CONTRAINDICATIONS AND PRECAUTIONS FOR THE ADMINISTRATION OF TIRZEPATIDE IN CHILDREN AND ADOLESCENTS: CLINICAL, PHARMACOLOGICAL, AND SAFETY ASPECTS

Abstract

Tirzepatide is a dual agonist of the glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors; it was initially developed for the treatment of type 2 diabetes mellitus and subsequently incorporated into the pharmacological management of obesity in specific populations. Its use in children and adolescents requires distinguishing between different therapeutic indications, as regulatory approval varies according to age, the condition being treated, and the country. In Brazil, the National Health Surveillance Agency (Anvisa) expanded the indication for Mounjaro® to include type 2 diabetes mellitus in pediatric patients aged 10 years and older, whereas the indication for chronic weight management remains restricted to adults. Key contraindications associated with tirzepatide include a personal or family history of medullary thyroid carcinoma, multiple endocrine neoplasia syndrome type 2 (MEN 2), and severe hypersensitivity to the drug or formulation components. Beyond formal contraindications, certain conditions require caution or represent clinical situations where administration should be avoided or carefully individualized—such as severe gastroparesis, a history of pancreatitis, biliary disease, risk of dehydration, renal impairment secondary to volume depletion, and concomitant use of hypoglycemic agents. In children and adolescents, these issues are particularly significant due to specific characteristics regarding growth, pubertal development, body composition, and nutritional needs. This article reviews the formal contraindications, precautions, potential risks, and evidence limitations regarding the pediatric use of tirzepatide.