WARNING

Recorlev (levoketoconazole) is a medication primarily used for the treatment of endogenous Cushing’s syndrome. It works by inhibiting cortisol synthesis, helping to manage the symptoms associated with excess cortisol production.

Like any medication, Recorlev is associated with certain risks and potential side effects. It’s essential to note that individual responses to medications can vary, and patients should always consult with their healthcare provider for personalized information. Here are some general risks associated with Recorlev:

• Adrenal Insufficiency: Since Recorlev reduces cortisol production, there is a risk of adrenal insufficiency, a condition where the adrenal glands do not produce enough cortisol. This can lead to symptoms such as fatigue, weakness, and low blood pressure.
• Hepatotoxicity: There may be a risk of liver-related side effects, and liver function should be monitored regularly during treatment.
• QT Prolongation: There may be an increased risk of prolongation of the QT interval in the heart’s electrical activity. This could lead to abnormal heart rhythms, though serious events appear to be rare.
• Drug Interactions: Recorlev may interact with other medications. It’s crucial to inform your healthcare provider about all the medications, supplements, and herbal products you are taking.
• Hypokalemia: This medication may lead to low potassium levels, which can affect heart function. Regular monitoring of potassium levels is typically recommended.
• Edema (Fluid Retention): Some patients may experience fluid retention, leading to swelling. Monitoring for signs of edema is important.
• Gastrointestinal Issues: Common side effects may include nausea, vomiting, and abdominal pain.

It’s important for patients to attend regular follow-up appointments with their healthcare provider to monitor for any potential side effects and to adjust the treatment plan as needed. If you or someone you know is considering or is already taking Recorlev, it’s crucial to consult with a healthcare professional for the most up-to-date and relevant information based on the individual’s health status.

Why is this medication prescribed?

Recorlev (levoketoconazole) is prescribed for the treatment of endogenous Cushing’s syndrome in adults. Cushing’s syndrome is a disorder characterized by the overproduction of cortisol, a hormone produced by the adrenal glands. This excess cortisol can lead to various symptoms, including weight gain, high blood pressure, muscle weakness, and changes in skin appearance.

Recorlev works by inhibiting an enzyme called 11-beta-hydroxylase, which is involved in the synthesis of cortisol. By blocking this enzyme, Recorlev helps to reduce the production of cortisol and alleviate the symptoms associated with Cushing’s syndrome.

How should this medicine be used?

Here are general guidelines on how Recorlev may be used:

• Dosage: The recommended dosage of Recorlev can vary depending on individual factors and the severity of Cushing’s syndrome. It is determined by the prescribing healthcare provider.
• Administration: Recorlev is usually taken orally, with or without food. The tablets should be swallowed whole with water and not crushed or split.
• Monitoring: Patients taking Recorlev typically require regular monitoring of cortisol levels and other relevant laboratory tests. This helps healthcare providers assess the effectiveness of the treatment and adjust the dosage if necessary.
• Individualized Treatment: The treatment plan with Recorlev is often individualized based on the patient’s response to the medication and any observed side effects. Regular communication with the healthcare provider is crucial for optimizing the treatment.
• Adherence to Prescribed Schedule: It’s important for patients to take Recorlev exactly as prescribed by their healthcare provider. Missing doses or altering the prescribed schedule may affect the efficacy of the treatment.
• Medical Supervision: Recorlev therapy should be conducted under the supervision of a healthcare professional experienced in the management of Cushing’s syndrome. Regular follow-up visits are essential to assess the patient’s response to treatment and address any potential concerns.

It’s important for individuals prescribed Recorlev to communicate openly with their healthcare provider about their symptoms, any side effects experienced, and any other medications or supplements they may be taking. This information helps the healthcare provider make informed decisions about the ongoing management of Cushing’s syndrome. As always, the information provided here is general, and specific instructions may vary based on individual health circumstances, so it’s crucial to follow the guidance of the prescribing healthcare professional.

Other uses for this medicine

Recorlev (levoketoconazole) is primarily indicated for the treatment of endogenous Cushing’s syndrome in adults. It is not approved for other uses, and its use should be guided by a healthcare professional based on the individual’s specific medical condition.

What special precautions should I follow?

Regarding special precautions, it’s crucial to follow your healthcare provider’s advice and adhere to the recommended guidelines. Here are some general precautions associated with Recorlev:

• Liver Function Monitoring: Regular monitoring of liver function is often recommended during Recorlev treatment. Elevated liver enzymes may occur, and if significant abnormalities are detected, dose adjustments or discontinuation may be necessary.
• Adrenal Insufficiency Risk: Due to its mechanism of action in inhibiting cortisol synthesis, Recorlev can lead to adrenal insufficiency. This condition can be serious, so healthcare providers may monitor for signs and symptoms such as fatigue, weakness, and low blood pressure. In some cases, supplemental glucocorticoids may be required.
• QT Interval Prolongation: There may be a risk of QT interval prolongation, which could lead to abnormal heart rhythms. Patients with a history of QT prolongation or those taking other medications that can prolong the QT interval may require careful monitoring.
• Hypokalemia (Low Potassium): Recorlev may cause hypokalemia, which is a low level of potassium in the blood. Regular monitoring of potassium levels is typically advised, and supplements may be prescribed if needed.
• Fluid Retention (Edema): Edema, or fluid retention, is a potential side effect of Recorlev. Monitoring for signs of edema, such as swelling, is important.
• Interactions with Other Medications: Inform your healthcare provider about all medications, supplements, and herbal products you are taking. Some drugs may interact with Recorlev, potentially affecting its effectiveness or increasing the risk of side effects.
• Pregnancy and Breastfeeding: The safety of Recorlev during pregnancy and breastfeeding has not been well studied. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential risks and benefits with your healthcare provider.

