The recommended duration of therapy is 9 months, with a dosage of 16 mg administered orally once daily [see Clinical Studies (14.1)]. When discontinuing therapy, reduce the dosage to 8 mg once daily for the last 2 weeks of therapy [see Warnings and Precautions (5.1)].

The delayed release capsules should be swallowed whole in the morning, at least 1 hour before a meal. Do not open, crush or chew.

If a dose is missed, take the prescribed dose at the next scheduled time. Do not double the next dose.

Safety and efficacy of treatment with subsequent courses of TARPEYO have not been established.