Xultophy 100/3.6

XULTOPHY 100/3.6- insulin degludec and liraglutide injection, solution
Novo Nordisk

WARNING: RISK OF THYROID C-CELL TUMORS

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)].
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.

Limitations of Use:

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)].
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)].
XULTOPHY 100/3.6 is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
XULTOPHY 100/3.6 has not been studied in combination with prandial insulin.

2 DOSAGE AND ADMINISTRATION

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 [see Dosage and Administration (2.2)].
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)].

2.2 Recommended Starting Dose

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

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

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

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 [see Warnings and Precautions (5.5)]

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

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