Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of
- 30 kg/m² or greater (obese), or
- 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
DOSAGE AND ADMINISTRATION
The recommended dosage of Saxenda is 3 mg daily. The dose escalation schedule in Table 1 should be used to reduce the likelihood of gastrointestinal symptoms. If patients do not tolerate an increased dose during dose escalation, consider delaying dose escalation for approximately one additional week. Saxenda should be discontinued, however, if a patient cannot tolerate the 3 mg dose, as efficacy has not been established at lower doses (0.6, 1.2, 1.8, and 2.4 mg).
Table 1: Dose Escalation Schedule
|5 and onward||3 mg|
Saxenda should be taken once daily at any time of day, without regard to the timing of meals. Saxenda can be injected subcutaneously in the abdomen, thigh, or upper arm. The injection site and timing can be changed without dose adjustment. Saxenda must not be administered intravenously or intramuscularly.
When initiating Saxenda in patients taking insulin secretagogues (such as sulfonylureas), consider reducing the dose of the insulin secretagogue (for example, by one-half) to reduce the risk for hypoglycemia, and monitor blood glucose. Saxenda and insulin should not be used together [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].Conversely, if discontinuing Saxenda in patients with type 2 diabetes, monitor for an increase in blood glucose.
Evaluate the change in body weight 16 weeks after initiating Saxenda and discontinue Saxenda if the patient has not lost at least 4% of baseline body weight, since it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
If a dose is missed, the once-daily regimen should be resumed as prescribed with the next scheduled dose. An extra dose or increase in dose should not be taken to make up for the missed dose. If more than 3 days have elapsed since the last Saxenda dose, patients should reinitiate Saxenda at 0.6 mg daily and follow the dose escalation schedule in Table 1, which may reduce the occurrence of gastrointestinal symptoms associated with reinitiation of treatment.
Prior to initiation of Saxenda, patients should be trained by their healthcare professional on proper injection technique. Training reduces the risk of administration errors such as needle sticks and incomplete dosing. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations.
Saxenda solution should be inspected prior to each injection, and the solution should be used only if it is clear, colorless, and contains no particles.
The following serious adverse reactions are described below or elsewhere in the prescribing information:
- Risk of Thyroid C-Cell Tumors
- Acute Pancreatitis
- Acute Gallbladder Disease
- Risk for Hypoglycemia with Concomitant Use of Anti-Diabetic Therapy
- Heart Rate Increase
- Renal Impairment
- Hypersensitivity Reactions
- Suicidal Behavior and Ideation