Source: FDA, National Drug Code (US) Revision Year: 2020
TURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.
Administer TURALIO on an empty stomach, at least one hour before or two hours after a meal or snack [see Warnings and Precautions (5.1), Clinical Pharmacology (12.2, 12.3)].
The recommended dosage of TURALIO is 400 mg taken twice daily on an empty stomach until disease progression or unacceptable toxicity [see Dosage and Administration (2.1), Clinical Pharmacology (12.3)].
Swallow TURALIO capsules whole. Do not open, break, or chew the capsules.
If a patient vomits or misses a dose of TURALIO, instruct the patient to take the next dose at its scheduled time.
The recommended dose reductions for adverse reactions are provided in Table 1.
Table 1. Recommended Dose Reductions for TURALIO for Adverse Reactions:
| Dose Reduction | Total Daily Dose | Administration of Total Daily Dose |
|---|---|---|
| First | 600 mg | 200 mg in the morning and 400 mg in the evening |
| Second | 400 mg | 200 mg twice daily |
Permanently discontinue TURALIO in patients who are unable to tolerate 200 mg orally twice daily.
The recommended dosage modifications for adverse reactions are summarized in Table 2.
Table 2. Recommended Dosage Modifications for TURALIO for Adverse Reactions:
| Adverse Reaction | Severity | TURALIO Dosage Modifications |
|---|---|---|
| Hepatotoxicity [see Warnings and Precautions (5.1)] | ||
| Increased ALT and/or AST | Greater than 3 to 5 times ULN | • Withhold and monitor liver tests weekly. • If AST and ALT are less than or equal to 3 times ULN within 4 weeks, resume at reduced dose. • If AST or ALT is not less than or equal to 3 times ULN in 4 weeks, permanently discontinue TURALIO. |
| Greater than 5 to 10 times ULN | • Withhold and monitor liver tests twice weekly. • If AST and ALT are less than or equal to 3 times ULN within 4 weeks, resume at reduced dose. • If AST or ALT is not less than or equal to 3 times ULN in 4 weeks, permanently discontinue TURALIO. | |
| Greater than 10 times ULN | • Permanently discontinue TURALIO. • Monitor liver tests twice weekly until AST or ALT is less than or equal to 5 times ULN, then weekly until less than or equal to 3 times ULN. | |
| Increased ALP?footnote? and GGT | ALP greater than 2 times ULN with GGT greater than 2 times ULN | • Permanently discontinue TURALIO. Monitor liver tests twice weekly until ALP is less than or equal to 5 times ULN, then weekly until less than or equal to 2 times ULN. |
| Increased bilirubin | TB greater than ULN to less than 2 times ULN or DB greater than ULN and less than 1.5 times ULN | • Withhold and monitor liver tests twice weekly. • If an alternate cause for increased bilirubin is confirmed and bilirubin is less than ULN within 4 weeks, resume at reduced dose. • If bilirubin is not less than ULN in 4 weeks, permanently discontinue TURALIO. |
| TB greater or equal to 2 times ULN or DB greater than 1.5 times ULN | • Permanently discontinue TURALIO. • Monitor liver tests twice weekly until bilirubin is less than or equal to ULN. | |
| Adverse Reactions or Other Laboratory Abnormalities [see Adverse Reactions (6.1)] | ||
| Any | Severe or intolerable | • Withhold until improvement or resolution. • Resume at a reduced dose upon improvement or resolution. |
ALT = alanine aminotransferase; ALP = alkaline phosphatase; AST = aspartate aminotransferase; DB = direct bilirubin; GGT = gamma-glutamyl transferase; TB = total bilirubin; ULN = upper limit of normal
* Confirm ALP elevations as liver isozyme fraction.
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.
If concomitant use of a moderate or strong CYP3A inhibitor or UGT inhibitor is discontinued, increase the TURALIO dose (after 3 plasma half-lives of the moderate or strong CYP3A inhibitor or UGT inhibitor) to the dose that was used before starting the inhibitor [see Clinical Pharmacology (12.3)].
Table 3. Recommended Dosage Reductions for TURALIO for Concomitant Use of Moderate or Strong CYP3A Inhibitors or UGT Inhibitors:
| Planned Total Daily Dose | Modified Total Daily Dose | Administration of Modified Total Daily Dose |
|---|---|---|
| 800 mg | 400 mg | 200 mg twice daily |
| 600 mg* | 400 mg | 200 mg twice daily |
| 400 mg* | 200 mg | 200 mg once daily |
* Planned total daily dose refers to recommended dose reductions for TURALIO for adverse reactions based on dosing recommendations in Table 2.
Avoid the concomitant use of proton pump inhibitors (PPI) while taking TURALIO. As an alternative to a PPI, administer TURALIO 2 hours before or 2 hours after taking a locally-acting antacid, or if using a histamine 2 (H2)-receptor antagonist, administer TURALIO at least 2 hours before or 10 hours after taking an H2-receptor antagonist [see Clinical Pharmacology (12.3)].
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 200 mg in the morning and 400 mg in the evening [see Clinical Pharmacology (12.3)].
Due to the high plasma protein binding, TURALIO is not expected to be dialyzable [see Clinical Pharmacology (12.3)].
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Keep containers closed and do not remove desiccant from bottles.
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