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Insulin Degludec and Liraglutide

Pronunciation

(IN su lin de GLOO dek & lir a GLOO tide)

Index Terms

  • Liraglutide and Insulin Degludec
  • Xultophy

Pharmacologic Category

  • Antidiabetic Agent, Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist
  • Insulin, Long-Acting

Use: Labeled Indications

Diabetes mellitus, type 2: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (<50 units daily) or liraglutide (≤1.8 mg daily).

Limitations of use: Not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of the rodent C-cell tumor findings to humans; has not been studied in patients with a history of pancreatitis; not recommended for use in combination with any other product containing liraglutide or another GLP-1 receptor agonist; not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis; has not been studied in combination with prandial insulin

Contraindications

Hypersensitivity to insulin degludec, liraglutide, or any component of the formulation; history of or family history of medullary thyroid carcinoma (MTC); patients with multiple endocrine neoplasia syndrome type 2 (MEN2); during episodes of hypoglycemia

ALERT: U.S. Boxed Warning

Thyroid C-cell tumor risk:

Liraglutide, one of the components of insulin degludec/liraglutide, causes dose-dependent and treatment duration–dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether insulin degludec/liraglutide 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.

Insulin degludec/liraglutide is contraindicated in patients with a personal or family history of MTC and in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of insulin degludec/liraglutide and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with insulin degludec/liraglutide.

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