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.

Safety and Tolerability Evaluated in 5 Clinical Studies

Adverse reactions, in studies up to 56 weeks, reported in ≥2% of patients treated with Saxenda® and more frequently than with placebo

aDocumented symptomatic (defined as documented symptoms of hypoglycemia in combination with a plasma glucose ≤70 mg/dL) in patients with type 2 diabetes (Study 2).

See study designs below.

Established Long-Term Safety: In a 3-year study, the safety profile of Saxenda® was consistent with previous 56-week studies(1)

Study 1 (1-year)2

  • Results from a 56-week, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Saxenda®
  • Patients with a BMI ≥30, or ≥27 with 1 or more weight-related comorbidities (N=3,731) were randomized to receive once-daily Saxenda® (n=2,487) or placebo (n=1,244) in conjunction with a lifestyle modification program that included increased physical activity and a 500-kcal/day-deficit diet
  • Patients underwent a 4-week dose-escalation period followed by 52 weeks on the full dose
  • The primary end points were mean percent weight change, percentage of patients achieving ≥5% of baseline weight loss, and percentage of patients achieving >10% of baseline weight loss at 56 weeks
  • Secondary end points included changes in waist circumference, blood pressure, and lipids3
  • Mean baseline body weight was 233.9 lb and mean BMI was 38.3 kg/m2
  • Patients with type 2 diabetes were excluded from participating

Study 1 (3-year)2

  • Results from a 160-week randomized, double-blind, placebo-controlled study to evaluate the long-term safety and efficacy of Saxenda®
  • Patients with pre-diabetes and with a BMI of either ≥30, or ≥27 with at least 1 additional comorbidity, were randomized to receive once-daily Saxenda® (n=1,505) or placebo (n=749) in conjunction with a lifestyle modification program that included increased physical activity and a 500-kcal/day-deficit diet
  • Patients underwent a 4-week dose escalation period followed by 156 weeks on the full dose, with a 12-week off-drug observational follow-up period1
  • The study evaluated percentage of patients achieving weight loss of at least 5% of body weight at both 1 year and 3 years
  • Mean baseline body weight was 233.9 lb and mean BMI was 38.3 kg/m2

Study 22

  • Results from a 56-week, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Saxenda®
  • Patients with type 2 diabetes with a BMI ≥27 (N=635) were randomized to receive once-daily Saxenda® (n=423) or placebo (n=212), in conjunction with a lifestyle modification program that included increased physical activity and a 500-kcal/day-deficit diet
  • Patients were randomized, then underwent a 4-week dose-escalation period followed by 52 weeks on the full dose
  • The primary end points were mean percent weight change, percentage of patients achieving ≥5% of baseline weight loss, and percentage of patients achieving >10% of baseline weight loss at 56 weeks
  • Mean baseline body weight was 233.0 lb and mean BMI was 37.1 kg/m2
  • Patients were to have an A1C of 7% to 10% and be treated with metformin, a sulfonylurea, or a glitazone as a single agent or in any combination, or with diet and exercise alone

Study 32

  • Results from a 56-week, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Saxenda®
  • Patients with a BMI ≥30, or ≥27 with 1 or more weight-related comorbidities (N=422) were randomized to receive once-daily Saxenda® (n=212) or placebo (n=210) in conjunction with a lifestyle modification program that included increased physical activity and a 500-kcal/day-deficit diet 
  • Patients were first treated with a low-calorie diet (total energy intake: 1,200-1,400 kcal/day) and with increased physical activity in the run-in period lasting up to 12 weeks. Patients who lost at least 5% of screening body weight during the run-in period were randomized, then underwent a 4-week dose-escalation period followed by 52 weeks on the full dose4
  • The primary end points were mean percent weight change from randomization to week 56, percentage of patients not gaining more than 0.5% body weight from randomization to week 56, and percentage of patients achieving ≥5% weight loss from randomization to week 56
  • Mean baseline body weight was 219.1 lb and mean BMI was 35.6 kg/m
  • Patients with type 2 diabetes were excluded from participating

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:

  • Patients with a personal or family history of MTC or 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 a hypersensitivity reaction occurs, patients should stop taking Saxenda® and promptly seek medical advice
  • Suicidal Behavior and Ideation: In the Saxenda® clinical trials, 9 (0.3%) of 3,384 patients treated with Saxenda® and 2 (0.1%) 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

  • There are no data on the presence of liraglutide in human breast milk; liraglutide was present in the milk of lactating rats
  • 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. le Roux CW, Astrup A, Fujioka K, et al; for the SCALE Obesity and Prediabetes NN8022-1839 Study Group. 3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial [published online February 22, 2017]. Lancet. doi:10.1016/S0140-6736(17)30069-7.
  2. Saxenda® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2017.
  3. Data on file. Novo Nordisk Inc; Plainsboro, NJ.
  4. Wadden TA, Hollander P, Klein S, et al; on behalf of NN8022-1923 Investigators. Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: the SCALE Maintenance randomized study. Int J Obes (Lond). 2013;37(11):1443-1451 and supplementary information. www.nature.com/ijo/journal/v37/n11/extref/ijo2013120x1.doc.