- TURALIO can cause serious and potentially fatal liver injury [see WARNINGS AND PRECAUTIONS (5.1)].
- Monitor liver tests prior to initiation of TURALIO and at specified intervals during treatment. Withhold and dose reduce or permanently discontinue TURALIO based on severity of hepatotoxicity [see DOSAGE AND ADMINISTRATION (2.3), WARNINGS AND PRECAUTIONS (5.1)].
- TURALIO is available only through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program [see WARNINGS AND PRECAUTIONS (5.2)].
Approved Risk Evaluation and Mitigation Strategies (REMS)
Patient Counseling Information
Updated September 2019