Find a TGCT CenterENLIVEN Safety Data
People depicted are not actual patients or HCPs.
TURALIO can cause serious and potentially fatal liver injury, including vanishing bile duct syndrome.
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. Monitoring and prompt cessation of TURALIO may not eliminate the risk of serious and potentially fatal liver injury.
TURALIO is available only through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program.
In ENLIVEN, 3 of 61 (5%) patients who received TURALIO developed signs of serious liver injury, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × upper limit of normal (ULN) with total bilirubin ≥2 × ULN. In these patients, peak ALT ranged from 6 to 9 × ULN, peak total bilirubin ranged from 2.5 to 15 × ULN, and alkaline phosphatase (ALP) was ≥2 × ULN. ALT, AST, and total bilirubin improved to <2 × ULN in these three patients 1 to 7 months after discontinuing TURALIO.1
Adverse reactions led to dose reductions or interruptions in 38% of patients; 13% discontinued treatment1
Most common adverse reactions in patients receiving TURALIO1
ALP, alkaline phosphatase; ALT, alanine transaminase; AST, aspartate transaminase; LDH, lactate dehydrogenase.
Avoid TURALIO in patients with preexisting increased serum transaminases, total bilirubin, or direct bilirubin (>ULN); or active liver or biliary tract disease, including increased ALP.1
Monitor liver tests, including AST, ALT, total bilirubin, direct bilirubin, ALP, and gamma-glutamyl transferase (GGT), prior to initiation of TURALIO, weekly for the first 8 weeks, every 2 weeks for the next month and every 3 months thereafter.1
Withhold and dose reduce, or permanently discontinue TURALIO based on the severity of the hepatotoxicity. Refer patients to a hepatologist if liver tests do not return to normal. Rechallenge with a reduced dose of TURALIO may result in a recurrence of increased serum transaminases, bilirubin, or ALP or other signs of liver injury. Monitor liver tests weekly for the first month after rechallenge.1
Please see additional Important Safety Information, including Boxed Warning, below.
TURALIO is the first FDA-approved systemic therapy for symptomatic TGCT (also known as PVNS or GCT-TS) associated with sever morbidity or functional limitations and not amenable to improvement with surgery1
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend that—prior to the initiation of
therapy—all patients be evaluated and managed by a multidisciplinary team with expertise and experience in sarcoma3
Pexidartinib is a NCCN Category 1 recommended therapy option for TGCT/PVNS in the NCCN Guidelines® for Soft Tissue Sarcoma.3
A Category 1 recommendation means that, based upon
high-level evidence, there is uniform NCCN consensus
that intervention is appropriate3
A comprehensive MDT may be the key to
providing optimal treatment and long-term
care for patients with TGCT
MDT, multidisciplinary team.
TURALIO REMS Program
Because of the risk of hepatotoxicity, TURALIO is available only through a Risk Evaluation and Mitigation Strategy (REMS) Program.
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