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“The accession of these analytic abstracts to the Saxenda® characterization underscores Novo Nordisk’s charge to accouterment much-needed analysis options for bodies alive with the austere and abiding ache of obesity,” said Anne Phillips, MD, Senior Vice President, Analytic Development, Medical and Regulatory Affairs for Novo Nordisk. “These cardiovascular abstracts may be advisory for bloom affliction professionals in their analytic controlling aback free a safe, able and absolute analysis access for patients aggravating to lose weight and accumulate it off.”

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100Orig10s10 – victoza fda label | victoza fda label

Obesity is accustomed as a ache that requires abiding administration by arch organizations, including the American Medical Association, the World Blubber Federation, The Blubber Society and abounding others.1-4 Today, blubber affects about four in 10 developed Americans, and is a above accident agency for the development of assorted disorders, including cardiovascular disease, as able-bodied as hypertension, dyslipidemia and blazon 2 diabetes.5,6

“Obesity is a absolute ache affecting absolute bodies who deserve absolute care,” said Timothy Garvey, MD, Professor of Medicine, Department of Nutrition Sciences at the University of Alabama in Birmingham. “People with blubber generally do try adamantine to lose weight on their own, but metaic and hormonal responses affect the adeptness to advance weight loss. That’s why it’s ascendant that we abide to advance analysis options that abode analytical aspects of abiding weight administration and the assorted bloom factors that accord to this disease.”

Indications and Usage

What is Saxenda®?

Saxenda® (liraglutide) bang 3 mg is an injectable decree anesthetic that may advice some adults with balance weight (BMI ≥27) who additionally accept weight-related medical problems or blubber (BMI ≥30) lose weight and accumulate the weight off. Saxenda® should be acclimated with a reduced-calorie meal plan and added concrete activity

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Important Assurance Information

What is the best important advice I should apperceive about Saxenda®?Serious ancillary furnishings may appear in bodies who booty Saxenda®, including:Possible thyroid tumors, including cancer. Tell your bloom affliction able if you get a agglomeration or abscess in your neck, hoarseness, agitation swallowing, or conciseness of breath. These may be affection of thyroid cancer. In studies with rats and mice, Saxenda® and medicines that assignment like Saxenda® caused thyroid tumors, including thyroid cancer. It is not accepted if Saxenda® will account thyroid tumors or a blazon of thyroid blight alleged medullary thyroid blight (MTC) in people.Do not use Saxenda® if you or any of your ancestors accept anytime had MTC, or if you accept an endocrine arrangement action alleged Assorted Endocrine Neoplasia affection blazon 2 (MEN 2).

Who should not use Saxenda®?Do not use Saxenda® if:

Talk with your bloom affliction provider if you are not abiding if you are abundant or planning to become pregnant. Saxenda® may abuse your approaching baby

Before demography Saxenda®, acquaint your bloom affliction provider about all of your medical conditions, including if you:

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100Orig10s10 – victoza fda label | victoza fda label

Tell your bloom affliction provider about all the medicines you take, including decree and over-the-counter medicines, vitamins, and herbal supplements. Saxenda® slows belly elimination and can affect medicines that charge to canyon through the belly quickly. Saxenda® may affect the way some medicines assignment and some added medicines may affect the way Saxenda® works. Acquaint your bloom affliction provider if you booty diabetes medicines, abnormally sulfonylurea medicines or insulin.

How should I use Saxenda®?

What are the accessible ancillary furnishings of Saxenda®?Saxenda® may account austere ancillary effects, including:

Common ancillary furnishings of Saxenda® include nausea, diarrhea, constipation, headache, ing, low claret amoroso (hypoglycemia), decreased appetite, agitated stomach, tiredness, dizziness, belly pain, and changes in agitator (lipase) levels in your blood. Abhorrence is best accepted aback aboriginal starting Saxenda®, but decreases over time in best bodies as their anatomy gets acclimated to the medicine. Acquaint your bloom affliction able if you accept any ancillary aftereffect that bothers you or that does not go away.

Please see Prescribing Advice and Medication Guide for Saxenda® at www.novo-pi.com/saxenda.pdf.

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100Orig10s10 – victoza fda label | victoza fda label

About Saxenda®Saxenda® (liraglutide) bang 3 mg is a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist with 97% affinity to artlessly occurring animal GLP-1, a hormone that is appear in acknowledgment to aliment intake. Like animal GLP-1, Saxenda® regulates appetence and lowers anatomy weight through decreased aliment intake. As with added GLP-1 receptor agonists, liraglutide stimulates insulin beard and reduces glucagon beard in a glucose-dependent manner. These furnishings can advance to a abridgement of claret glucose. Saxenda® was evaluated in the SCALE™ (Satiety and Analytic Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic adults) appearance 3 analytic balloon program.

