HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the informationneeded to use SAXENDA® safely and effectively. See fullprescribing information for SAXENDA®.
SAXENDA® (liraglutide) injection, for subcutaneous use
Initial U.S. Approval: 2010
WARNING: RISK OF THYROID C-CELL TUMORS
See full prescribing information for complete
boxed warning.
• Liraglutide causes thyroid C-cell tumors atclinically relevant exposures in both genders ofrats and mice. It is unknown whether SAXENDA®
causes thyroid C-cell tumors, including medullary
thyroid carcinoma (MTC), in humans, as the humanrelevance of liraglutide-induced rodent thyroid
C-cell tumors has not been determined (5.1).
• SAXENDA® is contraindicated in patients with apersonal or family history of MTC or in patientswith Multiple Endocrine Neoplasia syndrome type2 (MEN 2). Counsel patients regarding the potential
risk of MTC and the symptoms of thyroid tumors (4,5.1, 13.1).
——— RECENT MAJOR CHANGES ———Dosage and Administration (2.2)....................................06/2022
Contraindications (4).......................................................06/2022——— INDICATIONS AND USAGE ———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) 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 (e.g. hypertension, type 2
diabetes mellitus, or dyslipidemia) (1).
Pediatric patients aged 12 years and older with:• body weight above 60 kg and• an initial BMI corresponding to 30 kg/m2 for adults (obese) byinternational cut-offs (1).

FULL PRESCRIBING INFORMATION: CONTENTS*
BOXED WARNING: RISK OF THYROID C−CELL TUMORS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1
Patient Selection
2.2
Important Administration Instructions
2.3	Dosage in Adults and Pediatric Patients Aged 12 Years
and Older
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1
Risk of Thyroid C-cell Tumors
5.2
Acute Pancreatitis
5.3
Acute Gallbladder Disease
5.4	Hypoglycemia
5.5Heart Rate Increase
5.6
Renal Impairment
5.7
Hypersensitivity Reactions
5.8
Suicidal Behavior and Ideation
6 ADVERSE REACTIONS
6.1
Clinical Trials Experience
6.2
Post-Marketing Experience

Limitations of Use:
• SAXENDA® contains liraglutide and should not becoadministered with other liraglutide-containing products orwith any other GLP-1 receptor agonist(1).
• The safety and effectiveness of SAXENDA® in pediatric patientswith type 2 diabetes have not been established (1).
• The safety and efficacy of SAXENDA® in combination with otherproducts intended for weight loss have not been established (1).
——— DOSAGE AND ADMINISTRATION ———• Inject SAXENDA® subcutaneously in the abdomen, thigh, or
upper arm once daily at any time of day, without regard to thetiming of meals (2.2).
• The recommended dose of SAXENDA® is 3 mg daily (2.3).
• Initiate at 0.6 mg per day for one week. In weekly intervals,
increase the dose until a dose of 3 mg is reached (2.3).
• If pediatric patients do not tolerate an increased dose duringdose escalation, the dose may also be lowered to the previous
level. Dose escalation for pediatric patients may take up to 8
weeks (2.3).
• Pediatric patients who do not tolerate 3 mg daily may have theirdose reduced to 2.4 mg daily (2.3).
• Adult patients with type 2 diabetes should monitor blood
glucose prior to starting SAXENDA® and during SAXENDA®
treatment (2.3).
——— DOSAGE FORMS AND STRENGTHS ———• Injection: 6 mg/mL solution in a 3 mL pre-filled, singlepatient-use pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg,
2.4 mg or 3 mg (3).
——— CONTRAINDICATIONS ———• Personal or family history of medullary thyroid carcinoma or
Multiple Endocrine Neoplasia syndrome type 2 (4, 5.1).
• Hypersensitivity to liraglutide or any excipients in SAXENDA®
(4, 5.7).
• Pregnancy (4, 8.1).

concomitantly administered insulin secretagogues or insulin. In
the pediatric clinical trial, patients did not have type 2 diabetes.
Hypoglycemia occurred in SAXENDA® -treated pediatricpatients. Inform all patients of the risk of hypoglycemia andeducate them on the signs and symptoms of hypoglycemia(2, 5.4).
• Heart Rate Increase: Monitor heart rate at regular intervals (5.5).
• Renal Impairment: Has been reported postmarketing, usuallyin association with nausea, vomiting, diarrhea, or dehydration
which may sometimes require hemodialysis. Use caution when
initiating or escalating doses of SAXENDA® in patients withrenal impairment (5.6).
• Hypersensitivity Reactions: Postmarketing reports of serious
hypersensitivity reactions (e.g., anaphylactic reactions andangioedema). Discontinue SAXENDA® and other suspect
medications and promptly seek medical advice (5.7).
• Suicidal Behavior and Ideation: Monitor for depression or
suicidal thoughts. Discontinue SAXENDA® if symptoms develop(5.8).
——— ADVERSE REACTIONS ———• Most common adverse reactions, reported in greater than orequal to 5% are: nausea, diarrhea, constipation, vomiting,injection site reactions, headache, hypoglycemia, dyspepsia,
fatigue, dizziness, abdominal pain, increased lipase, upper
abdominal pain, pyrexia, and gastroenteritis (6.1).
To report SUSPECTED ADVERSE REACTIONS,
contact Novo Nordisk Inc. at 1-844-363-4448 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
——— DRUG INTERACTIONS ———• SAXENDA® delays gastric emptying. May impact absorption of
concomitantly administered oral medications. Use with caution(7).
See 17 for PATIENT COUNSELING INFORMATION and
Medication Guide.
Revised: 04/2023——— WARNINGS AND PRECAUTIONS ———• Thyroid C-cell Tumors: See Boxed Warning (5.1).
• Acute Pancreatitis: Discontinue promptly if pancreatitis issuspected. Do not restart if pancreatitis is confirmed (5.2).
• Acute Gallbladder Disease: If cholelithiasis or cholecystitis are
suspected, gallbladder studies are indicated (5.3).
• Hypoglycemia: Can occur in adults when SAXENDA® isused with an insulin secretagogue (e.g. a sulfonylurea) or
insulin. The risk may be lowered by a reduction in the dose of

7

DRUG INTERACTIONS
7.1
Oral Medications
8 USE IN SPECIFIC POPULATIONS
8.1
Pregnancy
8.2
Lactation
8.4
Pediatric Use
8.5
Geriatric Use
8.6
Renal Impairment
8.7
Hepatic Impairment
8.8
Gastroparesis
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1	Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1	Weight Management Trials in Adults with Overweightor Obesity1

14.2	Weight Management Trial in Pediatric Patients Ages 12
and Older with Obesity
14.3	Cardiovascular Outcomes Trial of Liraglutide 1.8
mg in Adult Patients with Type 2 Diabetes andCardiovascular Disease
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Recommended Storage
17 PATIENT COUNSELING INFORMATION*S ections or subsections omitted from the full prescribing
information are not listed.

SAXENDA ® (liraglutide) injection 3mg
FULL PRESCRIBING INFORMATION

1
INDICATIONS AND USAGE
SAXENDA® is indicated as an adjunct to a reduced-calorie diet andincreased physical activity for chronic weight management in:• Adult patients with an initial body mass index (BMI) of [seeDosage and Administration (2.1)]:• 30 kg/m2 or greater (obese), or• 27 kg/m2 or greater (overweight) in the presence of at least
one weight-related comorbid condition (e.g., hypertension,
type 2 diabetes mellitus, or dyslipidemia)• Pediatric patients aged 12 years and older with:• body weight above 60 kg and• an initial BMI corresponding to 30 kg/m2 or greater for
adults (obese) by international cut-offs (Cole Criteria,
Table 2) [see Dosage and Administration (2.1)]
Limitations of Use•SAXENDA® contains liraglutide and should not becoadministered with other liraglutide-containing products orwith any other GLP-1 receptor agonist.
• The safety and effectiveness of SAXENDA® in pediatric patientswith type 2 diabetes have not been established.
• The safety and effectiveness of SAXENDA® in combination withother products intended for weight loss, including prescription
drugs, over-the-counter drugs, and herbal preparations, havenot been established.

WARNING: RISK OF THYROID C-CELL TUMORS• Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors atclinically relevant exposures in both genders ofrats and mice. It is unknown whether SAXENDA®
causes thyroid C-cell tumors, including medullary
thyroid carcinoma (MTC), in humans, as thehuman relevance of liraglutide-induced rodent
thyroid C-cell tumors has not been determined[see Warnings and Precautions (5.1) and
Nonclinical Toxicology (13.1)].
• SAXENDA® is contraindicated in patients with apersonal or family history of MTC and in patientswith Multiple Endocrine Neoplasia syndrome
type 2 (MEN 2). Counsel patients regarding thepotential risk of MTC with use of SAXENDA®
and inform them of symptoms of thyroid tumors(e.g., a mass in the neck, dysphagia, dyspnea,
persistent hoarseness). Routine monitoring ofserum calcitonin or using thyroid ultrasoundis of uncertain value for early detection of
MTC in patients treated with SAXENDA® [seeContraindications (4), Warnings and Precautions(5.1)].
Table 1. BMI Conversion Chart
(lb)
125
130
135
Weight(kg) 56.8 59.1 61.4
Height
(in)
(cm)
58
147.3
26
27
28
59 149.9 2526
27
60 152.4 24
25
26
61 154.9 24
25
26
62
157.5
23
24
25
63 160.0 22
23
24
64 162.6 22
22
23
65
165.1
21
22
23
66
167.6
20
21
22
67 170.2 2020
21
68 172.7
19
20
21
69 175.3 18
19
20
70
177.8
18
19
19
71 180.3 1718
19
72 182.91718
18
73 185.4 17171874
188.0 1617
17
75 190.5 161617
76 193.0 15
16162DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Select patients for SAXENDA® treatment as an adjunct to a
reduced-calorie diet and increased physical activity for chronic
weight management based on the BMI values provided in Tables
1 and 2.
Adult and Pediatric Patients
BMI is calculated by dividing weight in (kilograms) by height (inmeters) squared. A chart for determining BMI based on height andweight is provided in Table 1.

140
63.6

145
65.9

150
68.2

155
70.5

160
72.7

165
75.0

170
77.3

175
79.5

180
81.8

185
84.1

190
86.4

195
88.6

200
90.9

205
93.2

210
95.5

215
97.7

220
225
100.0 102.3

29
28
27
27
26
25
24
23
23
22
21
21
20
20
19
19
18
18
17

30
29
28
27
27
26
25
24
23
23
22
21
21
20
20
19
19
18
18

31
30
29
28
27
27
26
25
24
24
23
22
22
21
20
20
19
19
18

32
31
30
29
28
28
27
26
25
24
24
23
22
22
21
20
20
19
19

34
32
31
30
29
28
28
27
26
25
24
24
23
22
22
21
21
20
20

35
33
32
31
30
29
28
28
27
26
25
24
24
23
22
22
21
21
20

36
34
33
32
31
30
29
28
27
27
26
25
24
24
23
22
22
21
21

37
35
34
33
32
31
30
29
28
27
27
26
25
24
24
23
23
22
21

38
36
35
34
33
32
31
30
29
28
27
27
26
25
24
24
23
23
22

39
37
36
35
34
33
32
31
30
29
28
27
27
26
25
24
24
23
23

40
38
37
36
35
34
33
32
31
30
29
28
27
27
26
25
24
24
23

41
39
38
37
36
35
34
33
32
31
30
29
28
27
27
26
25
24
24

42
40
39
38
37
36
34
33
32
31
30
30
29
28
27
26
26
25
24

43
41
40
39
38
36
35
34
33
32
31
30
29
29
28
27
26
26
25

44
43
41
40
38
37
36
35
34
33
32
31
30
29
29
28
27
26
26

45
44
42
41
39
38
37
36
35
34
33
32
31
30
29
28
28
27
26

46
45
43
42
40
39
38
37
36
35
34
33
32
31
30
29
28
28
27

Pediatric Patients Aged 12 Years and Older
BMI cut-offs for obesity in pediatric patients aged 12 years andolder are presented in Table 2.
Table 2: International Obesity Task Force BMI Cut-offs
for Obesity by Sex and Age for Pediatric Patients Aged 12
Years and Older (Cole Criteria)

Age (years)
12
12.5
13
13.5
14
14.5
15
15.5
16
16.5
17
17.5

2

Body mass index
30 kg/m2
Males
Females
26.02
26.67
26.43
27.24
26.84
27.76
27.25
28.20
27.63
28.57
27.98
28.87
28.30
29.11
28.60
29.29
28.88
29.43
29.14
29.56
29.41
29.69
29.70
29.84

2.2 Important Administration Instructions• Prior to initiation of SAXENDA®, train patients on proper
injection technique. Refer to the accompanying Instructions for
Use for complete administration instructions with illustrations.
• Inspect SAXENDA® visually prior to each injection. Only use if
solution is clear, colorless, and contains no particles.

