Drug Interaction Report

Levoketoconazole may increase the blood levels of leniolisib. This may increase the risk and/or severity of adverse effects such as headache, sinusitis, and atopic dermatitis (eczema). Talk to your doctor if you have any questions or concerns. Your doctor may be able to prescribe alternatives that do not interact, or you may need a dose adjustment or more frequent monitoring to safely use both medications. 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.

You should avoid the use of alcohol while being treated with levoketoconazole. Levoketoconazole 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 levoketoconazole may trigger a disulfiram-like reaction in some patients, with unpleasant symptoms such as flushing, palpitations, and nausea. Levoketoconazole 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 levoketoconazole unless directed otherwise by your doctor. Grapefruit juice may increase the blood levels of levoketoconazole. 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 levoketoconazole, 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.

Consumer information for this interaction is not currently available.

MONITOR: Coadministration with inhibitors of CYP450 3A4 including grapefruit or grapefruit juice may increase the plasma concentrations of leniolisib, which undergoes extensive CYP450 3A4-mediated first-pass metabolism in the gut wall and liver. In general, the effect of grapefruit juice is concentration-, dose- and preparation-dependent, and can vary widely among brands. Certain preparations of grapefruit juice (e.g., high dose, double strength) have sometimes demonstrated potent inhibition of CYP450 3A4, while other preparations (e.g., low dose, single strength) have typically demonstrated moderate inhibition. Pharmacokinetic interactions involving grapefruit juice are also subject to a high degree of interpatient variability, thus the extent to which a given patient may be affected is difficult to predict.

MANAGEMENT: Patients who regularly consume grapefruit or grapefruit juice should be monitored for adverse effects and altered plasma concentrations of leniolisib. Some authorities recommend to avoid grapefruit products during leniolisib treatment (UK).