Usual Adult Dose for Diabetes Type 2

Dose is directed in units of insulin degludec

Basal Insulin or GLP-1 Receptor Agonist Naive:

• Initial dose: 10 units subcutaneously once a day

Currently Receiving a Basal Insulin or GLP-1 Receptor Agonist: Discontinue therapy with basal insulin and/or liraglutide prior to initiating:

• Initial dose: 16 units subcutaneously once a day

TITRATION: Adjust dose up or down in increments of 2 units every 3 to 4 days based on individual metabolic needs, blood glucose monitoring, and glycemic goal until desired fasting plasma glucose is achieved
Maximum daily dose: 50 units (insulin degludec 50 units; liraglutide 1.8 mg)

Comments:

• Insulin degludec 1 unit and liraglutide 0.036 mg are provide per unit; a table providing the corresponding milligrams of liraglutide may be found in the manufacturer product labeling.
• To minimize the risk of hypoglycemia or hyperglycemia, additional titration may be necessary with changes in physical activity, food intake, during acute illness, or with use of concomitant medications.
• This combination drug is not recommended as first-line therapy because of the uncertainty of rodent C-cell tumor finding to humans.
• The combination drug has not been studied in combination with prandial insulin.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Renal Dose Adjustments

Mild and Moderate Renal Impairment: No specific dose adjustments provided, however, glucose monitoring should be intensified and dose adjustments made on an individual basis

Liver Dose Adjustments

No specific dose adjustments provided, however, glucose monitoring should be intensified and dose adjustments made on an individual basis

Dose Adjustments

Elderly: Initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions.

To minimize the risk of hypoglycemia or hyperglycemia, additional titration may be necessary with changes in physical activity, food intake, during acute illness, or with use of concomitant medications.

Missed doses:

• If a dose is missed, resume once-daily regimen as prescribed with next scheduled dose; do not administer an extra dose or increase the dose to make up for the missed dose.
• If more than 3 days have elapsed since the last dose, reinitiate at the recommended starting dose to mitigate any gastrointestinal symptoms associated with reinitiating therapy.

Precautions

US BOXED WARNING: Risk of Thyroid C-Cell Tumors:

• Liraglutide 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 this drug 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.
• This drug 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 risk of MTC 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 receiving this drug.

CONTRAINDICATIONS:

• Personal or family history of MTC
• MEN2
• During episodes of hypoglycemia
• Hypersensitivity to active substances or any product excipients; serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with liraglutide

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For subcutaneous use only; do not administer IV, IM, or use in an insulin pump
• To avoid medication errors, instruct patient to always check label prior to injection
• Administer subcutaneously once a day into thigh, upper arm, or abdomen; rotate injection sites within same region to reduce the risk of lipodystrophy
• May administer any time of the day, preferably at the same time each day
• Do not dilute or mix with any other insulin product or solution
• Do not split dose

Storage requirements:

• Protect from light
• Prior to first opening: Store in refrigerator 36F to 46F (2C to 8C); do not use if product has been frozen
• After first opening, store in refrigerator or store at room temperature (59F to 86F [15C and 30C]); discard 21 days after first opening
• Do not store pen with needle attached; always use a new needle for each injection

Reconstitution/preparation techniques:

• Prefilled syringe is for single-patient-use only
• Patient should be trained on proper injection technique; product information provides descriptions and illustrations
• Prefilled syringe dials in 1-unit increments
• Use caution in visually-impaired patients who may rely on audible clicks to dial dose

Compatibility: Do not mix with any other products; do not add to infusion fluids

General:

• This drug should not be used in patients with type I diabetes or for the treatment of diabetic ketoacidosis.
• This drug has not been studied in combination with prandial insulin or in patients with preexisting gastroparesis.

Monitoring:

• Monitor glycemic control; dose adjustments should be based on fasting plasma glucose; patients should self-monitor blood glucose (SMBG) frequently during therapy initiation and as clinically indicated
• Monitor for hyper and hypoglycemia; the prolonged effect of this product may delay recovery from hypoglycemia
• Monitor for symptoms of thyroid tumors
• Monitors serum potassium in patients at risk of hypokalemia
• Monitor for edema or worsening heart failure in patients receiving concomitant PPAR-gamma agonists

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide and Instructions for Use).
• Patients should be advised to never share pen with another person, even if the needle is changed; patients should understand that sharing needles or syringes with another person carries a risk for transmission of blood-borne pathogens
• Patients should be instructed to always check labels before dosing to prevent mix-ups between this drug and other injectable diabetes products.
• Patients should understand that this drug is administered once a day, at any time of the day, preferably at the same time each day; if a dose is missed, wait until next scheduled dose; if more than 3 days have elapsed since last dose, contact health care professional for guidance.
• Patients should be instructed on glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia.
• Patients should be instructed to check blood sugar prior to driving a car or operating machinery.
• Patients should be instructed to seek medical advice during periods of stress, such as fever, trauma, infection, or surgery as medical management of diabetes may change.
• Patients should be aware of the potential for gastrointestinal reactions and measures they need to take to ensure adequate fluid intake to avoid dehydration; patients should be instructed to seek medical advice for persistent and severe events.
• Patients should understand there is a risk for thyroid cancer; symptoms of thyroid cancer should be explained, and patients should report these symptoms if they develop.
• Patients should understand there is a potential risk for pancreatitis; patients should report persistent severe abdominal pain, especially if pain radiates to the back.
• Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.

Frequently asked questions

• How and where should I inject insulin?
• What are the different types of insulin?
• What is the difference between Soliqua and Xultophy?