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Intended for US Health Care Professionals.
Please see Important Safety Information at [ Ссылка ].
Please see Prescribing Information, including Boxed Warning, at [ Ссылка ].
Learn how to use the once-daily Saxenda® injection pen with this step-by-step demonstration. To ensure proper use and safety, patients should always refer to the full Instructions for Use in the Saxenda® Medication Guide before using their pen. The Instructions for Use and Medication Guide can be found with the Saxenda® pen. Learn more at [ Ссылка ].
Selected Important Safety Information
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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.
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 (eg, 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®.
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Indications and Usage
Saxenda® (liraglutide) injection 3 mg 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 (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia)
• Pediatric patients aged 12 years and older with body weight above 60 kg (132 lbs) and initial BMI corresponding to 30 kg/m2 or greater for adults (obese) by international cut-offs
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
Important Safety Information (cont'd)
Contraindications
Saxenda® is contraindicated in:
• Patients with a personal or family history of MTC or patients with MEN 2
• Patients with a serious hypersensitivity reaction to liraglutide or to any of the excipients in Saxenda®. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with Saxenda®
• Pregnancy
Warnings and Precautions
• Risk of Thyroid C-cell Tumors: If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated
• Acute Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with liraglutide postmarketing. Observe patients carefully for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back with or without vomiting). If pancreatitis is suspected, discontinue Saxenda® promptly and if pancreatitis is confirmed, do not not restart
• Acute Gallbladder Disease: Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in patients treated with Saxenda® than with placebo even after accounting for the degree of weight loss. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated
Please see full Important Safety Information at [ Ссылка ].
Saxenda® is a registered trademark of Novo Nordisk A/S. Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2022 Novo Nordisk All rights reserved. US22SX00232 July 2022
