Saxenda

SAXENDA- liraglutide injection, solution
Novo Nordisk

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 SAXENDA 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 [see Warnings and Precautions (5.1) and Nonclinical Toxicology (13.1)].
SAXENDA 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 potential risk of MTC with use of SAXENDA 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 treated with SAXENDA [see Contraindications (4), Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

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 [see Dosage and Administration (2.1)]:
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)
Pediatric patients aged 12 years and older with:
body weight above 60 kg and
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)]

Limitations of Use

SAXENDA contains liraglutide and should not be coadministered with other liraglutide-containing products or with any other GLP-1 receptor agonist.
The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established.
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

Table
(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

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.
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 dose adjustment is needed if changing the injection site and/or timing.
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 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.

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