• Inject SAXENDA® subcutaneously once daily at any time of day,without regard to the timing of meals.
• Inject SAXENDA® subcutaneously in the abdomen, thigh,or upper arm. No dose adjustment is needed if changing theinjection site and/or timing.
• Rotate injection sites within the same region in order to reduce
the risk of cutaneous amyloidosis [see Adverse Reactions (6.2)].
• If a dose is missed, resume the once-daily regimen as prescribedwith the next scheduled dose. Do not administer an extra dose or
increase the dose to make up for the missed dose.
• If more than 3 days have elapsed since the last SAXENDA®
dose, reinitiate SAXENDA® at 0.6 mg daily and follow the dose
escalation schedule in Table 3, to reduce the occurrence ofgastrointestinal adverse reactions associated with reinitiation oftreatment.
2.3 Dosage in Adults and Pediatric Patients Aged 12
Years and Older• Initiate SAXENDA® with a dose of 0.6 mg daily for one week.
Then follow the dose escalation schedule in Table 3 to minimize
gastrointestinal adverse reactions [see Adverse Reactions (6.1)].
Table 3. Dose Escalation Schedule
Week
1
2
3
4
5 and onward

Daily Dose
0.6 mg
1.2 mg
1.8 mg
2.4 mg
3 mg

47
46
44
43
41
40
39
38
36
35
34
33
32
31
31
30
29
28
27

Adult Patients• For adults, the recommended dosage of SAXENDA® is 3 mg
daily, lower doses are for titration only.
• Discontinue SAXENDA® if the patient cannot tolerate the 3 mg
dose.
• If patients do not tolerate an increased dose during dose
escalation, consider delaying dose escalation for approximately
one additional week.
• Evaluate the change in body weight 16 weeks after initiating
SAXENDA® and discontinue SAXENDA® if the patient has not
lost at least 4% of baseline body weight, since it is unlikely thatthe patient will achieve and sustain clinically meaningful weightloss with continued treatment.
• In adult patients with type 2 diabetes, monitor blood glucose
prior to starting SAXENDA® and during SAXENDA® treatment.
Pediatric Patients• For pediatric patients, the recommended maintenance dosage of
SAXENDA® is 3 mg daily. Pediatric 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 pediatric patients do not tolerate an increased dose duringdose escalation, the dose may also be lowered to the previous
level. Dose escalation for pediatric patients may take up to
8 weeks.
• Evaluate the change in BMI after 12 weeks on the maintenancedose and discontinue SAXENDA® if the patient has not had areduction in BMI of at least 1% from baseline, since it is unlikelythat the patient will achieve and sustain clinically meaningfulweight loss with continued treatment.

SAXENDA ® (liraglutide) injection 3mg
3
DOSAGE FORMS AND STRENGTHS
Injection: 6 mg/mL clear, colorless solution in a 3 mL pre-filled,
single-patient-use pen that delivers doses of 0.6 mg, 1.2 mg,
1.8 mg, 2.4 mg, or 3 mg.
4
CONTRAINDICATIONSSAXENDA® is contraindicated in:• Patients with a personal or family history of medullary thyroid
carcinoma (MTC) or patients with Multiple Endocrine Neoplasia
syndrome type 2 (MEN 2) [see Warnings and Precautions (5.1)].
• 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® [see Warnings andPrecautions (5.7)].
• Pregnancy [see Use in Specific Populations (8.1)].
5
WARNINGS AND PRECAUTIONS
5.1 Risk of Thyroid C-cell Tumors
Liraglutide causes dose-dependent and treatment-durationdependent thyroid C-cell tumors (adenomas and/or carcinomas)
at clinically relevant exposures in both genders of rats and mice[see Nonclinical Toxicology (13.1)]. Malignant thyroid C-cellcarcinomas were detected in rats and mice. It is unknown whether
SAXENDA® will cause thyroid C-cell tumors, including medullary
thyroid carcinoma (MTC), in humans, as the human relevance ofliraglutide-induced rodent thyroid C-cell tumors has not been
determined.
Cases of MTC in patients treated with liraglutide have beenreported in the postmarketing period; the data in these reports are
insufficient to establish or exclude a causal relationship between
MTC and liraglutide use in humans.
SAXENDA® is contraindicated in patients with a personal orfamily history of MTC or in patients with MEN 2. Counsel patients
regarding the potential risk for MTC with the use of SAXENDA®
and inform them of symptoms of thyroid tumors (e.g., a mass in theneck, dysphagia, dyspnea, persistent hoarseness).
Routine monitoring of serum calcitonin or using thyroid ultrasoundis of uncertain value for early detection of MTC in patients treatedwith SAXENDA®. Such monitoring may increase the risk of
unnecessary procedures, due to low test specificity for serum
calcitonin and a high background incidence of thyroid disease.
Significantly elevated serum calcitonin may indicate MTC, andpatients with MTC usually have calcitonin values greater than 50
ng/L. If serum calcitonin is measured and found to be elevated, thepatient should be further evaluated. Patients with thyroid nodules
noted on physical examination or neck imaging should also be
further evaluated.
5.2 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 forsigns 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.
In SAXENDA® clinical trials in adults, acute pancreatitis was
confirmed by adjudication in 9 (0.3%) of 3291 SAXENDA® treated patients and 2 (0.1%) of 1843 placebo-treated patients. In
addition, there were 2 cases of acute pancreatitis in SAXENDA® treated patients who prematurely withdrew from these clinical
trials, occurring 74 and 124 days after the last dose. There were
2 additional cases in SAXENDA® -treated patients, 1 during an
off-treatment follow-up period within 2 weeks of discontinuing
SAXENDA®, and 1 that occurred in a patient who completed
treatment and was off-treatment for 106 days.
In a SAXENDA® pediatric clinical trial, pancreatitis was notindependently adjudicated. Pancreatitis was reported in 1
(0.8%) SAXENDA® -treated patient and resulted in treatment
discontinuation.
Liraglutide has been studied in a limited number of adult patientswith a history of pancreatitis. It is unknown if patients with a historyof pancreatitis are at higher risk for development of pancreatitis on
SAXENDA®.
5.3 Acute Gallbladder Disease
In SAXENDA® clinical trials in adults, 2.2% of SAXENDA® -treatedpatients reported adverse events of cholelithiasis versus 0.8% ofplacebo-treated patients. The incidence of cholecystitis was 0.8%
in SAXENDA® -treated patients versus 0.4% in placebo-treatedpatients. The majority of SAXENDA® -treated patients with adverse
events of cholelithiasis and cholecystitis required cholecystectomy.
Substantial or rapid weight loss can increase the risk ofcholelithiasis; however, the incidence of acute gallbladder disease
was greater in SAXENDA® -treated patients than in placebo-treatedpatients even after accounting for the degree of weight loss. Ifcholelithiasis is suspected, gallbladder studies and appropriate
clinical follow-up are indicated.

5.4 Hypoglycemia
Adult patients with type 2 diabetes mellitus on an insulin
secretagogue (e.g., sulfonylurea) or insulin may have an increased
risk of hypoglycemia with use of SAXENDA®, including severe
hypoglycemia. In patients with type 2 diabetes, monitor blood
glucose prior to starting SAXENDA® and during SAXENDA®
treatment [see Dosage and Administration (2) and Adverse Reactions(6.1)].
The risk of hypoglycemia may be lowered by a reduction in thedose of sulfonylurea (or other concomitantly administered insulin
secretagogues) or insulin. Inform patients using these concomitant
medications of the risk of hypoglycemia and educate them on thesigns and symptoms of hypoglycemia.
In the pediatric clinical trial, patients did not have type 2 diabetes
but were provided with blood glucose meters. Clinically significant
hypoglycemia, defined as blood glucose <54 mg/dL, occurred in
1.6% of the SAXENDA® - treated patients compared to 0.8% ofplacebo-treated patients [see Adverse Reactions (6.1)]. Inform allpediatric patients of the risk of hypoglycemia and educate them on
the signs and symptoms of hypoglycemia.
5.5 Heart Rate Increase
Mean increases in resting heart rate of 2 to 3 beats per minute (bpm)were observed with routine clinical monitoring in SAXENDA® treated adult patients compared to placebo in clinical trials. Morepatients treated with SAXENDA®, compared with placebo, hadchanges from baseline at two consecutive visits of more than 10
bpm (34% versus 19%, respectively) and 20 bpm (5% versus 2%,
respectively). At least one resting heart rate exceeding 100 bpm wasrecorded for 6% of SAXENDA® -treated patients compared with 4%of placebo-treated patients, with this occurring at two consecutive
study visits for 0.9% and 0.3%, respectively. Tachycardia wasreported as an adverse reaction in 0.6% of SAXENDA® -treatedpatients and in 0.1% of placebo-treated patients.
In a clinical pharmacology trial that monitored heart ratecontinuously for 24 hours, SAXENDA® treatment was associatedwith a heart rate that was 4 to 9 bpm higher than that observed withplacebo.
In a pediatric clinical trial, mean increases from baseline in restingheart rate of 3 to 7 bpm were observed with SAXENDA® treatment.
Heart rate should be monitored at regular intervals consistent withusual clinical practice. Patients should inform health care providersof 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.
5.6 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, sometimes requiring
hemodialysis [see Adverse Reactions (6.2)]. Some of these eventswere reported in patients without known underlying renal disease.
A majority of the reported events occurred in patients who had
experienced nausea, vomiting, or diarrhea leading to volume
depletion. Some of the reported events occurred in patients
receiving one or more medications known to affect renal function
or volume status. Altered renal function has been reversed in manyof the reported cases with supportive treatment and discontinuationof potentially causative agents, including liraglutide. Use caution
when initiating or escalating doses of SAXENDA® in patients withrenal impairment [see Use in Specific Populations (8.6)].
5.7 Hypersensitivity Reactions
There have been reports of serious hypersensitivity reactions (e.g.,
anaphylactic reactions and angioedema) in patients treated withSAXENDA® [see Contraindications (4) and Adverse Reactions(6.1, 6.2)]. If a hypersensitivity reaction occurs, the patient should
discontinue SAXENDA® and other suspect medications andpromptly seek medical advice.
Anaphylaxis and angioedema have been reported with other
GLP-1 receptor agonists. Use caution in a patient with a history ofanaphylaxis or angioedema with another GLP-1 receptor agonist
because it is unknown whether such patients will be predisposed tothese reactions with SAXENDA®.
5.8 Suicidal Behavior and Ideation
In SAXENDA® adult clinical trials, 9 (0.3%) of 3384 SAXENDA® treated patients and 2 (0.1%) of the 1941 placebo-treated patients
reported suicidal ideation; one of these SAXENDA® -treatedpatients attempted suicide.
In a SAXENDA® pediatric clinical trial, 1 (0.8%) of the 125
SAXENDA® -treated patients died by suicide. There was insufficient
information to establish a causal relationship to SAXENDA®.
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 historyof suicidal attempts or active suicidal ideation.
6
ADVERSE REACTIONS
The following serious adverse reactions are described below orelsewhere in the prescribing information:

3• Risk of Thyroid C-Cell Tumors [see Warnings and Precautions(5.1)]• Acute Pancreatitis [see Warnings and Precautions (5.2)]• Acute Gallbladder Disease [see Warnings and Precautions (5.3)]• Risk for Hypoglycemia with Concomitant Use of Anti-Diabetic
Therapy [see Warnings and Precautions (5.4)]• Heart Rate Increase [see Warnings and Precautions (5.5)]• Renal Impairment [see Warnings and Precautions (5.6)]• Hypersensitivity Reactions [see Warnings and Precautions (5.7)]• Suicidal Behavior and Ideation [see Warnings and Precautions(5.8)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical trials ofa drug cannot be directly compared to rates in the clinical studiesof another drug and may not reflect the rates observed in practice.
SAXENDA® was evaluated for safety in 5 double-blind, placebo
controlled trials that included 3384 overweight or obese adultpatients treated with SAXENDA® for a treatment period up to 56
weeks (3 trials), 52 weeks (1 trial), and 32 weeks (1 trial) and one
trial of 56 weeks in 125 pediatric patients with obesity aged 12 years
and older [see Clinical Studies (14.1, 14.2)]. All patients received
study drug in addition to a reduced-calorie diet and increased
physical activity counseling. In the adult trials, patients received
SAXENDA® for a mean treatment duration of 46 weeks (median, 56
weeks). Baseline characteristics included a mean age of 47 years,
71% women, 85% white, 39% with hypertension, 15% with type 2
diabetes, 34% with dyslipidemia, 29% with a BMI greater than 40
kg/m2, and 9% with cardiovascular disease. In one of the 56-week
trials, a subset of patients (with abnormal glucose measurements
at randomization) [see Clinical Studies (14.1)] were enrolled for aplacebo-controlled 160-week period instead, followed by a 12-week
off-treatment follow-up. For those participating in this 160-weekperiod, patients received SAXENDA® for a mean treatment durationof 110 weeks (median, 159 weeks). For all trials, dosing was initiatedand increased weekly to reach the 3 mg dose.
In adult clinical trials, 9.8% of patients treated with SAXENDA®
and 4.3% of patients treated with placebo prematurely discontinued
treatment as a result of adverse reactions. The most common
adverse reactions leading to discontinuation were nausea (2.9%versus 0.2% for SAXENDA® and placebo, respectively), vomiting(1.7% versus less than 0.1%), and diarrhea (1.4% versus 0%).
Adverse reactions reported in greater than or equal to 2% of
SAXENDA® -treated adult patients and more frequently than inplacebo-treated patients are shown in Table 4. Adverse reactions
reported in greater than or equal to 3% of SAXENDA® -treated
pediatric patients and more frequently than in placebo-treatedpatients are shown in Table 5.
Table 4. Adverse Reactions Occurring in ≥2% of
SAXENDA® -treated Adult Patients and More Frequently
than Placebo
Placebo SAXENDA®
N = 1941
N = 3384%%
Nausea13.8
39.3
Diarrhea
9.9
20.9
Constipation
8.5
19.4
Vomiting
3.9
15.7
Injection Site Reaction1
10.5
13.9
Headache
12.6
13.6
Hypoglycemia in T2DM2
6.6
12.6
Dyspepsia
2.7
9.6
Fatigue
4.6
7.5
Dizziness
5.0
6.9
Abdominal Pain
3.1
5.4
Increased Lipase
2.2
5.3
Upper Abdominal Pain
2.7
5.1
Gastroenteritis
3.2
4.7
Gastroesophageal Reflux Disease
1.7
4.7
Abdominal Distension
3.0
4.5
Eructation
0.2
4.5
Urinary Tract Infection
3.1
4.3
Flatulence
2.5
4.0
Viral Gastroenteritis
1.6
2.8
Insomnia
1.7
2.4
Dry Mouth
1.0
2.3
Asthenia
0.8
2.1
Anxiety
1.6
2.0

