Adverse reactions of Infigratinib

In the pivotal clinical study of cholangiocarcinoma, patients treated with infigratinib (N=108) reported the following information:

Serious Adverse Reactions: The incidence rate was 32%, including infections, anemia, fever, abdominal pain, hypercalcemia, and sepsis, among others.

Fatal Adverse Reactions: One case (0.9%) of death due to sepsis was reported.

Adverse Reactions Leading to Permanent Discontinuation: The incidence rate was 15%, including increased creatinine, fatigue, subretinal fluid, and calcinosis, among others.

Adverse Reactions Leading to Dose Interruption: The incidence rate was 64%, including hyperphosphatemia, hypercalcemia, palmar-plantar erythrodysesthesia syndrome, stomatitis, diarrhea, and increased creatinine, among others.

Adverse Reactions Leading to Dose Reduction: The incidence rate was 60%, including hyperphosphatemia, stomatitis, palmar-plantar erythrodysesthesia syndrome, increased creatinine, increased lipase, hypercalcemia, and onycholysis, among others.

Most Common Adverse Reactions (incidence ≥20%): 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%): increased creatinine, increased blood phosphate, decreased blood phosphate, increased alkaline phosphatase, decreased hemoglobin, increased alanine aminotransferase, increased lipase, increased blood calcium, lymphopenia, decreased blood sodium, increased triglycerides, increased aspartate aminotransferase, increased uric acid, thrombocytopenia, leukopenia, decreased albumin, increased bilirubin, and decreased blood potassium.

Other Clinically Relevant Adverse Reactions: cataract (12%) and fracture (1%).

FDA，2021.05