Weightdosage

Inject SAXENDA subcutaneously in the abdomen, thigh, or upper arm once daily at any time of day, without regard to the timing of meals.

The recommended dose of SAXENDA is 3 mg daily.

Initiate at 0.6 mg per day for one week. In weekly intervals, increase the dose until a dose of 3 mg is reached.

If pediatric patients do not tolerate an increased dose during dose escalation, the dose may also be lowered to the previous level. Dose escalation for pediatric patients may take up to 8 weeks.

Pediatric patients who do not tolerate 3 mg daily may have their dose reduced to 2.4 mg daily.

Adult patients with type 2 diabetes should monitor blood glucose prior to starting SAXENDA and during SAXENDA treatment.

2.1 Important

Administration Instructions

Prior to initiation of SAXENDA, train patients on proper injection technique. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations.

Inspect SAXENDA visually prior to each injection. Only use if solution is clear, colorless, and contains no particles.

Administer SAXENDA in combination with a reduced-calorie diet and increased physical activity.

Inject SAXENDA subcutaneously once daily at any time of day, without regard to the timing of meals.

Inject SAXENDA subcutaneously in the abdomen, thigh, or upper arm. No dosage adjustment is needed if changing the injection site and/or timing.

Rotate injection sites within the same region in order to reduce the risk of cutaneous amyloidosis.

If a dose is missed, resume the once-daily regimen as prescribed with the 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 SAXENDA dosage, reinitiate SAXENDA at 0.6 mg daily and follow the dosage escalation schedule in Table 1, to reduce the risk of gastrointestinal adverse reactions associated with reinitiation of treatment.

2.2 Dosage in

Adults and Pediatric Patients Aged 12 Years and Older

Initiate SAXENDA with a dose of 0.6 mg daily for one week. Then follow the dosage escalation schedule in Table 1 to reduce the risk of gastrointestinal adverse reactions. Table 1. Dosage Escalation Schedule Week Daily Dose 1 0.6 mg 2 1.2 mg 3 1.8 mg 4 2.4 mg 5 and onward 3 mg Adult Patients

For adults, the recommended dosage of SAXENDA is 3 mg daily, lower dosages are for titration only.

Discontinue SAXENDA if the patient cannot tolerate the 3 mg dosage.

If patients do not tolerate an increased dose during dosage escalation, consider delaying dosage escalation for approximately one additional week.

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.

In adult patients with type 2 diabetes, monitor blood glucose prior to starting SAXENDA and during SAXENDA treatment. Pediatric Patients

For pediatric patients, the recommended maintenance dosage of SAXENDA is 3 mg daily. Pediatric patients who do not tolerate 3 mg daily may have their maintenance dose reduced to 2.4 mg daily. Discontinue SAXENDA if the patient cannot tolerate the 2.4 mg dose.

If pediatric patients do not tolerate an increased dose during dosage escalation, the dose may also be lowered to the previous level. Dosage escalation for pediatric patients may take up to 8 weeks.

Evaluate the change in BMI after 12 weeks on the maintenance dose and discontinue SAXENDA if the patient has not had a reduction in BMI of at least 1% from baseline, since it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.