TURALIO® (pexidartinib) showed an established safety profile

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People depicted are not actual patients or HCPs.

The following safety profile is a partial presentation of the risks associated with TURALIO.a

Please see full Indication and Important Safety Information below, including Boxed Warning, and Medication Guide

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. aThe safety of TURALIO 250 mg orally twice daily administered with a low-fat meal has been established based on additional pharmacokinetic data and adequate and well-controlled studies of TURALIO 400 mg orally twice daily administered on an empty stomach.1

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 sarcoma2

Pexidartinib is a category 1 recommendation for TGCT/PVNS in the NCCN Guidelines® for Soft Tissue Sarcoma.

A category 1 recommendation means that, based upon
high-level evidence, there is uniform NCCN consensus
that intervention is appropriate2

A comprehensive MDT may be the key to
providing optimal treatment and long-term
care for patients with TGCT

MDT, multidisciplinary team.

In ENLIVEN, serious liver enzyme elevations were seen within the first 2 months and were
manageable and reversible1,3

In ENLIVEN, signs of serious liver injury occurred in 5% of patients (3 of 61 patients) receiving TURALIO. All cases occurred within the first 2 months. Upon stopping treatment, patient liver enzyme elevations were reversible, with all returning to normal within 1 to 7 months1,3

bThe same 2 patients with hepatotoxicity who reported serious adverse reactions also discontinued the study.1,3

In the final analysis:
No new safety signals were observed after long-term treatment with TURALIO (data cutoff June 1, 2021).4

TURALIO data from the pooled post-hoc analysis demonstrated that the safety profile is consistent with data from the ENLIVEN study with no late-emerging toxicities

In the pooled analysis of 130 patients, the most common adverse reactions were similar to those seen in the original data analysis cutoff of March 20175

TURALIO was generally well tolerated, with most TEAEs being low Grade (1 or 2)
even with long-term treatment.
The most frequent adverse events were5:

  • hair color change (75%)
  • arthralgia (39%)
  • aspartate aminotransferase increase (31%)
  • fatigue (61%)
  • diarrhea (32%)
  • dysgeusia (30%)
  • nausea (47%)
  • hair color change (75%)
  • fatigue (61%)
  • nausea (47%)
  • arthralgia (39%)
  • diarrhea (32%)
  • aspartate aminotransferase
    increase (31%)
  • dysgeusia (30%)
  • No new safety signals or serious mixed or cholestatic hepatotoxicity cases occurred during long-term follow-up5
  • Most liver abnormalities (92%) were aminotransferase elevations; 4 patients (3%) experienced mixed/cholestatic hepatotoxicity (all within the first 2 months of treatment), which was reversible in all cases (recovery spanned 1 to 7 months)5

aThe safety of TURALIO 250 mg orally twice daily administered with a low-fat meal has been established based on additional pharmacokinetic data and adequate and well-controlled studies of TURALIO 400 mg orally twice daily administered on an empty stomach.1

Proactive monitoring with the TURALIO REMS Program

TURALIO can cause serious and potentially fatal liver injury.

Because of the risk of hepatotoxicity, TURALIO is available only through a Risk Evaluation and Mitigation Strategy (REMS) Program.

 
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References: 1. TURALIO [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2023. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed December 12, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 3. Tap WD et al; ENLIVEN investigators. Lancet. 2019;394(10197):478-487. 4. Wagner AJ. Slides presented at: CTOS Connective Tissue Oncology Society; November 16-19, 2022; Vancouver, BC, Canada. 5. Gelderblom H et al. Cancer. 2021;127(6):884-893.