Drug Interactions between Aloh-Gel and nirogacestat

Citrate, or citric acid, can increase the absorption of aluminum hydroxide. This may lead to elevated blood levels of aluminum, particularly in individuals with reduced kidney function, since aluminum is primarily eliminated by the kidneys. Excess aluminum may deposit and cause problems in various tissues including bone, brain, heart, liver, muscles, and spleen. Over time, weak bones, bone pain, fractures, skeletal deformity, brain disorders, and anemia may develop. Talk to your doctor before using aluminum hydroxide if you have kidney impairment or are on hemodialysis. You should avoid or limit the consumption of citrate-containing foods and beverages (e.G., soft drinks, citrus fruits, fruit juices) during treatment with aluminum hydroxide. Be aware that some effervescent and dispersible drug formulations may also contain citrate and should be restricted as well. Even if you do not have kidney problems, it may be best to separate the dosing of aluminum hydroxide and citrate-containing products by 2 to 3 hours. Talk to a healthcare professional 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.

When aluminum hydroxide is taken during enteral nutrition therapy (tube feeding), the tube may get clogged. Therefore, aluminum hydroxide should not be mixed with or given after high-protein tube feedings. The dose should be separated from the feeding by as much as possible, and the tube should be thoroughly flushed before administration of the dose.

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GENERALLY AVOID: Grapefruit, grapefruit juice, Seville oranges, and starfruit may significantly increase the plasma concentrations and pharmacologic effects of nirogacestat. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in these fruits. Coadministration of multiple doses of nirogacestat (150 mg twice daily) with the moderate CYP450 3A4 inhibitors erythromycin and fluconazole are predicted to increase the AUC of nirogacestat by 2.73-fold and 3.18-fold, respectively. The interaction has not been studied with grapefruit, Seville oranges, or starfruit. 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. Increased systemic exposure to nirogacestat may increase the risk of adverse effects including diarrhea, ovarian toxicity, hepatotoxicity, electrolyte abnormalities, and non-melanoma skin cancers.

MANAGEMENT: Patients treated with nirogacestat should avoid consumption of grapefruit, grapefruit juice, Seville oranges, starfruit, or any supplement containing grapefruit.