SAXENDA ® (liraglutide) injection 3mg
1	T he most common reactions, each reported by 1% to 2.5%of SAXENDA® -treated patients and more commonly than byplacebo-treated patients, included erythema, pruritus, and rash at
the injection site.
2	D efined as blood glucose <54 mg/dL with or without symptomsof hypoglycemia in patients with type 2 diabetes not on
concomitant insulin (Study 2, SAXENDA® N=423, Placebo
N=212). See text below for further information regarding
hypoglycemia in patients with and without type 2 diabetes. T2DM
= type 2 diabetes mellitus
Table 5. Adverse Reactions Occurring in ≥3% of
SAXENDA® -treated Pediatric Patients and More
Frequently than Placebo in a 56 Week Clinical Trial
Placebo SAXENDA®
N = 126
N = 125%%
Nausea14.3
42.4
Vomiting
4.0
34.4
Diarrhea
14.3
22.4
Hypoglycemia1
4.0
15.2
Gastroenteritis
4.8
12.8
Dizziness
3.2
10.4
Pyrexia7.1
8.0
Abdominal discomfort
0.8
4.8
Constipation
2.4
4.8
Dyslipidemia
3.2
4.8
Fatigue
3.2
4.8
Cough
3.2
4.0
Depression
2.4
4.0
Dyspepsia
2.4
4.0
Pain in extremity
2.4
4.0
Injection site pain
3.2
3.2
Flatulence0
3.2
Increased Blood Creatine Kinase
2.4
3.2
Increased Lipase
0.8
3.2
Rash
0
3.2
1	D efined as blood glucose <70 mg/dL with symptoms ofhypoglycemia. Pediatric patients did not have type 2 diabetes
mellitus. See text below for more detailed hypoglycemia
information.
Hypoglycemia
Adult Patients with Type 2 Diabetes
In a clinical trial in adult patients with type 2 diabetes mellitus andoverweight (excess weight) or obesity, severe hypoglycemia (defined
as requiring the assistance of another person) occurred in 3 (0.7%)
of 422 SAXENDA® -treated patients (all taking a sulfonylurea) andin none of the 212 placebo-treated patients. In this trial, among
patients taking a sulfonylurea, hypoglycemia defined as a plasma
glucose less than 54 mg/dL with or without symptoms occurred in
31 (28.2%) of 110 SAXENDA® -treated patients and 7 (12.7%) of 55
placebo-treated patients. The doses of sulfonylureas were reduced
by 50% at the beginning of the trial per protocol. Among patients
not taking a sulfonylurea, blood glucose less than 54 mg/dL with orwithout symptoms occurred in 22 (7.1%) of 312 SAXENDA® -treatedpatients and 7 (4.5%) of 157 placebo-treated patients.
In a SAXENDA® clinical trial in adult patients with overweight(excess weight) or obesity with type 2 diabetes mellitus treated withbasal insulin and SAXENDA® in combination with a reduced-calorie
diet and increased physical activity and up to 2 oral anti-diabetes
medications, severe hypoglycemia was reported by 3 (1.5%) of 195
SAXENDA® -treated patients and 2 (1.0%) of 197 placebo-treatedpatients. No meaningful difference in hypoglycemia, defined asblood glucose less than 54 mg/dL with or without symptoms, wasreported between groups.
Adult Patients without Type 2 Diabetes
In SAXENDA® clinical trials in adult patients without type 2
diabetes mellitus, there was no systematic capturing or reportingof hypoglycemia; patients were not provided with blood glucose
meters or hypoglycemia diaries. Spontaneously reported
symptomatic episodes of unconfirmed hypoglycemia were reported
by 46 (1.6%) of 2962 SAXENDA® -treated patients and 19 (1.1%)of 1729 placebo-treated patients. Fasting plasma glucose values
obtained at routine clinic visits less than 54 mg/dL, irrespective of
hypoglycemic symptoms, occurred in 2 (0.1%) SAXENDA® -treatedpatients and 1 (0.1%) placebo-treated patients.
Pediatric Patients without Type 2 Diabetes
In a 56-week placebo-controlled clinical trial of pediatric patients
without type 2 diabetes mellitus in which blood glucose meters
were provided, 19 (15.2%) of SAXENDA® -treated patients had
hypoglycemia with a blood glucose less than 70 mg/dL withsymptoms as compared to 5 (4.0%) of placebo-treated patients.
Four (4) events of hypoglycemia defined as a plasma glucose lessthan 54 mg/dL occurred in 2 (1.6%) of 125 SAXENDA® -treatedpatients and 1 event occurred in 1 (0.8%) of 126 placebo-treatedpatients. No severe hypoglycemic episodes, defined as requiring
assistance of another person to actively administer carbohydrate,
glucagon, or other resuscitative actions, occurred in the SAXENDA®
treatment group.
Gastrointestinal Adverse Reactions
In the adult clinical trials, approximately 68% of SAXENDA® treated patients and 39% of placebo-treated patients reported
gastrointestinal disorders; the most frequently reported was nausea(39% and 14% of patients treated with SAXENDA® and placebo,
respectively). The percentage of patients reporting nausea declined
as treatment continued. Other common adverse reactions that
occurred at a higher incidence among SAXENDA® -treated patients
included diarrhea, constipation, vomiting, dyspepsia, abdominal
pain, dry mouth, gastritis, gastroesophageal reflux disease,flatulence, eructation and abdominal distension. Most episodesof gastrointestinal events were mild or moderate and did not leadto discontinuation of therapy (6.2% with SAXENDA® versus 0.8%
with placebo discontinued treatment as a result of gastrointestinal
adverse reactions). There have been reports of gastrointestinal
adverse reactions, such as nausea, vomiting, and diarrhea,
associated with volume depletion and renal impairment.
In a pediatric clinical trial, 8.0% of patients treated with SAXENDA®
versus no patients who received placebo discontinued treatment as aresult of gastrointestinal adverse reactions. Most adverse reactions
leading to discontinuation were due to vomiting and nausea (4.8%
and 3.2% of SAXENDA® -treated patients, respectively).
Asthenia, Fatigue, Malaise, Dysgeusia and Dizziness
Events of asthenia, fatigue, malaise, dysgeusia and dizzinesswere mainly reported within the first 12 weeks of treatment withSAXENDA® and were often co-reported with gastrointestinal events
such as nausea, vomiting, and diarrhea.
Immunogenicity
The detection of antibody formation is highly dependent on thesensitivity and specificity of the assay. Additionally, the observed
incidence of antibody (including neutralizing antibody) positivity
in an assay may be influenced by several factors including assay
methodology, sample handling, timing of sample collection,
concomitant medications, and underlying disease. For thesereasons, the incidence of antibodies to SAXENDA® cannot bedirectly compared with the incidence of antibodies of other products.
Patients treated with SAXENDA® may develop anti-liraglutide
antibodies. Anti-liraglutide antibodies were detected in 42 (2.8%)of 1505 SAXENDA® -treated adult patients with a post-baseline
assessment. Antibodies that had a neutralizing effect on liraglutide
in an in vitro assay occurred in 18 (1.2%) of 1505 SAXENDA® treated patients. Presence of antibodies may be associated with ahigher incidence of injection site reactions and reports of low blood
glucose. In clinical trials, these events were usually classified as
mild and resolved while patients continued on treatment.
In a pediatric clinical trial, anti-liraglutide antibodies were detected
in 14 (12%) of 117 SAXENDA® -treated patients with a postbaseline assessment; 5 (4.3%) had persistent antibodies as definedby more than 2 antibody visits at least 16 weeks apart. Two patients(1.7%) remained positive throughout the follow-up period; 1 (0.9%)
had antibodies cross reactive to native GLP-1. No patients had
neutralizing antibodies.
Allergic Reactions
Urticaria was reported in 0.7% of SAXENDA® -treated patientsand 0.5% of placebo-treated patients. Anaphylactic reactions,asthma, bronchial hyperreactivity, bronchospasm, oropharyngeal
swelling, facial swelling, angioedema, pharyngeal edema, type IV
hypersensitivity reactions have been reported in patients treatedwith liraglutide in clinical trials. Cases of anaphylactic reactions withadditional symptoms such as hypotension, palpitations, dyspnea,
and edema have been reported with marketed use of liraglutide.
Anaphylactic reactions may potentially be life-threatening.
Breast Cancer
In SAXENDA® clinical trials in adults, breast cancer confirmed
by adjudication was reported in 17 (0.7%) of 2379 SAXENDA® treated women compared with 3 (0.2%) of 1300 placebo-treated
women, including invasive cancer (13 SAXENDA® - and 2 placebotreated women) and ductal carcinoma in situ (4 SAXENDA® - and 1
placebo-treated woman). The majority of cancers were estrogenand progesterone-receptor positive. There were too few cases
to determine whether these cases were related to SAXENDA®.
In addition, there are insufficient data to determine whether
SAXENDA® has an effect on pre-existing breast neoplasia.
Papillary Thyroid Cancer
In SAXENDA® clinical trials in adults, papillary thyroid carcinoma
confirmed by adjudication was reported in 8 (0.2%) of 3291
SAXENDA® -treated patients compared with no cases among 1843
placebo-treated patients. Four of these papillary thyroid carcinomas
were less than 1 cm in greatest diameter and 4 were diagnosed insurgical pathology specimens after thyroidectomy prompted byfindings identified prior to treatment.

4
Colorectal Neoplasms
In SAXENDA® clinical trials in adults, benign colorectal neoplasms(mostly colon adenomas) confirmed by adjudication were reported
in 20 (0.6%) of 3291 SAXENDA® -treated patients compared with 7(0.4%) of 1843 placebo-treated patients. Six positively adjudicatedcases of malignant colorectal neoplasms were reported in 5
SAXENDA® -treated patients (0.2%, mostly adenocarcinomas) and1 in a placebo-treated patient (0.1%, neuroendocrine tumor of therectum).
Cardiac Conduction Disorders
In SAXENDA® clinical trials in adults, 11 (0.3%) of 3384
SAXENDA® -treated patients compared with none of the 1941
placebo-treated patients had a cardiac conduction disorder,
reported as first degree atrioventricular block, right bundle branch
block, or left bundle branch block.
Hypotension
Adverse reactions related to hypotension (hypotension, orthostatic
hypotension, circulatory collapse, and decreased blood pressure)
were reported more frequently with SAXENDA® (1.1%) comparedwith placebo (0.5%) in SAXENDA® clinical trials in adults. Systolicblood pressure decreases to less than 80 mmHg were observed in
4 (0.1%) SAXENDA® -treated patients compared with no placebotreated patients. One of the SAXENDA® -treated patients had
hypotension associated with gastrointestinal adverse reactions andrenal failure [see Warnings and Precautions (5.6)].
Laboratory Abnormalities
Liver Enzymes
Increases in alanine aminotransferase (ALT) greater than or equal
to 10 times the upper limit of normal were observed in 5 (0.15%)
SAXENDA® -treated patients (two of whom had ALT greater than 20
and 40 times the upper limit of normal) compared with 1 (0.05%)
placebo-treated patient during the SAXENDA® clinical trials.
Because clinical evaluation to exclude alternative causes of ALT andaspartate aminotransferase (AST) increases was not done in mostcases, the relationship to SAXENDA® is uncertain. Some increases
in ALT and AST were associated with other confounding factors(such as gallstones).
Serum Calcitonin
Calcitonin, a biological marker of MTC, was measured throughout
the clinical development program [see Warnings and Precautions(5.1)]. More patients treated with SAXENDA® in the clinical trials
were observed to have high calcitonin values during treatment,
compared with placebo. The proportion of patients with calcitoningreater than or equal to 2 times the upper limit of normal at the endof the trial was 1.2% in SAXENDA® -treated patients and 0.6% inplacebo-treated patients. Calcitonin values greater than 20 ng/Lat the end of the trial occurred in 0.5% of SAXENDA® -treatedpatients and 0.2% of placebo-treated patients; among patientswith pretreatment serum calcitonin less than 20 ng/L, none had
calcitonin elevations to greater than 50 ng/L at the end of the trial.
Serum Lipase and Amylase
Serum lipase and amylase were routinely measured in the
SAXENDA® clinical trials. Among SAXENDA® -treated patients,
2.1% had a lipase value at anytime during treatment of greater thanor equal to 3 times the upper limit of normal compared with 1.0% of
placebo-treated patients. 0.1% of SAXENDA® -treated patients had
an amylase value at anytime in the trial of greater than or equal to
3 times the upper limit of normal versus 0.1% of placebo-treatedpatients. The clinical significance of elevations in lipase or amylasewith SAXENDA® is unknown in the absence of other signs andsymptoms of pancreatitis [see Warnings and Precautions (5.2)].
6.2 Post-Marketing Experience
The following adverse reactions have been reported during postapproval use of liraglutide, the active ingredient of SAXENDA®.
Because these reactions are reported voluntarily from a populationof uncertain size, it is not always possible to reliably estimate theirfrequency or establish a causal relationship to drug exposure.
Neoplasms
	Medullary thyroid carcinoma
Gastrointestinal Disorders	Acute pancreatitis, hemorrhagic and necrotizing pancreatitis,
sometimes resulting in death, ileus
Metabolism and Nutrition Disorders	Dehydration resulting from nausea, vomiting and diarrhea
Renal and Urinary Disorders	Increased serum creatinine, acute renal failure or worsening ofchronic renal failure, sometimes requiring hemodialysis
General Disorders and Administration Site Conditions
	Allergic reactions: rash and pruritus
Immune System Disorders	Angioedema and anaphylactic reactions
Hepatobiliary Disorders	Hyperbilirubinemia, elevations of liver enzymes, cholestasis andhepatitis
Skin and Subcutaneous Tissue Disorders	Cutaneous amyloidosis

