——— CONTRAINDICATIONS ———• Personal or family history of MTC or in patients with MEN 2(4).
• Serious hypersensitivity reaction to semaglutide or any of the excipients in OZEMPIC® (4).

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use OZEMPIC ® safely
and effectively. See full prescribing information for OZEMPIC ®.
OZEMPIC ® (semaglutide) injection, for subcutaneous use
Initial U.S. Approval: 2017——— WARNINGS AND PRECAUTIONS ———• Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis issuspected. Do not restart if pancreatitis is confirmed (5.2).
• Diabetic Retinopathy Complications: Has been reported in a clinical trial. Patients with a historyof diabetic retinopathy should be monitored (5.3).
• Never share an OZEMPIC® pen between patients, even if the needle is changed (5.4).
• Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk ofhypoglycemia, including severe hypoglycemia. Reducing dose of insulin secretagogue or insulin
may be necessary (5.5).
• Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe
adverse gastrointestinal reactions (5.6).
• Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis andangioedema) have been reported. Discontinue OZEMPIC® if suspected and promptly seek
medical advice (5.7).
• Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies
are indicated (5.8).

WARNING: RISK OF THYROID C−CELL TUMORS
See full prescribing information for complete boxed warning.
• In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether
OZEMPIC ® causes thyroid C-cell tumors, including medullary thyroid
carcinoma (MTC), in humans as the human relevance of semaglutide-induced
rodent thyroid C-cell tumors has not been determined (5.1, 13.1).
• OZEMPIC ® is contraindicated in patients with a personal or family history of
MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Counsel patients regarding the potential risk of MTC and symptoms ofthyroid tumors (4, 5.1).
——— INDICATIONS AND USAGE ———OZEMPIC® is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as:• an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
mellitus (1).
• to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus
and established cardiovascular disease (1).
Limitations of Use:
• Has not been studied in patients with a history of pancreatitis. Consider another antidiabetic
therapy (1, 5.2).
• Not for treatment of type 1 diabetes mellitus (1).

——— ADVERSE REACTIONS ———The most common adverse reactions, reported in ≥5% of patients treated with OZEMPIC® are:nausea, vomiting, diarrhea, abdominal pain and constipation (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc., at 1-888693-6742 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
——— DRUG INTERACTIONS ———Oral Medications: OZEMPIC® delays gastric emptying. May impact absorption of concomitantly
administered oral medications. Use with caution (7.2).

——— DOSAGE AND ADMINISTRATION ———• Administer once weekly at any time of day, with or without meals (2.1).
• Start at 0.25 mg once weekly. After 4 weeks, increase the dosage to 0.5 mg once weekly (2.2).
• If additional glycemic control is needed, increase the dosage to 1 mg once weekly after at least 4
weeks on the 0.5 mg dose (2.2).
• If additional glycemic control is needed, increase the dosage to 2 mg once weekly after at least 4
weeks on the 1 mg dosage (2.2)• If a dose is missed administer within 5 days of missed dose (2.2).
• Inject subcutaneously in the abdomen, thigh, or upper arm (2.2).

——— USE IN SPECIFIC POPULATIONS ———Females and Males of Reproductive Potential: Discontinue OZEMPIC® in women at least 2 months
before a planned pregnancy due to the long washout period for semaglutide (8.3).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 9/2023——— DOSAGE FORMS AND STRENGTHS ———Injection: 2 mg/3 mL (0.68 mg/mL) available in:• Single-patient-use pen that delivers 0.25 mg or 0.5 mg per injection (3)Injection: 4 mg/3 mL (1.34 mg/mL) available in:• Single-patient-use pen that delivers 1 mg per injection (3)Injection: 8 mg/3 mL (2.68 mg/mL) available in:• Single-patient-use pen that delivers 2 mg per injection (3)FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: RISK OF THYROID C−CELL TUMORS
1
INDICATIONS AND USAGE
2
DOSAGE AND ADMINISTRATION
2.1	Important Administration Instructions
2.2 Recommended Dosage
3
DOSAGE FORMS AND STRENGTHS
4CONTRAINDICATIONS5WARNINGS AND PRECAUTIONS
5.1 Risk of Thyroid C-Cell Tumors
5.2 Pancreatitis
5.3	Diabetic Retinopathy Complications
5.4	Never Share an OZEMPIC® Pen Between Patients
5.5	Hypoglycemia with Concomitant Use of Insulin
Secretagogues or Insulin
5.6	Acute Kidney Injury
5.7	Hypersensitivity
5.8 Acute Gallbladder Disease

6

7

8

10
11

ADVERSE REACTIONS
6.1	Clinical Trials Experience
6.2	Immunogenicity
6.3 Postmarketing Experience
DRUG INTERACTIONS
7.1	Concomitant Use with an Insulin Secretagogue(e.g., Sulfonylurea) or with Insulin
7.2	Oral Medications
USE IN SPECIFIC POPULATIONS
8.1	Pregnancy
8.2	Lactation
8.3	Females and Males of Reproductive Potential
8.4	Pediatric Use
8.5	Geriatric Use
8.6	Renal Impairment
8.7	Hepatic Impairment
OVERDOSAGEDESCRIPTION

112

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	Overview of Clinical Studies
14.2	Monotherapy Use of OZEMPIC® in Patients withType 2 Diabetes Mellitus
14.3	Combination Therapy Use of OZEMPIC® in
Patients with Type 2 Diabetes Mellitus
14.4	Cardiovascular Outcomes Trial of OZEMPIC®
in Patients with Type 2 Diabetes Mellitus andCardiovascular Disease
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing
information are not listed.

OZEMPIC ® (semaglutide) injection, for subcutaneous use
FULL PRESCRIBING INFORMATIONWARNING: RISK OF THYROID C−CELL TUMORS• In rodents, semaglutide causes dose-dependent and treatment-durationdependent thyroid C-cell tumors at clinically relevant exposures. It is unknown
whether OZEMPIC ® causes thyroid C-cell tumors, including medullary thyroid
carcinoma (MTC), in humans as human relevance of semaglutide-induced
rodent thyroid C-cell tumors has not been determined [see Warnings andPrecautions (5.1) and Nonclinical Toxicology (13.1)].
• OZEMPIC ® is contraindicated in patients with a personal or family history of
MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2) [see Contraindications (4)]. Counsel patients regarding the potential risk
for MTC with the use of OZEMPIC ® and inform them of symptoms of thyroid
tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness).
Routine monitoring of serum calcitonin or using thyroid ultrasound is of
uncertain value for early detection of MTC in patients treated with OZEMPIC ®
[see Contraindications (4) and Warnings and Precautions (5.1)].
1
INDICATIONS AND USAGEOZEMPIC® is indicated:• as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
mellitus.
• to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal
myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus andestablished cardiovascular disease.
Limitations of Use• OZEMPIC® has not been studied in patients with a history of pancreatitis. Consider otherantidiabetic therapies in patients with a history of pancreatitis [see Warnings and Precautions(5.2)].
• OZEMPIC® is not indicated for use in patients with type 1 diabetes mellitus.
2
DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions• Inspect OZEMPIC® visually before use. It should appear clear and colorless. Do not use
OZEMPIC® if particulate matter and coloration is seen.
• Administer OZEMPIC® once weekly, on the same day each week, at any time of the day, with orwithout meals.
• Inject OZEMPIC® subcutaneously to the abdomen, thigh, or upper arm. Instruct patients to use
a different injection site each week when injecting in the same body region.
• When using OZEMPIC® with insulin, instruct patients to administer as separate injections andto never mix the products. It is acceptable to inject OZEMPIC® and insulin in the same body
region, but the injections should not be adjacent to each other.
2.2 Recommended Dosage• Initiate OZEMPIC® with a dosage of 0.25 mg injected subcutaneously once weekly for 4
weeks. The 0.25 mg dosage is intended for treatment initiation and is not effective for glycemic
control.
• After 4 weeks on the 0.25 mg dosage, increase the dosage to 0.5 mg once weekly.
• If additional glycemic control is needed after at least 4 weeks on the 0.5 mg dosage, the dosage
may be increased to 1 mg once weekly.
• If additional glycemic control is needed after at least 4 weeks on the 1 mg dosage, the dosage
may be increased to 2 mg once weekly. The maximum recommended dosage is 2 mg once
weekly.
• The day of weekly administration can be changed if necessary as long as the time between two
doses is at least 2 days (>48 hours).
• If a dose is missed, administer OZEMPIC® as soon as possible within 5 days after the missed
dose. If more than 5 days have passed, skip the missed dose and administer the next dose on
the regularly scheduled day. In each case, patients can then resume their regular once weekly
dosing schedule.
3
DOSAGE FORMS AND STRENGTHS
Injection: clear, colorless solution available in 3 pre-filled, disposable, single-patient-use pens:
Dose perInjection
0.25 mg
0.5 mg
1 mg
2 mg

Total Strength
per Total Volume

Strength
per mL

2 mg / 3 mL

0.68 mg/mL

4 mg /3 mL
8 mg /3 mL

1.34 mg/mL
2.68 mg/mL

The 2 mg/1.5 mL (1.34 mg/mL) strength is not currently marketed by Novo Nordisk Inc.
4
CONTRAINDICATIONSOZEMPIC® is contraindicated in patients with:• A personal or family history of MTC or in patients with MEN 2 [see Warnings and Precautions(5.1)].
• A serious hypersensitivity reaction to semaglutide or to any of the excipients in OZEMPIC®.
Serious hypersensitivity reactions including anaphylaxis and angioedema have been reportedwith OZEMPIC® [see Warnings and Precautions (5.7)].
5
WARNINGS AND PRECAUTIONS
5.1 Risk of Thyroid C-Cell Tumors
In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent
increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime
exposure at clinically relevant plasma exposures [see Nonclinical Toxicology (13.1)]. It is unknown
whether OZEMPIC® causes thyroid C-cell tumors, including MTC, in humans as human relevanceof semaglutide-induced rodent thyroid C-cell tumors has not been determined.
Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have beenreported in the postmarketing period; the data in these reports are insufficient to establish or
exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.

2

OZEMPIC® is contraindicated in patients with a personal or family history of MTC or in patientswith MEN 2. Counsel patients regarding the potential risk for MTC with the use of OZEMPIC® andinform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistenthoarseness).
Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early
detection of MTC in patients treated with OZEMPIC®. Such monitoring may increase the risk of
unnecessary procedures, due to the low test specificity for serum calcitonin and a high backgroundincidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC andpatients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured andfound to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on
physical examination or neck imaging should also be further evaluated.
5.2 Pancreatitis
In glycemic control trials, acute pancreatitis was confirmed by adjudication in 7 OZEMPIC® -treatedpatients (0.3 cases per 100 patient years) versus 3 in comparator-treated patients (0.2 cases per 100
patient years). One case of chronic pancreatitis was confirmed in an OZEMPIC® -treated patient. In a
2-year trial, acute pancreatitis was confirmed by adjudication in 8 OZEMPIC® -treated patients (0.27
cases per 100 patient years) and 10 placebo-treated patients (0.33 cases per 100 patient years), bothon a background of standard of care.
After initiation of OZEMPIC®, observe patients carefully for signs and symptoms of pancreatitis(including persistent severe abdominal pain, sometimes radiating to the back and which may or may
not be accompanied by vomiting). If pancreatitis is suspected, OZEMPIC® should be discontinued
and appropriate management initiated; if confirmed, OZEMPIC® should not be restarted.
5.3 Diabetic Retinopathy Complications
In a 2-year trial involving patients with type 2 diabetes and high cardiovascular risk, more events ofdiabetic retinopathy complications occurred in patients treated with OZEMPIC® (3.0%) compared toplacebo (1.8%). The absolute risk increase for diabetic retinopathy complications was larger among
patients with a history of diabetic retinopathy at baseline (OZEMPIC® 8.2%, placebo 5.2%) thanamong patients without a known history of diabetic retinopathy (OZEMPIC® 0.7%, placebo 0.4%).
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic
retinopathy. The effect of long-term glycemic control with semaglutide on diabetic retinopathy
complications has not been studied. Patients with a history of diabetic retinopathy should bemonitored for progression of diabetic retinopathy.
5.4 Never Share an OZEMPIC ® Pen Between PatientsOZEMPIC® pens must never be shared between patients, even if the needle is changed. Pen-sharing
poses a risk for transmission of blood-borne pathogens.
5.5 Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
Patients receiving OZEMPIC® in combination with an insulin secretagogue (e.g., sulfonylurea) or
insulin may have an increased risk of hypoglycemia, including severe hypoglycemia [see Adverse
Reactions (6.1) and Drug Interactions (7)].
The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or otherconcomitantly administered insulin secretagogue) or insulin. Inform patients using these
concomitant medications of the risk of hypoglycemia and educate them on the signs and symptomsof hypoglycemia.
5.6 Acute Kidney Injury
There have been postmarketing reports of acute kidney injury and worsening of chronic renal failure,
which may sometimes require hemodialysis, in patients treated with GLP-1 receptor agonists. Someof these events have been reported in patients without known underlying renal disease. A majorityof the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, ordehydration. Monitor renal function when initiating or escalating doses of OZEMPIC® in patients
reporting severe adverse gastrointestinal reactions.
5.7 Hypersensitivity
Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patientstreated with OZEMPIC®. If hypersensitivity reactions occur, discontinue use of OZEMPIC®; treat
promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patientswith a previous hypersensitivity to OZEMPIC® [see Contraindications (4) and Adverse Reactions(6.3)].
Anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists. Use caution ina patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist because it
is unknown whether such patients will be predisposed to anaphylaxis with OZEMPIC®.
5.8 Acute Gallbladder Disease
Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in
GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis wasreported in 1.5% and 0.4% of patients-treated with OZEMPIC® 0.5 mg and 1 mg, respectively.
Cholelithiasis was not reported in placebo-treated patients. If cholelithiasis is suspected, gallbladderstudies and appropriate clinical follow-up are indicated.
6
ADVERSE REACTIONS
The following serious adverse reactions are described below or elsewhere in the prescribing
information:• Risk of Thyroid C-cell Tumors [see Warnings and Precautions (5.1)]• Pancreatitis [see Warnings and Precautions (5.2)]• Diabetic Retinopathy Complications [see Warnings and Precautions (5.3)]• Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings andPrecautions (5.5)]• Acute Kidney Injury [see Warnings and Precautions (5.6)]• Hypersensitivity [see Warnings and Precautions (5.7)]• Acute Gallbladder Disease [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 of a drug cannot be directly compared to rates in the clinical trials of
another drug and may not reflect the rates observed in practice.
Pool of Placebo-Controlled Trials
The data in Table 1 are derived from 2 placebo-controlled trials (1 monotherapy trial and 1 trial in
combination with basal insulin) in patients with type 2 diabetes [see Clinical Studies (14)]. These
data reflect exposure of 521 patients to OZEMPIC® and a mean duration of exposure to OZEMPIC®
of 32.9 weeks. Across the treatment arms, the mean age of patients was 56 years, 3.4% were 75 years
or older and 55% were male. In these trials 71% were White, 7% were Black or African American,

