For chronic weight management in adult patients with a BMI >30 kg/m2, or >27 kg/m2 with one or more weight-related comorbidities, as an adjunct to a reduced-calorie diet and increased physical activity. Click for Limitations of Use.

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Experience the Science of Saxenda®

The Story Starts Here—Food Intake and Endogenous GLP-1 (7-37)

The incretin hormone GLP-1 and its receptors are present throughout the body—in the gut, heart, kidneys, muscles, lungs, pituitary gland, vascular endothelium, and peripheral and central nervous systems.1,2

GLP-1 has been shown to help regulate appetite via signals from the brain.2
When nutrients are ingested, GLP-1 is released into the circulation by enteroendocrine L-cells in the small intestine and colon.1-3
During this process, GLP-1 also activates regions in the brain (such as the hypothalamus) involved in appetite regulation.2,4,5
However, once released, natural GLP-1 is rapidly inactivated by the enzymes dipeptidyl peptidase-4 (DPP-4) and neutral endopeptidase (NEP), resulting in a half-life of less than 2 minutes.6
Weight loss may lead to a decrease in GLP-1 secretion. This decrease in GLP-1 levels makes it more difficult for patients to maintain weight loss, creating a physiological basis for weight regain.7

Saxenda®—an analog of native GLP-1 (7-37)

Saxenda® is an analog of endogenous GLP-1, produced through recombinant DNA technology, with 97% amino acid sequence homology to the native hormone.1,6
But, unlike endogenous GLP-1, Saxenda® provides stability against metabolic degradation by the enzymes DPP-4 and NEP.6
Its design, with the addition of a C-16 fatty acid chain and the substitution of arginine for lysine, prolongs absorption of Saxenda® and leads to a 13-hour half-life.6

A Mechanism of Action—in action

Saxenda® binds to and activates the GLP-1 receptor in areas of the brain involved in appetite regulation,a such as the hypothalamus.1,2,6
The use of Saxenda® in patients with obesity helps to control appetite, leading to weight loss through decreased caloric intake.1
aShown in animal models.

Delivered to Ensure Bioavailability

Because of its structural formula as a peptide, Saxenda® is delivered subcutaneously and avoids first-pass metabolism associated with oral medications.8
Saxenda® is slowly absorbed from the subcutis, resulting in a long half-life of 13 hours and allowing for once-daily administration.6

Give patients a shot at weight loss

 

Selected Important Safety Information

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®.

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 (obesity) 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)

Limitations of Use

  • Saxenda® is not indicated for the treatment of type 2 diabetes
  • 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
  • Saxenda® has not been studied in patients taking insulin. Saxenda® and insulin should not be used together
  • The effects of Saxenda® on cardiovascular morbidity and mortality have not been established
  • The safety and efficacy of Saxenda® in combination with other products for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established
  • Saxenda® has not been studied in patients with a history of pancreatitis

Important Safety Information (cont'd)

Contraindications

Saxenda® is contraindicated in the following conditions:

  • Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

  • Patients with a prior serious hypersensitivity reaction to liraglutide or to any of the product components

  • 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: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with liraglutide. After initiation of Saxenda® observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Saxenda® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Saxenda® should not be restarted
  • 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
  • Risk of Hypoglycemia with Concomitant Use of Anti-Diabetic Therapy: When Saxenda® is used with an insulin secretagogue (eg, a sulfonylurea) serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue to reduce the risk of hypoglycemia. Monitor blood glucose parameters prior to starting Saxenda® and during Saxenda® treatment in patients with type 2 diabetes mellitus
  • Heart Rate Increase: Mean increases in resting heart rate of 2 to 3 beats per minute (bpm) were observed with routine clinical monitoring in patients treated with Saxenda® compared to placebo in clinical trials. Heart rate should be monitored at regular intervals consistent with usual clinical practice. Patients should inform healthcare providers of palpitations or feelings of a racing heartbeat while at rest during Saxenda® treatment. For patients who experience a sustained increase in resting heart rate while taking Saxenda®, Saxenda® should be discontinued
  • Renal Impairment: In patients treated with GLP-1 receptor agonists, including Saxenda®, there have been reports of acute renal failure and worsening of chronic renal failure, usually in association with nausea, vomiting, diarrhea, or dehydration, which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Saxenda® in patients with renal impairment
  • Hypersensitivity Reactions: Serious hypersensitivity reactions (eg, anaphylaxis and angioedema) have been reported during postmarketing use of liraglutide. If symptoms of hypersensitivity reactions occur, patients must stop taking Saxenda® and promptly seek medical advice
  • Suicidal Behavior and Ideation: In the Saxenda® clinical trials, 6 (0.2%) of 3,384 patients treated with Saxenda® and none of the 1,941 with placebo reported suicidal ideation; one of the patients treated with Saxenda® attempted suicide. Patients treated with Saxenda® should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue Saxenda® in patients who experience suicidal thoughts or behaviors. Avoid Saxenda® in patients with a history of suicidal attempts or active suicidal ideation

Adverse Events

  • The most common adverse reactions, reported in ≥5% are: nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase

Drug Interactions

  • Oral Medications: Saxenda® causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. Monitor for potential consequences of delayed absorption of oral medications concomitantly administered with Saxenda®

Use in Specific Populations

  • Nursing mothers should either discontinue Saxenda® or discontinue nursing
  • Safety and effectiveness of Saxenda® have not been established in pediatric patients. Saxenda® is not recommended for use in pediatric patients
  • Saxenda® slows gastric emptying. Saxenda® has not been studied in patients with preexisting gastroparesis

Please click here for Prescribing Information.

References

  1. van Bloemendaal L, ten Kulve JS, la Fleur SE, Ijzerman RG, Diamant M. Effects of glucagon-like peptide 1 on appetite and body weight: focus on the CNS. J Endocrinol. 2014;221(1):T1-T16.
  2. Madsbad S. The role of glucagon-like peptide-1 impairment in obesity and potential therapeutic implications. Diabetes Obes Metab. 2014;16(1):9-21.
  3. De Silva A, Bloom SR. Gut hormones and appetite control: a focus on PYY and GLP-1 as therapeutic targets in obesity. Gut Liver. 2012;6(1):10-20.
  4. Pannacciulli N, Le DS, Salbe AD, et al. Postprandial glucagon-like peptide-1 (GLP-1) response is positively associated with changes in neuronal activity of brain areas implicated in satiety and food intake regulation in humans. Neuroimage. 2007;35(2):511-517.
  5. Baggio LL, Drucker DJ. Biology of incretins: GLP-1 and GIP. Gastroenterology. 2007;132:2131-2157.
  6. Saxenda® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2016.
  7. Sumithran P, Prendergast LA, Delbridge E, et al. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011;365(17):1597-1604.
  8. Bruno BJ, Miller GD, Lim CS. Basics and recent advances in peptide and protein drug delivery. Ther Deliv. 2013;4(11):1443–1467.