A Long-term Study to Further Evaluate the Risk of Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment
A study to evaluate the long-term risk of hepatic failure with TURALIO™ (pexidartinib) and the mechanism of liver injury based upon optional liver biopsy information among patients who received or are receiving TURALIO™ (pexidartinib) and experience hepatotoxicity.
• Adult participants with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery
• Age ≥18 years old
• Emergence of at least one of the following liver test abnormalities due to TURALIO™ (pexidartinib) exposure:
‣ Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 × upper limit of normal (ULN) with concurrent total bilirubin (TBIL) \>2 × ULN
⁃ Isolated TBIL \>2 × ULN (excluding patients with Gilbert's syndrome)
⁃ Isolated AST or ALT \>10 × ULN
⁃ Alkaline phosphatase (ALP) \>2 x ULN with gamma-glutamyl transferase (GGT) \>2 x ULN
• Consent to study procedures, long-term safety follow-up, and use of data from the TURALIO™ (pexidartinib) Risk Evaluation and Mitigation Strategy (REMS) program