For: Diabetes Type 2
Xultophy 100/3.6 (insulin degludec and liraglutide) is a fixed-ratio combination of the long-acting basal insulin analog, insulin degludec (Tresiba), and the a glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Victoza), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
XULTOPHY 100/3.6- insulin degludec and liraglutide injection, solution
Novo Nordisk
WARNING: RISK OF THYROID C-CELL TUMORS
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Liraglutide, one of the components of XULTOPHY 100/3.6, 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 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 [see Warnings and Precautions ( 5.1 ) and Nonclinical Toxicology (13)].
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XULTOPHY 100/3.6 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 XULTOPHY 100/3.6 and inform them of symptoms of thyroid tumors (e.g. 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 XULTOPHY 100/3.6 [see Contraindications (4), Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
XULTOPHY 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily).
Limitations of Use:
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XULTOPHY 100/3.6 is 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 [see Warnings and Precautions (5.1)].
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XULTOPHY 100/3.6 has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)]. Consider other antidiabetic therapies in patients with a history of pancreatitis.
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XULTOPHY 100/3.6 is not recommended for use in combination with any other product containing liraglutide or another GLP-1 receptor agonist [see Warnings and Precautions (5.5)].
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XULTOPHY 100/3.6 is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
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XULTOPHY 100/3.6 has not been studied in combination with prandial insulin.
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage Information
The following are important dosing information for XULTOPHY 100/3.6, a combination of insulin degludec and liraglutide:
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Discontinue therapy with liraglutide or basal insulin prior to initiation of XULTOPHY 100/3.6.
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The recommended starting dosage of XULTOPHY 100/3.6 is 16 units (16 units of insulin degludec and 0.58 mg of liraglutide) given subcutaneously once daily.
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Administer XULTOPHY 100/3.6 once-daily at the same time each day with or without food.
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The maximum daily dosage of XULTOPHY 100/3.6 is 50 units (50 units of insulin degludec and 1.8 mg of liraglutide) [see Warnings and Precautions (5.5)].
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The XULTOPHY 100/3.6 pen delivers doses from 10 to 50 units with each injection (see Table 1) [see Dosage and Administration (2.2)]
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Use alternative antidiabetic products if patients require a XULTOPHY 100/3.6 daily dosage:
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Persistently below 16 units [Dosage and Administration (2.2)], or
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Over 50 units.
