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Insulin Degludec / Liraglutide Dosage

Applies to the following strength(s): 100 units-3.6 mg/mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for Diabetes Type 2

Individualize dose in accordance with patient's needs.
-Discontinue both liraglutide and basal insulin prior to initiation with this combination product.
-This drug is prescribed in dose steps: One dose step provides insulin degludec 1 unit plus liraglutide 0.036 mg; the dose counter on pen shows dose steps
-Maximum daily dose: 50 dose steps (insulin degludec 50 units-liraglutide 1.8 mg)

-Initial dose: 16 dose steps (insulin degludec 16 units-liraglutide 0.58 mg) subcutaneously once a day
-Titrate up or down by 2 units every 3 to 4 days based on metabolic needs, blood glucose monitoring results, and glycemic control goal until the desired fasting plasma glucose is achieved.
-Maintenance dose: 16 to 50 units (dose steps) subcutaneously once a day
-Maximum daily dose: 50 units (50 dose steps: insulin degludec 50 units-liraglutide 1.8 mg)

Comments:
-This combination drug is not recommended as first-line therapy because of the uncertain relevance of the rodent C-cell tumor finding to humans.
-This drug should not be used in combination with any other product containing liraglutide or another GLP-1 receptor agonist.
-The combination drug has not been studied in combination with prandial insulin.
-Alternative antidiabetic therapy should be considered if patients require a daily dose persistently below 16 units per day or over 50 units per day.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on basal insulin (less than 50 units per day) or liraglutide (less than or equal to 1.8 mg per day).

Renal Dose Adjustments

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

Liver Dose Adjustments

Data not available

Dose Adjustments

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

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 starting dose (16 units) to mitigate any gastrointestinal symptoms associated with reinitiating therapy.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Xultophy(R); it consists of a communication plan. For additional information: http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm

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.

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, 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 lipodystropy.
-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
-Product labeling provides a chart that displays units of insulin degludec and milligrams of liraglutide contained in each dose step.

Storage requirements:
-Do not use if product has been frozen.
-Keep cap on to protect from light.
-Prior to first opening: Store in refrigerator 36F to 46F (2C to 8C)
-After first opening, store in refrigerator or store at room temperature between 59F and 86F (15C and 30C); discard 21 days after first opening.

Reconstitution/preparation techniques: The pre-filled syringe is for use by one person only; consult product labeling for detailed instructions on use.

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

General:
-For patients with a history of pancreatitis, other antidiabetic therapies should be considered.
-This drug has not been studied in combination with prandial insulin.
-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 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 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 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 medicinal products.
-Patients should understand that this drug is administered once a day any time of the day, preferably at the same time each day; if a dose is missed, they should wait until the next scheduled dose, if more than 3 days have elapsed since the last dose, they should contact their health care professional for guidance.
-Patients should be instructed on glucose monitoring, proper injection technique, and the 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 take measures to ensure adequate fluid intake to avoid dehydration and 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.

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