5.5 mg/dL; withhold TRUSELTIQ and initiate phosphate-lowering therapy for serum phosphate >7.5 mg/dL; withhold, reduce the dose, or permanently discontinue TRUSELTIQ based on duration and severity of hyperphosphatemia**Embryo-fetal toxicity:**TRUSELTIQ can cause fetal harm. Advise pregnant women of the potential risk to the fetus; advise females of reproductive potential and men who are partnered with women of reproductive potential to use effective contraception during treatment with TRUSELTIQ and for 1 month after the final dose **Adverse reactions** **Most common adverse reactions (incidence ≥20%, all grades):**nail toxicity, stomatitis, dry eye, fatigue, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, constipation, abdominal pain, dry mouth, eyelash changes, diarrhea, dry skin, decreased appetite, blurred vision, and vomiting**Most common laboratory abnormalities (incidence ≥20%, all grades):**increased creatinine, increased phosphate, decreased phosphate, increased alkaline phosphatase, decreased hemoglobin, increased alanine aminotransferase, increased lipase, increased calcium, decreased lymphocytes, decreased sodium, increased triglycerides, increased aspartate aminotransferase (AST), increased urate, decreased platelets, decreased leukocytes, decreased albumin, increased bilirubin, and decreased potassium **Drug interactions** **CYP3A inhibitors:**Avoid use with strong and moderate CYP3A inhibitors**CYP3A inducers:**Avoid use with strong and moderate CYP3A inducers**Gastric acid–reducing agents:**Avoid coadministration with proton pump inhibitors, histamine-2 receptor antagonists (H2RA), and locally acting antacids. If coadministration of H2RA or locally acting antacids cannot be avoided, separate TRUSELTIQ administration**H2RA:**Take TRUSELTIQ 2 hours before or 10 hours after**Locally-acting antacid:**Take TRUSELTIQ 2 hours before or 2 hours after **Dosage and administration** **Prior to initiating TRUSELTIQ:**Confirm FGFR2 fusion or rearrangement; perform comprehensive ophthalmic exam including OCT; confirm negative pregnancy test in females of reproductive potential**Starting dose:**Take TRUSELTIQ orally once daily on Days 1-21 of 28-day cycles; continue treatment until disease progression or unacceptable toxicity. Take TRUSELTIQ on an empty stomach with a glass of water at least 1 hour before or 2 hours after food- No renal or hepatic impairment – 125 mg (one 100 mg capsule and one 25 mg capsule) – Mild and moderate renal impairment (creatinine clearance 30-89 mL/min) – 100 mg (one 100 mg capsule) – Mild hepatic impairment (total bilirubin >upper limit of normal [ULN] to 1.5 x ULN or AST > ULN) – 100 mg (one 100 mg capsule) – Moderate hepatic impairment (total bilirubin >1.5 to 3 x ULN with any AST) – 75 mg (three 25 mg capsules) – No renal or hepatic impairment **Dose modification:**Consult the TRUSELTIQ full Prescribing Information for dose modifications and monitoring recommendations for RPED, hyperphosphatemia, and other Grades 3-4 adverse reactions **For additional information, please see the U.S. ****Full Prescribing Information for TRUSELTIQ** **References**1Banales, J., Cardinale, V., Carpino, G. et al. Cholangiocarcinoma: current knowledge and future perspectives consensus statement from the European Network for the Study of Cholangiocarcinoma (ENS-CCA). Nat Rev Gastroenterol Hepatol 13, 261–280 (2016). https://doi.org/10.1038/nrgastro.2016.51 2 Banales, J.M., Marin, J.J.G., Lamarca, A. et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol 17, 557–588 (2020). https://doi.org/10.1038/s41575-020-0310-z]]>