OZEMPIC ® (semaglutide) injection, for subcutaneous use
and 19% were Asian; 21% identified as Hispanic or Latino ethnicity. At baseline, patients had type2 diabetes for an average of 8.8 years and had a mean HbA1c of 8.2%. At baseline, 8.9% of the
population reported retinopathy. Baseline estimated renal function was normal (eGFR ≥90 mL/
min/1.73m2) in 57.2%, mildly impaired (eGFR 60 to 90 mL/min/1.73m2) in 35.9% and moderately
impaired (eGFR 30 to 60 mL/min/1.73m2) in 6.9% of patients.
Pool of Placebo- and Active-Controlled Trials
The occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2
diabetes participating in 7 placebo- and active-controlled glycemic control trials [see Clinical Studies(14)] including two trials in Japanese patients evaluating the use of OZEMPIC® as monotherapy
and add-on therapy to oral medications or insulin. In this pool, a total of 3150 patients with type 2
diabetes were treated with OZEMPIC® for a mean duration of 44.9 weeks. Across the treatment arms,
the mean age of patients was 57 years, 3.2% were 75 years or older and 57% were male. In thesetrials, 60% were White, 6% were Black or African American, and 31% were Asian; 16% identified
as Hispanic or Latino ethnicity. At baseline, patients had type 2 diabetes for an average of 8.2 years
and had a mean HbA1c of 8.2%. At baseline, 7.8% of the population reported retinopathy. Baseline
estimated renal function was normal (eGFR ≥90 mL/min/1.73m2) in 63.1%, mildly impaired (eGFR
60 to 90 mL/min/1.73m2) in 34.3%, and moderately impaired (eGFR 30 to 60 mL/min/1.73m2) in
2.5% of the patients.
Common Adverse Reactions
Table 1 shows common adverse reactions, excluding hypoglycemia, associated with the useof OZEMPIC® in the pool of placebo-controlled trials. These adverse reactions occurred morecommonly on OZEMPIC® than on placebo and occurred in at least 5% of patients treated withOZEMPIC®.
Table 1. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of
OZEMPIC ® -Treated Patients with Type 2 Diabetes Mellitus
PlaceboOZEMPIC ® 0.5 mg OZEMPIC ® 1 mg
(N=262)(N=260)(N=261)Adverse Reaction%%%
Nausea
6.1
15.8
20.3
Vomiting
2.3
5.0
9.2
Diarrhea
1.9
8.5
8.8
Abdominal pain
4.6
7.3
5.7
Constipation
1.5
5.0
3.1
In the pool of placebo- and active-controlled trials and in the 2-year cardiovascular outcomes trial,
the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to
those listed in Table 1.
In a clinical trial with 959 patients treated with OZEMPIC® 1 mg or OZEMPIC® 2 mg once weekly
as add-on to metformin with or without sulfonylurea treatment for 40 weeks, no new safety signals
were identified.
Gastrointestinal Adverse Reactions
In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently
among patients receiving OZEMPIC® than placebo (placebo 15.3%, OZEMPIC® 0.5 mg 32.7%,
OZEMPIC® 1 mg 36.4%). The majority of reports of nausea, vomiting, and/or diarrhea occurred
during dose escalation. More patients receiving OZEMPIC® 0.5 mg (3.1%) and OZEMPIC® 1 mg
(3.8%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving
placebo (0.4%).
In the trial with OZEMPIC® 1 mg and 2 mg, gastrointestinal adverse reactions occurred more
frequently among patients receiving OZEMPIC® 2 mg (34.0%) vs OZEMPIC® 1 mg (30.8%).
In addition to the reactions in Table 1, the following gastrointestinal adverse reactions with afrequency of <5% were associated with OZEMPIC® (frequencies listed, respectively, as: placebo;
0.5 mg; 1 mg): dyspepsia (1.9%, 3.5%, 2.7%), eructation (0%, 2.7%, 1.1%), flatulence (0.8%, 0.4%,1.5%), gastroesophageal reflux disease (0%, 1.9%, 1.5%), and gastritis (0.8%, 0.8%, 0.4%).
Other Adverse Reactions
Hypoglycemia
Table 2 summarizes the incidence of events related to hypoglycemia by various definitions in theplacebo-controlled trials.
Table 2. Hypoglycemia Adverse Reactions in Placebo-Controlled Trials in Patientswith Type 2 Diabetes Mellitus® 0.5
Placebo OZEMPICOZEMPIC ® 1 mg
mg
Monotherapy(30 weeks)
N=129
N=127
N=130
Severe†0%0%0%Documented symptomatic (≤70 mg/dL
0%
1.6%
3.8%
glucose threshold)†Severe or Blood Glucose Confirmed
Symptomatic (≤56 mg/dL glucose
1.6%
0%
0%
threshold)Add-on to Basal Insulin with orwithout Metformin(30 weeks)
N=132
N=132
N=131
Severe†0%0%
1.5%Documented symptomatic (≤70 mg/dL
15.2%
16.7%
29.8%
glucose threshold)Severe† or Blood Glucose Confirmed
Symptomatic (≤56 mg/dL glucose
5.3%
8.3%
10.7%
threshold)† “Severe” hypoglycemia adverse reactions are episodes requiring the assistance of another person.

Hypoglycemia was more frequent when OZEMPIC® was used in combination with a sulfonylurea [seeWarnings and Precautions (5.5) and Clinical Studies (14)]. Severe hypoglycemia occurred in 0.8%
and 1.2% of patients when OZEMPIC® 0.5 mg and 1 mg, respectively, was co-administered with3

a sulfonylurea. Documented symptomatic hypoglycemia occurred in 17.3% and 24.4% of patients
when OZEMPIC® 0.5 mg and 1 mg, respectively, was co-administered with a sulfonylurea. Severe or
blood glucose confirmed symptomatic hypoglycemia occurred in 6.5% and 10.4% of patients when
OZEMPIC® 0.5 mg and 1 mg, respectively, was co-administered with a sulfonylurea.
Injection Site Reactions
In placebo-controlled trials, injection site reactions (e.g., injection-site discomfort, erythema) werereported in 0.2% of OZEMPIC® -treated patients.
Increases in Amylase and Lipase
In placebo-controlled trials, patients exposed to OZEMPIC® had a mean increase from baseline inamylase of 13% and lipase of 22%. These changes were not observed in placebo-treated patients.
Cholelithiasis
In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients-treated withOZEMPIC® 0.5 mg and 1 mg, respectively. Cholelithiasis was not reported in placebo-treatedpatients.
Increases in Heart Rate
In placebo-controlled trials, OZEMPIC® 0.5 mg and 1 mg resulted in a mean increase in heart rate of
2 to 3 beats per minute. There was a mean decrease in heart rate of 0.3 beats per minute in placebotreated patients.
Fatigue, Dysgeusia and Dizziness
Other adverse reactions with a frequency of >0.4% were associated with OZEMPIC® include fatigue,
dysgeusia and dizziness.
6.2 Immunogenicity
Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals,patients treated with OZEMPIC® may develop anti-semaglutide antibodies. The detection of
antibody formation is highly dependent on the sensitivity 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 these reasons, the incidenceof antibodies to semaglutide in the studies described below cannot be directly compared with theincidence of antibodies in other studies or to other products.
Across the placebo- and active-controlled glycemic control trials, 32 (1.0%) OZEMPIC® -treatedpatients developed anti-drug antibodies (ADAs) to the active ingredient in OZEMPIC® (i.e.,
semaglutide). Of the 32 semaglutide-treated patients that developed semaglutide ADAs, 19 patients(0.6% of the overall population) developed antibodies cross-reacting with native GLP-1. The in vitro
neutralizing activity of the antibodies is uncertain at this time.
6.3 Postmarketing Experience
The following adverse reactions have been reported during post-approval use of semaglutide, theactive ingredient of OZEMPIC®. Because these reactions are reported voluntarily from a populationof uncertain size, it is not always possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.
Gastrointestinal Disorders: Ileus
Hypersensitivity: anaphylaxis, angioedema, rash, urticaria.
Hepatobiliary: cholecystitis, cholecystectomy
7
7.1

DRUG INTERACTIONS
Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with
InsulinOZEMPIC® stimulates insulin release in the presence of elevated blood glucose concentrations.
Patients receiving OZEMPIC® in combination with an insulin secretagogue (e.g., sulfonylurea) or
insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. When initiating
OZEMPIC®, consider reducing the dose of concomitantly administered insulin secretagogue (suchas sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions (5.5)
and Adverse Reactions (6)].
7.2 Oral MedicationsOZEMPIC® causes a delay of gastric emptying, and thereby has the potential to impact the absorptionof concomitantly administered oral medications. In clinical pharmacology trials, semaglutide did
not affect the absorption of orally administered medications to any clinically relevant degree [seeClinical Pharmacology (12.3)]. Nonetheless, caution should be exercised when oral medications areconcomitantly administered with OZEMPIC®.
8USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are limited data with semaglutide use in pregnant women to inform a drug-associated risk foradverse developmental outcomes. There are clinical considerations regarding the risks of poorly
controlled diabetes in pregnancy (see Clinical Considerations). Based on animal reproduction
studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy.
OZEMPIC® should be used during pregnancy only if the potential benefit justifies the potential risk
to the fetus.
In pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structuralabnormalities and alterations to growth occurred at maternal clinical exposure based on AUC. In
rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy
losses or structural abnormalities were observed at clinical exposure (rabbit) and ≥2-fold the MRHD
(monkey). These findings coincided with a marked maternal body weight loss in both animal species(see Data).
In the U.S. general population, the estimated background risk of major birth defects and miscarriage
in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The estimatedbackground risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with aperi-conceptional HbA1c >7 and has been reported to be as high as 20 to 25% in women with a periconceptional HbA1c >10. The estimated background risk of miscarriage for the indicated populationis unknown.
Clinical Considerations
Disease-Associated Maternal and/or Embryo/fetal Risk
Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients withpre-gestational diabetes. Poorly controlled diabetes during pregnancy increases the maternal riskfor diabetic ketoacidosis, pre- eclampsia, spontaneous abortions, preterm delivery, and delivery
complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth,and macrosomia related morbidity.

