Usual Adult Dose for Diabetes Type 2

Initial dose: 0.6 mg subcutaneously once a day for 1 week

• Titration: After 1 week, increase to 1.2 mg subcutaneously once a day; if acceptable glycemic control is not achieved, may increase to 1.8 mg subcutaneously once a day

Maintenance dose: 1.2 to 1.8 mg subcutaneously once a day
Maximum dose: 1.8 mg/day

Comments:

• Initial dose of 0.6 mg once a day is intended to reduce gastrointestinal symptoms of therapy initiation; it is not an effective dose for glycemic control.
• Consider dose reduction of insulin secretagogue when initiating therapy with this drug to reduce the risk of hypoglycemia; the concurrent use of prandial insulin has not been studied.
• This drug is not a substitute for insulin and should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Uses:

• As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus
• To reduce the risk of major cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.

Usual Adult Dose for Cardiovascular Risk Reduction

Initial dose: 0.6 mg subcutaneously once a day for 1 week

• Titration: After 1 week, increase to 1.2 mg subcutaneously once a day; if acceptable glycemic control is not achieved, may increase to 1.8 mg subcutaneously once a day

Maintenance dose: 1.2 to 1.8 mg subcutaneously once a day
Maximum dose: 1.8 mg/day

Comments:

• Initial dose of 0.6 mg once a day is intended to reduce gastrointestinal symptoms of therapy initiation; it is not an effective dose for glycemic control.
• Consider dose reduction of insulin secretagogue when initiating therapy with this drug to reduce the risk of hypoglycemia; the concurrent use of prandial insulin has not been studied.
• This drug is not a substitute for insulin and should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Uses:

• As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus
• To reduce the risk of major cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.

Usual Adult Dose for Weight Loss

Dose escalation should be followed to reduce the likelihood of gastrointestinal symptoms; dose escalation may be delayed by 1 additional week if necessary:
Week 1: Inject 0.6 mg subcutaneously once a day
Week 2: Inject 1.2 mg subcutaneously once a day
Week 3: Inject 1.8 mg subcutaneously once a day
Week 4: Inject 2.4 mg subcutaneously once a day
Week 5: Inject 3 mg subcutaneously once a day

MAINTENANCE dose: 3 mg subcutaneously once a day

• If maintenance dose is not tolerated, discontinuation is recommended; efficacy for chronic weight management has not been established at lower doses.

Comments:

• Saxenda and Victoza both contain liraglutide; Saxenda is indicated for use in chronic weight management and should not be used for the treatment of type 2 diabetes mellitus.
• Saxenda should not be used in combination with any other GLP-1 receptor agonist.
• The safety and effectiveness of Saxenda in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
• Evaluate weight loss at 16 weeks; if 4% or more of body weight has not been lost, it is unlikely the patient will achieve and sustain clinically meaningful weight loss with continued treatment.

Use: As an adjunct to a reduced-caloried diet and increased physical activity for chronic weight management in adult patients with an initial BMI of 30 kg/m2 or greater (obese) or an initial BMI of 27 kg/m2 (overweight) or greater in the presence of at least 1 weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

BMI=Body Mass Index is calculated by dividing weight in kilograms by height in meters squared. Charts are available for determining BMI based on height and weight, including a chart in Saxenda product labeling.

Usual Pediatric Dose for Diabetes Type 2

10 years or older:
Initial dose: 0.6 mg subcutaneously once a day

• Titration: After 1 week, may increase to 1.2 mg/day if additional glycemic control is required, a further increase to 1.8 mg/day may occur after at least one week of treatment with 1.2 mg/day

Maintenance dose: 0.6 to 1.8 mg subcutaneously once a day
Maximum dose: 1.8 mg/day

Comments:

• Consider dose reduction of insulin secretagogue when initiating therapy with this drug to reduce the risk of hypoglycemia; the concurrent use of prandial insulin has not been studied.
• This drug is not a substitute for insulin and should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Use: As an adjunct to diet and exercise to improve glycemic control in children and adolescents 10 years or older with type 2 diabetes mellitus.

