Applies to the following strength(s): 18 mg/3 mL
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Diabetes Type 2
Initial dose: 0.6 mg subcutaneously once a day for 1 week; this dose is intended to reduce gastrointestinal symptoms and is not an effective dose for glycemic control.
Maintenance dose: Inject 1.2 mg subcutaneously once a day; if acceptable glycemic control is not achieved, may increase to 1.8 mg subcutaneously once a day
Maximum dose: 1.8 mg once a day
-Consider dose reduction of the insulin secretagogue to reduce the risk of hypoglycemia.
-This drug is not recommended as a first-line therapy for patients with inadequate glycemic control on diet and exercise.
Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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
-Consider dose reduction of the insulin secretagogue to reduce the risk of hypoglycemia; conversely when discontinuing use in a patient with type 2 diabetes, monitor for an increase in blood glucose.
-If a dose of 3 mg once daily is not tolerated, discontinuation is recommended; efficacy for chronic weight management has not been established at lower doses.
-Evaluate weight loss at 16 weeks; if at least 4% of body weight has not been lost, it is unlikely the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
Use: 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), this drug is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management.
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(R) product labeling.
Renal Dose Adjustments
No dose adjustment recommended, however use with caution, especially when initiating and escalating doses.
Liver Dose Adjustments
No dose adjustment recommended, however use with caution as there is limited experience in this population.
Consider dose reduction of the insulin secretagogue to reduce the risk of hypoglycemia.
The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Victoza and Saxenda. Each has a communication plan. For additional information: www.fda.gov/REMS
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 could not be ruled out by clinical or nonclinical studies.
-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.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-For subcutaneous use only; do not administer IV or IM
-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
-If it is more than 12 hours since a dose should have been used, skip the missed dose and resume dosing with next scheduled dose, an extra dose or increase in dose should not be taken to make up for a missed dose.
-To mitigate gastrointestinal symptoms, the starting dose is 0.6 mg once daily; patients must be titrated to effective doses.
-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.
-If concomitantly given with insulin, administer as separate injections; may be given in the same body region, but not adjacent to each other.
-Pens and needles should not be shared with another person.
-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 refrigerate; 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.
-This drug has not been studied in patients with a history of pancreatitis, consider alternative therapy.
-This drug should not be used to treat patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
-This drug is not recommended as a first-line therapy in patients with type 2 diabetes mellitus.
-Saxenda(R) is not indicated for the treatment of type 2 diabetes mellitus.
-Saxenda(R) should not be used in combination with any other GLP-1 receptor agonists or used with insulin.
-Blood glucose and hemoglobin A1C measurements should be measured periodically to assess efficacy
-Observe for signs and symptoms of pancreatitis
-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 reactions and take measures to ensure adequate fluid intake to avoid dehydration and to seek medical advice for persistent and severe events.
-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.
-Inform patients that hypersensitivity reactions may occur; patients should be instructed to contact their health care professional.
-Patients should be aware of signs and symptoms of hypoglycemia and how it should be managed; patients should be advised to take precautions to avoid hypoglycemia while driving and using machines.