OZEMPIC ® (semaglutide) injection, for subcutaneous use
Structural formula:
O

7
H H

10

H
N

H3C

E

G

20
T

F

T

S

D

V

S

S

Y

L

E

G

Q

A

A

O

H
N

30
E

F

I

A

37
W

L

V

R

G

R

G OH

Lys26

CH3

O
H
N

O

O

O

N
H

O

NH
O
O

O

NH
OH

OH
O
O

OZEMPIC® is a sterile, aqueous, clear, colorless solution. Each 3 mL pre-filled single-patient use
pen contains semaglutide 2 mg (0.68 mg/mL), 4 mg (1.34 mg/mL), or 8 mg (2.68 mg/mL). Each 1
mL of OZEMPIC® solution also contains the following inactive ingredients: disodium phosphate
dihydrate, 1.42 mg; propylene glycol, 14.0 mg; phenol, 5.50 mg; and water for injections. OZEMPIC®
has a pH of approximately 7.4. Hydrochloric acid or sodium hydroxide may be added to adjust pH.
The 2 mg/1.5 mL (1.34 mg/mL) strength is not currently marketed by Novo Nordisk Inc.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts
as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for
native GLP-1.
GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1
receptors.
The principal mechanism of protraction resulting in the long half-life of semaglutide is albuminbinding, which results in decreased renal clearance and protection from metabolic degradation.
Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme.
Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion andlowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high,insulin secretion is stimulated, and glucagon secretion is inhibited. The mechanism of blood glucose
lowering also involves a minor delay in gastric emptying in the early postprandial phase.
12.2 Pharmacodynamics
Semaglutide lowers fasting and postprandial blood glucose and reduces body weight. All
pharmacodynamic evaluations were performed after 12 weeks of treatment (including dose
escalation) at steady state with semaglutide 1 mg.
Fasting and Postprandial Glucose
Semaglutide reduces fasting and postprandial glucose concentrations. In patients with type 2
diabetes, treatment with semaglutide 1 mg resulted in reductions in glucose in terms of absolutechange from baseline and relative reduction compared to placebo of 29 mg/dL (22%) for fasting
glucose, 74 mg/dL (36%) for 2-hour postprandial glucose, and 30 mg/dL (22%) for mean 24-hourglucose concentration (see Figure 1).
Figure 1. Mean 24-hour plasma glucose profiles (standardized meals) in patientswith type 2 diabetes before (baseline) and after 12 weeks of treatment withsemaglutide or placebo
250

Plasma glucose (mg/dL)

Data
Animal Data
In a combined fertility and embryofetal development study in rats, subcutaneous doses of 0.01,
0.03 and 0.09 mg/kg/day (0.06-, 0.2-, and 0.6-fold the MRHD) were administered to males for 4
weeks prior to and throughout mating and to females for 2 weeks prior to mating, and throughout
organogenesis to Gestation Day 17. In parental animals, pharmacologically mediated reductions inbody weight gain and food consumption were observed at all dose levels. In the offspring, reduced
growth and fetuses with visceral (heart blood vessels) and skeletal (cranial bones, vertebra, ribs)
abnormalities were observed at the human exposure.
In an embryofetal development study in pregnant rabbits, subcutaneous doses of 0.0010,
0.0025 or 0.0075 mg/kg/day (0.02-, 0.2-, and 1.2-fold the MRHD) were administered throughout
organogenesis from Gestation Day 6 to 19. Pharmacologically mediated reductions in maternal bodyweight gain and food consumption were observed at all dose levels. Early pregnancy losses andincreased incidences of minor visceral (kidney, liver) and skeletal (sternebra) fetal abnormalities
were observed at ≥0.0025 mg/kg/day, at clinically relevant exposures.
In an embryofetal development study in pregnant cynomolgus monkeys, subcutaneous doses of
0.015, 0.075, and 0.15 mg/kg twice weekly (0.5-, 3-, and 8-fold the MRHD) were administeredthroughout organogenesis, from Gestation Day 16 to 50. Pharmacologically mediated, marked initialmaternal body weight loss and reductions in body weight gain and food consumption coincided withthe occurrence of sporadic abnormalities (vertebra, sternebra, ribs) at ≥0.075 mg/kg twice weekly(≥3X human exposure).
In a pre- and postnatal development study in pregnant cynomolgus monkeys, subcutaneous dosesof 0.015, 0.075, and 0.15 mg/kg twice weekly (0.3-, 2-, and 4-fold the MRHD) were administeredfrom Gestation Day 16 to 140. Pharmacologically mediated marked initial maternal body weightloss and reductions in body weight gain and food consumption coincided with an increase in earlypregnancy losses and led to delivery of slightly smaller offspring at ≥0.075 mg/kg twice weekly (≥2X
human exposure).
8.2 Lactation
Risk Summary
There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant,or the effects on milk production. Semaglutide was present in the milk of lactating rats, however, due
to species-specific differences in lactation physiology, the clinical relevance of these data are notclear (see Data). The developmental and health benefits of breastfeeding should be considered alongwith the mother’s clinical need for OZEMPIC® and any potential adverse effects on the breastfed
infant from OZEMPIC® or from the underlying maternal condition.
Data
In lactating rats, semaglutide was detected in milk at levels 3-12 fold lower than in maternal plasma.
8.3 Females and Males of Reproductive Potential
Discontinue OZEMPIC® in women at least 2 months before a planned pregnancy due to the long
washout period for semaglutide [see Use in Specific Populations (8.1)].
8.4 Pediatric Use
Safety and efficacy of OZEMPIC® have not been established in pediatric patients (younger than 18
years).
8.5 Geriatric Use
In the pool of placebo- and active-controlled glycemic control trials, 744 (23.6%) OZEMPIC® -treatedpatients were 65 years of age and over and 102 OZEMPIC® -treated patients (3.2%) patients were
75 years of age and over. In SUSTAIN 6, the cardiovascular outcome trial, 788 (48.0%) OZEMPIC® treated patients were 65 years of age and over and 157 OZEMPIC® -treated patients (9.6%) patientswere 75 years of age and over.
No overall differences in safety or efficacy were detected between these patients and younger
patients, but greater sensitivity of some older individuals cannot be ruled out.
8.6 Renal Impairment
No dose adjustment of OZEMPIC® is recommended for patients with renal impairment. In subjects
with renal impairment including end-stage renal disease (ESRD), no clinically relevant change insemaglutide pharmacokinetics (PK) was observed [see Clinical Pharmacology (12.3)].
8.7 Hepatic Impairment
No dose adjustment of OZEMPIC® is recommended for patients with hepatic impairment. In a study
in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide
pharmacokinetics (PK) was observed [see Clinical Pharmacology (12.3)].
10 OVERDOSAGEIn the event of overdose, appropriate supportive treatment should be initiated according to thepatient’s clinical signs and symptoms. Consider contacting the Poison Help line (1-800-222-1222)
or a medical toxicologist for additional overdosage management recommendations. A prolonged
period of observation and treatment for these symptoms may be necessary, taking into account thelong half-life of OZEMPIC® of approximately 1 week.
11 DESCRIPTIONOZEMPIC® (semaglutide) injection, for subcutaneous use, contains semaglutide, a human GLP-1
receptor agonist (or GLP-1 analog). The peptide backbone is produced by yeast fermentation. The
main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position
26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified
in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4(DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty
di-acid. The molecular formula is C187H291N45O59 and the molecular weight is 4113.58 g/mol.

4

200

150

100

0

2

4

14
16
18
6
8
10
12
Time since start of breakfast meal (hours)

OZEMPIC ® - baseline (n=37)
Placebo - baseline (n=38)

20

22

24

OZEMPIC ® 1 mg - end of treatment (n=36)
Placebo - end of treatment (n=37)

Insulin Secretion
Both first-and second-phase insulin secretion are increased in patients with type 2 diabetes treatedwith OZEMPIC® compared with placebo.
Glucagon Secretion
Semaglutide lowers the fasting and postprandial glucagon concentrations. In patients with type2 diabetes, treatment with semaglutide resulted in the following relative reductions in glucagon
compared to placebo, fasting glucagon (8%), postprandial glucagon response (14-15%), and mean
24 hour glucagon concentration (12%).
Glucose dependent insulin and glucagon secretion
Semaglutide lowers high blood glucose concentrations by stimulating insulin secretion and lowering
glucagon secretion in a glucose-dependent manner. With semaglutide, the insulin secretion rate inpatients with type 2 diabetes was similar to that of healthy subjects (see Figure 2).

OZEMPIC ® (semaglutide) injection, for subcutaneous use
Figure 2. Mean insulin secretion rate versus glucose concentration in patients with
type 2 diabetes during graded glucose infusion before (baseline) and after 12 weeks
of treatment with semaglutide or placebo and in untreated healthy subjects
Insulin secretion rate (pmol/kg/min)

14
12
10
8
6
4
2
0
90

100

110

120 130 140 150 160 170 180 190 200 210
Plasma glucose (mg/dL)

OZEMPIC ® - baseline (n=37)
Placebo - baseline (n=38)
Healthy subjects (n=12)

OZEMPIC ® 1 mg - end of treatment (n=36)
Placebo - end of treatment (n=37)

During induced hypoglycemia, semaglutide did not alter the counter regulatory responses ofincreased glucagon compared to placebo and did not impair the decrease of C-peptide in patientswith type 2 diabetes.
Gastric emptying
Semaglutide causes a delay of early postprandial gastric emptying, thereby reducing the rate at
which glucose appears in the circulation postprandially.
Cardiac electrophysiology (QTc)
The effect of semaglutide on cardiac repolarization was tested in a thorough QTc trial. Semaglutide
does not prolong QTc intervals at doses up to 1.5 mg at steady-state.
12.3 Pharmacokinetics
Absorption
Absolute bioavailability of semaglutide is 89%. Maximum concentration of semaglutide is reached
1 to 3 days post dose.
Similar exposure is achieved with subcutaneous administration of semaglutide in the abdomen,thigh, or upper arm.
In patients with type 2 diabetes, semaglutide exposure increases in a dose-proportional mannerfor once-weekly doses of 0.5 mg, 1 mg and 2 mg. Steady-state exposure is achieved following 4-5
weeks of once-weekly administration. In patients with type 2 diabetes, the mean population-PK
estimated steady-state concentrations following once weekly subcutaneous administration of 0.5
mg and 1 mg semaglutide were approximately 65.0 ng/mL and 123.0 ng/mL, respectively. In the trial
comparing semaglutide 1 mg and 2 mg, the mean steady state concentrations were 111.1 ng/mL and
222.1 ng/mL, respectively.
Distribution
The mean apparent volume of distribution of semaglutide following subcutaneous administration inpatients with type 2 diabetes is approximately 12.5L. Semaglutide is extensively bound to plasma
albumin (>99%).
Elimination
The apparent clearance of semaglutide in patients with type 2 diabetes is approximately 0.05 L/h.
With an elimination half-life of approximately 1 week, semaglutide will be present in the circulation
for about 5 weeks after the last dose.
Metabolism
The primary route of elimination for semaglutide is metabolism following proteolytic cleavage of thepeptide backbone and sequential beta-oxidation of the fatty acid sidechain.
Excretion
The primary excretion routes of semaglutide-related material are via the urine and feces.
Approximately 3% of the dose is excreted in the urine as intact semaglutide.
Specific Populations
Based on a population pharmacokinetic analysis, age, sex, race, and ethnicity, and renal impairment
do not have a clinically meaningful effect on the pharmacokinetics of semaglutide. The exposure ofsemaglutide decreases with an increase in body weight. However, semaglutide doses of 0.5 mg and
1 mg provide adequate systemic exposure over the body weight range of 40-198 kg evaluated in theclinical trials. The effects of intrinsic factors on the pharmacokinetics of semaglutide are shown in
Figure 3.

5

Figure 3. Impact of intrinsic factors on semaglutide exposure
Intrinsic factor
Relative exposure (Cavg)
Ratio and 90% CI
Sex
Male
65-74 years
Age>74 years
Black or African American
Race
Asian
Ethnicity
Hispanic or Latino
55 kg
Body weight
127 kgMild
Renal impairment Moderate
Severe0.5
12Semaglutide exposure (Cavg) relative to reference subject profile: non-Hispanic/non-Latino, White, female below
65 years, body weight 85 kg, with normal renal function. Population PK model also included maintenance dose andinjection site as covariates. Body weight test categories (55 and 127 kg) represent the 5% and 95% percentiles in thedataset. Abbreviations: Cavg: average semaglutide concentration. CI: Confidence interval.