SAXENDA ® (liraglutide) injection 3mg
7
DRUG INTERACTIONS
7.1 Oral Medications
SAXENDA® causes a delay of gastric emptying, and thereby has thepotential to impact the absorption of concomitantly administeredoral medications. In clinical pharmacology trials, liraglutide did notaffect 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®.
8USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
SAXENDA® is contraindicated during pregnancy because weightloss offers no potential benefit to a pregnant woman and may
result in fetal harm [see Clinical Considerations]. There are noavailable data with liraglutide in pregnant women to inform a drug
associated risk for major birth defects and miscarriage. SAXENDA®
should not be used during pregnancy. If a patient wishes to become
pregnant, or pregnancy occurs, treatment with SAXENDA® should
be discontinued.
Animal reproduction studies identified increased adverse embryofetal developmental outcomes from exposure during pregnancy.
Liraglutide exposure was associated with early embryonic deaths
and an imbalance in some fetal abnormalities in pregnant rats
administered liraglutide during organogenesis at doses thatapproximate clinical exposures at the maximum recommended
human dose (MRHD) of 3 mg/day. In pregnant rabbits administeredliraglutide during organogenesis, decreased fetal weight andan increased incidence of major fetal abnormalities were seen at
exposures below the human exposures at the MRHD [see Animal
Data].
The estimated background risk of major birth defects andmiscarriage for the indicated populations is unknown. In the U.S.
general population, the estimated background risk of major birthdefects and miscarriage of clinically recognized pregnancies is2-4% and 15-20%, respectively.
Clinical Considerations
Disease-associated maternal and/or embryofetal risk
A minimum weight gain, and no weight loss, is recommended forall pregnant women, including those who are already overweight orobese, due to the necessary weight gain that occurs in maternal
tissues during pregnancy.
Animal Data
Liraglutide has been shown to be teratogenic in rats at or above
0.8-times systemic exposures in obese humans resulting fromthe maximum recommended human dose (MRHD) of 3 mg/day
based on plasma area under the time-concentration curve (AUC)
comparison. Liraglutide has been shown to cause reduced growthand increased total major abnormalities in rabbits at systemic
exposures below exposure in obese humans at the MRHD based on
plasma AUC comparison.
Female rats given subcutaneous doses of 0.1, 0.25 and 1 mg/kg/
day liraglutide beginning 2 weeks before mating through gestation
day 17 had estimated systemic exposures 0.8-, 3-, and 11-times
the exposure in obese humans at the MRHD based on plasma AUC
comparison. The number of early embryonic deaths in the 1 mg/kg/
day group increased slightly. Fetal abnormalities and variations in
kidneys and blood vessels, irregular ossification of the skull, and amore complete state of ossification occurred at all doses. Mottled
liver and minimally kinked ribs occurred at the highest dose. The
incidence of fetal malformations in liraglutide-treated groups
exceeding concurrent and historical controls were misshapen
oropharynx and/or narrowed opening into larynx at 0.1 mg/kg/day
and umbilical hernia at 0.1 and 0.25 mg/kg/day.
Pregnant rabbits given subcutaneous doses of 0.01, 0.025 and0.05 mg/kg/day liraglutide from gestation day 6 through day 18
inclusive, had estimated systemic exposures less than the exposurein obese humans at the MRHD of 3 mg/day at all doses, basedon plasma AUC comparison. Liraglutide decreased fetal weightand dose-dependently increased the incidence of total major
fetal abnormalities at all doses. The incidence of malformations
exceeded concurrent and historical controls at 0.01 mg/kg/day(kidneys, scapula), greater than or equal to 0.01 mg/kg/day (eyes,
forelimb), 0.025 mg/kg/day (brain, tail and sacral vertebrae, major
blood vessels and heart, umbilicus), greater than or equal to 0.025
mg/kg/day (sternum) and at 0.05 mg/kg/day (parietal bones, major
blood vessels). Irregular ossification and/or skeletal abnormalities
occurred in the skull and jaw, vertebrae and ribs, sternum, pelvis,
tail, and scapula; and dose-dependent minor skeletal variations
were observed. Visceral abnormalities occurred in blood vessels,lung, liver, and esophagus. Bilobed or bifurcated gallbladder wasseen in all treatment groups, but not in the control group.
In pregnant female rats given subcutaneous doses of 0.1, 0.25 and1 mg/kg/day liraglutide from gestation day 6 through weaning or
termination of nursing on lactation day 24, estimated systemic
exposures were 0.8-, 3-, and 11-times exposure in obese humans at
the MRHD of 3 mg/day, based on plasma AUC comparison. A slightdelay in parturition was observed in the majority of treated rats.
Group mean body weight of neonatal rats from liraglutide-treateddams was lower than neonatal rats from control group dams. Bloody
scabs and agitated behavior occurred in male rats descended fromdams treated with 1 mg/kg/day liraglutide. Group mean body weightfrom birth to postpartum day 14 trended lower in F2 generation rats
descended from liraglutide-treated rats compared to F2 generation
rats descended from controls, but differences did not reachstatistical significance for any group.
8.2 Lactation
Risk Summary
There are no data on the presence of liraglutide in human milk,
the effects on the breastfed infant, or effects on milk production.
Liraglutide was present in the milk of lactating rats (see Data).
The developmental and health benefits of breastfeeding should beconsidered along with the mother’s clinical need for SAXENDA®
and any potential adverse effects on the breastfed infant fromSAXENDA® or from the underlying maternal condition.
Data
In lactating rats, liraglutide was present unchanged in milk
at concentrations approximately 50% of maternal plasma
concentrations.
8.4 Pediatric Use
The safety and effectiveness of SAXENDA® as an adjunct to a
reduced-calorie diet and increased physical activity for chronic
weight management have been established in pediatric patients
aged 12 years and older with body weight above 60 kg and an
initial BMI corresponding to 30 kg/m2 or greater for adults (obese)by international cut-offs (see Table 2). Use of SAXENDA® for thisindication is supported by a 56-week double-blind, placebocontrolled clinical trial in 251 pediatric patients aged 12 to 17 years,
a pharmacokinetic study in pediatric patients, and studies in adults
with obesity [see Clinical Pharmacology (12.3) and Clinical Studies(14.1,14.2)].
In the pediatric clinical trial, there was one death due to suicide ina SAXENDA® -treated patient [see Warnings and Precautions (5.8)];
one SAXENDA® -treated patient had an event of pancreatitis [seeWarnings and Precautions (5.2)]; more episodes of hypoglycemia
confirmed by self blood glucose monitoring occurred in
SAXENDA® -treated patients compared to placebo [see Warnings
and Precautions (5.4) and Adverse Reactions (6.1)]; and mean
increases in resting heart rate of 3 to 7 bpm from baseline wereobserved with SAXENDA® -treated patients [see Warnings andPrecautions (5.5)].
The safety and effectiveness of SAXENDA® have not been
established in patients less than 12 years of age.
8.5 Geriatric Use
In the SAXENDA® clinical trials, 232 (6.9%) of the SAXENDA® treated patients were 65 years of age and over, and 17 (0.5%) of
the SAXENDA® -treated patients were 75 years of age and over. No
overall differences in safety or effectiveness were observed between
these patients and younger patients, but greater sensitivity of someolder individuals cannot be ruled out.
8.6 Renal Impairment
There is limited experience with SAXENDA® in patients with mild,moderate, and severe renal impairment, including end-stage renal
disease. However, there have been postmarketing reports of acuterenal failure and worsening of chronic renal failure with liraglutide,which may sometimes require hemodialysis [see Warnings andPrecautions (5.6) and Adverse Reactions (6.2)]. SAXENDA®
should be used with caution in this patient population [see ClinicalPharmacology (12.3)].
8.7 Hepatic Impairment
There is limited experience in patients with mild, moderate, orsevere hepatic impairment. Therefore, SAXENDA® should be usedwith caution in this patient population [see Clinical Pharmacology(12.3)].
8.8 Gastroparesis
SAXENDA® slows gastric emptying. SAXENDA® has not beenstudied in patients with pre-existing gastroparesis.
10
OVERDOSAGE
Overdoses have been reported in clinical trials and post-marketinguse of liraglutide. Effects have included severe nausea, severe
vomiting and severe hypoglycemia. In the event of overdosage,
appropriate supportive treatment should be initiated according to
the patient’s clinical signs and symptoms.
11
DESCRIPTIONSAXENDA® contains liraglutide, an analog of human GLP-1 and acts
as a GLP-1 receptor agonist. The peptide precursor of liraglutide,produced by a process that includes expression of recombinant
DNA in Saccharomyces cerevisiae, has been engineered to be 97%
homologous to native human GLP-1 by substituting arginine forlysine at position 34. Liraglutide is made by attaching a C-16 fatty
acid (palmitic acid) with a glutamic acid spacer on the remaining
lysine residue at position 26 of the peptide precursor. The molecular
formula of liraglutide is C172H265N43O51 and the molecular weight is3751.2 Daltons. The structural formula (Figure 1) is:5
His
C-16 fatty acid(palmitoyl)

Ala

Glu

Gly

Thr

Phe

Thr

Ser

Asp

Lys

Glu

Val
Ser

Glu
Ala

Ala

Gln

Gly

Glu

Leu

Tyr

Ser

Phe
Ile

Ala

Trp

Leu

Val

Arg

Gly

Arg

Gly

Lys

Figure 1. Structural Formula of liraglutide
SAXENDA® injection is a sterile, aqueous, clear, colorless oralmost colorless solution for subcutaneous use. Each 1 mL of
SAXENDA® solution contains 6 mg of liraglutide and the following
inactive ingredients: disodium phosphate dihydrate, 1.42 mg;
propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.
SAXENDA® has a pH of approximately 8.15, hydrochloric acidor sodium hydroxide may be added to adjust pH. Each pre-filled
pen contains a 3 mL solution of SAXENDA® equivalent to 18 mg
liraglutide (free-base, anhydrous).
12
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Liraglutide is an acylated human glucagon-like peptide-1(GLP-1) receptor agonist with 97% amino acid sequencehomology to endogenous human GLP-1(7-37). Like endogenous
GLP-1, liraglutide binds to and activates the GLP-1 receptor,a cell-surface receptor coupled to adenylyl cyclase activation
through the stimulatory G-protein, Gs. Endogenous GLP-1 has
a half-life of 1.5-2 minutes due to degradation by the ubiquitous
endogenous enzymes, dipeptidyl peptidase 4 (DPP-4) and neutral
endopeptidases (NEP). Unlike native GLP-1, liraglutide is stableagainst metabolic degradation by both peptidases and has aplasma half-life of 13 hours after subcutaneous administration. The
pharmacokinetic profile of liraglutide, which makes it suitable foronce-daily administration, is a result of self-association that delays
absorption, plasma protein binding, and stability against metabolic
degradation by DPP-4 and NEP.
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 administrationof liraglutide resulted in the presence of liraglutide in specific brain
regions regulating appetite, including the hypothalamus. Althoughliraglutide activated neurons in brain regions known to regulate
appetite, specific brain regions mediating the effects of liraglutide
on appetite were not identified in rats.
12.2 Pharmacodynamics
Liraglutide lowers body weight through decreased calorie intake.
Liraglutide does not increase 24-hour energy expenditure.
As with other GLP-1 receptor agonists, liraglutide stimulates insulin
secretion and reduces glucagon secretion in a glucose-dependent
manner. These effects can lead to a reduction of blood glucose.
Cardiac Electrophysiology (QTc) in healthy volunteers
The effect of liraglutide on cardiac repolarization was tested in a QTc
study. Liraglutide at steady-state concentrations after daily doses
up to 1.8 mg did not produce QTc prolongation. The maximum
liraglutide plasma concentration (Cmax) in overweight and obese
subjects treated with liraglutide 3 mg is similar to the Cmax observedin the liraglutide QTc study in healthy volunteers.
12.3 Pharmacokinetics
Absorption - Following subcutaneous administration, maximum
concentrations of liraglutide are achieved at 11 hours post dosing.
The average liraglutide steady state concentration (AUCt/24)
reached approximately 116 ng/mL in obese (BMI 30-40 kg/m2)
subjects following administration of SAXENDA®. Liraglutide
exposure increased proportionally in the dose range of 0.6 mg
to 3 mg. The intra-subject coefficient of variation for liraglutide
AUC was 11% following single dose administration. Liraglutide
exposures were considered similar among three subcutaneous
injection sites (upper arm, abdomen, and thigh). Absolutebioavailability of liraglutide following subcutaneous administration
is approximately 55%.
Distribution - The mean apparent volume of distribution after
subcutaneous administration of liraglutide 3 mg is 20-25 L (fora person weighing approximately 100 kg). The mean volume of
distribution after intravenous administration of liraglutide is 0.07 L/
kg. Liraglutide is extensively bound to plasma protein (greater than
98%).
Metabolism - During the initial 24 hours following administrationof a single [3H]-liraglutide dose to healthy subjects, the major
component in plasma was intact liraglutide. Liraglutide is
endogenously metabolized in a similar manner to large proteins
without a specific organ as a major route of elimination.
Elimination - Following a [3H]-liraglutide dose, intact liraglutide was
not detected in urine or feces. Only a minor part of the administeredradioactivity was excreted as liraglutide-related metabolites inurine or feces (6% and 5%, respectively). The majority of urine
and feces radioactivity was excreted during the first 6-8 days. The
mean apparent clearance following subcutaneous administration

