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Adverse reactions of Ponatinib

The most common adverse reactions (occurring in >20% of patients) include:

Ponatinib monotherapy:

Rash and related conditions, arthralgia, abdominal pain, fatigue, headache, constipation, hypertension, xerosis cutis, hepatotoxicity, fluid retention and edema, pyrexia, pancreatitis/elevated lipase, nausea, hemorrhage, anemia, arterial occlusive events, and cardiac arrhythmias.

The most common Grade 3 or 4 laboratory abnormalities (>20%) are thrombocytopenia, neutropenia, and leukopenia.

Ponatinib in combination with chemotherapy:

Hepatotoxicity, arthralgia, rash and related conditions, headache, pyrexia, abdominal pain, constipation, fatigue, nausea, oral mucositis, hypertension, pancreatitis/elevated lipase, peripheral neuropathy, hemorrhage, febrile neutropenia, fluid retention and edema, vomiting, paresthesia, and cardiac arrhythmias.

The most common Grade 3 or 4 laboratory abnormalities (>20%) include leukopenia, neutropenia, thrombocytopenia, lymphopenia, decreased hemoglobin, elevated lipase, and elevated alanine aminotransferase.

FDA,2022.02