Patients with Renal impairment - Renal impairment does not impact the pharmacokinetics ofsemaglutide in a clinically relevant manner. This was shown in a study with a single dose of 0.5 mg
semaglutide in patients with different degrees of renal impairment (mild, moderate, severe, ESRD)
compared with subjects with normal renal function. This was also shown for subjects with both type2 diabetes and renal impairment based on data from clinical studies (Figure 3).
Patients with Hepatic impairment - Hepatic impairment does not have any impact on the exposure ofsemaglutide. The pharmacokinetics of semaglutide were evaluated in patients with different degreesof hepatic impairment (mild, moderate, severe) compared with subjects with normal hepatic function
in a study with a single-dose of 0.5 mg semaglutide.
Pediatric Patients - Semaglutide has not been studied in pediatric patients.
Drug Interaction Studies
In vitro studies have shown very low potential for semaglutide to inhibit or induce CYP enzymes, andto inhibit drug transporters.
The delay of gastric emptying with semaglutide may influence the absorption of concomitantly
administered oral medicinal products [see Drug Interactions (7.2)]. The potential effect of semaglutide
on the absorption of co-administered oral medications was studied in trials at semaglutide 1 mg
steady-state exposure.
No clinically relevant drug-drug interaction with semaglutide (Figure 4) was observed based on
the evaluated medications; therefore, no dose adjustment is required when co-administered withsemaglutide. In a separate study, no apparent effect on the rate of gastric emptying was observedwith semaglutide 2.4 mg.
Figure 4. Impact of semaglutide on the exposure of co-administered oral
medications
Co-administered
Relative exposure
Recommendation
medication
Ratio and 90% CI
AUC0-12h
Cmax
AUC0-168h
S-warfarin
Cmax
AUC0-168h
R-warfarin
Cmax
AUC0-120h
DigoxinCmax
AUC0-72h
Atorvastatin
Cmax
0-24h
Ethinylestradiol AUC
Cmax
AUC
Levonorgestrel C 0-24h
max

Metformin

No dose adjustment
No dose adjustment
No dose adjustment
No dose adjustment
No dose adjustment
No dose adjustment
No dose adjustment
0.5

1

2

Relative exposure in terms of AUC and Cmax for each medication when given with semaglutide compared to without
semaglutide. Metformin and oral contraceptive drug (ethinylestradiol/levonorgestrel) were assessed at steady state.
Warfarin (S-warfarin/R-warfarin), digoxin and atorvastatin were assessed after a single dose.
Abbreviations: AUC: area under the curve. Cmax: maximum concentration. CI: confidence interval.

13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 2-year carcinogenicity study in CD-1 mice, subcutaneous doses of 0.3, 1 and 3 mg/kg/day[2-, 11-, and 30-fold the maximum recommended human dose (MRHD) of 2 mg/week, based on
AUC] were administered to the males, and 0.1, 0.3 and 1 mg/kg/day (1-, 2-, and 7-fold MRHD) wereadministered to the females. A statistically significant increase in thyroid C-cell adenomas and anumerical increase in C-cell carcinomas were observed in males and females at clinically relevant
exposures.
In a 2-year carcinogenicity study in Sprague Dawley rats, subcutaneous doses of 0.0025, 0.01, 0.025
and 0.1 mg/kg/day were administered (below quantification, 0.2-, 0.5-, and 3-fold the exposure at theMRHD). A statistically significant increase in thyroid C-cell adenomas was observed in males andfemales at all dose levels, and a statistically significant increase in thyroid C-cell carcinomas wasobserved in males at ≥0.01 mg/kg/day, at clinically relevant exposures.
Human relevance of thyroid C-cell tumors in rats is unknown and could not be determined by clinicalstudies or nonclinical studies [see Boxed Warning and Warnings and Precautions (5.1)].
Semaglutide was not mutagenic or clastogenic in a standard battery of genotoxicity tests (bacterial
mutagenicity (Ames), human lymphocyte chromosome aberration, rat bone marrow micronucleus).
In a combined fertility and embryo-fetal development study in rats, subcutaneous doses of 0.01, 0.03
and 0.09 mg/kg/day (0.06-, 0.2-, and 0.6-fold the MRHD) were administered to male and female rats.
Males were dosed for 4 weeks prior to mating, and females were dosed for 2 weeks prior to mating
and throughout organogenesis until Gestation Day 17. No effects were observed on male fertility.
In females, an increase in estrus cycle length was observed at all dose levels, together with a small

OZEMPIC ® (semaglutide) injection, for subcutaneous use

aThe intent-to-treat population includes all randomized and exposed patients. At week 30 the primary HbA

1c endpoint
was missing for 10%, 7% and 7% of patients and during the trial rescue medication was initiated by 20%, 5% and 4%of patients randomized to placebo, OZEMPIC ® 0.5 mg and OZEMPIC ® 1 mg, respectively. Missing data were imputed
using multiple imputation based on retrieved dropouts.
bIntent-to-treat analysis using ANCOVA adjusted for baseline value and country.
c p <0.0001 (2-sided) for superiority, adjusted for multiplicity.

The mean baseline body weight was 89.1 kg, 89.8 kg, 96.9 kg in the placebo, OZEMPIC® 0.5 mg,
and OZEMPIC® 1 mg arms, respectively. The mean changes from baseline to week 30 were -1.2 kg,-3.8 kg and -4.7 kg in the placebo, OZEMPIC® 0.5 mg, and OZEMPIC® 1 mg arms, respectively. The
difference from placebo (95% CI) for OZEMPIC® 0.5 mg was -2.6 kg (-3.8, -1.5), and for OZEMPIC®
1 mg was -3.5 kg (-4.8, -2.2).
14.3 Combination Therapy Use of OZEMPIC ® in Patients with Type 2 Diabetes
Mellitus
Combination with metformin and/or thiazolidinediones
In a 56-week, double-blind trial (NCT01930188), 1231 patients with type 2 diabetes mellitus wererandomized to OZEMPIC® 0.5 mg once weekly, OZEMPIC® 1 mg once weekly, or sitagliptin 100 mg
once daily, all in combination with metformin (94%) and/or thiazolidinediones (6%). Patients had amean age of 55 years and 51% were men. The mean duration of type 2 diabetes was 6.6 years, andthe mean BMI was 32 kg/m2. Overall, 68% were White, 5% were Black or African American, and 25%
were Asian; 17% identified as Hispanic or Latino ethnicity.
Treatment with OZEMPIC® 0.5 mg and 1 mg once weekly for 56 weeks resulted in a statisticallysignificant reduction in HbA1c compared to sitagliptin (see Table 4 and Figure 5).
Table 4. Results at Week 56 in a Trial of OZEMPIC ® Compared to Sitagliptin in
Adult Patients with Type 2 Diabetes Mellitus in Combination with Metformin and/or
Thiazolidinediones
OZEMPIC® 0.5 mg OZEMPIC® 1 mg
SitagliptinaIntent-to-Treat (ITT) Population (N)
409
409
407
HbA1c (%)
Baseline (mean)
8.0
8.0
8.2
Change at week 56b
-1.3
-1.5
-0.7
Difference from sitagliptinb
-0.6
-0.8
[95% CI][-0.7, -0.4]c[-0.9, -0.6]c
Patients (%) achieving HbA1c <7%667340
FPG (mg/dL)
Baseline (mean)
168
167
173
Change at week 56b
-35
-43
-23
aThe intent-to-treat population includes all randomized and exposed patients. At week 56 the primary HbA

1c endpoint
was missing for 7%, 5% and 6% of patients and during the trial rescue medication was initiated by 5%, 2% and 19% of
patients randomized to OZEMPIC ® 0.5 mg, OZEMPIC ® 1 mg and sitagliptin, respectively. Missing data were imputed
using multiple imputation based on retrieved dropouts.
bIntent-to-treat analysis using ANCOVA adjusted for baseline value and country.
c p <0.0001 (2-sided) for superiority, adjusted for multiplicity.

The mean baseline body weight was 89.9 kg, 89.2 kg, 89.3 kg in the OZEMPIC® 0.5 mg, OZEMPIC®
1 mg, and sitagliptin arms, respectively. The mean changes from baseline to week 56 were -4.2 kg,-5.5 kg, and -1.7 kg for the OZEMPIC® 0.5 mg, OZEMPIC® 1 mg, and sitagliptin arms, respectively.

OZEMPIC® 1 mg was -3.8 kg (-4.5, -3.1).
Figure 5. Mean HbA1c (%) over time - baseline to week 56
8.5
OZEMPIC ® 0.5 mg
OZEMPIC ® 1 mg

Sitagliptin

8.0
HbA1c (%)

reduction in numbers of corpora lutea at ≥0.03 mg/kg/day. These effects were likely an adaptive
response secondary to the pharmacological effect of semaglutide on food consumption and bodyweight.
14 CLINICAL STUDIES
14.1 Overview of Clinical Studies
OZEMPIC® has been studied as monotherapy and in combination with metformin, metformin andsulfonylureas, metformin and/or thiazolidinedione, and basal insulin in patients with type 2 diabetes
mellitus. The efficacy of OZEMPIC® was compared with placebo, sitagliptin, exenatide extendedrelease (ER), and insulin glargine.
Most trials evaluated the use of OZEMPIC® 0.5 mg, and 1 mg, with the exception of the trial
comparing OZEMPIC® and exenatide ER where only the 1 mg dose was studied. One trial evaluatedthe use of OZEMPIC® 2 mg once weekly.
In patients with type 2 diabetes mellitus, OZEMPIC® produced clinically relevant reduction frombaseline in HbA1c compared with placebo.
The efficacy of OZEMPIC® was not impacted by age, gender, race, ethnicity, BMI at baseline, bodyweight (kg) at baseline, diabetes duration and level of renal function impairment.
14.2 Monotherapy Use of OZEMPIC ® in Patients with Type 2 Diabetes Mellitus
In a 30-week double-blind trial (NCT02054897), 388 patients with type 2 diabetes mellitus
inadequately controlled with diet and exercise were randomized to OZEMPIC® 0.5 mg or OZEMPIC®
1 mg once weekly or placebo. Patients had a mean age of 54 years and 54% were men. The mean
duration of type 2 diabetes was 4.2 years, and the mean BMI was 33 kg/m2. Overall, 64% wereWhite, 8% were Black or African American, and 21% were Asian; 30% identified as Hispanic or
Latino ethnicity.
Monotherapy with OZEMPIC® 0.5 mg and 1 mg once weekly for 30 weeks resulted in a statisticallysignificant reduction in HbA1c compared with placebo (see Table 3).
Table 3. Results at Week 30 in a Trial of OZEMPIC ® as Monotherapy in Adult Patientswith Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise
PlaceboOZEMPIC® 0.5 mg OZEMPIC® 1 mg
Intent-to-Treat (ITT) Population (N)a
129
128
130
HbA1c (%)
Baseline (mean)
8.0
8.1
8.1
Change at week 30b
-0.1
-1.4
-1.6
Difference from placebob [95% CI]-1.2 [-1.5, -0.9]c-1.4 [-1.7, -1.1]cPatients (%) achieving HbA1c <7%287370
FPG (mg/dL)
Baseline (mean)
174
174
179
Change at week 30b
-15
-41
-44

6

The difference from sitagliptin (95% CI) for OZEMPIC® 0.5 mg was -2.5 kg (-3.2, -1.8), and for

7.5
7.0
6.5
6.0
0

Number of patientsOZEMPIC ® 0.5 mg 409
OZEMPIC ® 1 mg 409
Sitagliptin
407

4

8

12 16

23
30
40
Week post randomization
383
378
387

56

56 (MI)

382
387
384

409
409
407

Observed mean HbA1c at scheduled visits and retrieved dropout multiple imputation (MI) based estimate at week 56 with standard error

Combination with metformin or metformin with sulfonylurea
In a 56-week, open-label trial (NCT01885208), 813 patients with type 2 diabetes mellitus on
metformin alone (49%), metformin with sulfonylurea (45%), or other (6%) were randomized to
OZEMPIC® 1 mg once weekly or exenatide 2 mg once weekly. Patients had a mean age of 57 years
and 55% were men. The mean duration of type 2 diabetes was 9 years, and the mean BMI was 34
kg/m2. Overall, 84% were White, 7% were Black or African American, and 2% were Asian; 24%
identified as Hispanic or Latino ethnicity.
Treatment with OZEMPIC® 1 mg once weekly for 56 weeks resulted in a statistically significant
reduction in HbA1c compared to exenatide 2 mg once weekly (see Table 5).
Table 5. Results at Week 56 in a Trial of OZEMPIC ® Compared to Exenatide 2 mg
Once Weekly in Adult Patients with Type 2 Diabetes Mellitus in Combination with
Metformin or Metformin with Sulfonylurea
OZEMPIC® 1 mg Exenatide ER 2 mgaIntent-to-Treat (ITT) Population (N)404405
HbA1c (%)
Baseline (mean)
8.4
8.3
Change at week 56b
-1.4
-0.9
Difference from exenatideb-0.5[95% CI][-0.7, -0.3]c
Patients (%) achieving HbA1c <7%6240
FPG (mg/dL)
Baseline (mean)
191
188
Change at week 56b-44-34
aThe intent-to-treat population includes all randomized and exposed patients. At week 56 the primary HbA

1c endpoint
was missing for 9% and 11% of patients and during the trial rescue medication was initiated by 5% and 10% of patientsrandomized to OZEMPIC ® 1 mg and exenatide ER 2 mg, respectively. Missing data were imputed using multiple
imputation based on retrieved dropouts.
bIntent-to-treat analysis using ANCOVA adjusted for baseline value and country.
c p <0.0001 (2-sided) for superiority, adjusted for multiplicity.

