A comprehensive weight-management support program for adult patients taking Saxenda®
Saxenda® (liraglutide) injection 3 mg For chronic weight management as an adjunct to a reduced calorie diet and increased physical activity in adults with a BMI ≥30 kg/m2, or ≥27 kg/m2 with one or more weight-related comorbidities, and for patients aged 12-17 years with body weight above 60 kg (132 lbs) and an initial BMI corresponding to ≥30 kg/m2 for adults by international cut-offs. Click for Limitations of Use.
SaxendaCare® helps to empower your patients
Enrolled patients learn scientifically proven weight-loss and maintenance strategies through personalized coaching, helpful emails, phone support and more.
Patients can call 1-877-304-6894 anytime with questions about Saxenda®
Saxenda® Welcome Kit
Getting your patients off to a good start begins with a Saxenda® Welcome Kit. They’ll receive a Welcome Letter and portion plate, plus a Health and Wellness guide—all mailed right to their home.
Health and Wellness guide
SaxendaCare® coaching options
Newly enrolled SaxendaCare® members can choose to receive support, either through Noom, a weight-loss application and personalized meal-planning service, or through live phone calls with SaxendaCare® coaches.
App-based support, powered by Noom
Full access to Noom’s interactive content, recipes and tracking tools for calories, exercise and more
Personalized plan tailored to fit individual lifestyles
Virtual 1:1 and group support
Dynamic support system through in-app messaging, designed to keep patients motivated
Live phone calls with SaxendaCare® coaches
SaxendaCare® coaches are registered dietitians, certified in weight management
Enrolled patients can call their coaches for help with SaxendaCare® and goal setting
Coaches help patients with accountability and questions they may have along the way
Comprehensive skill-building curriculum
Emails guide patients through a skill-building curriculum that can help lead to positive behavior change.
Weekly email topics include:
Reminders about dosing and refills
Focusing on short-term goals
Celebrating the small steps
Weekly email topics include:
Making small changes
Setting goals and expectations
Finding creative ways to stay on track
Rewards for progress made
Weekly email topics include:
Understanding negative self-talk
Introducing the plate method
Building a healthy, balanced meal, including controlling portions and cutting calories
Fiber, fresh fruit and vegetables, and choosing foods with good fats
Weekly email topics include:
Different kinds of physical activity
Aerobic exercise, resistance training and flexibility training
Fitting activity into each day
Scheduling time for being active and having a support system
Patients enrolled in award-winning SaxendaCare® are more adherent to therapy than those who are not enrolled.1,a
Important Safety Information for Saxenda® (liraglutide) injection 3 mg
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 (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.
Saxenda® is contraindicated in:
Patients with a personal or family history of MTC or patients with MEN 2.
Patients with a prior serious hypersensitivity reaction to liraglutide or to any of the excipients in Saxenda®.
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 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.
Hypoglycemia: Adult patients with type 2 diabetes on an insulin secretagogue (eg, a sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia with use of Saxenda®. The risk may be lowered by a reduction in the dose of insulin secretagogues or insulin. In pediatric patients without type 2 diabetes, hypoglycemia occurred. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms.
Heart Rate Increase: Mean increases in resting heart rate of 2 to 3 beats per minute (bpm) were observed in patients treated with Saxenda®. Monitor heart rate at regular intervals and inform patients to report palpitations or feelings of a racing heartbeat while at rest during treatment with Saxenda®. Discontinue Saxenda® in patients who experience a sustained increase in resting heart rate.
Renal Impairment: Acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis, have been reported, usually in association with nausea, vomiting, diarrhea, or dehydration. 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 in patients treated with liraglutide. If a hypersensitivity reaction occurs, patients should stop taking Saxenda® and promptly seek medical advice.
Suicidal Behavior and Ideation: In adult clinical trials, 9 (0.3%) of 3,384 patients treated with Saxenda® and 2 (0.1%) of the 1,941 treated with placebo reported suicidal ideation; one of the Saxenda® treated patients attempted suicide. In a pediatric trial, 1(0.8%) of the 125 Saxenda® treated patients died by suicide. There was insufficient information to establish a causal relationship to Saxenda®. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue treatment if patients experience suicidal thoughts or behaviors. Avoid Saxenda® in patients with a history of suicidal attempts or active suicidal ideation.
The most common adverse reactions, reported in ≥5% are nausea, diarrhea, constipation, vomiting, injection site reactions, headache, hypoglycemia, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase, upper abdominal pain, pyrexia, and gastroenteritis.
Saxenda® causes a delay of gastric emptying and 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.
Saxenda® has not been studied in patients less than 12 years of age.
Saxenda® slows gastric emptying. Saxenda® has not been studied in patients with preexisting gastroparesis.
Please click here for Saxenda® Prescribing Information, including Boxed Warning.