Usual Pediatric Dose for Weight Loss

12 years and older:
Dose escalation should be followed to reduce the likelihood of gastrointestinal symptoms; dose escalation may be delayed if necessary based on tolerability; dose escalation may take up to 8 weeks:
Week 1: Inject 0.6 mg subcutaneously once a day
Week 2: Inject 1.2 mg subcutaneously once a day
Week 3: Inject 1.8 mg subcutaneously once a day
Week 4: Inject 2.4 mg subcutaneously once a day
Week 5: Inject 3 mg subcutaneously once a day

MAINTENANCE dose: 2.4 or 3 mg subcutaneously once a day

• If maintenance dose is not tolerated, discontinuation is recommended; efficacy for chronic weight management has not been established at lower doses.

Comments:

• Saxenda and Victoza both contain liraglutide; Saxenda is indicated for use in chronic weight management and should not be used for the treatment of type 2 diabetes mellitus.
• Saxenda should not be used in combination with any other GLP-1 receptor agonist.
• The safety and effectiveness of Saxenda in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
• Evaluate weight loss at 12 weeks on the maintenance dose; if 1% or more of body weight has not been lost, it is unlikely the patient will achieve and sustain clinically meaningful weight loss with continued treatment and this drug should be discontinued.

Use: As an adjunct to a reduced-caloried diet and increased physical activity for chronic weight management in pediatric patients with a body weight above 60 kg and an initial BMI of 30 kg/m2 or greater.

BMI=Body Mass Index is calculated by dividing weight in kilograms by height in meters squared. Charts are available for determining BMI based on height and weight, including a chart in Saxenda product labeling.

Usual Pediatric Dose for Obesity

12 years and older:
Dose escalation should be followed to reduce the likelihood of gastrointestinal symptoms; dose escalation may be delayed if necessary based on tolerability; dose escalation may take up to 8 weeks:
Week 1: Inject 0.6 mg subcutaneously once a day
Week 2: Inject 1.2 mg subcutaneously once a day
Week 3: Inject 1.8 mg subcutaneously once a day
Week 4: Inject 2.4 mg subcutaneously once a day
Week 5: Inject 3 mg subcutaneously once a day

MAINTENANCE dose: 2.4 or 3 mg subcutaneously once a day

• If maintenance dose is not tolerated, discontinuation is recommended; efficacy for chronic weight management has not been established at lower doses.

Comments:

• Saxenda and Victoza both contain liraglutide; Saxenda is indicated for use in chronic weight management and should not be used for the treatment of type 2 diabetes mellitus.
• Saxenda should not be used in combination with any other GLP-1 receptor agonist.
• The safety and effectiveness of Saxenda in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
• Evaluate weight loss at 12 weeks on the maintenance dose; if 1% or more of body weight has not been lost, it is unlikely the patient will achieve and sustain clinically meaningful weight loss with continued treatment and this drug should be discontinued.

Use: As an adjunct to a reduced-caloried diet and increased physical activity for chronic weight management in pediatric patients with a body weight above 60 kg and an initial BMI of 30 kg/m2 or greater.

BMI=Body Mass Index is calculated by dividing weight in kilograms by height in meters squared. Charts are available for determining BMI based on height and weight, including a chart in Saxenda product labeling.