SAXENDA ® (liraglutide) injection 3mg
of a single dose of liraglutide is approximately 0.9-1.4 L/h with anelimination half-life of approximately 13 hours, making liraglutide
suitable for once daily administration.
Specific Populations
Elderly - Age had no effect on the pharmacokinetics of liraglutide
based on a pharmacokinetic study in healthy elderly subjects (65to 83 years) and population pharmacokinetic analyses of data fromoverweight and obese patients 18 to 82 years of age [see Use inSpecific Populations (8.5)].
Gender - Based on the results of population pharmacokinetic
analyses, females have 24% lower weight adjusted clearance of
SAXENDA® compared to males.
Race and Ethnicity - Race and ethnicity had no effect on thepharmacokinetics of liraglutide based on the results of population
pharmacokinetic analyses that included overweight and obese
patients of Caucasian, Black, Asian and Hispanic/Non-Hispanicgroups.
Body Weight - Body weight significantly affects the pharmacokinetics
of liraglutide based on results of population pharmacokinetic
analyses conducted in patients with body weight range of 60-234
kg. The exposure of liraglutide decreases as baseline body weightincreases.
Pediatric - A population pharmacokinetic analysis was conducted
for SAXENDA® using data from 134 pediatric patients (12 to 17
years of age) with obesity. The liraglutide exposure in the pediatricpatients was similar to that in adults with obesity [see Use inSpecific Populations (8.4)].
Renal Impairment - The single-dose pharmacokinetics of liraglutide
were evaluated in patients with varying degrees of renal impairment.
Patients with mild (estimated creatinine clearance 50-80 mL/min) to
severe (estimated creatinine clearance less than 30 mL/min) renal
impairment and patients with end-stage renal disease requiring
dialysis were included in the trial. Compared to healthy subjects,
liraglutide AUC in mild, moderate, and severe renal impairment andin end-stage renal disease was on average 35%, 19%, 29% and
30% lower, respectively [see Use in Specific Populations (8.6)].
Hepatic Impairment - The single-dose pharmacokinetics ofliraglutide were evaluated in patients with varying degrees ofhepatic impairment. Patients with mild (Child Pugh score 5-6) tosevere (Child Pugh score greater than 9) hepatic impairment were
included in the trial. Compared to healthy subjects, liraglutide AUC
in subjects with mild, moderate and severe hepatic impairment
was on average 11%, 14% and 42% lower, respectively [see Use inSpecific Populations (8.7)].
Drug Interactions
In vitro assessment of drug−drug interactions
Liraglutide has low potential for pharmacokinetic drug-druginteractions related to cytochrome P450 (CYP) and plasma protein
binding.
In vivo assessment of drug−drug interactions
The drug-drug interaction studies were performed at steady statewith liraglutide 1.8 mg/day. The effect on rate of gastric emptying
was equivalent between liraglutide 1.8 mg and 3 mg (acetaminophen
AUC0-300min). Administration of the interacting drugs was timed sothat Cmax of liraglutide (8-12 h) would coincide with the absorption
peak of the co-administered drugs.
Oral Contraceptives
A single dose of an oral contraceptive combination productcontaining 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel
was administered under fed conditions and 7 hours after the doseof liraglutide at steady state. Liraglutide lowered ethinylestradiol
and levonorgestrel Cmax by 12% and 13%, respectively. There
was no effect of liraglutide on the overall exposure (AUC) of
ethinylestradiol. Liraglutide increased the levonorgestrel AUC0-∞
by 18%. Liraglutide delayed Tmax for both ethinylestradiol andlevonorgestrel by 1.5 h.
DigoxinA single dose of digoxin 1 mg was administered 7 hours after thedose of liraglutide at steady state. The concomitant administration
with liraglutide resulted in a reduction of digoxin AUC by 16%; Cmax
decreased by 31%. Digoxin median time to maximal concentration(Tmax) was delayed from 1 h to 1.5 h.
Lisinopril
A single dose of lisinopril 20 mg was administered 5 minutes after
the dose of liraglutide at steady state. The co-administration withliraglutide resulted in a reduction of lisinopril AUC by 15%; Cmax
decreased by 27%. Lisinopril median Tmax was delayed from 6 h to
8 h with liraglutide.
Atorvastatin
Liraglutide did not change the overall exposure (AUC) of atorvastatin
following a single dose of atorvastatin 40 mg, administered 5 hours
after the dose of liraglutide at steady state. Atorvastatin Cmax was
decreased by 38% and median Tmax was delayed from 1 h to 3 hwith liraglutide.
Acetaminophen
Liraglutide did not change the overall exposure (AUC) of
acetaminophen following a single dose of acetaminophen 1000 mg,
administered 8 hours after the dose of liraglutide at steady state.

Acetaminophen Cmax was decreased by 31% and median Tmax was
delayed up to 15 minutes.
Griseofulvin
Liraglutide did not change the overall exposure (AUC) of griseofulvinfollowing co-administration of a single dose of griseofulvin 500 mg
with liraglutide at steady state. Griseofulvin Cmax increased by 37%
while median Tmax did not change.
Insulin Detemir
No pharmacokinetic interaction was observed between liraglutide
and insulin detemir when separate subcutaneous injections of
insulin detemir 0.5 Unit/kg (single-dose) and liraglutide 1.8 mg(steady state) were administered to patients with type 2 diabetes
mellitus.
13
NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of
Fertility
A 104-week carcinogenicity study was conducted in male andfemale CD-1 mice at doses of 0.03, 0.2, 1, and 3 mg/kg/day
liraglutide administered by bolus subcutaneous injection yielding
systemic exposures 0.2-, 2-, 10- and 43-times the exposure inobese humans, respectively, at the maximum recommended humandose (MRHD) of 3 mg/day based on plasma AUC comparison. A
dose-related increase in benign thyroid C-cell adenomas was seenin the 1 and the 3 mg/kg/day groups with incidences of 13% and
19% in males and 6% and 20% in females, respectively. C-celladenomas did not occur in control groups or 0.03 and 0.2 mg/
kg/day groups. Treatment-related malignant C-cell carcinomas
occurred in 3% of females in the 3 mg/kg/day group. Thyroid C-celltumors are rare findings during carcinogenicity testing in mice. A
treatment-related increase in fibrosarcomas was seen on the dorsal
skin and subcutis, the body surface used for drug injection, in males
in the 3 mg/kg/day group. These fibrosarcomas were attributed tothe high local concentration of drug near the injection site. The
liraglutide concentration in the clinical formulation (6 mg/mL) is
10-times higher than the concentration in the formulation used toadminister 3 mg/kg/day liraglutide to mice in the carcinogenicity
study (0.6 mg/mL).
A 104-week carcinogenicity study was conducted in male andfemale Sprague Dawley rats at doses of 0.075, 0.25 and 0.75 mg/
kg/day liraglutide administered by bolus subcutaneous injection
with exposures 0.5-, 2- and 7-times the exposure in obese
humans, respectively, resulting from the MRHD based on plasma
AUC comparison. A treatment-related increase in benign thyroid
C-cell adenomas was seen in males in 0.25 and 0.75 mg/kg/day
liraglutide groups with incidences of 12%, 16%, 42%, and 46%
and in all female liraglutide-treated groups with incidences of 10%,27%, 33%, and 56% in 0 (control), 0.075, 0.25, and 0.75 mg/kg/
day groups, respectively. A treatment-related increase in malignant
thyroid C-cell carcinomas was observed in all male liraglutidetreated groups with incidences of 2%, 8%, 6%, and 14% and infemales at 0.25 and 0.75 mg/kg/day with incidences of 0%, 0%,4%, and 6% in 0 (control), 0.075, 0.25, and 0.75 mg/kg/day groups,
respectively. Thyroid C-cell carcinomas are rare findings during
carcinogenicity testing in rats.
Studies in mice demonstrated that liraglutide-induced C-cellproliferation was dependent on the GLP-1 receptor and thatliraglutide did not cause activation of the REarranged during
Transfection (RET) proto-oncogene in thyroid C-cells.
Human relevance of thyroid C-cell tumors in mice and rats
is unknown and has not been determined by clinical studies
or nonclinical studies [see Boxed Warning and Warnings andPrecautions (5.1)].
Liraglutide was negative with and without metabolic activationin the Ames test for mutagenicity and in a human peripheral
blood lymphocyte chromosome aberration test for clastogenicity.
Liraglutide was negative in repeat-dose in vivo micronucleus tests
in rats.
In rat fertility studies using subcutaneous doses of 0.1, 0.25 and1 mg/kg/day liraglutide, males were treated for 4 weeks prior toand throughout mating and females were treated 2 weeks prior toand throughout mating until gestation day 17. No direct adverse
effects on male fertility was observed at doses up to 1 mg/kg/day,a high dose yielding an estimated systemic exposure 11-times the
exposure in obese humans at the MRHD, based on plasma AUC
comparison. In female rats, an increase in early embryonic deaths
occurred at 1 mg/kg/day. Reduced body weight gain and foodconsumption were observed in females at the 1 mg/kg/day dose.
14
CLINICAL STUDIES
14.1 Weight Management Trials in Adults with
Overweight or Obesity
The safety and efficacy of SAXENDA® for chronic weight management
in conjunction with reduced caloric intake and increased physicalactivity were studied in three 56-week, randomized, double-blind,placebo-controlled trials. In all studies, SAXENDA® was titrated to
3 mg daily during a 4-week period. All patients received instruction
for a reduced-calorie diet (approximately 500 kcal/day deficit) andphysical activity counseling (recommended increase in physicalactivity of minimum 150 mins/week) that began with the first doseof study medication or placebo and continued throughout the trial.

6
Study 1 enrolled 3731 patients with obesity (BMI greater than orequal to 30 kg/m2) or with overweight (BMI 27-29.9 kg/m2) andat least one weight-related comorbid condition such as treatedor untreated dyslipidemia or hypertension; patients with type 2
diabetes mellitus were excluded. Patients were randomized in a
2:1 ratio to either SAXENDA® or placebo. Patients were stratified
based on the presence or absence of abnormal blood glucose
measurements at randomization. All patients were treated for up to
56 weeks. Those patients with abnormal glucose measurements at
randomization (2254 of the 3731 patients) were treated for a total of
160 weeks. At baseline, mean age was 45 years (range 18-78), 79%
were women, 85% were Caucasian, 10% were African American,
and 11% were Hispanic/Latino. Mean baseline body weight was
106.3 kg and mean BMI was 38.3 kg/m2.
Study 2 was a 56-week trial that enrolled 635 patients with type2 diabetes and with either overweight or obesity (as defined
above). Patients were to have an HbA1c of 7-10% and be treatedwith metformin, a sulfonylurea, or a glitazone as single agent orin any combination, or with a reduced-calorie diet and physicalactivity alone. Patients were randomized in a 2:1 ratio to receive
either SAXENDA® or placebo. The mean age was 55 years (range
18-82), 50% were women, 83% were Caucasian, 12% were African
American, and 10% were Hispanic/Latino. Mean baseline bodyweight was 105.9 kg and mean BMI was 37.1 kg/m2.
Study 3 was a 56-week trial that enrolled 422 patients with obesity(BMI greater than or equal to 30 kg/m2) or with overweight (BMI
27-29.9 kg/m2) and at least one weight-related comorbid condition
such as treated or untreated dyslipidemia or hypertension; patientswith type 2 diabetes mellitus were excluded. All patients were firsttreated with a low-calorie diet (total energy intake 1200-1400 kcal/day) in a run-in period lasting up to 12 weeks. Patients who lost atleast 5% of their screening body weight after 4 to 12 weeks during
the run-in were then randomized, with equal allocation, to receive
either SAXENDA® or placebo for 56 weeks. The mean age was
46 years (range 18-73), 81% were women, 84% were Caucasian,
13% were African American, and 7% were Hispanic/Latino. Meanbaseline body weight was 99.6 kg and mean BMI was 35.6 kg/m2.
The proportions of patients who discontinued study drug in the
56-week trials were 27% for the SAXENDA® -treated group and
35% for the placebo-treated group, and in the 160-week trial the
proportions of patients who discontinued were 47% and 55%,
respectively. In the 56-week trials, approximately 10% of patientstreated with SAXENDA® and 4% of patients treated with placebo
discontinued treatment due to an adverse reaction [see Adverse
Reactions (6.1)]. The majority of patients who discontinued
SAXENDA® due to adverse reactions did so during the first few
months of treatment. In the 160-week trial the proportions ofpatients who discontinued due to an adverse reaction was 13% and
6% for SAXENDA® - and placebo-treated patients, respectively.
Effect of SAXENDA ® on Body Weight in 56-week Trials
For Study 1 and Study 2, the primary efficacy parameters were mean
percent change in body weight and the percentages of patientsachieving greater than or equal to 5% and 10% weight loss frombaseline to week 56. For Study 3, the primary efficacy parameters
were mean percent change in body weight from randomization to
week 56, the percentage of patients not gaining more than 0.5%
body weight from randomization (i.e., after run-in) to week 56,
and the percentage of patients achieving greater than or equal to
5% weight loss from randomization to week 56. Because losing
at least 5% of fasting body weight through lifestyle intervention
during the 4- to 12-week run-in was a condition for their continued
participation in the randomized treatment period, the results may
not reflect those expected in the general population.
Table 6 presents the results for the changes in weight observedin Studies 1, 2, and 3. After 56 weeks, treatment with SAXENDA®
resulted in a statistically significant reduction in weight comparedwith placebo. Statistically significantly greater proportions ofpatients treated with SAXENDA® achieved 5% and 10% weightloss than those treated with placebo. In Study 3, statisticallysignificantly more patients randomized to SAXENDA® than placebo
had not gained more than 0.5% of body weight from randomization
to week 56.