It’s crucial to attend all follow-up appointments as scheduled and to communicate any concerns or side effects to your healthcare provider promptly. Every individual may respond differently to medications, so your healthcare provider will tailor the treatment plan based on your specific health needs and conditions. Always consult with your healthcare provider for the most up-to-date and relevant information, as guidelines and recommendations may change over time.

What special dietary instructions should I follow?

• Potassium Balance: If hypokalemia is a concern, your healthcare provider may recommend dietary adjustments to maintain a proper potassium balance. This may involve incorporating potassium-rich or potassium-limited foods, depending on your specific needs.
• Consistent Diet: Maintain a consistent diet and avoid sudden, significant changes in your eating habits.

What should I do if I forget a dose?

• If You Forget a Dose:
  • Take the missed dose as soon as you remember, unless it is close to the time of your next scheduled dose.
  • If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule.
  • Do not double up on doses to make up for a missed one.
• Contact Your Healthcare Provider: If you have questions about what to do if you miss a dose, contact your healthcare provider or pharmacist for guidance.

What side effects can this medication cause?

Recorlev (levoketoconazole) may cause side effects, and individual responses can vary. It’s important to note that the information provided here is based on general knowledge, and there may be updates or additional information that you should discuss with your healthcare provider. Common and serious side effects associated with Recorlev may include:

Common Side Effects:

• Nausea and Vomiting: Some individuals may experience nausea and vomiting when taking Recorlev.
• Edema (Fluid Retention): Swelling due to fluid retention may occur.
• Hypokalemia (Low Potassium): Recorlev may lead to low levels of potassium in the blood.
• Hypertension (High Blood Pressure): Elevated blood pressure may occur in some individuals.
• Headache: Headaches are a reported side effect.
• Fatigue: Some people may experience fatigue or weakness.

Serious Side Effects:

• Adrenal Insufficiency: Due to the inhibition of cortisol synthesis, there is a risk of adrenal insufficiency. This can manifest as fatigue, weakness, and low blood pressure.
• Liver Function Abnormalities: Elevated liver enzymes may occur, and regular monitoring of liver function is often recommended.
• QT Interval Prolongation: Recorlev may cause prolongation of the QT interval in the heart’s electrical activity, which could lead to abnormal heart rhythms.
• Allergic Reactions: Although uncommon, some individuals may experience allergic reactions. Seek medical attention if you notice symptoms like rash, itching, or swelling.
• Fluid Retention: Severe cases of fluid retention, leading to heart failure, have been reported.

It’s crucial to promptly report any unusual or severe symptoms to your healthcare provider. Additionally, discuss your medical history, current medications, and any concerns you may have with your healthcare team.

This is not an exhaustive list of side effects, and individual responses can vary. Always refer to the specific information provided by your healthcare provider or the medication’s prescribing information for the most accurate and up-to-date details. If you experience any side effects, contact your healthcare provider for guidance. If you are having a medical emergency, call emergency services immediately.

What should I know about storage and disposal of this medication?

Storage and Disposal of Recorlev:

Storage:

• Store as Directed: Keep Recorlev at room temperature, away from excessive heat and moisture.
• Keep Container Closed: Store the medication in its original container with the lid tightly closed.
• Avoid Sunlight: Protect Recorlev from direct sunlight.
• Out of Reach of Children: Keep the medication out of reach of children and pets.

Disposal:

• Dispose as Instructed: Follow your healthcare provider’s instructions or local guidelines for proper disposal of unused or expired medication.
• Do Not Flush: Do not flush Recorlev down the toilet unless specifically instructed to do so. Check with your local pharmacy or waste disposal facility for proper disposal options.

In case of emergency/overdose

• Seek Medical Attention: In the case of an overdose or if you suspect someone has taken too much Recorlev, seek emergency medical attention immediately.
• Symptoms of Overdose: Overdose symptoms may include symptoms of cortisol deficiency (adrenal insufficiency), such as extreme fatigue, weakness, and low blood pressure.

What other information should I know?

• Regular Monitoring: Your healthcare provider may schedule regular monitoring appointments to check your response to Recorlev and to monitor for any potential side effects.
• Follow-up Appointments: Attend all follow-up appointments as scheduled. These appointments are crucial for assessing the effectiveness of the treatment and making any necessary adjustments.
• Communication with Healthcare Provider: Inform your healthcare provider about any changes in your health, new medications, or any concerns you may have.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss this with your healthcare provider. The safety of Recorlev in these situations is not well-studied.
• Other Medications and Supplements: Inform your healthcare provider about all medications, supplements, and herbal products you are taking to avoid potential interactions.

Always consult with your healthcare provider and carefully read the medication’s prescribing information for the most accurate and up-to-date guidance. If you have specific questions or concerns, your healthcare provider is the best source for personalized information based on your health status.