Renal Dose Adjustments

No dose adjustment recommended, however use caution, especially in patients who experience dehydration

Liver Dose Adjustments

No dose adjustment recommended, however use caution as there is limited experience in this population

Dose Adjustments

For patients concomitantly receiving insulin or insulin secretagogue, consider dose reduction of insulin or insulin secretagogue to reduce the risk of hypoglycemia

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.
• Liraglutide 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 medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
• Serious hypersensitivity to the active substance or any product components
• Pregnancy (Saxenda)

Safety and efficacy have not been established for use in chronic weight management in patients younger than 12 years; safety and efficacy have not been established for use in type 2 diabetes in patients younger than 10 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For subcutaneous use only; do not administer IV or IM
• There are 2 different products: Victoria is used for type 2 diabetes; Saxenda for chronic weight management; they should not be used concomitantly or interchangeably
• Patients should be trained on proper injection technique
• Inject subcutaneously once a day into the abdomen, thigh, or upper arm; may be given at any time of day without regard to meals
• Never share a pen between patients, even if the needle is changed; do not reuse or share needles or syringes between patients as this presents a risk for transmission of blood-borne pathogens
• To mitigate gastrointestinal symptoms, the starting dose is 0.6 mg once daily; patients must be titrated to effective doses.
• If concomitantly given with insulin, administer as separate injections; may be given in the same body region, but not adjacent to each other

Missed dose:

• If a dose is missed, resume dosing with next scheduled dose, an extra dose or increase in dose should not be taken to make up for a missed dose.
• If more than 3 days/doses are missed this drug should be reinitiated at 0.6 mg to mitigate any gastrointestinal symptoms; the dose can be titrated at the physician's discretion

Storage requirements:

• Refrigerate prior to first use (36 to 46F; 2 to 8C); do not freeze and do not use if it has been frozen
• After first use, may store at controlled room temperature (59 to 86F; 15 to 30C) or in the refrigerator; use within 30 days
• Keep pen cap on when not in use, do not store pen with needle attached
• Protect from excessive heat and sunlight

Reconstitution/preparation techniques: Patients should receive proper training from their healthcare provider prior to first use. See product labeling for specific instructions.

Compatibility: Do not mix with other medicinal products

General:

• A 13% reduction in risk for the composite endpoint of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke was demonstrated in the LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results - A Long Term Evaluation) trial; this study provides the evidence for the expanded use of this drug for reducing cardiovascular risk in patients with type 2 diabetes.
• This drug slows gastric emptying; it has not been studied in patients with preexisting gastroparesis.
• This drug should not be used to treat patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective.

Monitoring:

• Monitor for dehydration, especially in the presence of adverse gastrointestinal events
• Monitor for hypoglycemia, hemoglobin A1C measurements should be measured periodically in patients with type 2 diabetes to assess efficacy
• Observe for signs and symptoms of pancreatitis and acute gallbladder disease
• Monitor heart rate, especially in patients using this drug for chronic weight loss
• Monitor for emergence or worsening depression, suicidal thoughts or behaviors, and/or any unusual changes in mood and behavior

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Patients should be advised to never share a 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.
• Counsel patients to report symptoms of thyroid tumors such as a lump in their neck, persistent hoarseness, dysphagia, or dyspnea.
• Patients should be aware of the potential for gastrointestinal (GI) adverse reactions and take measures to avoid dehydration; patients should be instructed to seek medical advice if they suspect they are becoming dehydrated or for persistent and severe GI events.
• Patients should be advised of the potential for pancreatitis, acute gallbladder disease, hepatitis, and worsening renal function; they should understand what to watch for and promptly seek medical care if signs or symptoms develop.
• Patients with diabetes 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 signs and symptoms of hypoglycemia and how it should be managed and they should be advised to take precautions to avoid hypoglycemia while driving and using machines.
• Patients should be advised to report emergence or worsening of depression and/or unusual changes in mood or behaviors.
• Inform patients that hypersensitivity reactions may occur requiring prompt medical attention.

Frequently asked questions

• What foods should I avoid while on Saxenda?
• When is the best time of day to take Victoza?
• Will Victoza help with weight loss?
• Does Victoza need to be refrigerated?
• How and where do you use the Victoza pen?
• How many doses are in a Victoza pen?
• How and where do you inject liraglutide?
• Can Victoza and Januvia be used together?
• Can liraglutide be used for weight loss?