SAXENDA ® (liraglutide) injection 3mg

7Table 6. Changes in Weight at Week 56 for Studies 1, 2, and 3
Study 1 (Obesityor overweight withcomorbidity)
SAXENDA® Placebo
N=2487
N=1244

Study 2 (Type 2
Study 3 (Obesity or overweight
diabetes with obesity or with comorbidity following at
overweight)
least 5% weight loss with diet)
SAXENDA® Placebo
SAXENDA®
Placebo
N=423
N=212
N=212
N=210

106.2
(21.2)-7.4-4.5*(-5.2;-3.8)

106.2(21.7)-3.0

105.7(21.9)-5.4-3.7*(-4.7;-2.7)

106.5(21.3)-1.7

100.4(20.8)-4.9-5.2*(-6.8;-3.5)

98.7(21.2)
0.3

62.3%

34.4%

49.0%

16.4%

44.2%

21.7%

WeightBaseline mean (SD) (kg)Percent change from baseline (LSMean)
Difference from placebo (LSMean)(95% CI)% of Patients losing greater than orequal to 5% body weight
Difference from placebo (LSMean)(95% CI)% of Patients losing greater than
10% body weight
Difference from placebo (LSMean)(95% CI)

27.9*(23.9;31.9)

32.6*(25.1;40.1)

33.9%

15.4%

22.6*
(13.9;31.3)

22.4%

18.5*
(15.2;21.7)

5.5%

25.4%

16.9*
(11.7;22.1)

6.9%

18.5*
(11.7;25.3)

SD = Standard Deviation; CI = Confidence Interval* p < 0.0001 compared to placebo. Type 1 error was controlled across the three endpoints.
Includes all randomized subjects who had a baseline body weight measurement. All available body weight data during the 56 weektreatment period are included in the analysis. In Studies 1 and 2 missing values for week 56 were handled using multiple imputations
analysis. In Study 3 missing values for week 56 were handled using weighted regression analysis.
The cumulative frequency distributions of change in body weight from baseline to week 56 are shown in Figure 2 for Studies 1 and 2. One
way to interpret this figure is to select a change in body weight of interest on the horizontal axis and note the corresponding proportionsof patients (vertical axis) in each treatment group who achieved at least that degree of weight loss. For example, note that the verticalline arising from -10% in Study 1 intersects the SAXENDA® and placebo curves at approximately 34% and 15%, respectively, whichcorrespond to the values shown in Table 6.
Cumulative Frequency (%)

100
90
80
70
60
50
40
30
20
10
0
-30 -25 -20 -15 -10 -5 0
5 10
Change in body weight (%)
Saxenda ®
Placebo

Cumulative Frequency (%)

100
90
80
70
60
50
40
30
20
10
0
-30 -25 -20 -15 -10 -5 0
5 10
Change in body weight (%)
Saxenda ®
Placebo15

20

ITT, multiple imputations (MI)20

15

ITT, multiple imputations (MI)Figure 2. Change in body weight (%) from baseline to week 56 (Study 1 on left and Study 2 on right)
0
-1
-2
-3
-4
-5
-6
-7
-8
-9
-10

Saxenda ®

Placebo-3.5

Change in Body Weight (%)

Change in Body Weight (%)

The time courses of weight loss with SAXENDA® and placebo from baseline through week 56 are depicted in Figures 3 and 4.

-3.0

-7.4
-9.2
0 2 4 6 8 12 16 20 24 28 32 36 40 44
2273 2159 2073 Weeks 1919

N, Saxenda® 2487
N, Placebo 1244

1150

1057

983

50

56 ITT-MI
1812
822

885

2487
1244

0
-1
-2
-3
-4
-5
-6
-7
-8
-9
-10

Saxenda ®

Placebo
-1.7

-2.8

-5.4
-6.7

0 2 4 6 8 12 16 20 24 28 32 36 40 44
385
365
346 Weeks 329

N, Saxenda® 423
N, Placebo 212

193

166

145

50

124

56 ITT-MI
318
116

423
212

Change in Body Weight (%)

Observed values for patients on study drug completing each
Observed values for patients on study drug completing eachscheduled visit, and ITT with multiple imputations (ITT-MI)
scheduled visit, and ITT with multiple imputations (ITT-MI)
Figure 3. Change from baseline (%) in body weight (Study 1 on left and Study 2 on right)
7
6
5
4
3
2
1
0
-1
-2
-3
-4 Low cal. diet
-5
-6
-7
-8
-9
-12 -8 -6 -4 -2 0 2 4 6

N, Saxenda®
N, Placebo

212
210

Saxenda ®

Placebo

0.3

0.0

-4.9
-6.8
10 14 18 22 26 30 34 38 42 46 50

190
180

Weeks

172
159

56

ITT-WA

156
144

177
169

Observed values for patients on study drug completing each scheduled visit, and ITT with weighted average (ITT-WA)
Figure 4. Change from baseline (%) in body weight during Study 3

SAXENDA ® (liraglutide) injection 3mg
with Abnormal Blood Glucose at Randomization)
The numbers and percentages of patients known to have lost greater than or equal to 5% body weightat week 56 and/or week 160 in Study 1 (patients with abnormal glucose at randomization only) aresummarized in Table 7 for descriptive purposes.
Table 7. Changes in Weight at Week 56 and Week 160 for Study 1 (Subset of Patientswith Abnormal Blood Glucose at Randomization)
SAXENDA®
Placebo
N = 1505
N = 749
Baseline mean body weight (SD) (kg)107.5 (21.6)
107.9 (21.8)
Number (%) of patients known to lose greater than or equal to 5% body817 (56%)
182 (25%)weight at 56 weeks
Number (%) of patients known to lose greater than or equal to 5% body424 (28%)102 (14%)weight at 160 weeks
Number (%) of patients known to lose greater than or equal to 5% body391 (26%)
74 (10%)weight at both 56 weeks and 160 weeks
Number (%) of patients with weight assessment at 160 weeks
747 (50%)322 (43%)
SD = Standard Deviation
Includes all randomized subjects who had a baseline body weight measurement. All available bodyweight data at 56 and 160 weeks are included in the analysis.
Effect of SAXENDA ® on Anthropometry and Cardiometabolic Parameters in 56-week
TrialsChanges in waist circumference and cardiometabolic parameters with SAXENDA® are shown in Table
8 for Study 1 (patients without diabetes mellitus) and Table 9 for Study 2 (patients with type 2 diabetes).
Results from Study 3, which also enrolled patients without diabetes mellitus, were similar to Study 1.
Table 8. Mean Changes in Anthropometry and Cardiometabolic Parameters in Study 1(Patients without Diabetes)
SAXENDA®
Placebo
N = 2487
N = 1244
Change from
Change fromBaseline
Baseline
SAXENDA® minus
Baseline (LSMean1) Baseline (LSMean1) Placebo (LSMean)
Waist Circumference (cm)
115.0
-8.2
114.5
-4.0
-4.2
Systolic Blood Pressure (mmHg)
123.0
-4.3
123.3
-1.5
-2.8
Diastolic Blood Pressure (mmHg) 78.7
-2.7
78.9
-1.8
-0.9
Heart Rate (bpm)2
71.4
2.6
71.3
0.1
2.5
HbA1c (%)
5.6
-0.3
5.6
-0.1
-0.2
% Change% Change Relative Difference
from Baselinefrom Baseline of SAXENDA® to
Baseline (LSMean1) Baseline (LSMean1) Placebo (LSMean)
Total Cholesterol (mg/dL)*
193.8
-3.2
194.4
-0.9
-2.3
LDL Cholesterol (mg/dL)*
111.8
-3.1
112.3
-0.7
-2.4
HDL Cholesterol (mg/dL)*
51.4
2.3
50.9
0.5
1.9
Triglycerides (mg/dL)†
125.7
-13.0
128.3
-4.1
-7.1
Based on last observation carried forward method while on study drug
1	Least squares mean adjusted for treatment, country, sex, pre-diabetes status at screening, baseline
BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixedfactors, and the baseline value as covariate.
2 See Warnings and Precautions (5.5)* Baseline value is the geometric mean†	Values are baseline median, median % change, and the Hodges-Lehmann estimate of the mediantreatment difference.
Table 9. Mean Changes in Anthropometry and Cardiometabolic Parameters in Study 2(Patients with Diabetes Mellitus)
SAXENDA®
Placebo
N = 423
N = 212
Change from
Change fromBaseline
Baseline
SAXENDA® minus
1
Baseline (LSMean ) Baseline (LSMean1) Placebo (LSMean)
Waist Circumference (cm)
118.1
-6.0
117.3
-2.8
-3.2
Systolic Blood Pressure (mmHg)
128.9
-3.0
129.2
-0.4
-2.6
Diastolic Blood Pressure (mmHg) 79.0
-1.0
79.3
-0.6
-0.4
Heart Rate (bpm)2
74.0
2.0
74.0
-1.5
3.4
HbA1c (%)
7.9
-1.3
7.9
-0.4
-0.9
% Change% Change Relative Difference
from Baselinefrom Baseline of SAXENDA® to
1
Baseline (LSMean ) Baseline (LSMean1) Placebo (LSMean)
Total Cholesterol (mg/dL)*
171.0
-1.4
169.4
2.4
-3.7
LDL Cholesterol (mg/dL)*
86.4
0.9
85.2
3.3
-2.3
HDL Cholesterol (mg/dL)*
45.2
4.8
45.4
1.9
2.9
Triglycerides (mg/dL)†
156.2
-14.5
155.8
-0.7
-13.5
Based on last observation carried forward method while on study drug
1	Least squares mean adjusted for treatment, country, sex, background treatment, baseline HbA1c
stratum and an interaction between background treatment and HbA1c stratum as fixed factors, andthe baseline value as covariate.
2 See Warnings and Precautions (5.5)* Baseline value is the geometric mean†	Values are baseline median, median % change, and the Hodges-Lehmann estimate of the mediantreatment difference.

8

14.2 Weight Management Trial in Pediatric Patients Ages 12 and Older with Obesity
SAXENDA® was evaluated in a 56-week, double-blind, randomized, parallel group, placebo controlled
multicenter trial in 251 pubertal pediatric patients aged 12 to 17 years, with BMI corresponding to
30 kg/m2 or greater for adults by international cut-off points [see Dosage and Administration (2.1)]
and BMI of 95th percentile or greater for age and sex (NCT02918279). 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 as judged by the investigator.
Escalation of the trial product was not allowed if the subject had a self-monitored plasma glucose(SMPG) < 56 mg/dL or < 70 mg/dL in the presence of symptoms of hypoglycemia during the weekprior to or during the dose escalation visits. The proportion of patients who reached the 3 mg dose was
82.4%; for 8.8% of patients 2.4 mg was the maximum tolerated dose.
The mean age was 14.5 years: 40.6% of patients were male, 87.6% were White, 0.8% were Asian, 8%
were Black or African American; 22.3% were of Hispanic or Latino ethnicity. The mean baseline bodyweight was 100.8 kg, and mean Body Mass Index (BMI) was 35.6 kg/m2.
The proportions of patients who discontinued study drug were 19.2% for the SAXENDA® -treated groupand 20.6% for the placebo-treated group; 10.4% of patients treated with SAXENDA® and no patientstreated with placebo discontinued treatment due to an adverse reaction [see Adverse Reactions (6.1)].
The primary endpoint was change in BMI SDS. At baseline, mean BMI SDS was 3.14 in the SAXENDA®
group and 3.20 in the placebo group. At week 56, treatment with SAXENDA® resulted in statisticallysignificant reduction in BMI SDS from baseline compared to placebo. The observed mean change
in BMI SDS from baseline to week 56 was -0.23 in the SAXENDA® group and -0.00 in the placebogroup. The estimated treatment difference in BMI SDS reduction from baseline between SAXENDA®
and placebo was -0.22 with a 95% confidence interval of -0.37, -0.08; p=0.0022.
The time course of change in BMI SDS with SAXENDA® and placebo from baseline through week 56
are depicted in Figure 5.
BMI SDS, change from baseline

Effect of SAXENDA ® on Body Weight in a 160-week Trial (Study 1, Subset of Patients

-0.00

0.0

-0.02

-0.1

-0.2

-0.23
-0.25

-0.3
N, Saxenda®
N, Placebo

125
126

123
125

119
123

120
119

118
116

119
116

110
105

107
101

113
105

125
126

0

0

16

20

25

30

42

51

56

FAS-MITime since randomization (weeks)
Saxenda ®

Placebo

BMI SDS: Body mass index standard deviation score. Line graphs are observed means. Error bar is:+/- standard error of mean
Number at week 56 are estimated means using multiple imputation (jump to reference) for patientscompleting each scheduled visits.
Figure 5. Change from Baseline in BMI SDS
Changes in weight and BMI with SAXENDA® are shown in Table 10. Changes in waist circumference
and cardiometabolic parameters with SAXENDA® are shown in Table 11.
Table 10. Changes in Weight and BMI at Week 56 for Study 4 (Pediatric Patients Ages
12 to Less than 18)
SAXENDA®
Placebo
SAXENDA® minus
N = 125
N = 126
Placebo
Body Weight
Baseline mean Body Weight (kg)
99.3
102.2
Mean Change from Baseline (%)
-2.65
2.37
-5.01
BMI
Baseline mean BMI (kg/m2)
35.3
35.8
Mean Change from Baseline (%)
-4.29
0.35
-4.64
Proportion of patients with greater thanor equal to 5% reduction in baseline BMI
43.3%
18.7%
24.6%
at week 56 (%)
Proportion of patients with greater thanor equal to 10% reduction in baseline BMI
26.1%
8.1%
18.0%
at week 56 (%)
Full Analysis Set. For body weight and BMI, baseline values are means, changes from baseline atweek 56 are estimated means (least-squares) and treatment contrasts at week 56 are estimatedtreatment differences. Missing observations were imputed from the placebo arm based on a jump toreference multiple (x100) imputation approach.