The mean baseline body weight was 96.2 kg and 95.4 kg in the OZEMPIC® 1 mg and exenatide ER
arms, respectively. The mean changes from baseline to week 56 were -4.8 kg and -2.0 kg in the
OZEMPIC® 1 mg and exenatide ER arms, respectively. The difference from exenatide ER (95% CI) for
OZEMPIC® 1 mg was -2.9 kg (-3.6, -2.1).
Combination with metformin or metformin with sulfonylurea
In a 30-week, open-label trial (NCT02128932), 1089 patients with type 2 diabetes mellitus wererandomized to OZEMPIC® 0.5 mg once weekly, OZEMPIC® 1 mg once weekly, or insulin glargine
once daily on a background of metformin (48%) or metformin and sulfonylurea (51%). Patients hada mean age of 57 years and 53% were men. The mean duration of type 2 diabetes was 8.6 years, andthe mean BMI was 33 kg/m2. Overall, 77% were White, 9% were Black or African American, and 11%
were Asian; 20% identified as Hispanic or Latino ethnicity.
Patients assigned to insulin glargine had a baseline mean HbA1c of 8.1% and were started on adose of 10 U once daily. Insulin glargine dose adjustments occurred throughout the trial period
based on self-measured fasting plasma glucose before breakfast, targeting 71 to <100 mg/dL. In
addition, investigators could titrate insulin glargine at their discretion between study visits. Only
26% of patients had been titrated to goal by the primary endpoint at week 30, at which time the mean
daily insulin dose was 29 U per day.
Treatment with OZEMPIC® 0.5 mg and 1 mg once weekly for 30 weeks resulted in a statisticallysignificant reduction in HbA1c compared with the insulin glargine titration implemented in this study
protocol (see Table 6).

OZEMPIC ® (semaglutide) injection, for subcutaneous use
in Adult Patients with Type 2 Diabetes Mellitus in Combination with Metformin or
Metformin with Sulfonylurea
OZEMPIC® 0.5 mg OZEMPIC® 1 mg Insulin GlargineaIntent-to-Treat (ITT) Population (N)
362
360
360
HbA1c (%)
Baseline (mean)
8.1
8.2
8.1
Change at week 30b
-1.2
-1.5
-0.9
Difference from insulin glargineb
-0.3
-0.6
[95% CI][-0.5, -0.1]c[-0.8, -0.4]c
Patients (%) achieving HbA1c <7%556640
FPG (mg/dL)
Baseline (mean)
172
179
174
Change at week 30b
-35
-46
-37
aThe intent-to-treat population includes all randomized and exposed patients. At week 30 the primary HbA1c endpoint

was missing for 8%, 6% and 6% of patients and during the trial rescue medication was initiated by 4%, 3% and 1%of patients randomized to OZEMPIC ® 0.5 mg, OZEMPIC ® 1 mg and insulin glargine, respectively. Missing data were
imputed using multiple imputation based on retrieved dropouts.
b Intent-to-treat analysis using ANCOVA adjusted for baseline value, country and stratification factors.
c p <0.0001 (2-sided) for superiority, adjusted for multiplicity.

The mean baseline body weight was 93.7 kg, 94.0 kg, 92.6 kg in the OZEMPIC® 0.5 mg, OZEMPIC®
1 mg, and insulin glargine arms, respectively. The mean changes from baseline to week 30 were
-3.2 kg, -4.7 kg and 0.9 kg in the OZEMPIC® 0.5 mg, OZEMPIC® 1 mg, and insulin glargine arms,
respectively. The difference from insulin glargine (95% CI) for OZEMPIC® 0.5 mg was -4.1 kg (-4.9,-3.3) and for OZEMPIC® 1 mg was -5.6 kg (-6.4, -4.8).
Combination with metformin or metformin with sulfonylurea
In a 40-week, double-blind trial (NCT03989232), 961 patients with type 2 diabetes currently
treated with metformin with or without sulfonylurea treatment were randomized to OZEMPIC®
2 mg or OZEMPIC® 1 mg once weekly. Patients had a mean age of 58.0 years and 58.6% weremen. The mean duration of type 2 diabetes was 9.5 years and the mean BMI was 34.6 kg/m2. At
randomization, 53.3% of patients were treated with sulfonylurea and metformin. Overall, 88.1% wereWhite, 4.5% were Black or African American, and 7.2% were Asian; 11.6% identified as Hispanic or
Latino ethnicity. Treatment with OZEMPIC® 2 mg once weekly for 40 weeks resulted in a statisticallysignificant reduction in HbA1c compared with OZEMPIC® 1 mg (see Table 7). Patients were stratified
by region (Japan/outside Japan) at randomization.
Table 7. Results at Week 40 in a Trial of OZEMPIC ® 2 mg Compared to OZEMPIC ® 1
mg in Adult Patients with Type 2 Diabetes Mellitus in Combination With Metformin
or Metformin with Sulfonylurea
OZEMPIC® 1 mg OZEMPIC® 2 mg
Intent-to-Treat (ITT) Population (N)a481
480
HbA1c (%)
Baseline (mean)
8.8
8.9
Change at week 40b
-1.9
-2.1
Difference from OZEMPIC® 1 mg
-0.2
[95% CI][-0.31 ; -0.04]cPatients (%) achieving HbA1c <7%a5664
FPG (mg/dL)
Baseline (mean)
196
193
Change at week 40b-55-59
aThe intent-to-treat population includes all randomized subjects. At week 40 the primary HbA

1c endpoint was missing for
3% and 5% of patients randomized to OZEMPIC ® 1 mg and OZEMPIC ® 2 mg, respectively. Missing data were imputed
using multiple imputation based on retrieved dropouts. For calculation of proportions, imputed values are dichotomized
and the denominator is the number of all randomized subjects.
bIntent-to-treat analysis using ANCOVA adjusted for baseline value and stratification factor.
c p <0.01 (2-sided) for superiority, adjusted for multiplicity.

The mean baseline body weight was 98.6 kg and 100.1 kg in the OZEMPIC® 1 mg and OZEMPIC®
2 mg arms, respectively. The mean changes from baseline to week 40 were -5.6 kg and -6.4 kg in the
OZEMPIC® 1 mg and OZEMPIC® 2 mg arms, respectively. The difference between treatment arms inbody weight change from baseline at week 40 was not statistically significant.
Combination with basal insulin
In a 30-week, double-blind trial (NCT02305381), 397 patients with type 2 diabetes mellitus
inadequately controlled with basal insulin, with or without metformin, were randomized to
OZEMPIC® 0.5 mg once weekly, OZEMPIC® 1 mg once weekly, or placebo. Patients with HbA1c≤ 8.0% at screening reduced their insulin dose by 20% at start of the trial to reduce the risk ofhypoglycemia. Patients had a mean age of 59 years and 56% were men. The mean duration of type 2
diabetes was 13 years, and the mean BMI was 32 kg/m2. Overall, 78% were White, 5% were Black or
African American, and 17% were Asian; 12% identified as Hispanic or Latino ethnicity.
Treatment with OZEMPIC® resulted in a statistically significant reduction in HbA1c after 30 weeks oftreatment compared to placebo (see Table 8).

7

Table 8. Results at Week 30 in a Trial of OZEMPIC ® in Adult Patients with Type 2

Diabetes Mellitus in Combination with Basal Insulin with or without Metformin
PlaceboOZEMPIC® 0.5 mg OZEMPIC® 1 mga
Intent-to-Treat (ITT) Population (N)
133
132
131
HbA1c (%)
Baseline (mean)
8.4
8.4
8.3
Change at week 30b
-0.2
-1.3
-1.7
Difference from placebob
-1.1
-1.6
[95% CI][-1.4, -0.8]c[-1.8, -1.3]c
Patients (%) achieving HbA1c <7%135673
FPG (mg/dL)
Baseline (mean)
154
161
153
Change at week 30b
-8
-28
-39
aThe intent-to-treat population includes all randomized and exposed patients. At week 30 the primary HbA

1c endpoint
was missing for 7%, 5% and 5% of patients and during the trial rescue medication was initiated by 14%, 2% and 1%of patients randomized to placebo, OZEMPIC ® 0.5 mg and OZEMPIC ® 1 mg, respectively. Missing data were imputed
using multiple imputation based on retrieved dropouts.
bIntent-to-treat analysis using ANCOVA adjusted for baseline value, country and stratification factors.
c p <0.0001 (2-sided) for superiority, adjusted for multiplicity.

The mean baseline body weight was 89.9 kg, 92.7 kg, and 92.5 kg in the placebo, OZEMPIC® 0.5 mg,
and OZEMPIC® 1 mg arms, respectively. The mean changes from baseline to week 30 were -1.2 kg,-3.5 kg, and -6.0 kg in the placebo, OZEMPIC® 0.5 mg, and OZEMPIC® 1 mg arms, respectively. The
difference from placebo (95% CI) for OZEMPIC® 0.5 mg was -2.2 kg (-3.4, -1.1), and for OZEMPIC®
1 mg was -4.7 kg (-5.8, -3.6).
14.4 Cardiovascular Outcomes Trial of OZEMPIC ® in Patients with Type 2 Diabetes
Mellitus and Cardiovascular Disease
SUSTAIN 6 (NCT01720446) was a multi-center, multi-national, placebo-controlled, doubleblind cardiovascular outcomes trial. In this trial, 3,297 patients with inadequately controlled type2 diabetes and atherosclerotic cardiovascular disease were randomized to OZEMPIC® (0.5 mg or
1 mg) once weekly or placebo for a minimum observation time of 2 years. The trial compared the riskof Major Adverse Cardiovascular Event (MACE) between semaglutide and placebo when these wereadded to and used concomitantly with standard of care treatments for diabetes and cardiovasculardisease. The primary endpoint, MACE, was the time to first occurrence of a three-part composite
outcome which included cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.
Patients eligible to enter the trial were; 50 years of age or older and had established, stable,
cardiovascular, cerebrovascular, peripheral artery disease, chronic kidney disease or NYHA
class II and III heart failure or were 60 years of age or older and had other specified risk factors
for cardiovascular disease. In total, 1,940 patients (58.8%) had established cardiovascular disease
without chronic kidney disease, 353 (10.7%) had chronic kidney disease only, and 442 (13.4%)
had both cardiovascular disease and kidney disease; 562 patients (17%) had cardiovascular risk
factors without established cardiovascular disease or chronic kidney disease. In the trial 453 patients(13.7%) had peripheral artery disease. The mean age at baseline was 65 years, and 61% were men.
The mean duration of diabetes was 13.9 years, and mean BMI was 33 kg/m2. Overall, 83% wereWhite, 7% were Black or African American, and 8% were Asian; 16% identified as Hispanic or Latino
ethnicity. Concomitant diseases of patients in this trial included, but were not limited to, heart failure(24%), hypertension (93%), history of ischemic stroke (12%) and history of a myocardial infarction(33%). In total, 98.0% of the patients completed the trial and the vital status was known at the endof the trial for 99.6%.
For the primary analysis, a Cox proportional hazards model was used to test for non-inferiority of
OZEMPIC® to placebo for time to first MACE using a risk margin of 1.3. The statistical analysis plan
pre specified that the 0.5 mg and 1 mg doses would be combined. Type-1 error was controlled acrossmultiple tests using a hierarchical testing strategy.
OZEMPIC® significantly reduced the occurrence of MACE. The estimated hazard ratio for time to first
MACE was 0.74 (95% CI: 0.58, 0.95). Refer to Figure 6 and Table 9.
Figure 6. Kaplan-Meier: Time to First Occurrence of a MACE in the SUSTAIN 6 Trial
10
Placebo8
Patients with Event (%)

Table 6. Results at Week 30 in a Trial of OZEMPIC ® Compared to Insulin Glargine

6
OZEMPIC ®
4
HR: 0.74
95% CI [0.58 - 0.95]

20
0Patients at risk
OZEMPIC ® 1648
Placebo
1649

8

16

24

32

40

48

56

64

72

80

88

96

104 109

1524
1479

1505
1460

Time from Randomization (Weeks)
1619
1616

1601
1586

1584
1567

1568
1534

1543
1508

The treatment effect for the primary composite endpoint and its components in the SUSTAIN 6 trial
is shown in Table 9.

OZEMPIC ® (semaglutide) injection, for subcutaneous use
Table 9. Treatment Effect for MACE and its Components, Median Study Observation
Time of 2.1 Years
Hazard ratio
PlaceboOZEMPIC ®
vs Placebo
N=1649 (%) N=1648 (%)(95% CI)a
Composite of cardiovascular death,
non-fatal myocardial infarction,
non-fatal stroke (time to firstoccurrence)Non-fatal Myocardial Infarction
Non-fatal Stroke
Cardiovascular Death
Fatal or Non-fatal Myocardial
Infarction
Fatal or Non-fatal Stroke

146 (8.9)

108 (6.6)

0.74 (0.58, 0.95)

64 (3.9)44 (2.7)
46 (2.8)47 (2.9)27 (1.6)
44 (2.7)

0.74 (0.51, 1.08)
0.61 (0.38, 0.99)
0.98 (0.65, 1.48)

67 (4.1)

54 (3.3)

0.81 (0.57, 1.16)

46 (2.8)30 (1.8)

0.65 (0.41, 1.03)

a Cox-proportional hazards models with treatment as factor and stratified by evidence of cardiovascular disease, insulin

treatment and renal impairment.

