Pexidartinib is a kinase inhibitor 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. MedsAcross supplies Pexidartinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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. TURALIO is a kinase inhibitor 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.
Source: US FDA prescribing information
Pexidartinib is a small molecule tyrosine kinase inhibitor that targets colony stimulating factor 1 receptor (CSF1R), KIT proto-oncogene receptor tyrosine kinase (KIT), and FMS-like tyrosine kinase 3 (FLT3) harboring an internal tandem duplication (ITD) mutation. Overexpression of the CSF1R ligand promotes cell proliferation and accumulation in the synovium. In vitro, pexidartinib inhibited proliferation of cell lines dependent on CSF1R and ligand-induced autophosphorylation of CSF1R. Pexidartinib also inhibited the proliferation of a CSF1R dependent cell line in vivo.
Source: US FDA prescribing information
Recommended Dosage: 250 mg orally twice daily with a low-fat meal (approximately 11 to 14 grams of total fat). See full prescribing information for dosage modifications due to adverse reactions, renal impairment and hepatic impairment.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning (hepatotoxicity turalio): can cause serious and potentially fatal liver injury, including vanishing bile duct syndrome. Monitor liver tests prior to initiation of TURALIO and at specified intervals during treatment. Withhold and dose reduce or permanently discontinue TURALIO based on severity of hepatotoxicity. Monitoring and prompt cessation of TURALIO may not eliminate the risk of serious and potentially fatal liver injury. Embryo-Fetal Toxicity: May cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use an effective non-hormonal method of contraception. Potential Risks Associated with a High-Fat Meal: May increase incidence and severity of adverse reactions, including hepatotoxicity. Avoid taking TURALIO with a high-fat meal (approximately 55 to 65 grams of total fat).
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Hepatotoxicity. Most common adverse reactions (>20%) were increased lactate dehydrogenase, increased aspartate aminotransferase, hair color changes, fatigue, increased alanine aminotransferase, decreased neutrophils, increased cholesterol, increased alkaline phosphatase, decreased lymphocytes, eye edema, decreased hemoglobin, rash, dysgeusia, and decreased phosphate.
Source: US FDA prescribing information
Use with Hepatotoxic Products: Avoid coadministration of TURALIO with other products known to cause hepatotoxicity. Moderate or Strong CYP3A Inhibitors: Reduce the dose of TURALIO if concomitant use of moderate or strong CYP3A inhibitors cannot be avoided. Strong CYP3A Inducers: Avoid concomitant use of strong CYP3A inducers. UGT Inhibitors: Reduce the dose of TURALIO if concomitant use of UGT inhibitors cannot be avoided. Acid-Reducing Agents: Avoid concomitant use of proton pump inhibitors. Use histamine-2 receptor antagonists or antacids if needed. High-Fat Meal: Avoid taking TURALIO with a high-fat meal. CYP3A Substrates: Avoid concomitant use with CYP3A substrates where minimal concentration changes may lead to serious therapeutic failure.
Source: US FDA prescribing information
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).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Pexidartinib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Turalio 125 mg capsuleOral | Daiichi Sankyo | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 2 August 2019 | Drugs@FDA |
| EU (EMA) | Refused | EMA medicines data |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Pexidartinib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Pexidartinib, including Turalio.
Yes. The US FDA first approved Pexidartinib on 2 August 2019, according to Drugs@FDA.
No listed presentation of Pexidartinib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Pexidartinib is classified under ATC code L01XE (ALK inhibitor).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.