Straightforward, twice-daily, oral dosing for TGCT

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TURALIO dosage and administration1:

The recommended dosage of TURALIO is 250 mg taken orally twice daily for a total of 500 mg per day. TURALIO must be taken with a low-fat meal (approximately 11 to 14 grams of total fat).

Taking TURALIO with a high-fat meal (approximately 55 to 65 grams of total fat) increases pexidartinib concentrations and may increase the risk of adverse reactions, including hepatotoxicity. Consider referring patients to a dietician as deemed necessary.

It’s important to swallow TURALIO capsules whole and not open, break, or chew them.

If patients vomit or miss a dose of TURALIO, they should take the next dose at its scheduled time.

Recommended dosage and dosage adjustments1

Recommended TURALIO dose reductions for adverse reactions

Total daily dose Administration of
total daily dose
with low-fat meal
Recommended starting dose 500 mg
total daily dose
250 mg twice daily
First
dose reduction
375 mg
total daily dose
125 mg in the morning
250 mg in the evening
Second
dose reduction
250 mg
total daily dose
125 mg twice daily

Permanently discontinue TURALIO in patients who are unable to tolerate 125 mg orally twice daily.

The recommended dosage modifications for TURALIO for adverse reactions are summarized in Table 2 of the TURALIO full Prescribing Information.

Avoid concomitant use of TURALIO with moderate or strong CYP3A inhibitors or UGT inhibitors during treatment with TURALIO.

If concomitant use with a moderate or strong CYP3A inhibitor or UGT inhibitor cannot be avoided, reduce the TURALIO dose according to the recommendations in Table 3 of the TURALIO full Prescribing Information.

Dosage Modification for Renal Impairment

The recommended dosage of TURALIO for patients with mild to severe renal impairment (creatinine clearance [CLcr] 15 to 89 mL/min estimated by Cockcroft-Gault using actual body weight) is 125 mg in the morning and 250 mg in the evening with a low-fat meal.

Dose Modification for Hepatic Impairment

The recommended dosage of TURALIO for patients with moderate hepatic impairment (total bilirubin greater than 1.5 to 3 times ULN, not due to Gilbert's syndrome, with any AST) is 125 mg twice daily with a low-fat meal. TURALIO has not been studied in patients with severe hepatic impairment (total bilirubin greater than 3 to 10 times ULN and any AST).

CYP3A, cytochrome P450, family 3, subfamily A;
UGT, uridine diphosphate glucuronosyltransferase;
ULN, upper limit of normal.

Monitor the patients’ liver tests and complete and submit the Patient Status Forms to the REMS Program according to the following schedule1:

Permanently discontinue TURALIO in patients who are unable to tolerate 125 mg orally twice daily.

Refer to TURALIO full Prescribing Information for additional dosing guidelines.
Download the TURALIO Medication Guide

For more information, visit www.TURALIOREMS.com or call 1-833-887-2546.

Duration of therapy

Treatment should be continued until disease progression or unacceptable toxicity

In ENLIVEN (part 1 ITT population, n=61)1

of patients received TURALIO for 6 months or longer of patients received TURALIO for >1 year

ITT, intent to treat.

Discover the efficacy data from the ENLIVEN trial
ENLIVEN DATA

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Reference: 1. TURALIO [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2023.