16 HOW SUPPLIED/STORAGE AND HANDLINGHow Supplied
Injection: clear, colorless solution of 0.68 mg/mL, 1.34 mg/mL or 2.68 mg/mL of semaglutide
available in pre-filled, disposable, single-patient-use pens in the following packaging configurations:
Dose perInjection
0.25 mg
0.5 mgTotal Strength
per Total Volume Doses per Pen
4 doses of 0.25 mg andInitiation
2 doses of 0.5 mg
2 mg / 3 mLorMaintenance
4 doses of 0.5 mg
Use ForCartonContents

for worsening renal function and explain the associated signs and symptoms of renal impairment,
as well as the possibility of dialysis as a medical intervention if acute kidney injury occurs [seeWarnings and Precautions (5.6)].
Hypersensitivity Reactions
Inform patients that serious hypersensitivity reactions have been reported during postmarketing useof OZEMPIC®. Advise patients on the symptoms of hypersensitivity reactions and instruct them tostop taking OZEMPIC® and seek medical advice promptly if such symptoms occur [see Warnings
and Precautions (5.7)].
Acute Gallbladder Disease
Inform patients of the potential risk for cholelithiasis or cholecystitis. Instruct patients to contact
their physician if cholelithiasis or cholecystitis is suspected for appropriate clinical follow-up [seeWarnings and Precautions (5.8)].
Pregnancy
Advise a pregnant woman of the potential risk to a fetus. Advise women to inform their healthcare
provider if they are pregnant or intend to become pregnant [see Use in Specific Populations (8.1),(8.3)].
Missed doses
Inform patients if a dose is missed, it should be administered as soon as possible within 5 days after
the missed dose. If more than 5 days have passed, the missed dose should be skipped and the next
dose should be administered on the regularly scheduled day. In each case, inform patients to resume
their regular once weekly dosing schedule [see Dosage and Administration (2.2)].

NDC

1 pen
6 NovoFine ® 0169-4181-13
Plus needles

1 pen
4 NovoFine ® 0169-4130-13
Plus needles
1 pen
2 mg
Maintenance 8 mg / 3 mL
4 doses of 2 mg
4 NovoFine ® 0169-4772-12
Plus needles
The 2 mg/1.5 mL (1.34 mg/mL) strength (NDC 0169-4132-12) is not currently marketed by Novo
Nordisk Inc.
1 mg

Maintenance 4 mg / 3 mL

4 doses of 1 mg

Each OZEMPIC® pen is for use by a single patient. An OZEMPIC® pen must never be shared between
patients, even if the needle is changed [see Warnings and Precautions (5.4)].
Recommended Storage
Prior to first use, OZEMPIC® should be stored in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC)
(Table 10). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do notfreeze OZEMPIC® and do not use OZEMPIC® if it has been frozen.
After first use of the OZEMPIC® pen, the pen can be stored for 56 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). Do not freeze. Keep
the pen cap on when not in use. OZEMPIC® should be protected from excessive heat and sunlight.
Always remove and safely discard the needle after each injection and store the OZEMPIC® pen
without an injection needle attached. Always use a new needle for each injection.
The storage conditions are summarized in Table 10:
Table 10. Recommended Storage Conditions for the OZEMPIC ® Pen
Prior to first use
After first use
Refrigerated
Room Temperature
Refrigerated
36°F to 46°F
59°F to 86°F
36°F to 46°F
(2°C to 8°C)
(15°C to 30°C)(2°C to 8°C)
Until expiration date
56 days
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions
for Use).
Risk of Thyroid C-cell Tumors
Inform patients that semaglutide causes thyroid C-cell tumors in rodents and that the humanrelevance of this finding has not been determined. Counsel patients to report symptoms of thyroid
tumors (e.g., a lump in the neck, hoarseness, dysphagia, or dyspnea) to their physician [see Boxed
Warning and Warnings and Precautions (5.1)].
Pancreatitis
Inform patients of the potential risk for pancreatitis. Instruct patients to discontinue OZEMPIC®
promptly and contact their physician if pancreatitis is suspected (severe abdominal pain that may
radiate to the back, and which may or may not be accompanied by vomiting) [see Warnings andPrecautions (5.2)].
Diabetic Retinopathy Complications
Inform patients to contact their physician if changes in vision are experienced during treatment withOZEMPIC® [see Warnings and Precautions (5.3)].
Never Share an OZEMPIC® Pen Between Patients
Advise patients that they must never share an OZEMPIC® pen with another person, even if theneedle is changed, because doing so carries a risk for transmission of blood-borne pathogens [seeWarnings and Precautions (5.4)].
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
Inform patients that the risk of hypoglycemia is increased when OZEMPIC® is used with an insulin
secretagogue (such as a sulfonylurea) or insulin. Educate patients on the signs and symptoms ofhypoglycemia [see Warnings and Precautions (5.5)].
Acute Kidney Injury
Advise patients treated with OZEMPIC® of the potential risk of dehydration due to gastrointestinal
adverse reactions and take precautions to avoid fluid depletion. Inform patients of the potential risk

8

Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd
Denmark
For information about OZEMPIC® contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-888-693-6742
Version: 9OZEMPIC® and NovoFine ® are registered trademarks of Novo Nordisk A/S.
PATENT INFORMATION:
http://www.novonordisk-us.com/products/product-patents.html© 2023 Novo Nordisk All rights reserved.
US23OZM00590 10/2023

OZEMPIC ® (semaglutide) injection, for subcutaneous use Medication Guide
Medication Guide
OZEMPIC® (oh-ZEM-pick)(semaglutide) injection, for subcutaneous use
Do not share your OZEMPIC® pen with other people, even if the needle has beenchanged. You may give other people a serious infection, or get a serious infection
from them.
Read this Medication Guide before you start using OZEMPIC® and each time you get a refill.
There may be new information. This information does not take the place of talking to your healthcare
provider about your medical condition or your treatment.
What is the most important information I should know about OZEMPIC®?
OZEMPIC® may cause serious side effects, including:• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lumpor swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be
symptoms of thyroid cancer. In studies with rodents, OZEMPIC® and medicines that work likeOZEMPIC® caused thyroid tumors, including thyroid cancer. It is not known if OZEMPIC® willcause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in
people.
• Do not use OZEMPIC® if you or any of your family have ever had a type of thyroid cancer called
medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple
Endocrine Neoplasia syndrome type 2 (MEN 2).
What is OZEMPIC®?
OZEMPIC® is an injectable prescription medicine used:• along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes
mellitus.
• to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults
with type 2 diabetes mellitus with known heart disease.
It is not known if OZEMPIC® can be used in people who have had pancreatitis.
OZEMPIC® is not for use in people with type 1 diabetes.
It is not known if OZEMPIC® is safe and effective for use in children under 18 years of age.
Do not use OZEMPIC® if:• you or any of your family have ever had a type of thyroid cancer called medullary thyroid
carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine
Neoplasia syndrome type 2 (MEN 2).
• you have had a serious allergic reaction to semaglutide or any of the ingredients in OZEMPIC®.
See the end of this Medication Guide for a complete list of ingredients in OZEMPIC®. Symptoms
of a serious allergic reaction include:• swelling of your face, lips, tongue or throat• problems breathing or swallowing• severe rash or itching • fainting or feeling dizzy• very rapid heartbeat
Before using OZEMPIC®, tell your healthcare provider if you have any other medical
conditions, including if you:• have or have had problems with your pancreas or kidneys.
• have a history of diabetic retinopathy.
• are pregnant or plan to become pregnant. It is not known if OZEMPIC® will harm your unborn
baby. You should stop using OZEMPIC® 2 months before you plan to become pregnant. Talk to
your healthcare provider about the best way to control your blood sugar if you plan to become
pregnant or while you are pregnant.
• are breastfeeding or plan to breastfeed. It is not known if OZEMPIC® passes into your breast milk.
You should talk with your healthcare provider about the best way to feed your baby while using
OZEMPIC®.
Tell your healthcare provider about all the medicines you take, including prescription andover-the-counter medicines, vitamins, and herbal supplements. OZEMPIC® may affect the way somemedicines work and some medicines may affect the way OZEMPIC® works.
Before using OZEMPIC®, talk to your healthcare provider about low blood sugar andhow to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes,
including insulin or sulfonylureas.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist
when you get a new medicine.
How should I use OZEMPIC®?
• Read the Instructions for Use that comes with OZEMPIC®.
• Use OZEMPIC® exactly as your healthcare provider tells you to.
• Your healthcare provider should show you how to use OZEMPIC® before you use it
for the first time.
• OZEMPIC® is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or
upper arm. Do not inject OZEMPIC® into a muscle (intramuscularly) or vein (intravenously).
• Use OZEMPIC® 1 time each week, on the same day each week, at any time of theday.
• You may change the day of the week you use OZEMPIC® as long as your last dose was given 2 ormore days before.
Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark
OZEMPIC® is a registered trademark of Novo Nordisk A/S.
PATENT Information: http://novonordisk-us.com/products/product-patents.html© 2022 Novo Nordisk All rights reserved. US23OZM00590 10/2023

9• If you miss a dose of OZEMPIC®, take the missed dose as soon as possible within 5 days after
the missed dose. If more than 5 days have passed, skip the missed dose and take your next doseon the regularly scheduled day.
• OZEMPIC® may be taken with or without food.
• Do not mix insulin and OZEMPIC® together in the same injection.
• You may give an injection of OZEMPIC® and insulin in the same body area (such as your stomacharea), but not right next to each other.
• Change (rotate) your injection site with each injection. Do not use the same site for each
injection.
• Check your blood sugar as your healthcare provider tells you to.
• Stay on your prescribed diet and exercise program while using OZEMPIC®.
• Talk to your healthcare provider about how to prevent, recognize and manage low blood sugar(hypoglycemia), high blood sugar (hyperglycemia), and problems you have because of yourdiabetes.
• Your healthcare provider will check your diabetes with regular blood tests, including your blood
sugar levels and your hemoglobin A1C.
• Do not share your OZEMPIC® pen with other people, even if the needle has beenchanged. You may give other people a serious infection, or get a serious infection from them.
Your dose of OZEMPIC® and other diabetes medicines may need to change because of:• change in level of physical activity or exercise, weight gain or loss, increased stress, illness,change in diet, fever, trauma, infection, surgery or because of other medicines you take.
• If you take too much OZEMPIC®, call your healthcare provider or go to the nearest hospitalemergency room right away.
What are the possible side effects of OZEMPIC®?
OZEMPIC® may cause serious side effects, including:• See “What is the most important information I should know about OZEMPIC®?”• inflammation of your pancreas (pancreatitis). Stop using OZEMPIC® and call yourhealthcare provider right away if you have severe pain in your stomach area (abdomen) that will
not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
• changes in vision. Tell your healthcare provider if you have changes in vision during treatment
with OZEMPIC®.
• low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you
use OZEMPIC® with another medicine that can cause low blood sugar, such as a sulfonylurea or
insulin. Signs and symptoms of low blood sugar may include:• dizziness or light-headedness • blurred vision• anxiety, irritability, or mood changes• sweating• slurred speech • hunger• confusion or drowsiness• shakiness• weakness• headache• fast heartbeat• feeling jittery• kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea,
and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to getworse. It is important for you to drink fluids to help reduce your chance of dehydration.
• serious allergic reactions. Stop using OZEMPIC® and get medical help right away, if you
have any symptoms of a serious allergic reaction including:• swelling of your face, lips, tongue or throat• problems breathing or swallowing• severe rash or itching • fainting or feeling dizzy• very rapid heartbeat• gallbladder problems. Gallbladder problems have happened in some people who takeOZEMPIC®. Tell your healthcare provider right away if you get symptoms of gallbladder problems
which may include:• pain in your upper stomach (abdomen)• yellowing of skin or eyes (jaundice)• fever			• clay-colored stools
The most common side effects of OZEMPIC® may include nausea, vomiting, diarrhea,
stomach (abdominal) pain, and constipation.
Talk to your healthcare provider about any side effect that bothers you or does not go away.
These are not all the possible side effects of OZEMPIC®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
General information about the safe and effective use of OZEMPIC®.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
Do not use OZEMPIC® for a condition for which it was not prescribed. Do not give OZEMPIC® toother people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about OZEMPIC® that is written
for health professionals.
For more information, go to OZEMPIC.com or call 1-888-693-6742.
What are the ingredients in OZEMPIC®?
Active Ingredient: semaglutide
Inactive Ingredients: disodium phosphate dihydrate, propylene glycol, phenol and water for
injection
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: 03/2022

OZEMPIC ® (semaglutide) injection, 0.25 mg or 0.5 mg doses, Instructions For Use

Supplies you will need to give your OZEMPIC® injection:• OZEMPIC® pen• a new NovoFine® Plus or NovoFine® needle• 1 alcohol swab
• 1 gauze pad or cotton ball
• 1 sharps disposal container for throwing away used OZEMPIC®
pens and needles. See “Disposing of used OZEMPIC®
pens and needles” at the end of these instructions.
OZEMPIC® pen and NovoFine® Plus needle (example)
Pen
Dose
Dose
windowcounter
selector

Expiration date (EXP)on back of pen label
0

Flow
check
symbolDose
pointer
Dashed line
(used to guideto your dose)

Pen cap

Outer
needle cap

Inner
Paper
needle cap Needle tab

Step 1.
Prepare your pen with a new needle• Wash your hands withA
soap and water.
• Check the name andcolored label of yourpen, to make sure that it
contains OZEMPIC®.
This is especially
important if you takemore than 1 type of
medicine.
• Pull off the pen cap.

