Important Dosage Information

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XULTOPHY 100/3.6 is a combination of insulin degludec and liraglutide.

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Administer XULTOPHY 100/3.6 by subcutaneous injection once-daily at the same time each day with or without food.

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The XULTOPHY 100/3.6 pen delivers doses from 10 to 50 units with each injection. Table 1 presents the units of insulin degludec and the milligrams of liraglutide in each dosage of XULTOPHY 100/3.6 [see Dosage and Administration (2.2)].

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The maximum dose of XULTOPHY 100/3.6 is 50 units daily (50 units of insulin degludec and 1.8 mg of liraglutide) [see Warnings and Precautions (5.5)].

Recommended Starting Dose

In patients naïve to basal insulin or a GLP-1 receptor agonist

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The recommended starting dose of XULTOPHY 100/3.6 is 10 units (10 units of insulin degludec and 0.36 mg of liraglutide) given subcutaneously once-daily (see Table 1).

In patients currently on basal insulin or a GLP-1 receptor agonist

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Discontinue therapy with basal insulin or GLP-1 receptor agonist prior to initiation of XULTOPHY 100/3.6.

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The recommended starting dose of XULTOPHY 100/3.6 is 16 units (16 units of insulin degludec and 0.58 mg of liraglutide) given subcutaneously once-daily (see Table 1).

Table 1: Units of Insulin Degludec and Milligrams of Liraglutide in Each Dosage of XULTOPHY 100/3.6

* The dose counter on the XULTOPHY 100/3.6 pen displays numbers for the even units and displays lines for the odd units.

Titration of XULTOPHY 100/3.6

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After starting the recommended starting dose of XULTOPHY 100/3.6 [see Dosage and Administration (2.2)], titrate the dosage upwards or downwards by two units (see Table 2) once weekly or twice weekly (every three to four days), based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal until the desired fasting plasma glucose is achieved.

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To minimize the risk of hypoglycemia or hyperglycemia, additional titration may be needed with changes in physical activity, meal patterns (i.e., macronutrient content or timing of food intake), or renal or hepatic function; during acute illness; or when used with other medications [see Warnings and Precautions (5.4) and Drug Interactions (7)].

Table 2: Recommended Titration of XULTOPHY 100/3.6 (Once or Twice Weekly)

Missed Doses

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Instruct patients who miss a dose of XULTOPHY 100/3.6 to resume the once-daily regimen as prescribed with the next scheduled dose. Do not administer an extra dose or increase the dose to make up for the missed dose.

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If more than three days have elapsed since the last XULTOPHY 100/3.6 dose, reinitiate XULTOPHY 100/3.6 at the recommended starting dose to mitigate any gastrointestinal symptoms associated with reinitiation of treatment [see Dosage and Administration (2.1, 2.2, 2.3)].

Important Administration Instructions

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The XULTOPHY 100/3.6 pen is for single-patient-use only [see Warnings and Precautions (5.3)].

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Train patients on proper use and injection technique before initiating XULTOPHY 100/3.6.

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Always check the label on the XULTOPHY 100/3.6 pen before administration [see Warnings and Precautions (5.5)].

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Inspect visually for particulate matter and discoloration prior to administration. Only use XULTOPHY 100/3.6 if the solution appears clear and colorless.

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Inject XULTOPHY 100/3.6 subcutaneously into the thigh, upper arm, or abdomen.

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Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.4), Adverse Reactions (6.1, 6.3)].

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During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.4)].

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Use XULTOPHY 100/3.6 with caution in patients with visual impairment who may rely on audible clicks to dial their dose.

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The XULTOPHY 100/3.6 pen dials in one-unit increments.​

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Do not administer XULTOPHY 100/3.6 intravenously or in an insulin infusion pump.

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Do not dilute or mix XULTOPHY 100/3.6 with any other insulin or solutions.

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Do not split the dose of XULTOPHY 100/3.6.