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Insulin Degludec-Liraglutide

Risk of Thyroid C-Cell Tumors

  • Liraglutide, one of the components of XULTOPHY 100/3.6, causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether XULTOPHY 100/3.6 causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.   
  • XULTOPHY 100/3.6 is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors. 

Approved Risk Evaluation and Mitigation Strategies (REMS)

XULTOPHY (Insulin Degludec-Liraglutide) Injection

Patient Counseling Information

Medication Guides

Patient Medication Guide - XULTOPHY 100/3.6

Package Inserts

Insuli Degludec-Liraglutide

Additional Information

Updated January 2018