Dosebutton• Check that the
OZEMPIC® medicine
in your pen is clear
and colorless.
Look through the pen
window. If OZEMPIC®
looks cloudy or contains
particles, do not use thepen.
• Take a new needle,
and tear off the paper tab.
Do not attach a newneedle to your pen until
you are ready to give yourinjection.

• Push the needle
straight onto the pen.
Turn until it is ontight.

• The needle is coveredby 2 caps. You must
remove both caps.
If you forget to remove
both caps, you will not
inject any medicine.
• Pull off the outerneedle cap. Do not
throw it away.
• Pull off the innerneedle cap and throw
it away. A drop of
OZEMPIC® may appear
at the needle tip. This isnormal, but you must still
check the OZEMPIC®
flow if you use a new pen
for the first time.

B

C

D

E

F

Always use a new needle for each injection. This
will reduce the risk of contamination, infection, leakage ofOZEMPIC®, and blocked needles leading to the wrong dose.
Do not reuse or share your needles with other people.
You may give other people a serious infection, or geta serious infection from them.
Never use a bent or damaged needle.
Step 2.
First Time Use for Each New Pen: Check the OZEMPIC®
flow• Check the OZEMPIC®
G
flow before the first
injection with eachnew pen only.
0
If your OZEMPIC® pen isalready in use, go to Step
3 “Select your dose”.
• Turn the dose selector
until the dose countershows the flow check0
Flow check
symbol ().
symbolselected• Hold the pen with theneedle pointing up.
Press and hold in thedose button until thedose counter shows 0.
The 0 must line up withthe dose pointer.
A drop of OZEMPIC® willappear at the needle tip.
• If no drop appears,
repeat Step 2 above asshown in Figure G and
Figure H up to 6 times.
If there is still no drop,change the needle andrepeat Step 2 as shownin Figure G and Figure H
1 more time.
Do not use the pen if
a drop of OZEMPIC® still
does not appear.
Contact Novo Nordisk at
1-888-693-6742.

H

0

INSTRUCTIONS FOR USEOZEMPIC ® [oh-ZEM-pick](semaglutide) injection, for subcutaneous use
0.25 mg or 0.5 mg doses(pen delivers doses in 0.25 mg or 0.5 mg increments only)• Read these instructions carefully before using yourOZEMPIC® 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.
• Do not share your OZEMPIC® pen with other people,
even if the needle has been changed. You may giveother people a serious infection, or get a serious
infection from them.
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 OZEMPIC® pen.
• Start by checking your pen to make sure that it
contains OZEMPIC®, then look at the pictures below to
get to know the different parts of your pen and needle.
• Your pen is a prefilled, single-patient-use, dial-a-dose
pen. It contains 2 mg of semaglutide, and you can select dosesof 0.25 mg or 0.5 mg. Each prefilled pen contains 4 doses of0.25 mg and 2 doses of 0.5 mg or contains 4 doses of 0.5 mg.
• Your pen is made to be used with NovoFine® Plus or
NovoFine® disposable needles up to a length of 8 mm.
• NovoFine® Plus 32G 4 mm disposable needles are included
with your OZEMPIC® pen.
• Always use a new needle for each injection.

10

Always make sure that a drop appears at the needle tip
before you use a new pen for the first time. This makes sure thatOZEMPIC® flows.
If no drop appears, you will not inject any OZEMPIC®, 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 OZEMPIC® flow before your first
injection with each new pen.
Step 3.
Select your dose
• Turn the dose selector
until the dose counter
stops and shows yourdose (0.25 mg or
0.5 mg).
The dashed line in thedose counter ( ) will
guide you to your dose.
Make sure you know thedose of OZEMPIC® you
should use. If you selectthe wrong dose, you canturn the dose selector
forward or backwards tothe correct dose.

I
0

Dashedline

0.25

Example:0.25 mg
selected

0.5

Example:0.5 mgselected

Always use the dose counter and the dose pointer tosee 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.
Only doses of 0.25 mg or 0.5 mg can be selected withthe dose selector. The selected dose must line up exactlywith the dose pointer to make sure that you get a correct dose.
The dose selector changes the dose. Only the dose counterand dose pointer will show how many mg you selectfor each dose.
You can select 0.25 mg or 0.5 mg for each dose. When yourpen contains less than 0.5 or 0.25 mg, the dose counter stops
before 0.5 mg or 0.25 mg is shown.
The dose selector clicks differently when turned forward or
backward. Do not count the pen clicks.

OZEMPIC ® (semaglutide) injection, 0.25 mg or 0.5 mg doses, Instructions For Use
How much OZEMPIC® is left?
• To see how muchJ
OZEMPIC® is left inyour pen, use the dosecounter:0Turn the dose selector
until the dose counter
stops.
• If it shows 0.5, at
Exampleleast 0.5 mg is leftin your pen. If theDosedose counter stops
counter
before 0.5 mg,
0.25
stopped:there is not enough0.25 mg leftOZEMPIC® left for a
full dose of 0.5 mg.
• If it shows 0.25, at least 0.25 mg is left in your pen. If
the dose counter stops before 0.25 mg, there is notenough OZEMPIC® left for a full dose of 0.25 mg.
If there is not enough OZEMPIC® left in your pen for a
full dose, do not use it. Use a new OZEMPIC® pen.

• Press and hold down
the dose button until
the dose countershows 0.
The 0 must line up withthe dose pointer. You may
then hear or feel a click.
Continue pressing
the dose button while
keeping the needle inyour skin.
• Count 6 seconds
while keeping thedose button pressed.
• If the needle is removed
earlier, you may see a
stream of OZEMPIC®
coming from the needle
tip. If this happens, thefull dose will not bedelivered.

• Remove the needle
from your skin. You
can then release the dose
button.
If blood appears at the
injection site, press
lightly with a gauze pador cotton ball. Do not rub
the area.

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”.
Never touch the dose counter when you inject. This canstop the injection.
You may see a drop of OZEMPIC® at the needle tip after injecting.
This is normal and does not affect your dose.
Step 5.
After your injection• Carefully remove theneedle from the pen.
Do not put the needle
caps back on the needle
to avoid needle sticks.

• Place the needle ina sharps disposal
container right away to
reduce the risk of needle
sticks. See “Disposingof used OZEMPIC®
pens and needles”
below for more
information about how todispose of used pens andneedles the right way.

.25

L

• Put the pen cap on
your pen after each use toprotect OZEMPIC® fromlight.

M

P

Q

R

0

• 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.

K

0Count slowly:N

1-2-3-4-5-6
0Step 4.
Inject your dose
• Choose your injection
site and wipe the skinwith an alcohol swab.
Let the injection site dry
before you inject yourdose (See Figure K).

Always watch the dose counter to make sure you have
injected your complete dose. Hold the dose button down until
the dose counter shows 0.
How to identify a blocked 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 OZEMPIC® eventhough the dose counter has moved from the original dosethat you have set.

O

• If you do not have a
sharps disposal container,
follow a 1-handed needle
recapping method.
Carefully slip the needle
into the outer needle cap.
Dispose of the needle in a
sharps disposal container
as soon as possible.

S

Never try to put the inner needle cap back on theneedle. You may stick yourself with the needle.
Always remove the needle from your pen.
This will reduce the risk of contamination, infection, leakage ofOZEMPIC®, and blocked needles leading to the wrong dose.
If the needle is blocked, you will not inject any OZEMPIC®.
Always dispose of the needle after each injection.
Disposing of used OZEMPIC® pens and needles:• Put your used OZEMPIC® pen and needle 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

11• 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 OZEMPIC® that is out of date or no longer
needed.
Important• Caregivers must be very careful when handling usedneedles to prevent accidental needle stick injuries and prevent
passing (transmission) of infection.
• Never use a syringe to withdraw OZEMPIC® 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.
• 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 OZEMPIC® 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 OZEMPIC® pen?
• Store your new, unused OZEMPIC® pens in the refrigerator
between 36°F to 46°F (2°C to 8°C).
• Store your pen in use for 56 days at room temperature
between 59ºF to 86ºF (15ºC to 30ºC) or in a refrigerator between
36°F to 46°F (2°C to 8°C).
• The OZEMPIC® pen you are using should be disposed of(thrown away) after 56 days, even if it still has OZEMPIC® left init. Write the disposal date on your calendar.
• Do not freeze OZEMPIC®. Do not use OZEMPIC® if it has
been frozen.
• Unused OZEMPIC® pens may be used until the expiration date(“EXP”) printed on the label, if kept in the refrigerator.
• When stored in the refrigerator, do not store OZEMPIC® pensdirectly next to the cooling element.
• Keep OZEMPIC® away from heat and out of the light.
• Keep the pen cap on when not in use.
• Keep OZEMPIC® and all medicines out of the reach ofchildren.

For more information go to www.OZEMPIC.com
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd
Denmark
For information about OZEMPIC® contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-888-693-6742
Version: 2
OZEMPIC® and NovoFine® are registered trademarks of
Novo Nordisk A/S.
PATENT Information: http://novonordisk-us.com/
patients/products/product-patents.html
This Instructions for Use has been approvedby the U.S. Food and Drug Administration.
© 2023 Novo Nordisk All rights reserved.
US23OZM00590 10/2023

OZEMPIC ® (semaglutide) injection, 1 mg dose, Instructions For Use

Supplies you will need to give your OZEMPIC® injection:• OZEMPIC® pen 1 mg dose
• a new NovoFine® Plus or NovoFine® needle• 1 alcohol swab
• 1 gauze pad or cotton ball
• 1 sharps disposal container for throwing away used OZEMPIC®
pens and needles. See “Disposing of used OZEMPIC®
pens and needles” at the end of these instructions.
OZEMPIC® pen and NovoFine® Plus needle (example)
Pen
Dose
Dose
windowcounter
selector

Expiration date (EXP)on back of pen label
0

Flow
check
symbolPen cap

Outer
needle cap

Inner
Paper
needle cap Needle tab

Step 1.
Prepare your pen with a new needle• Wash your hands withA
soap and water.
• Check the name andcolored label of yourpen, to make sure that it
contains OZEMPIC®.
This is especially
important if you takemore than 1 type of
medicine.
• Pull off the pen cap.

Dose
pointer
Dashed line
(used to guideto your dose)

Dose
button• Check that the
OZEMPIC® medicine
in your pen is clear
and colorless.
Look through the pen
window. If OZEMPIC®
looks cloudy or contains
particles, do not use thepen.
• Take a new needle,
and tear off the paper tab.
Do not attach a newneedle to your pen until
you are ready to give yourinjection.

• Push the needle
straight onto the pen.
Turn until it is ontight.

• The needle is coveredby 2 caps. You must
remove both caps. If
you forget to remove both
caps, you will not inject
any medicine.
• Pull off the outerneedle cap. Do not
throw it away.
• Pull off the innerneedle cap and throw
it away. A drop of
OZEMPIC® may appear
at the needle tip. This isnormal, but you must still
check the OZEMPIC®
flow if you use a new pen
for the first time.

B

C

D

E

F

Always use a new needle for each injection. This
will reduce the risk of contamination, infection, leakage ofOZEMPIC®, and blocked needles leading to the wrong dose.
Do not reuse or share your needles with other people.
You may give other people a serious infection, or geta serious infection from them.
Never use a bent or damaged needle.
Step 2.
First Time Use for Each New Pen: Check the OZEMPIC®
flow• Check the OZEMPIC®
G
flow before the first
injection with eachnew pen only.
0
If your OZEMPIC® pen isalready in use, go to Step
3 “Select your dose”.
• Turn the dose selector
until the dose countershows the flow check0
Flow check
symbol ().
symbolselected• Hold the pen with theneedle pointing up.
Press and hold in thedose button until thedose counter shows 0.
The 0 must line up withthe dose pointer.
A drop of OZEMPIC® willappear at the needle tip.
• If no drop appears,
repeat Step 2 above asshown in Figure G and
Figure H up to 6 times.
If there is still no drop,change the needle andrepeat Step 2 as shownin Figure G and Figure H
1 more time.
Do not use the pen if
a drop of OZEMPIC® still
does not appear.
Contact Novo Nordisk at
1-888-693-6742.