SAXENDA ® (liraglutide) injection 3mg
Table 11. Mean Changes in Anthropometry and Cardiometabolic Parameters in Study 4(Pediatric Patients Ages 12 to Less than 18)
SAXENDA®
Placebo
N = 125
N = 126
Change from
Change from SAXENDA® minus
Baseline
Baseline
Baseline
Baseline
Placebo
Waist Circumference (cm)
105
-4.35
107
-1.42
-2.93
Systolic Blood Pressure (mmHg)
116
-1.21
117
0.84
-2.05
Diastolic Blood Pressure (mmHg)
72
0.77
73
-0.46
1.24
Heart Rate (bpm)*
75
1.87
78
-0.14
2.01
HbA1c (%)
5.3
-0.10
5.3
-0.03
-0.06
Relative Difference% Change% Changeof SAXENDA® to
Baseline from Baseline Baseline from Baseline
Placebo
Total Cholesterol (mg/dL)**
154.2
0.84
152.2
-0.03
0.88
LDL Cholesterol (mg/dL)**
85.5
1.74
82.5
3.01
-1.27
HDL Cholesterol (mg/dL)**
42.7
5.14
42.7
3.33
1.81
Triglycerides (mg/dL)**
109.1
-0.12
112.2
-1.35
1.23
* See Warnings and Precautions (5.5)
Full Analysis Set. Baseline values are means, changes from baseline at week 56 are estimatedmeans (least-squares) and treatment contrasts at week 56 are estimated treatment differences.
Missing observations were imputed from the placebo arm based on a jump to reference multiple(x100) imputation approach.
** Baseline values are geometric means.
14.3 Cardiovascular Outcomes Trial of Liraglutide 1.8 mg in Adult Patients withType 2 Diabetes and Cardiovascular Disease
Liraglutide 1.8 mg (Victoza®) is used in the treatment of type 2 diabetes mellitus in adults. The efficacy
of liraglutide at doses below 3 mg daily has not been established for chronic weight management.
The LEADER trial (NCT01179048) randomized 9340 patients with inadequately controlled type 2
diabetes and cardiovascular disease to liraglutide 1.8 mg or placebo in addition to standard of caretreatments for type 2 diabetes for a median duration of 3.5 years. Patients either were 50 years ofage or older with established, stable cardiovascular, cerebrovascular, peripheral vascular disease,chronic renal failure or chronic heart failure (80% of patients), or were 60 years of age or older and hadother specified risk factors of vascular disease (20% of patients).The population was 64% male, 78%
Caucasian, 10% Asian and 8% Black; 12% of the population was Hispanic or Latino.
In total, 96.8% of the patients completed the trial; vital status was known at the end of the trial for
99.7%. The primary endpoint was the time from randomization to first occurrence of a major adverse
cardiovascular event (MACE) defined as: cardiovascular death, non-fatal myocardial infarction, or
non-fatal stroke. No increased risk for MACE was observed with liraglutide 1.8 mg. The total number ofprimary component MACE endpoints was 1302 (608 [13.0%] with liraglutide 1.8 mg and 694 [14.9%]
with placebo).
16
HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
SAXENDA® injection: 6 mg/mL clear, colorless solution in a 3 mL single-patient-use pre-filled pen thatdelivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3 mg is available in the following package sizes:
3 x SAXENDA® pen NDC 0169-2800-13
5 x SAXENDA® pen NDC 0169-2800-15
16.2 Recommended Storage
Prior to first use, SAXENDA® should be stored in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). Do
not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze SAXENDA®
and do not use SAXENDA® if it has been frozen.
After initial use of the SAXENDA® pen, the pen can be stored for 30 days at controlled room temperature(59°F to 86°F; 15°C to 30°C) or in a refrigerator (36°F to 46°F; 2°C to 8°C). Keep the pen cap on when
not in use. Protect SAXENDA® from excessive heat and sunlight. Always remove and safely discard
the needle after each injection and store the SAXENDA® pen without an injection needle attached. This
will reduce the potential for contamination, infection, and leakage while also ensuring dosing accuracy.
17
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for
Use).
Instructions
Advise patients to take SAXENDA® exactly as prescribed. Instruct patients to follow the dose escalation
schedule and to not take more than the recommended dose.
Instruct adult patients to discontinue SAXENDA® if they have not achieved 4% weight loss by 16 weeks
of treatment. Instruct pediatric patients 12 years of age and older to discontinue SAXENDA® if they
have not achieved a BMI reduction of 1% from baseline after 12 weeks on the maintenance dose.
Risk of Thyroid C-cell Tumors
Inform patients that liraglutide causes benign and malignant thyroid C-cell tumors in mice and rats andthat the human relevance of this finding has not been determined. Counsel patients to report symptomsof thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia or dyspnea) to their health careprovider [see Boxed Warning and Warnings and Precautions (5.1)].
Acute Pancreatitis
Inform patients of the potential risk for acute pancreatitis. Explain that persistent severe abdominal
pain that may radiate to the back which may or may not be accompanied by vomiting is the hallmark
symptom of acute pancreatitis. Instruct patients to discontinue SAXENDA® promptly and contact theirhealth care provider if persistent severe abdominal pain occurs.
Acute Gallbladder Disease
Inform patients of the risk of acute gallbladder disease. Advise patients that substantial or rapid weightloss can increase the risk of gallbladder disease, but that gallbladder disease may also occur in theabsence of substantial or rapid weight loss. Instruct patients to contact their healthcare provider for
appropriate clinical follow-up if gallbladder disease is suspected.

9

Hypoglycemia
Inform pediatric patients of the risk of hypoglycemia and educate all patients on the signs and symptomsof hypoglycemia. Inform adult patients with type 2 diabetes mellitus on an insulin secretagogue (e.g.,
sulfonylurea) or insulin that they may have an increased risk of hypoglycemia when using SAXENDA®
and to report signs and/or symptoms of hypoglycemia to their healthcare provider.
Heart Rate Increase
Inform patients to report symptoms of sustained periods of heart pounding or racing while at rest to
their healthcare provider. Discontinue SAXENDA® in patients who experience a sustained increase in
resting heart rate.
Dehydration and Renal Impairment
Advise patients of the risk of dehydration due to gastrointestinal adverse reactions and to takeprecautions to avoid fluid depletion. Inform patients of the potential risk for worsening renal function,
which in some cases may require dialysis.
Hypersensitivity Reactions
Inform patients that serious hypersensitivity reactions have been reported during postmarketing useof SAXENDA®. Advise patients on the symptoms of hypersensitivity reactions and instruct them tostop taking SAXENDA® and seek medical advice promptly if such symptoms occur [see Warnings andPrecautions (5.7)].
Suicidal Behavior and Ideation
Advise patients to report emergence or worsening of depression, suicidal thoughts or behavior, and/or
any unusual changes in mood or behavior. Inform patients that if they experience suicidal thoughts or
behaviors, they should stop taking SAXENDA®.
Jaundice and Hepatitis
Inform patients that jaundice and hepatitis have been reported during postmarketing use of liraglutide.
Instruct patients to contact their healthcare provider if they develop jaundice.
Never Share a SAXENDA ® Pen Between Patients
Inform patients that they should never share a SAXENDA® pen with another person, even if the needle
is changed. Sharing of the pen between patients may pose a risk of transmission of infection.

Version: 10
SAXENDA® and VICTOZA® are registered trademarks of Novo Nordisk A/S.
PATENT Information: http://novonordisk-us.com/products/product-patents.html
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark
For information about SAXENDA® contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-844-363-4448© 2023 Novo Nordisk
US23SX00010
5/2023

SAXENDA® (liraglutide) injection 3mg Medication Guide
MEDICATION GUIDESAXENDA® (sax-end-ah) (liraglutide) injection for subcutaneous use
Do not share your SAXENDA® pen with others even if the needle has been changed.
You may give other people a serious infection or get a serious infection from them.

10• You can take SAXENDA® with or without food.
• Throw away the used SAXENDA® pen after 30 days.
Your healthcare provider should start you on a reduced calorie diet and increased physical activity
when you start taking SAXENDA®. Stay on this program while you are taking SAXENDA®.

What are the possible side effects of SAXENDA®?
What is the most important information I should know about SAXENDA®?
SAXENDA® may cause serious side effects, including:
Serious side effects may happen in people who take SAXENDA®, including:• See “What is the most important information I should know about SAXENDA®?”
Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump• inflammation of the pancreas (pancreatitis). Stop using SAXENDA® and call youror swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may behealthcare provider right away if you have severe pain in your stomach area (abdomen) that will®
symptoms of thyroid cancer. In studies with rats and mice, SAXENDA and medicines that work likenot go away, with or without vomiting. You may feel the pain from your stomach area (abdomen) to
SAXENDA® caused thyroid tumors, including thyroid cancer. It is not known if SAXENDA® will cause
your back.
thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
• gallbladder problems. SAXENDA® may cause gallbladder problems including gallstones.
Do not use SAXENDA ® if you or any of your family have ever had a type of thyroid cancer called
Some gallbladder problems need surgery. Call your healthcare provider if you have any of the
medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple
following symptoms:
Endocrine Neoplasia syndrome type 2 (MEN 2).
• pain in your upper stomach (abdomen)• yellowing of your skin or eyes (jaundice)• fever• clay-colored stools
What is SAXENDA®?
•
increased
risk
of
low
blood
sugar
(hypoglycemia)
in adults with type 2 diabetes
SAXENDA® is an injectable prescription medicine used for adults with obesity or overweight (excess
mellitus who also take medicines to treat type 2 diabetes mellitus such as
weight) who also have weight related medical problems, and children aged 12 to 17 years with a body
sulfonylureas or insulin.
weight above 132 pounds (60 kg) and obesity to help them lose weight and keep the weight off.
• risk of low blood sugar (hypoglycemia) in children who are 12 years of age and older• SAXENDA® should be used with a reduced calorie diet and increased physical activity.
without type 2 diabetes mellitus• SAXENDA® and VICTOZA® have the same active ingredient, liraglutide, and should not be used
• Signs and symptoms of low blood sugar may include:
together or with other GLP-1 receptor agonist medicines.
• shakiness• weakness• hunger• It is not known if SAXENDA® is safe and effective when taken with other prescription, over-the• sweating• dizziness• fast heartbeat
counter medicines, or herbal weight loss products.
• headache• confusion• feeling jittery• It is not known if SAXENDA® is safe and effective in children under 12 years of age.
• drowsiness• irritability• It is not known if SAXENDA® is safe and effective in children aged 12 to 17 years with type 2
		Talk to your healthcare provider about how to recognize and treat low blood sugar. You should
diabetes.
check your blood sugar before you start taking SAXENDA® and while you take SAXENDA®.
• increased heart rate. SAXENDA® can increase your heart rate while you are at rest. YourWho should not use SAXENDA®?
healthcare provider should check your heart rate while you take SAXENDA®. Tell your healthcare
Do not use SAXENDA® if:provider if you feel your heart racing or pounding in your chest and it lasts for several minutes.
• you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma • kidney problems (kidney failure). SAXENDA® may cause nausea, vomiting or diarrhea(MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome
leading to loss of fluids (dehydration). Dehydration may cause kidney failure which can lead totype 2 (MEN 2).
the need for dialysis. This can happen in people who have never had kidney problems before.
®
• you have had a serious allergic reaction to liraglutide or any of the ingredients in SAXENDA .
Drinking plenty of fluids may reduce your chance of dehydration.
®
See the end of this Medication Guide for a complete list of ingredients in SAXENDA . Symptoms 		Call your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not goof a serious allergic reaction include:
away, or if you cannot drink liquids by mouth.
• swelling of your face, lips, tongue, or throat • problems breathing or swallowing• serious allergic reactions. Stop using SAXENDA®, and get medical help right away if you• severe rash or itching• fainting or feeling dizzyhave any symptoms of a serious allergic reaction including:• very rapid heartbeat• swelling of your face, lips, tongue, or throat • problems breathing or swallowing• are pregnant or plan to become pregnant. SAXENDA® may harm your unborn baby.
• fainting or feeling dizzy• severe rash or itching• very rapid heartbeat
Before taking SAXENDA®, tell your healthcare provider about all of your medical• depression or thoughts of suicide. You should pay attention to any mental changes,
conditions, including if you:especially sudden changes, in your mood, behaviors, thoughts, or feelings. Call your healthcare• are taking certain medicines called GLP-1 receptor agonists.
provider right away if you have any mental changes that are new, worse, or worry you.
• have severe problems with your stomach, such as slowed emptying of your stomach
The most common side effects of SAXENDA® in adults include:(gastroparesis) or problems with digesting food.
• nausea• injection site reaction• tiredness (fatigue)• have or have had problems with your pancreas, kidneys or liver.
• change in enzyme (lipase) levels in your blood• have or have had depression or suicidal thoughts, or mental health issues.
• diarrhea• low blood sugar (hypoglycemia) • dizziness• are breastfeeding or plan to breastfeed. It is not known if SAXENDA® passes into your breast milk.
• constipation• headache• stomach pain
You and your healthcare provider should decide if you will use SAXENDA® or breastfeed.
• vomiting• upset stomach (dyspepsia)
Tell your healthcare provider about all the medicines you take including prescription, overthe-counter medicines, vitamins, and herbal supplements. SAXENDA® slows stomach emptying and Additional common side effects in children are fever and gastroenteritis
can affect medicines that need to pass through the stomach quickly. SAXENDA® may affect the way Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
some medicines work and some other medicines may affect the way SAXENDA® works.
These are not all the possible side effects of SAXENDA®. Call your doctor for medical advice about
Tell your healthcare provider if you take diabetes medicines, especially insulin and sulfonylurea
side effects. You may report side effects to FDA at 1-800-FDA-1088.
medicines. Talk with your healthcare provider if you are not sure if you take any of these medicines.
Keep your SAXENDA® pen, pen needles, and all medicines out of the reach of children.
®
How should I use SAXENDA ?
General information about the safe and effective use of SAXENDA®.
• Read the Instructions for Use that comes with SAXENDA®.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
• Use SAXENDA® exactly as prescribed by your healthcare provider.
Do not use SAXENDA® for a condition for which it was not prescribed. Do not give SAXENDA® to®
• Your healthcare provider should show you how to use SAXENDA before you use it for the firstother people, even if they have the same symptoms that you have. It may harm them.
time.
You can ask your pharmacist or healthcare provider for information about SAXENDA® that is written• Use SAXENDA® exactly as prescribed by your healthcare provider. Your dose should be increased for health professionals.
after using SAXENDA® for 1 week until you reach the 3 mg dose.
• Start SAXENDA® with 0.6 mg per day in your first week. In your second week, increase your daily What are the ingredients in SAXENDA®?
dose to 1.2 mg. In the third week, increase your daily dose to 1.8 mg. In the fourth week, increase Active ingredient: liraglutide
your daily dose to 2.4 mg and in the fifth week onwards, increase your daily dose to the full doseof 3 mg. After that, do not change your dose unless your healthcare provider tells you to. Children Inactive ingredients: disodium phosphate dihydrate, propylene glycol, phenol and water for
injection. Hydrochloric acid or sodium hydroxide may be added to adjust the pH.
may reduce their dose to 2.4 mg daily if the maximum dose is not tolerated.
• SAXENDA® is injected 1 time each day, at any time during the day.
• Inject your dose of SAXENDA® under the skin (subcutaneously) in your stomach area (abdomen),
upper leg (thigh), or upper arm, as instructed by your healthcare provider. Do not inject into avein or muscle.
• Change (rotate) your injection site within the area you choose with each injection to reduce yourrisk of getting lumps under the skin (cutaneous amyloidosis). Do not use the same site for each
injection.
• If you take too much SAXENDA®, call your healthcare provider right away. Taking too much
SAXENDA® may cause severe nausea, severe vomiting, and low blood sugar (hypoglycemia).
• If you miss your daily dose of SAXENDA®, just take your next daily dose as usual on the following
day. Do not take an extra dose of SAXENDA® or increase your dose on the following day to makeup for your missed dose. If you miss your dose of SAXENDA® for 3 days or more, call yourhealthcare provider to talk about how to restart your treatment.

Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark.
For information about SAXENDA® go to www.SAXENDA.com or contact:
Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536 1-844-363-4448.
SAXENDA®, VICTOZA®, and NovoFine ® are registered trademarks of Novo Nordisk A/S.
PATENT Information: http://novonordisk-us.com/products/product-patents.html
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: 06/2022© 2023 Novo Nordisk
US23SX00010 5/2023

SAXENDA® (liraglutide) injection 3mg Instructions for Use

Saxenda® pen and needle (example)
Pen
scale

Pen
window

Dose
counterDose
selector

15

9

12

3

6

0

(liraglutide) injection

Dose
pointerDosebuttonPen cap
0

Flow
check
symbolNovoFine®
Outer
Inner
Paper
needle cap needle cap Needle tab

NovoTwist ®
Outer
Inner
Paper
needle cap needle cap Needle tab

Step 1. Prepare yourA
pen with a new needle• Wash your hands withsoap and water.
• Check the name andcolored label of your pen,
to make sure that it contains
Saxenda®. This is especially
important if you take morethan 1 type of medicine.
• Pull off the pen cap.
• Check that Saxenda®
in your pen is clear
and colorless.
		Look through the pen
window. If Saxenda®
looks cloudy, do not use
the pen.

• Pull off the outerneedle cap. Do not
throw it away.

DE• Pull off the innerF
needle cap andthrow it away.
		A drop of Saxenda®
may appear at theneedle tip. This isnormal, but you
must still check the
Saxenda® flow, if you
use a new pen for the
first time.
Always use a new needle for each injection.
		This will prevent contamination, infection, leakage of
Saxenda®, and blocked needles leading to the wrong dose.
		Never use a bent or damaged needle.
	Do not attach a new needle to your pen until you are readyto take your injection.
Step 2. Check the
Saxenda® flow with eachnew pen.
• Check the Saxenda®
flow before your first
injection with each newpen.
		If your Saxenda® pen isalready in use, go to Step 3“Select your dose”.
• Turn the dose selector
until the dose countershows the flow check
symbol ().

G

NovoFine ®
C

NovoTwist ®

Step 3. Select your doseI
• Turn the dose selector
until the dose countershows your dose
0
(0.6 mg, 1.2 mg, 1.8 mg,
2.4 mg or 3 mg).
		Make sure you know thedose of Saxenda® you
should use.
		If you select the wrong
Exampledose, you can turn the
0.6
dose selector forward or
0.6 mgbackwards to the correct
selected
dose.
Always use the dosecounter and the dose pointer to see how many mg you
select.
		You will hear a “click” every time you turn the dose selector.
Do not set the dose by counting the number of clicks
you hear.
		Do not use the pen scale to set the dose. It does not show
exactly how much Saxenda® is left in your pen.
		Only doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3 mg
can be selected with the dose selector. The selected
dose must line up exactly with the dose pointer to make surethat you get a correct dose.
	The dose selector changes the dose. Only the dose counter anddose pointer will show how many mg you select for each dose.
		You can select up to 3 mg each dose. When your pen contains
less than 3 mg the dose counter stops before 3 mg is shown.
		The dose selector clicks differently when turned forward,
backwards or past the number of mg left. Do not count the pen
clicks.
	How much Saxenda®
is left?
• The pen scale shows
you about how much
Saxenda® is left in your
pen.

J

6
3

ExampleApprox.
3 mg left

00Flow check
symbolselected• Hold the pen with theHneedle pointing up.
		Press and hold in thedose button until the dosecounter shows 0. The 0
must line up with the dosepointer.
		A drop of Saxenda® willappear at the needle tip.
• If no drop appears,
repeat Step 2 above asshown in Figures G and H
up to 6 times. If there is still
no drop, change the needle
and repeat Step 2 as shownin Figures G and H 1 moretime.
		Do not use the pen
if a drop of Saxenda®
still does not appear.
Contact Novo Nordisk at
1-844-363-4448.
Always make surethat a drop appears
at the needle tip before you use a new pen for the first time.
This makes sure that Saxenda® flows.
		If no drop appears, you will not inject any Saxenda®, eventhough the dose counter may move. This may mean that
there is a blocked or damaged needle.
	A small drop may remain at the needle tip, but it will not be
injected.
		 Only check the Saxenda® flow before your first
injection with each new pen.
0

• Take a newneedle, and tear off
the paper tab.

B

• Push the needle
straight onto thepen. Turn until it
is on tight.

• To see how muchK
Saxenda® is left,
use the dose counter:
		Turn the dose selector until
the dose counter stops.
0		If it shows 3, at least 3
mg are left in your pen. If
the dose counter stops
before 3 mg, there is notenough Saxenda® left for a
Examplefull dose of 3 mg.
Dose	If you need more
2.4
counter
Saxenda® than what is
stopped:left in your pen
2.4 mg left
Only if trained or told by yourhealthcare provider, you may split your dose between yourcurrent pen and a new pen. Use a calculator to plan the doses as
instructed by your healthcare provider.
Be very careful to calculate correctly.
		If you are not sure how to split your dose using 2 pens, thenselect and inject the dose you need with a new pen.
Step 4. Inject your dose
• Insert the needle
into your skin as yourhealthcare provider has
shown you.
• Make sure you can
see the dose counter.
Do not cover it with yourfingers. This could stop the
injection.

L
0.6

Instructions for Use• Read these instructions carefully before using your
Saxenda® pen.
• Do not use your pen without proper training fromyour healthcare provider. Make sure that you know how
to give yourself an injection with the pen before you start yourtreatment.
If you are blind or have poor eyesight and cannot
read the dose counter on the pen, do not use this pen
without help. Get help from a person with good eyesight who
is trained to use the Saxenda® pen.
• You can refresh your training at any time by watching
the online training video at www.saxenda.com.
• Start by checking your pen to make sure that it
contains Saxenda®, then look at the pictures below to
get to know the different parts of your pen and needle.
• Your pen is a prefilled, dial-a-dose, single-patient-use
pen. It contains 18 mg of liraglutide, and you can select dosesof 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3 mg. Your pen is madeto be used with NovoFine ® or NovoTwist ® disposableneedles up to a length of 8 mm. Pen needles are not included
with your Saxenda® pen.

11

SAXENDA® (liraglutide) injection 3mg Instructions for Use• Press and hold down
the dose button until
the dose countershows 0. The 0 must line
up with the dose pointer.
You may then hear or feela click.

• Put the pen cap on
your pen after each use
to protect Saxenda® fromlight.

R

0

M

12• The Saxenda® pen you are using should be thrown away after
30 days, even if it still has Saxenda® left in it.
• Do not freeze Saxenda®. Do not use Saxenda® if it has beenfrozen.
• Unused Saxenda® pens may be used until the expiration dateprinted on the label, if kept in the refrigerator.
• Keep Saxenda® away from heat and out of the light.

0• Keep the needle inyour skin after the dosecounter has returned to 0
and count slowly to 6.
• If the needle is removed
earlier, you may see a
stream of Saxenda®
coming from the needle
tip. If this happens, the full
dose will not be delivered.

Count slowly:N0

1-2-3-4-5-6• Remove the needleOfrom your skin.
		If blood appears at the
injection site, press lightly.
Do not rub the area.
Always watch the dosecounter to know how
many mg you inject.
Hold the dose button down
until the dose countershows 0.
		How to identify ablocked or damaged needle?
• If 0 does not appear in the dose counter after continuously
pressing the dose button, you may have used a blocked ordamaged needle.
• If this happens you have not received any Saxenda® eventhough the dose counter has moved from the original dosethat you have set.
		How to handle a blocked needle?
		Change the needle as described in Step 5, and repeat all
steps starting with Step 1: “Prepare your pen with a newneedle”. Make sure you select the full dose you need.
		Never touch the dose counter when you inject. Thiscan stop the injection.
	You may see a drop of Saxenda® at the needle tip after
injecting. This is normal and does not affect your dose.
Step 5. After yourinjection• Carefully remove
the needle fromthe pen. Do not put
the needle caps backon the needle, toavoid needle sticks.

• Place the needle ina sharps container
right away to reduce therisk of needle sticks.

NovoFine ®
P

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NovoTwist ®

	If you do not have aS
sharps container,
follow a 1-handed needle
recapping method. Carefully
slip the needle into the outerneedle cap. Dispose of theneedle in a sharps container
as soon as possible.
Never try to put the
inner needle cap backon the needle. You may
stick yourself with the needle.
		Always remove the needle from your pen.
		This prevents contamination, infection, leakage of Saxenda ®,and blocked needles leading to the wrong dose. If the needle isblocked, you will not inject any Saxenda®.
	A lways dispose of the needle after each injection.
• Do not throw away in the household trash. Put theneedle and any empty Saxenda® pen or any pen used for
30 days still containing Saxenda® in a FDA-cleared sharps
disposal container right away after use.
• If you do not have a FDA-cleared sharps disposal container, you
may use a household container that is:• made of a heavy-duty plastic• can be closed with a tight-fitting, puncture-resistant lid,
without sharps being able to come out upright and stable
during use• leak-resistant• properly labeled to warn of hazardous waste inside thecontainer• When your sharps disposal container is almost full, you willneed to follow your community guidelines for the right way todispose of your sharps disposal container. There may be stateor local laws about how you should throw away used needles
and syringes. For more information about the safe sharps
disposal, and for specific information about sharps disposal in
the state that you live in, go to the FDA’s website at:
http://www.fda.gov/safesharpsdisposal• Do not dispose of your used sharps disposal container in yourhousehold trash unless your community guidelines permit this.
Do not recycle your used sharps disposal container.
• Safely dispose of Saxenda® that is out of date or no longer
needed.
Important• Caregivers must be very careful when handling usedneedles to prevent needle sticks and cross infection.
• Never use a syringe to withdraw Saxenda® from your pen.
• Always carry an extra pen and new needles with you, incase of loss or damage.
• Always keep your pen and needles out of reach of others,
especially children.
• Do not share your Saxenda® pen or needles withanyone else. You may give an infection to them or get an
infection from them.
• Always keep your pen with you. Do not leave it in a car orother place where it can get too hot or too cold.
Caring for your pen• Do not drop your pen or knock it against hard surfaces.
If you drop it or suspect a problem, attach a new needle andcheck the Saxenda® flow before you inject.
• Do not try to repair your pen or pull it apart.
• Do not expose your pen to dust, dirt or liquid.
• Do not wash, soak, or lubricate your pen. If necessary,clean it with mild detergent on a moistened cloth.
How should I store my Saxenda® pen?
• Store your new, unused Saxenda® pens in the refrigerator at
36°F to 46°F (2°C to 8°C).
• Store your pen in use for 30 days at 59ºF to 86ºF (15ºC to30ºC) or in a refrigerator at 36°F to 46°F (2°C to 8°C).

This Medication Guide and Instructions for Use havebeen approved by the U.S. Food andDrug Administration.
December 2020
© 2023 Novo Nordisk
US23SX00010 5/2023