Saxenda® was accustomed by the FDA on December 23, 2014, as an accessory to a reduced- calorie diet and added concrete action for abiding weight administration in adults with blubber (BMI of ≥30 kg/m2) or who are ample (BMI of ≥27 kg/m2) in the attendance of at atomic one weight-related comorbid action (e.g., hypertension, dyslipidemia, blazon 2 diabetes).

About obesityObesity is biologic-based abiding ache acute abiding management.1 Blubber is afflicted by genetic, physiological, ecology and cerebral factors and is associated with abounding austere bloom consequences.7,8

The all-around access in the prevalence of blubber is a accessible bloom affair that has astringent amount implications to bloom affliction systems.9,10 In the United States, 38% of adults, or added than 95 actor adults, alive with obesity.5 Despite the aerial prevalence of obesity, abounding bodies with blubber abridgement abutment in their efforts to lose weight and the ache charcoal essentially underdiagnosed and underreported.11

About Novo NordiskNovo Nordisk is a all-around healthcare aggregation that’s been authoritative avant-garde medicines to advice bodies with diabetes advance longer, convalescent lives for 95 years. This ancestry has accustomed us acquaintance and capabilities that additionally accredit us to advice bodies defeat added austere diseases including obesity, hemophilia and advance disorders. We abide abiding in our confidence that the blueprint for abiding success is to break focused, anticipate abiding and do business in a financially, socially and environmentally amenable way. With U.S. address in New Jersey and assembly and analysis accessories in four states, Novo Nordisk employs about 5,000 bodies throughout the country. For added information, appointment novonordisk.us, Facebook and Twitter.

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100Orig10s10 – victoza fda label | victoza fda label


1 American Medical Association House of Delegates. Recognition of blubber as a disease. Resolution 420 (A 13). http://www.npr.org/documents/2013/jun/ama-resolution-obesity.pdf Received May 15, 2013. Accessed October 16, 2018.

2 Bray GA, Kim KK, Wilding JPH. Obesity: a abiding relapsing accelerating ache process. A position account of the World Blubber Federation. Blubber Reviews. May 2017.

3 Mechanick JI, Garber AJ, Handelsman Y, Garvey WT, American Association of Analytic Endocrinologists’ position account on blubber and blubber medicine, Endocr Pract, 2012;18(5):642-648.

4 McKinney L. Diagnosis and Administration of Obesity. American Academy of Ancestors Physicians (AAFP). https://www.aafp.org/dam/AAFP/documents/patient_care/fitness/obesity-diagnosis-mono.pdf

100Orig10s10 - victoza fda label
100Orig10s10 – victoza fda label | victoza fda label

5 Blubber and overweight. Centers for Ache Control and Prevention website. https://www.cdc.gov/nchs/fastats/obesity-overweight.htm. Updated June 13, 2016. Accessed October 16, 2018.

6 Bays HE, Seger JC, Primack C, et al. Blubber algorithm 2016-2017. Presented by the Blubber Anesthetic Association. https://obesitymedicine.org/obesity-algorithm. Accessed October 16, 2018.

7 Wright SM, Aronne LJ. Causes of obesity. Abdom Imaging. 2012;37(5):730-732.

8 Guh DP, Zhang W, Bansback N, et al. The accident of co-morbidities accompanying to blubber and overweight: a analytical analysis and meta-analysis. BMC Accessible Health. 2009;9(88):1-20.

9 World Bloom Organization. Fact area no. 311: blubber and overweight. http://www.who.int/mediacentre/factsheets/fs311/en/. Updated June 2016. Accessed October 16, 2018.

100Orig10s10 - victoza fda label
100Orig10s10 – victoza fda label | victoza fda label

10 Cawley J, Meyerhoefer C. The medical affliction costs of obesity: an active variables approach. J Bloom Economics. 2012;31(1):219-230.

11 Crawford AG, Cote C, Couto J, et al. Prevalence of Obesity, Blazon II Diabetes Mellitus, Hyperlipidemia, and Hypertension in the United States: Findings from the GE Centricity Electronic Medical Record Database. Popul Bloom Manag. 2010;13:151–161.

Novo Nordisk is registered brand of Novo Nordisk A/S.© 2018 Novo Nordisk   All rights reserved.   US18SX00344   October 2018

SOURCE Novo Nordisk

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Reference ID: 10 – victoza fda label | victoza fda label