Infigratinib

  • TRADE NAME: Truseltiq (Helsinn)
  • INDICATIONS: Cholangiocarcinoma (in adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement).
  • CLASS: Fibroblast growth factor receptor inhibitor, Kinase inhibitor
  • HALF-LIFE: 33.5 hours

FDA APPROVAL DATE: 05/28/2021

CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:

antacids, CYP3A Inducers, CYP3A Inhibitors, histamine-2 (H2) receptor antagonists, Itraconazole, Lansoprazole, proton pump inhibitors, Rifampin


Insufficient data on use in pregnant women. Advise against breastfeeding during treatment and for 1 month after the last dose.

Under investigation for treating COVID-19

See adverse reactions attributed to class:

Kinase inhibitor

Infigratinib can cause retinal pigment epithelial detachment (RPED), which may result in symptoms such as blurred vision. Perform a comprehensive ophthalmic examination including optical coherence tomography prior to initiation of infigratinib, at 1 month, at 3 months, and then every 3 months thereafter during treatment.

Dry skin 23%

(package insert, 05/28/2021)

Edema / fluid retention (see also peripheral edema) 17%

(package insert, 05/28/2021)

Alopecia / hair loss 38%

(2021): Javle M+, Lancet Gastroenterol Hepatol 6(10), 803-81538%

Nail toxicity 57%

(package insert, 05/28/2021)

Epistaxis (nosebleed) 18%

(package insert, 05/28/2021)

Stomatitis (oral mucositis) 56%

(2021): Javle M+, Lancet Gastroenterol Hepatol 6(10), 803-81555%

Xerostomia (dry mouth) 25%

(package insert, 05/28/2021)

Dysgeusia (taste perversion) 32%

(package insert, 05/28/2021)

Fever (pyrexia) 15%

(package insert, 05/28/2021)

Headache 17%

(package insert, 05/28/2021)

Alanine aminotransferase (ALT) increased 51%

(package insert, 05/28/2021)

Alkaline phosphatase (ALP) increased 54%

(package insert, 05/28/2021)

Appetite decreased 22%

(package insert, 05/28/2021)

Aspartate aminotransferase (AST) increased 38%

(package insert, 05/28/2021)

Hyperbilirubinemia 24%

(package insert, 05/28/2021)

Hypercalcemia  43%

(package insert, 05/28/2021)

Hypercholesterolemia  18%

(package insert, 05/28/2021)

Hyperkalemia 17%

(package insert, 05/28/2021)

Hyperlipasemia 44%

(package insert, 05/28/2021)

Hyperphosphatemia 90%

(13% grade 3/4)

(2021): Javle M+, Lancet Gastroenterol Hepatol 6(10), 803-81577%

Hyperuricemia 37%

(package insert, 05/28/2021, Grade 3–4)

Hypoalbuminemia / albumin decreased 24%

(package insert, 05/28/2021)

Hypocalcemia 10%

(package insert, 05/28/2021)

Hypokalemia 21%

(package insert, 05/28/2021)

Hyponatremia 41%

(20% grade 3/4) (package insert, 05/28/2021)

Hypophosphatemia 64%

(31% grade 3/4) (package insert, 05/28/2021)

Serum creatinine increased 93%

(package insert, 05/28/2021)

Weight loss 15%

(package insert, 05/28/2021)

Abdominal pain 26%

(package insert, 05/28/2021)

Constipation 30%

(package insert, 05/28/2021)

Diarrhea 24%

(package insert, 05/28/2021)

Dyspepsia / functional dyspepsia / gastroparesis 17%

(package insert, 05/28/2021)

Nausea 19%

(package insert, 05/28/2021)

Vomiting  21%

(package insert, 05/28/2021)

Hemoglobin decreased 53%

(package insert, 05/28/2021)

Leukocytopenia (leukopenia) / leukocytes decreased 26%

(package insert, 05/28/2021)

Neutropenia (neutrophils decreased) 14%

(package insert, 05/28/2021)

Platelets decreased 37%

(package insert, 05/28/2021)

Arthralgia 32%

(package insert, 05/28/2021)

Asthenia / fatigue 44%

(2021): Javle M+, Lancet Gastroenterol Hepatol 6(10), 803-81540%

Pain in extremities 17%

(package insert, 05/28/2021)

Dry eye (keratoconjunctivitis sicca) 44%

(package insert, 05/28/2021)

Eyelash changes 25%

(package insert, 05/28/2021)

Retinal pigment epithelial detachment (RPED) 11%

(asymptomatic RPED)

(2021): Javle M+, Lancet Gastroenterol Hepatol 6(10), 803-81517% (grade 3 / 1 case)Fatal

Vision blurred 21%

(package insert, 05/28/2021)



Adverse reactions attributed to entire drug class Kinase inhibitor

Adverse effects 

(2020): Roskoski R Jr, Pharmacol Res 152, 104609 [REVIEW]

Page last updated 03/18/2022

Drug Eruption Mobile Site

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Incidence info

  • <1%
  • 1-5%
  • 5-10%
  • 10-15%
  • 15-20%
  • 20-30%
  • >30%

Seriousness info

  • Hospitalization possible
  • Life threatening
  • Fatal

Warnings in other populations info

  • Breast feeding
  • Geriatric
  • Pediatric
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