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.

Get answers to frequently asked questions

Get Answers to Frequently Asked Questions

Find answers to frequently asked questions about Saxenda®, including information about storage, dosing and administration, side effects, and potential drug interactions.

What is Saxenda®?

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) of1:

  • ≥30 kg/m2 (obese) or
  • ≥27 kg/m2 (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.

How does Saxenda® work?

Saxenda® lowers body weight through decreased calorie intake. Saxenda® does not increase 24-hour energy expenditure.1

Saxenda® is an acylated human GLP-1 receptor agonist with 97% amino acid sequence homology to endogenous human GLP-1 (7-37).1

GLP-1 is a physiological regulator of appetite and calorie intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation. In animal studies, peripheral administration of liraglutide resulted in the presence of liraglutide in specific brain regions regulating appetite, including the hypothalamus. Although liraglutide activated neurons in brain regions known to regulate appetite, specific brain regions mediating the effects of liraglutide on appetite were not identified in rats.1

How is Saxenda® supplied?

Saxenda® is supplied in a prefilled pen. Each prescription is a box of 3 or 5 prefilled multidose pens, each containing 18 mg/3 mL of liraglutide that can deliver the 0.6-, 1.2-, 1.8-, 2.4-, and 3-mg doses. [NDC #0169-2800-13; NDC #0169-2800-15]1

How is Saxenda® administered?

Saxenda® is subcutaneously injected in the abdomen, thigh, or upper arm using a prefilled, multidose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Saxenda® can be taken once daily at any time, independent of meals.1

Needles are sold separately and may require a prescription in some states.

Refer to the Instructions for Use for full details on administration.

What is the dose-escalation schedule?

Patients should follow a progressive 4-week dose-escalation schedule, which is designed to help minimize the likelihood of gastrointestinal symptoms. The starting dosage is 0.6 mg per day for 1 week. Patients should increase the dose each week until the full maintenance dose of 3 mg is reached, as prescribed by their health care professional.1 Refer patients to the Patient Sample Kit, if they received one, or to their prescribing health care professional for additional information on dosing. Patients who start with a sample pen will need a prescription to complete dose escalation.

What are the most common side effects patients have experienced?

The most common adverse reactions reported in ≥5% of patients were: nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase.1

Are there any drug-drug interactions?

Saxenda® causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials, liraglutide did not affect the absorption of the tested orally administered medications to any clinically relevant degree. Nonetheless, monitor for potential consequences of delayed absorption of oral medications concomitantly administered with Saxenda®.1

Can Saxenda® be co-administered with another GLP-1 receptor agonist?

Patients currently taking a GLP-1 receptor agonist should ask their health care professional if Saxenda® is right for them. Saxenda® is the only GLP-1 receptor agonist approved for chronic weight management.

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.1

Can Saxenda® be used with other weight-loss products?

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® causes a delay of gastric emptying, which may impact the absorption of other oral medications.

Can Saxenda® be co-administered with type 2 diabetes agents?

The risk for serious hypoglycemia is increased when Saxenda® is used in combination with insulin secretagogues (for example, sulfonylureas) in patients with type 2 diabetes mellitus. Therefore, patients may require a lower dose of sulfonylurea (or other concomitantly administered insulin secretagogues) in this setting. Saxenda® should not be used in patients taking insulin.1

Saxenda® can lower blood glucose. Monitor blood glucose parameters prior to starting Saxenda® and during Saxenda® treatment in patients with type 2 diabetes. Please check with the prescribing health care professional regarding adjustments in co-administered antidiabetic drugs based on glucose monitoring results and risk of hypoglycemia. Saxenda® is not indicated for the treatment of type 2 diabetes.1

How is Saxenda® stored?

Store new, unused Saxenda® pens in the refrigerator at 36°F to 46°F (2°C to 8°C). After first use, store pens at 59°F to 86°F (15°C to 30°C) or in a refrigerator at 36°F to 46°F (2°C to 8°C). Pens should be thrown away after 30 days, even if they still have Saxenda® left in them. Don’t freeze Saxenda®. Saxenda® that has been frozen should not be used. Each Saxenda® pen is for use by a single patient. Never share a Saxenda® pen between patients, even if the needle has been changed.1

What kind of needles should be used?

The Saxenda® pen should be used with Novo Nordisk disposable needles. Needles are sold separately and may require a prescription in some states. Novo Nordisk cannot guarantee that needles from other manufacturers will fit the pen because Novo Nordisk has only studied Novo Nordisk needles with the pen. NovoFine® 32G Tip needles can be prescribed with Saxenda® through your EHR system. If you have additional questions about Saxenda®, please call 1-800-727-6500.


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.

Reference

  1. Saxenda® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2016.