Find a TGCT CenterFor adults with symptomatic TGCT associated with severe morbidity or functional limitations
and not amenable to improvement with surgery.Twice-daily, oral dosing for TGCT
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).
Avoid taking TURALIO with a high-fat meal (approximately 55 to 65 grams of total fat) due to increased pexidartinib concentrations which may increase the risk of adverse reactions, including hepatotoxicity.
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.
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.
ENLIVEN DATA
