Recorlev was approved by the U.S. Food and Drug Administration (FDA) in 2021 to reduce higher than normal cortisol levels in adults with endogenous Cushing’s syndrome. The FDA approval also indicates the treatment’s use for adults with Cushing’s disease, and for those for whom surgery is not an option or has been ineffective.
The potential interaction between Recorlev and alcohol has not been thoroughly investigated. However, given its potential to cause liver injury, Recorlev’s U.S. label recommends that patients starting treatment avoid drinking alcohol in excess, as it may increase the risk of serious side effects.
In the SONICS trial that supported the therapy’s approval, urinary cortisol levels dropped to normal levels in about two-thirds of analyzed patients (67%) by the fifth month after starting Recorlev treatment, which lasted 2-21 weeks. Reductions in certain symptoms also were reported within a time frame of just a few weeks to 5-6 months.
Recorlev may cause several side effects, most commonly nausea and vomiting, easy bleeding or bruising, headache, liver injury, redness of the skin, fatigue, and upset stomach.