• Bone and connective tissue cancer

Turalio Generic Name & Formulations

General Description

Pexidartinib (as HCl) 125mg; caps.

Pharmacological Class

Kinase inhibitor.

How Supplied

Caps—28, 120


Generic Availability


Turalio Indications


In adults with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

Turalio Dosage and Administration


Swallow whole. Take with a low-fat meal (~11–14g of total fat). 250mg twice daily until disease progression or unacceptable toxicity. Mild to severe renal impairment (CrCl 15–89mL/min): 125mg in the AM and 250mg in the PM. Moderate hepatic impairment (total bilirubin >1.5–3×ULN, not due to Gilbert’s syndrome, with any AST): 125mg twice daily. Dose modifications for adverse reactions, concomitant moderate or strong CYP3A or UGT inhibitors, acid-reducing agents: see full labeling.


Not established.

Turalio Contraindications

Not Applicable

Turalio Boxed Warnings

Boxed Warning


Turalio Warnings/Precautions


Risk of liver injury (may be fatal). Avoid in patients with pre-existing increased serum transaminases, total/direct bilirubin >ULN, or active liver or biliary tract disease, including increased ALP. Monitor LFTs prior to initiation, weekly for the first 8 weeks, every 2 weeks for the next month, and then every 3 months thereafter. Withhold and reduce dose or permanently discontinue based on severity of hepatotoxicity. Severe hepatic impairment (total bilirubin >3–10×ULN and any AST): not studied. Embryo-fetal toxicity. Advise use of effective contraception during and for 1 month (females; use non-hormonal method) or for 1 week (males w. female partners) after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after last dose).



Turalio Pharmacokinetics




Fecal (65%), renal (27%).

Turalio Interactions


Avoid coadministration with a high-fat meal. Avoid concomitant other products known to cause hepatotoxicity. May be potentiated by moderate or strong CYP3A (including grapefruit or grapefruit juice) or UGT inhibitors; avoid; if unavoidable, reduce Turalio dose. Antagonized by strong CYP3A inducers (including St. John's wort) or proton pump inhibitors (alternatively, can use antacids or H2-blockers); avoid. Antagonizes CYP3A substrates (eg, hormonal contraceptives, others); avoid; if unavoidable, increase substrate dose. 

Turalio Adverse Reactions

Adverse Reactions

Increased lactate dehydrogenase, hair color changes, fatigue, increased AST, decreased neutrophils, increased cholesterol, decreased lymphocytes, eye edema, increased ALP, increased ALT, decreased hemoglobin, rash, dysgeusia, decreased phosphate.

Turalio Clinical Trials

See Literature

Turalio Note

Not Applicable

Turalio Patient Counseling

See Literature