Prescription Drug Information: Saxenda

SAXENDA- liraglutide injection, solution
A-S Medication Solutions

1 INDICATIONS AND USAGE

SAXENDA is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:

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Adult patients with an initial body mass index (BMI) of [see Dosage and Administration (2.1)]:

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30 kg/m² or greater (obese), or

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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)

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Pediatric patients aged 12 years and older with:

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body weight above 60 kg and

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an initial BMI corresponding to 30 kg/m2 or greater for adults (obese) by international cut-offs (Cole Criteria, Table 2) [see Dosage and Administration (2.1)]

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​ Limitations of Use

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SAXENDA contains liraglutide and should not be coadministered with other liraglutide-containing products or with any other GLP-1 receptor agonist.

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The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established.

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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.

2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

Select patients for SAXENDA treatment as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management based on the BMI values provided in Tables 1 and 2.

Adult and Pediatric Patients

BMI is calculated by dividing weight in (kilograms) by height (in meters) squared. A chart for determining BMI based on height and weight is provided in Table 1.

Table 1: BMI Conversion Chart

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(click image for full-size original)

​Pediatric Patients Aged 12 Years and Older

​BMI cut-offs for obesity in pediatric patients aged 12 years and older are presented in Table 2.

​Table 2: International Obesity Task Force BMI Cut-offs for Obesity by Sex and Age for Pediatric Patients Aged 12 Years and Older (Cole Criteria)

Age (years)	Body mass index 30 kg/m2
	Males	Females
12	26.02	26.67
12.5	26.43	27.24
13	26.84	27.76
13.5	27.25	28.20
14	27.63	28.57
14.5	27.98	28.87
15	28.30	29.11
15.5	28.60	29.29
16	28.88	29.43
16.5	29.14	29.56
17	29.41	29.69
17.5	29.70	29.84

2.2 Important Administration Instructions

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

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

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

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

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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.

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If more than 3 days have elapsed since the last SAXENDA dose, reinitiate SAXENDA at 0.6 mg daily and follow the dose escalation schedule in Table 3, to reduce the occurrence of gastrointestinal adverse reactions associated with reinitiation of treatment.

2.3 Dosage in Adults and Pediatric Patients Aged 12 Years and Older

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Initiate SAXENDA with a dose of 0.6 mg daily for one week. Then follow the dose escalation schedule in Table 3 to minimize gastrointestinal adverse reactions [see Adverse Reactions (6.1)].

Table 3: Dose 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

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

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

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

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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.

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

​ Pediatric Patients

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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.

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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.

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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.