol levels in people with Cushing syndrome. This condition often leads to weight gain. By treating this condition, Recorlev may indirectly cause weight loss in some people.

If you’re concerned about weight changes during your Recorlev treatment, talk with your doctor.

How does Recorlev compare with ketoconazole?

Both Recorlev and ketoconazole work in similar ways to lower cortisol levels in people with Cushing syndrome. Recorlev contains levoketoconazole as its active ingredient, which is a version of ketoconazole designed to target cortisol more directly.

Recorlev is FDA approved to treat Cushing syndrome. Ketoconazole is FDA approved to treat fungal infections but is sometimes prescribed off-label for Cushing syndrome. (Off-label use is when doctors prescribe a drug for a purpose other than what it’s approved for.)

To learn more about how Recorlev and ketoconazole compare, talk with your doctor. They can help determine which treatment may be right for you.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Risk of liver damage: Treatment with Recorlev may increase the risk of liver damage. Severe liver problems were not common in clinical trials of the drug, but other liver-related issues were reported more often. These include elevated liver enzymes and pain in the upper right side of your abdomen (near your liver).

Liver damage may also cause other symptoms such as loss of appetite, jaundice, or nausea and vomiting.

Due to the risk of liver damage, doctors typically do not prescribe Recorlev for people with certain liver conditions. Examples include cirrhosis and advanced liver cancer. Your doctor may also avoid prescribing Recorlev if you take other medications that could affect your liver.

Before starting your Recorlev treatment, your doctor will perform blood tests to check your liver function. They’ll repeat these tests during your treatment. If your liver function test results are unusual, your doctor will determine whether they’ll adjust your dosage or end your Recorlev treatment.

To learn more about this warning, talk with your doctor.

Risk of QT prolongation: Treatment with Recorlev may increase the risk of QT prolongation (a type of irregular heart rhythm). In extreme cases, this may lead to life threatening condition called torsades de pointes.

Significant changes in heart rhythm were not common in clinical trials of Recorlev. Changes in heart rhythm were typically mild and improved after Recorlev treatment was stopped or electrolyte levels were corrected.

Symptoms of QT prolongation may include dizziness, lightheadedness, or heart palpitations.

Because of this risk, doctors typically do not prescribe Recorlev for people with heart rhythm problems or those taking medications that can affect their heart rhythm.

Your doctor may use an electrocardiogram (EKG) to check your heart rhythm before you start taking Recorlev and periodically during your treatment. They may also check your blood levels of potassium and magnesium. If you have a heart rhythm problem during Recorlev treatment, your doctor may pause your treatment, lower your dose, or have you permanently stop taking Recorlev.

To learn more about this warning, talk with your doctor.

Other precautions

Before taking Recorlev, discuss your health history with your doctor. Recorlev may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

  • low blood levels of magnesium or potassium
  • previous allergic reaction to this or a similar drug
  • pregnancy
  • breastfeeding

Note: For more information about the potential negative effects of Recorlev, see the “Recorlev side effects” section.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.