In healthy subjects, the single maximum tolerated dose was determined to be 25 mg based upon the occurrence of symptomatic bradycardia after single doses of 75 mg. A few subjects received unintended doses of up to 200 mg daily for 3 to 4 days and experienced asymptomatic mild to moderate transient elevations of liver function tests.
One patient (with a history of depression) who took 84 mg siponimod experienced a slight elevation in liver transaminases.
If the overdose constitutes first exposure to siponimod or occurs during the dose titration phase of siponimod it is important to observe for signs and symptoms of bradycardia, which could include overnight monitoring. Regular measurements of pulse rate and blood pressure are required and electrocardiograms should be performed (see Dosage & Administration and Precautions).
There is no specific antidote to siponimod available. Neither dialysis nor plasma exchange would result in meaningful removal of siponimod from the body.