Insulindosage

Administer once-daily at same time each day with or without food.

XULTOPHY 100/3.6 pen delivers doses from 10 to 50 units with each injection; each XULTOPHY 100/3.6 dosage unit contains 1 unit of insulin degludec and 0.036 mg of liraglutide.

Maximum daily dosage is 50 units (50 units of insulin degludec and 1.8 mg of liraglutide).

Recommended starting dosage in patients naïve to basal insulin or GLP-1 receptor agonist is 10 units (10 units of insulin degludec and 0.36 mg of liraglutide) injected subcutaneously once-daily.

Discontinue therapy with liraglutide or basal insulin prior to initiation of XULTOPHY 100/3.6.

Recommended starting dosage in patients currently on basal insulin or GLP-1 receptor agonist is 16 units (16 units of insulin degludec and 0.58 mg of liraglutide) injected subcutaneously once-daily.

See Full Prescribing Information for titration recommendations.

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

Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.

Do not administer intravenously or by an infusion pump.

Do not dilute or mix with any other insulin products or solutions.

2.1 Important

Dosage Information

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

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

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.

The maximum dosage of XULTOPHY 100/3.6 is 50 units daily (50 units of insulin degludec and 1.8 mg of liraglutide).

2.2 Recommended

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

The recommended starting dosage of XULTOPHY 100/3.6 is 10 units (10 units of insulin degludec and 0.36 mg of liraglutide) injected subcutaneously once-daily (see Table 1 ). In patients currently on basal insulin or a GLP-1 receptor agonist

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

The recommended starting dosage of XULTOPHY 100/3.6 is 16 units (16 units of insulin degludec and 0.58 mg of liraglutide) injected subcutaneously once-daily (see Table 1 ). Table 1. Units of Insulin Degludec and Milligrams of Liraglutide in Each Dosage of XULTOPHY 100/3.6 XULTOPHY 100/3.6 (dose counter display) * insulin degludec component dose liraglutide component dose Comment ▪▪ ─ --- --- Priming symbol 10 10 units 0.36 mg Recommended starting dose for patients naïve to basal insulin or GLP-1 receptor agonist 11 11 units 0.4 mg 12 12 units 0.43 mg 13 13 units 0.47 mg 14 14 units 0.5 mg 15 15 units 0.54 mg 16 16 units 0.58 mg Recommended starting dose for patients currently on basal insulin or GLP-1 receptor agonist 17 17 units 0.61 mg 18 18 units 0.65 mg 19 19 units 0.68 mg 20 20 units 0.72 mg 21 21 units 0.76 mg 22 22 units 0.79 mg 23 23 units 0.83 mg 24 24 units 0.86 mg 25 25 units 0.9 mg 26 26 units 0.94 mg 27 27 units 0.97 mg 28 28 units 1.01 mg 29 29 units 1.04 mg 30 30 units 1.08 mg 31 31 units 1.12 mg 32 32 units 1.15 mg 33 33 units 1.19 mg 34 34 units 1.22 mg 35 35 units 1.26 mg 36 36 units 1.3 mg 37 37 units 1.33 mg 38 38 units 1.37 mg 39 39 units 1.4 mg 40 40 units 1.44 mg 41 41 units 1.48 mg 42 42 units 1.51 mg 43 43 units 1.55 mg 44 44 units 1.58 mg 45 45 units 1.62 mg 46 46 units 1.66 mg 47 47 units 1.69 mg 48 48 units 1.73 mg 49 49 units 1.76 mg 50 50 units 1.8 mg Maximum daily dosage * The dose counter on the XULTOPHY 100/3.6 pen displays numbers for the even units and displays lines for the odd units. 2.3 Titration of XULTOPHY 100/3.6

After starting the recommended starting dosage of XULTOPHY 100/3.6, 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.

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. Table 2. Recommended Titration of XULTOPHY 100/3.6 (Once or Twice Weekly) Self-Monitored Fasting Plasma Glucose XULTOPHY 100/3.6 Dosage Adjustment Above target range + 2 units (2 units of insulin degludec and 0.072 mg of liraglutide) Within target range 0 units Below target range - 2 units (2 units of insulin degludec and 0.072 mg of liraglutide)

2.4 Recommendations

Regarding Missed Doses

Instruct patients who miss a dose of XULTOPHY 100/3.6 to resume the once-daily dosage 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.

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 the risk of gastrointestinal adverse reactions associated with reinitiation of treatment.

2.5 Important

Administration Instructions

The XULTOPHY 100/3.6 pen is for single-patient-use only.

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

Always check the label on the XULTOPHY 100/3.6 pen before administration.

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

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

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.

During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring.

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

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

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

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

Do not split the dose of XULTOPHY 100/3.6.