Treatment with RETEVMO is commonly associated with a spectrum of adverse reactions, including gastrointestinal issues, fatigue, and hypertension in adults, and musculoskeletal pain and hematological changes in pediatric patients, alongside specific laboratory abnormalities.

Adverse Reaction Profile of RETEVMO (Selpercatinib)

The most common adverse reactions (≥25%) reported in adult patients with solid tumors (LIBRETTO-001 study) include edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache. For pediatric patients with solid tumors (LIBRETTO-121 study), common adverse reactions (≥25%) include musculoskeletal pain, diarrhea, headache, nausea, vomiting, coronavirus infection, abdominal pain, fatigue, pyrexia, and hemorrhage. Frequent Grade 3 or 4 laboratory abnormalities (≥5%) in adults include decreased lymphocytes, increased ALT, increased AST, decreased sodium, and decreased calcium. In pediatric patients, these include decreased calcium, decreased hemoglobin, and decreased neutrophils. Serious adverse reactions, dose interruptions, and discontinuations due to adverse events have been reported across studies, highlighting the need for careful patient monitoring. The specific adverse reaction profile can vary depending on the patient population and the specific clinical trial (e.g., LIBRETTO-431 for treatment-naïve NSCLC).