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Drug Interactions between belumosudil and ketoconazole

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Major

ketoconazole belumosudil

Applies to: ketoconazole and belumosudil

Consumer information for this interaction is not currently available.

GENERALLY AVOID: Use of hepatotoxic drugs together with ketoconazole or levoketoconazole may potentiate the risk of liver injury. Serious hepatotoxicity has been reported with levoketoconazole and hepatotoxicity requiring liver transplantation has been reported with the use of oral ketoconazole, of which levoketoconazole is an enantiomer. Some patients had no risk factors for liver disease. During clinical studies, drug-induced liver injury (peak ALT or AST greater than 3 times the upper limit of normal) occurred in 13% of patients using levoketoconazole.

MANAGEMENT: The use of ketoconazole or levoketoconazole with other potentially hepatotoxic agents should be avoided. Patients treated with levoketoconazole or ketoconazole should have liver tests performed prior to and during treatment. Levoketoconazole manufacturer recommends interrupting treatment immediately if signs of hepatotoxicity occur. Refer to levoketoconazole labeling for specific instructions on management of hepatotoxicity. Patients should be advised to seek medical attention if they experience potential signs and symptoms of hepatotoxicity such as fever, rash, itching, anorexia, nausea, vomiting, fatigue, malaise, right upper quadrant pain, dark urine, pale stools, and jaundice.

References

  1. (2019) "Product Information. Ketoconazole (ketoconazole)." Mylan Pharmaceuticals Inc
  2. (2022) "Product Information. Recorlev (levoketoconazole)." Xeris Pharmaceuticals Inc
  3. Auchus R, Pivonello R, Fleseriu M, et al. (2022) Levoketoconazole: a novel treatment for endogenous Cushing's syndrome. https://www.tandfonline.com/doi/pdf/10.1080/17446651.2021.1945440
  4. (2021) "Product Information. Ketoconazole (ketoconazole)." Burel Pharmaceuticals Inc
View all 4 references

Drug and food interactions

Moderate

ketoconazole food

Applies to: ketoconazole

You should avoid the use of alcohol while being treated with ketoconazole. Ketoconazole may cause liver damage and using it with alcohol or products containing alcohol may increase that risk. In addition, consumption of alcoholic beverages or products containing alcohol during treatment with ketoconazole may trigger a disulfiram-like reaction in some patients, with unpleasant symptoms such as flushing, palpitations, and nausea. Ketoconazole may be taken with or without food. You should avoid consumption of grapefruit, grapefruit juice, or any supplements that contain grapefruit extract during treatment with ketoconazole unless directed otherwise by your doctor. Grapefruit juice may increase the blood levels of ketoconazole. This may increase the risk and/or severity of side effects and liver problems. You should seek immediate medical attention if you develop signs and symptoms of liver damage during treatment with ketoconazole, such as joint pain or swelling, unusual bleeding or bruising, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, dark colored urine, light colored stools, and yellowing of the skin or eyes. Talk to your doctor if you have any questions or concerns. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Switch to professional interaction data

Moderate

belumosudil food

Applies to: belumosudil

Consumer information for this interaction is not currently available.

ADJUST DOSING INTERVAL: Administration with food increases the oral bioavailability of belumosudil. The mechanism has not been described. Administration of belumosudil (200 mg single oral dose) in healthy subjects, with a fatty and calorie-rich meal (approximately half of the calories were contained in the fat) increased the mean belumosudil peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) by 120% and 100%, respectively, compared to administration under fasting conditions. The time to reach peak concentration (Tmax) was delayed by 30 minutes. Administration of oral belumosudil 200 mg once daily with food in patients with chronic graft-versus-host disease (chronic GVHD) lead to steady-state concentrations of the drug with an accumulation ration of 1.4.

MANAGEMENT: To ensure maximal oral absorption, belumosudil should be administered with a meal, every day at the same time.

References

  1. (2024) "Product Information. Rezurock (belumosudil)." Sanofi
  2. (2024) "Product Information. Rezurock (belumosudil)." Kadmon Pharmaceuticals, 11/2023

Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.


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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.