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Important Safety Information | Patient Site
Prescribing Information
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 * Obesity is a Disease
   * Do You Know the Impact of Obesity?
   * What Causes Obesity?
   * Are You Diagnosing Obesity?
   * Understand your role
 * About Saxenda®
   * How Saxenda® Works
   * Adolescent Indication
 * Efficacy & Safety
   * Significant Weight Loss
   * Sustained Weight Loss
   * Additional Weight Loss
   * Secondary Efficacy End Points
   * Gastrointestinal Side Effects
   * Adverse Events
   * Liraglutide 1.8 mg CV Safety Data
 * Dosing & Administration
   * Saxenda® Dosing
   * Prescribing Saxenda®
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   * Saxenda® Together (for adolescents)
   * Family Weight Management
   * For Pharmacists
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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.

Prescribing Information
Important Safety Information | Patient Site




WEIGHT MANAGEMENT FOR THE NEXT GENERATION

It's not just a phase.

Up to 90% of adolescents with obesity will continue to have obesity in
adulthood.1,2






SAXENDA® IS APPROVED FOR ADOLESCENTS AGED 12 TO 17 WITH OBESITY3

You can help them now with Saxenda®, the first and only GLP-1 receptor agonist
to help weight management in adolescents, used along with a reduced-calorie diet
and increased physical activity.3* And knowing what to look for can help you
connect adolescents with treatment sooner.

*Based on a 56-week adolescent trial.

See virtual detail below
Patient Profile Efficacy Safety & Dosing

Patient Profile


Goal:
Wants to get to a healthier weight before starting high school and trying out
for the football team in the fall

History:
Enjoys playing sports and has a family history of obesity

Previous weight-loss attempts:
Lost weight last summer after starting football camp and limiting junk food, but
gained it back steadily once the school year started


Efficacy


PRIMARY END POINT



The observed mean change in BMI SDS from baseline was

-0.23 with Saxenda® (baseline = 3.14) and -0.00 with placebo (baseline = 3.2)3,4

(ETD: -0.22; 95% CI: -0.37, -0.08; p=0.0022)3,4

SUPPORTIVE SECONDARY END POINT



Compared with those using healthy nutrition and physical activity counseling
alone (baseline = 102.2 kg), adolescents saw reductions in body weight with
Saxenda® (baseline = 99.3 kg).3

BMI SDS, body mass index standard deviation score.

ETD, estimated treatment difference.



SUPPORTIVE SECONDARY END POINT



Estimated mean relative change in body weight (%) from baseline3,4

Baseline = 99.3 kg for Saxenda® and 102.2 kg for placebo




STUDY DESIGN

The effect of Saxenda® in adolescent patients was compared with placebo in a
56-week, randomized, double-blind, parallel-group study of 251 pubertal patients
aged 12 to 17 years with a BMI corresponding to ≥30 kg/m2 for adults by
international cut-off points and BMI of ≥95th percentile for age and sex. Both
groups received lifestyle therapy, consisting of healthy nutrition and physical
activity counseling for weight loss.3,4

After a 12-week lifestyle run-in period, patients were randomized 1:1 to
Saxenda® once daily or placebo once daily. The Saxenda® dose was titrated to 3
mg over a 4- to 8-week period based on tolerability.3 The primary end point was
change in BMI SDS. Select supportive secondary end points included change in
body weight.3,4

Saxenda® demonstrated statistically significant reduction in BMI SDS3,4

 * BMI SDS, also known as z-score, tells you the number of standard deviations
   an adolescent is from the population mean BMI matched for age and gender4,5
 * Due to growth during childhood and adolescence, BMI values alone cannot be
   used to assess efficacy5,6
 * BMI SDS reductions of at least 0.20 are considered clinically meaningful5

Safety & Dosing



AN ESTABLISHED SAFETY AND TOLERABILITY PROFILE

*Defined as blood glucose <70 mg/dL with symptoms of hypoglycemia. Pediatric
patients did not have type 2 diabetes mellitus.

 * 8% of patients taking Saxenda® vs 0% taking placebo discontinued treatment as
   a result of gastrointestinal adverse events3
 * Gastrointestinal adverse events occurred primarily during the dose-escalation
   period and diminished over time4
 * 1 death due to suicide in a patient treated with Saxenda® occurred in the
   trial3
 * 1 patient (0.8%) treated with Saxenda® experienced pancreatitis3
 * More episodes of hypoglycemia occurred in patients taking Saxenda® (1.6%) vs
   placebo (0.8%)3
 * Mean increases in resting heart rate of 3 to 7 bpm from baseline were
   observed with patients taking Saxenda®3

In addition to the clinical trial in adolescents, Saxenda® has been evaluated
for safety in 5 clinical trials with 3,384 adults.3


TITRATION TO HELP WITH TOLERABILITY

PATIENTS SHOULD FOLLOW A 4-WEEK DOSAGE ESCALATION TO REACH THE CLINICALLY
EFFICACIOUS 3 MG DOSAGE.

Patients who do not tolerate 3 mg daily may have their maintenance dose reduced
to 2.4 mg daily. Discontinue Saxenda® if the patient cannot tolerate the 2.4 mg
dose. If patients cannot tolerate an increased dosage during dosage escalation,
consider lowering the dosage to the previous level. Dosage escalation could take
up to 8 weeks.3

Evaluate the change in BMI after 12 weeks on the maintenance dose and
discontinue Saxenda® if the patient has not had a reduction in BMI of at least
1% from baseline, since it is unlikely that the patient will achieve and sustain
clinically meaningful weight loss with continued treatment.3


VIRTUAL PRESENTATION

AN OBESITY MANAGEMENT EXPERT WILL SHOW YOU WHY NOVO NORDISK IS SO EXCITED TO
INTRODUCE SAXENDA® FOR WEIGHT MANAGEMENT IN ADOLESCENTS WITH OBESITY.

Actor Portrayal
(17:05)

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Full Prescribing Information
Important Safety Information

Read more about the Saxenda® dosing schedule

Find out more >

Get additional support for your adolescent patients with Saxenda® Together

Learn more >

Weight management can involve the whole family

Discover how >

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Saxenda® Adolescents with Obesity Brochure
Efficacy, safety and dosing information for Saxenda®, a treatment option for
adolescents with obesity.
Download
Prescribing Information | Important Safety Information


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.


CONTRAINDICATIONS

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®.
 * 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
   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.


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.




REFERENCES

1. Lifshitz F. Obesity in children. J Clin Res Ped Endo. 2008;1(2):53-60.

2. Gordon-Larsen P, The NS, Adair LS. Longitudinal trends in obesity in the
United States from adolescence to the third decade of life. Obesity.
2010;18(9):1801-1804.

3. Saxenda [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2020.

4. Kelly AS, Auerbach P, Barrientos-Perez M, et al. A randomized, controlled
trial of liraglutide for adolescents with obesity. N Engl J Med.
2020;382:2117-2128.


5. Screening for obesity in children and adolescents: US Preventative Services
Task Force Recommendation Statement. US Preventative Services Task Force. JAMA.
2017;317(23):2417-2426.

6. European Medicines Agency. Guideline on clinical evaluation of medicinal
products used in weight control: addendum on weight control in children.
https://www.ema.europa.eu/en/clinical-evaluation-medicinal-products-used-weight-control.
Published August 7, 2016. Accessed July 9, 2020.

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Obesity
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      Utilizing Your EHR

 * Patient Support
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    * Product Education Library
   
   Disease Education
    * Disease Education Library
   
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    * Weight-Loss Support

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