TURALIO 200 mg capsules are supplied as size 0 with white opaque body and dark green opaque cap with white print "T10", available in:
� 28 count bottle NDC#: 65597-402-28
� 120 count bottle NDC#: 65597-402-20
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.
These highlights do not include all the information needed to use TURALIO safely and effectively. See full prescribing information for TURALIO.
TURALIO� (pexidartinib) capsules, for oral use
Initial U.S. Approval: 2019
WARNING: HEPATOTOXICITY
See full prescribing information for complete boxed warning.
TURALIO can cause serious and potentially fatal liver injury. (5.1)
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. (2.3, 5.1)
TURALIO is available only through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program. (5.2)
INDICATIONS AND USAGE
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. (1)
DOSAGE AND ADMINISTRATION
Important Administration Instructions: Administer TURALIO on an empty stomach, at least 1 hour before or 2 hours after a meal or snack (2.1).
Recommended Dosage: 400 mg orally twice daily (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 200 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity: May cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use an effective method of contraception. (5.3, 8.1, 8.3)
ADVERSE REACTIONS
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. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Use with Hepatotoxic Products: Avoid coadministration of TURALIO with other products known to cause hepatotoxicity. (7.1)
Strong CYP3A Inhibitors: Reduce the dose of TURALIO if concomitant use of strong CYP3A inhibitors cannot be avoided. (2.4, 7.2)
Strong CYP3A Inducers: Avoid concomitant use of strong CYP3A inducers. (7.2)
UGT Inhibitors: Reduce the dose of TURALIO if concomitant use of UGT inhibitors cannot be avoided. (2.4, 7.2)
Acid Reducing Agents: Avoid concomitant use of proton pump inhibitors. Use histamine-2 receptor antagonists or antacids if needed. (2.5, 7.2)
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
Renal Impairment: Reduce the dose for patients with mild to severe renal impairment. (2.6, 8.6)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 8/2019
