A new dosing regimen for Turalio® (pexidartinib) is now available for the treatment of adults with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery.
The recommended dose of Turalio is now 250mg orally twice daily (taken as two 125mg capsules) with a low-fat meal (approximately 11 to 14 grams of total fat) until disease progression or unacceptable toxicity. Previously, the dose was 400mg orally twice daily (taken as two 200mg capsules) on an empty stomach.
Turalio is supplied as 125mg capsules in 28- and 120-count bottles; the 200mg capsules have been discontinued. Patients may be switched to the 125mg capsules once the 200mg capsules have been finished.
The dosing update was based on pharmacokinetic data demonstrating that lowering the dose of Turalio and taking it with a low-fat meal (11 to 14 grams of total fat) helped to minimize the potential for drug overexposure. Study findings also showed no clinically significant difference in efficacy between Turalio 250mg with a low-fat meal and Turalio 400mg on an empty stomach.
“The new dose reflects study data that evaluated the impact of food on Turalio exposure should patients not follow the previous recommended dietary requirements when taking the medication,” said Dan Switzer, Head of US Oncology Business, Daiichi Sankyo, Inc. “As patient safety is our primary goal, we will continue to inform health care professionals about the new dosing regimen of Turalio so that they can continue to treat appropriate patients with tenosynovial giant cell tumor with the only FDA-approved therapy.”
Due to the risk of serious and potentially fatal liver injury, Turalio is available only through a restricted program called the Turalio REMS.
- Turalio® new dosing regimen now available in the US for certain patients with tenosynovial giant cell tumor. News release. Daiichi Sankyo. Accessed February 1, 2023. https://www.businesswire.com/news/home/20230131005896/en/TURALIO%C2%AE-New-Dosing-Regimen-Now-Available-in-the-U.S.-for-Certain-Patients-with-Tenosynovial-Giant-Cell-Tumor.
- Turalio. Package insert. Daiichi Sankyo; 2022. Accessed February 1, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211810s009lbl.pdf.