Clinical Information
Gen. Code and Des.
73258 liraglutide SUBCUT PEN INJCTR 3 MG/0.5ML
GCN and Des.
37637 liraglutide SUBCUT PEN INJCTR 3 MG/0.5ML
Strength
18MG3ML
Dose Form
PEN INJECTOR (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
68200600 INCRETIN MIMETICS
Active Ingredients
10773 liraglutide 204656202
Inactive Ingredients
2468 propylene glycol 57556
3199 phenol 108952
SAXENDA- liraglutide injection, solution
Novo Nordisk
WARNING: RISK OF THYROID C-CELL TUMORS
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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)].
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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
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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)
Limitations of Use
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Saxenda is not indicated for the treatment of type 2 diabetes mellitus.
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Saxenda and Victoza� both contain the same active ingredient, liraglutide, and therefore should not be used together. Saxenda should not be used in combination with any other GLP-1 receptor agonist.
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Saxenda has not been studied in patients taking insulin. Saxenda and insulin should not be used together [see Warnings and Precautions (5.4)].
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The effects of Saxenda on cardiovascular morbidity and mortality 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.
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Saxenda has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)].
2 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).
DOSAGE FORMS AND STRENGTHS
Solution for subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL).