Saxenda

BOXED WARNING

Quoted from the FDA label

Quoted in full from the FDA product label.

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 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • Liraglutide causes 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 ( 5.1 ). • SAXENDA is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors ( 4 , 5.1 , 13.1 ).

INDICATIONS AND USAGE

Quoted from the FDA label

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/m 2 or greater (obese), or ▪ 27 kg/m 2 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/m 2 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. SAXENDA is a glucagon like peptide 1 (GLP-1) receptor agonist 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/m 2 or greater (obese), or • 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g. hypertension, type 2 diabetes mellitus, or dyslipidemia) ( 1 ). Pediatric patients aged 12 years and older with: • body weight above 60 kg and • an initial BMI corresponding to 30 kg/m 2 for adults (obese) by international cut-offs ( 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 ( 1 ). • The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established ( 1 ). • The safety and efficacy of SAXENDA in combination with other products intended for weight loss have not been established ( 1) .

What this page is

A reproduction of a public FDA label record. Everything quoted above is the labeller's wording as published by the FDA, not this site's. Nothing here is regulatory, legal or medical advice, and a label being reproduced says nothing about whether a product is available in any particular country. Labels are revised often; the retrieval date above says when this copy was taken, and the full current label is at the link.