Medically reviewed by Drugs.com. Last updated on Oct 26, 2021.
Generic name: PEXIDARTINIB HYDROCHLORIDE 200mg
Dosage form: capsule
Important Administration Instructions
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.
Dosage Modifications for Adverse Reactions
The recommended dose reductions for adverse reactions are provided in Table 1.
|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.
|Adverse Reaction||Severity||TURALIO Dosage Modifications|
|ALT = alanine aminotransferase; ALP = alkaline phosphatase; AST = aspartate aminotransferase; DB = direct bilirubin; GGT = gamma-glutamyl transferase; TB = total bilirubin; ULN = upper limit of normal|
|Hepatotoxicity [see Warnings and Precautions (5.1)]|
|Increased ALT and/or AST||Greater than 3 to 5 times ULN||
|Greater than 5 to 10 times ULN||
|Greater than 10 times ULN||
|Increased ALP* and GGT||ALP greater than 2 times ULN with GGT greater than 2 times ULN||
|Increased bilirubin||TB greater than ULN to less than 2 times ULN
DB greater than ULN and less than 1.5 times ULN
|TB greater or equal to 2 times ULN
DB greater than 1.5 times ULN
|Adverse Reactions or Other Laboratory Abnormalities [see Adverse Reactions (6.1)]|
|Any||Severe or intolerable||
Concomitant Use of Moderate or Strong CYP3A Inhibitors or UGT Inhibitors
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)].
|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|
Concomitant Use of Acid-Reducing Agents
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)].
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 200 mg in the morning and 400 mg in the evening [see Clinical Pharmacology (12.3)].
Dosage Modification for Hepatic Impairment
The recommended dosage of TURALIO for patients with moderate hepatic impairment (total bilirubin greater than 1.5 and up to 3 times upper limit of normal (ULN), not due to Gilbert's syndrome, with any AST) is 200 mg twice daily [see Clinical Pharmacology (12.3)]. TURALIO has not been studied in patients with severe hepatic impairment (total bilirubin greater than 3 to 10 times ULN and any AST).
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- Drug class: multikinase inhibitors
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