Xultophy 100/3.6 (Page 2 of 12)

2.3 Titration of XULTOPHY 100/3.6

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.
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)

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 Missed Doses

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.
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)].

2.5 Important Administration Instructions

The XULTOPHY 100/3.6 pen is for single-patient-use only [see Warnings and Precautions (5.3)].
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 [see Warnings and Precautions (5.5)].
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 cutaneousamyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.4), Adverse Reactions (6.1, 6.3)].
During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.4 )].
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, intramuscularly, or in an insulin infusion pump.
Do not dilute or mix XULTOPHY 100/3.6 with any other insulin products or solutions.
Do not split the dose of XULTOPHY 100/3.6.

3 DOSAGE FORMS AND STRENGTHS

XULTOPHY 100/3.6 injection: 100 units insulin degludec per mL and 3.6 mg liraglutide per mL available as a clear, colorless solution in a 3 mL pre-filled, disposable, single-patient-use pen injector.

4 CONTRAINDICATIONS

XULTOPHY 100/3.6 is contraindicated:

In patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions (5.1)].
During episodes of hypoglycemia [see Warnings and Precautions (5.6)].
In patients with hypersensitivity to XULTOPHY 100/3.6, either insulin degludec or liraglutide, or any of its excipients. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with liraglutide, one of the components of XULTOPHY 100/3.6 [see Warnings and Precautions (5.8 )].

5 WARNINGS AND PRECAUTIONS

5.1 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 (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice [see Nonclinical Toxicology (13.1)]. Malignant thyroid C-cell carcinomas were detected in rats and mice. It is unknown whether XULTOPHY 100/3.6 will cause 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.

Cases of MTC in patients treated with liraglutide have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and liraglutide use in humans.

XULTOPHY 100/3.6 is contraindicated in patients with a personal or family history of MTC or in patients with 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. Such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

5.2 Pancreatitis

Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with liraglutide, one of the components of XULTOPHY 100/3.6. In glycemic control trials of liraglutide, there have been 13 cases of pancreatitis among liraglutide-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with liraglutide were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a liraglutide-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse.

After initiation of XULTOPHY 100/3.6, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, XULTOPHY 100/3.6 should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, restarting XULTOPHY 100/3.6 is not recommended.

Liraglutide, one of the components of XULTOPHY 100/3.6, has been studied in a limited number of patients with a history of pancreatitis. It is unknown if patients with a history of pancreatitis are at higher risk for development of pancreatitis on liraglutide.

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