Frequently Asked Questions

Get the answers you need to help set patients up for weight-loss success

As you consider prescribing Saxenda ® for your patients, you may have some questions. Below you will find answers that will help you treat effectively and communicate pertinent information to your patients and staff. You can also call 1-844-845-6913 anytime with questions about Saxenda ® .

ABOUT SAXENDA ®

What is Saxenda ® ?

• Adult patients with an initial body mass index (BMI) of 30 kg/m 2 or greater (obese) or 27 kg/m 2 or greater (overweight) in the presence of at least 1 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 lb) and initial BMI corresponding to 30 kg/m 2 or greater for adults (obese) by international cut-offs

What is the mechanism of action of Saxenda ® ?

GLP-1 is a native hormone that is released in response to food intake and acts as a physiological regulator of appetite. 1,2 97% similar to native GLP-1, Saxenda ® works in the brain a to increase feelings of satiety and decrease hunger and thereby reduce food intake, leading to weight loss. 1,3

a Shown in animal models.

What are the common side effects?

The most common side effects, reported in ≥5% are: nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase. 1

Nausea is the most common side effect when first starting Saxenda ® , but tends to decrease over time as your patient’s body gets used to treatment. 1

Follow the dosing schedule to help reduce the likelihood of gastrointestinal symptoms. 1

How do I prescribe Saxenda ® ?

Once you’ve verified that your patient is covered and the prior authorization (PA) is approved, you can prescribe Saxenda ® through your electronic health record (EHR) system. In some states, a separate prescription may be required for the NovoFine ® 32G Tip needles.

When you prescribe, you can also provide your patient with a Saxenda ® Sample Kit to help them get started right away.

TAKING SAXENDA ®

What is the Saxenda ® adult dosing schedule?

• Patients should follow a 4-week dose escalation in order to reach the clinically efficacious 3 mg dose, which reduces the likelihood of gastrointestinal symptoms 1
• The Saxenda ® starting dose is 0.6 mg per day for 1 week 1
• Patients increase the dose by 0.6 mg each week until the full maintenance dose of 3 mg is reached 1

What tips can I provide to patients to help manage nausea?

Nausea is the most common side effect when first starting Saxenda ® , but decreases over time for most people as their body gets used to treatment. 1 If a patient experiences nausea, you may consider advising them to 4 :

• Eat bland, low-fat foods, like crackers, toast, and rice
• Eat foods that contain water, like soups and gelatin
• Avoid lying down after they eat
• Go outdoors for fresh air

Remember to reinforce adherence to the dosing schedule, which is designed to reduce the likelihood of gastrointestinal symptoms. 1

What if my adult patients cannot tolerate an increased dosage?

If adult patients cannot tolerate an increased dose during dose escalation, consider delaying escalation for approximately 1 week. If a patient cannot tolerate the 3 mg dose, discontinue treatment. 1

How should Saxenda ® be stored?

Instruct patients to store new, unused Saxenda ® pens in the refrigerator between 36 °F and 46 °F (2 °C to 8 °C). Once a patient is actively using the pen, it can be stored at room temperature (59 °F to 86 °F; 15 °C to 30 °C) or in a refrigerator for 30 days. 1

Refer patients to the full Prescribing Information for more details regarding injection and pen storage.

How do patients inject Saxenda ® ?

Consider administering the first injection of Saxenda ® in office to demonstrate the correct injection technique.

Patients will inject their dose of Saxenda ® under the skin in the stomach area (abdomen), upper leg (thigh), or upper arm daily. Indicate each of the 3 appropriate injection areas when prescribing Saxenda ® and ensure that patients understand that they should never inject into a vein or muscle. 1

Refer patients to the Instructions for Use in the full Prescribing Information for full usage instructions.

Is there a guide to help me and my staff learn the injection technique?

Our step-by-step video will guide you through the Saxenda ® injection technique.

Refer patients to the Instructions for Use in the Prescribing Information for more information regarding proper injection, storage, and handling techniques.

PATIENT SUPPORT & SAVINGS

How do I ensure treatment coverage for my patients?

Novo Nordisk has developed a 3-step process to help identify patients with Saxenda ® coverage and help those without coverage gain access. See the steps here.

How often should I follow up with my adult patients?

Consider scheduling the first follow-up visit with your patient between 2 and 8 weeks to evaluate initial progress and monitor for side effects. Remain an active part of their treatment journey by following up regularly and encouraging them to reach out to you or your staff with any questions along the way. Remember to follow up with patients at 16 weeks to evaluate change in body weight, especially if a PA reauthorization is necessary to ensure treatment coverage. If a patient has not lost at least 4% of baseline body weight, it is unlikely they will achieve and sustain clinically meaningful weight loss with continued treatment. In this case, Saxenda ® should be discontinued. Looking for help with implementing a follow-up protocol for Saxenda ® ? Review the Follow-up Guide here.

Does Novo Nordisk offer a support program for adult Saxenda ® patients?

Yes! The Saxenda ® Hotline is free on-demand phone support to help your patients get started with Saxenda ® , the hotline does not provide medical advice and is intended to complement, not replace, your care. While your patients will learn about Saxenda ® from you, phone support may help reinforce the information you provide. Encourage your patients to call the Saxenda ® hotline 1-844-845-6913 to get additional support.

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

• Adult patients with an initial body mass index (BMI) of 30 kg/m 2 or greater (obese) or 27 kg/m 2 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/m 2 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.

Contraindications

Saxenda ® is contraindicated in:

• Patients with a personal or family history of MTC or patients with MEN 2
• Patients with a serious hypersensitivity reaction to liraglutide or to any of the excipients in Saxenda ® . Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with Saxenda ®
• 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: 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 Saxenda ® . 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

Adverse Reactions

• 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

Drug Interactions

• 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.