H

0

INSTRUCTIONS FOR USEOZEMPIC ® [oh-ZEM-pick](semaglutide) injection, for subcutaneous use
1 mg dose(pen delivers doses in 1 mg increments only)• Read these instructions carefully before using yourOZEMPIC® 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.
• Do not share your OZEMPIC® pen with other people,
even if the needle has been changed. You may giveother people a serious infection, or get a serious
infection from them.
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 OZEMPIC® pen.
• Start by checking your pen to make sure that it
contains OZEMPIC®, then look at the pictures below to
get to know the different parts of your pen and needle.
• Your pen is a prefilled, single-patient-use, dial-a-dose
pen. It contains 4 mg of semaglutide, and you can only selectdoses of 1 mg. Each prefilled pen contains 4 doses of 1 mg.
• Your pen is made to be used with NovoFine® Plus or
NovoFine® disposable needles up to a length of 8 mm.
• NovoFine® Plus 32G 4 mm disposable needles are included
with your OZEMPIC® pen.
• Always use a new needle for each injection.

12

Always make sure that a drop appears at the needle tip
before you use a new pen for the first time. This makes sure thatOZEMPIC® flows.
If no drop appears, you will not inject any OZEMPIC®, 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 OZEMPIC® flow before your first
injection with each new pen.
Step 3.
Select your dose
• Turn the dose selector
until the dose counter
stops and shows your
1 mg dose.
The dashed line in thedose counter ( ) will
guide you to 1 mg.

I
0Dashed
line

1

1 mg
selected

Always use the dose counter and the dose pointer to
see that 1 mg has been selected.
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.
Only doses of 1 mg can be selected with the dose
selector. 1 mg must line up exactly with the dose pointer tomake sure that you get a correct dose.
The dose selector changes the dose. Only the dose counterand dose pointer will show that 1 mg has been
selected.
You can only select 1 mg for each dose. When your pen
contains less than 1 mg, the dose counter stops before 1 mg isshown.
The dose selector clicks differently when turned forward or
backward. Do not count the pen clicks.

OZEMPIC ® (semaglutide) injection, 1 mg dose, Instructions For Use
How much OZEMPIC® is left?
• To see how muchJ
OZEMPIC® is left inyour pen, use the dosecounter:0Turn the dose selector
until the dose counter
stops.
• If it shows 1, atleast 1 mg is left
Dose
in your pen. If thecounter1
dose counter
stopped:stops before 1 mg,
1 mg left
there is not enoughOZEMPIC® left for a
full dose of 1 mg.
If there is not enough OZEMPIC® left in your pen for a
full dose, do not use it. Use a new OZEMPIC® pen.

• Press and hold down
the dose button until
the dose countershows 0.
The 0 must line up withthe dose pointer. You may
then hear or feel a click.
Continue pressing
the dose button while
keeping the needle inyour skin.
• Count 6 seconds
while keeping thedose button pressed.
• If the needle is removed
earlier, you may see a
stream of OZEMPIC®
coming from the needle
tip. If this happens, thefull dose will not bedelivered.

• Remove the needle
from your skin. You
can then release the dose
button.
If blood appears at the
injection site, press
lightly with a gauze pador cotton ball. Do not rub
the area.

Step 5.
After your injection• Carefully remove theneedle from the pen.
Do not put the needle
caps back on the needle
to avoid needle sticks.

• Place the needle ina sharps disposal
container right away to
reduce the risk of needle
sticks. See “Disposingof used OZEMPIC®
pens and needles”
below for more
information about how todispose of used pens andneedles the right way.

1

L

• Put the pen cap on
your pen after each use toprotect OZEMPIC® fromlight.

P

Q

R

M
0

• 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.

K

0Count slowly:N

1-2-3-4-5-6
0Step 4.
Inject your dose
• Choose your injection
site and wipe the skinwith an alcohol swab.
Let the injection site dry
before you inject yourdose (See Figure K).

How to identify a blocked 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 OZEMPIC® 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”.
Never touch the dose counter when you inject. This canstop the injection.
You may see a drop of OZEMPIC® at the needle tip after injecting.
This is normal and does not affect your dose.

O

Always watch the dose counter to make sure you have
injected your complete dose. Hold the dose button down until
the dose counter shows 0.

• If you do not have a
sharps disposal container,
follow a 1-handed needle
recapping method.
Carefully slip the needle
into the outer needle cap.
Dispose of the needle in a
sharps disposal container
as soon as possible.

S

Never try to put the inner needle cap back on theneedle. You may stick yourself with the needle.
Always remove the needle from your pen.
This will reduce the risk of contamination, infection, leakage ofOZEMPIC®, and blocked needles leading to the wrong dose.
If the needle is blocked, you will not inject any OZEMPIC®.
Always dispose of the needle after each injection.
Disposing of used OZEMPIC® pens and needles:• Put your used OZEMPIC® pen and needle 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 state

13

or 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 OZEMPIC® that is out of date or no longer
needed.
Important• Caregivers must be very careful when handling usedneedles to prevent accidental needle stick injuries and prevent
passing (transmission) of infection.
• Never use a syringe to withdraw OZEMPIC® 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.
• 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 OZEMPIC® 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 OZEMPIC® pen?
• Store your new, unused OZEMPIC® pens in the refrigerator
between 36°F to 46°F (2°C to 8°C).
• Store your pen in use for 56 days at room temperature
between 59ºF to 86ºF (15ºC to 30ºC) or in a refrigerator between
36°F to 46°F (2°C to 8°C).
• The OZEMPIC® pen you are using should be disposed of(thrown away) after 56 days, even if it still has OZEMPIC® left init. Write the disposal date on your calendar.
• Do not freeze OZEMPIC®. Do not use OZEMPIC® if it has
been frozen.
• Unused OZEMPIC® pens may be used until the expiration date(“EXP”) printed on the label, if kept in the refrigerator.
• When stored in the refrigerator, do not store OZEMPIC® pensdirectly next to the cooling element.
• Keep OZEMPIC® away from heat and out of the light.
• Keep the pen cap on when not in use.
• Keep OZEMPIC® and all medicines out of the reach ofchildren.

For more information go to www.OZEMPIC.com
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd
Denmark
For information about OZEMPIC® contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-888-693-6742
Version: 4OZEMPIC® and NovoFine® are registered trademarks of
Novo Nordisk A/S.
PATENT Information: http://novonordisk-us.com/
patients/products/product-patents.html
This Instructions for Use has been approvedby the U.S. Food and Drug Administration.
© 2023 Novo Nordisk All rights reserved.
US23OZM00590 10/2023

OZEMPIC ® (semaglutide) injection, 2 mg dose, Instructions For Use

Supplies you will need to give your OZEMPIC® injection:• OZEMPIC® pen 2 mg dose
• a new NovoFine® Plus or NovoFine® needle• 1 alcohol swab
• 1 gauze pad or cotton ball
• 1 sharps disposal container for throwing away used OZEMPIC®
pens and needles. See “Disposing of used OZEMPIC®
pens and needles” at the end of these instructions.
OZEMPIC® pen and NovoFine® Plus needle (example)
Pen
Dose
Dose
windowcounter
selector

Expiration date (EXP)on back of pen label
0

Flow
check
symbolPen cap

Outer
needle cap

Inner
Paper
needle cap Needle tab

Step 1.
Prepare your pen with a new needle• Wash your hands withA
soap and water.
• Check the name andcolored label of yourpen, to make sure that it
contains OZEMPIC®.
This is especially
important if you takemore than 1 type of
medicine.
• Pull off the pen cap.

Dose
pointer
Dashed line
(used to guideto your dose)

Dose
button• Check that the
OZEMPIC® medicine
in your pen is clear
and colorless.
Look through the pen
window. If OZEMPIC®
looks cloudy or contains
particles, do not use thepen.
• Take a new needle,
and tear off the paper tab.
Do not attach a newneedle to your pen until
you are ready to give yourinjection.

• Push the needle
straight onto the pen.
Turn until it is ontight.

• The needle is coveredby 2 caps. You must
remove both caps. If
you forget to remove both
caps, you will not inject
any medicine.
• Pull off the outerneedle cap. Do not
throw it away.
• Pull off the innerneedle cap and throw
it away. A drop of
OZEMPIC® may appear
at the needle tip. This isnormal, but you must still
check the OZEMPIC®
flow if you use a new pen
for the first time.

B

C

D

E

F

Always use a new needle for each injection. This
will reduce the risk of contamination, infection, leakage ofOZEMPIC®, and blocked needles leading to the wrong dose.
Do not reuse or share your needles with other people.
You may give other people a serious infection, or geta serious infection from them.
Never use a bent or damaged needle.
Step 2.
First Time Use for Each New Pen: Check the OZEMPIC®
flow• Check the OZEMPIC®
G
flow before the first
injection with eachnew pen only.
0
If your OZEMPIC® pen isalready in use, go to Step
3 “Select your dose”.
• Turn the dose selector
until the dose countershows the flow check0
Flow check
symbol ().
symbolselected• Hold the pen with theneedle pointing up.
Press and hold in thedose button until thedose counter shows 0.
The 0 must line up withthe dose pointer.
A drop of OZEMPIC® willappear at the needle tip.
• If no drop appears,
repeat Step 2 above asshown in Figure G and
Figure H up to 6 times.
If there is still no drop,change the needle andrepeat Step 2 as shownin Figure G and Figure H
1 more time.
Do not use the pen if
a drop of OZEMPIC® still
does not appear.
Contact Novo Nordisk at
1-888-693-6742.

H

0

INSTRUCTIONS FOR USEOZEMPIC ® [oh-ZEM-pick](semaglutide) injection, for subcutaneous use
2 mg dose(pen delivers doses in 2 mg increments only)• Read these instructions carefully before using yourOZEMPIC® 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.
• Do not share your OZEMPIC® pen with other people,
even if the needle has been changed. You may giveother people a serious infection, or get a serious
infection from them.
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 OZEMPIC® pen.
• Start by checking your pen to make sure that it
contains OZEMPIC®, then look at the pictures below to
get to know the different parts of your pen and needle.
• Your pen is a prefilled, single-patient-use, dial-a-dose
pen. It contains 8 mg of semaglutide, and you can only selectdoses of 2 mg. Each prefilled pen contains 4 doses of 2 mg.
• Your pen is made to be used with NovoFine® Plus or
NovoFine® disposable needles up to a length of 8 mm.
• NovoFine® Plus 32G 4 mm disposable needles are included
with your OZEMPIC® pen.
• Always use a new needle for each injection.

14

Always make sure that a drop appears at the needle tip
before you use a new pen for the first time. This makes sure thatOZEMPIC® flows.
If no drop appears, you will not inject any OZEMPIC®, 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 OZEMPIC® flow before your first
injection with each new pen.
Step 3.
Select your dose
• Turn the dose selector
until the dose counter
stops and shows your2 mg dose.
The dashed line in thedose counter ( ) will
guide you to 2 mg.

I
0Dashed
line

2

2 mg
selected

Always use the dose counter and the dose pointer to
see that 2 mg has been selected.
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.
Only doses of 2 mg can be selected with the dose
selector. 2 mg must line up exactly with the dose pointer tomake sure that you get a correct dose.
The dose selector changes the dose. Only the dose counterand dose pointer will show that 2 mg has been
selected.
You can only select 2 mg for each dose. When your pen
contains less than 2 mg, the dose counter stops before 2 mg isshown.
The dose selector clicks differently when turned forward or
backward. Do not count the pen clicks.

OZEMPIC ® (semaglutide) injection, 2 mg dose, Instructions For Use
How much OZEMPIC® is left?
• To see how muchJ
OZEMPIC® is left inyour pen, use the dosecounter:0Turn the dose selector
until the dose counter
stops.
• If it shows 2, atleast 2 mg is left
Dose
in your pen. If thecounter2
dose counter
stopped:stops before 2 mg,
2 mg left
there is not enoughOZEMPIC® left for a
full dose of 2 mg.
If there is not enough OZEMPIC® left in your pen for a
full dose, do not use it. Use a new OZEMPIC® pen.

• Press and hold down
the dose button until
the dose countershows 0.
The 0 must line up withthe dose pointer. You may
then hear or feel a click.
Continue pressing
the dose button while
keeping the needle inyour skin.
• Count 6 seconds
while keeping thedose button pressed.
• If the needle is removed
earlier, you may see a
stream of OZEMPIC®
coming from the needle
tip. If this happens, thefull dose will not bedelivered.

• Remove the needle
from your skin. You
can then release the dose
button.
If blood appears at the
injection site, press
lightly with a gauze pador cotton ball. Do not rub
the area.

Step 5.
After your injection• Carefully remove theneedle from the pen.
Do not put the needle
caps back on the needle
to avoid needle sticks.

• Place the needle ina sharps disposal
container right away to
reduce the risk of needle
sticks. See “Disposingof used OZEMPIC®
pens and needles”
below for more
information about how todispose of used pens andneedles the right way.

2

L

• Put the pen cap on
your pen after each use toprotect OZEMPIC® fromlight.

P

Q

R

M
0

• 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.

K

0Count slowly:N

1-2-3-4-5-6
0Step 4.
Inject your dose
• Choose your injection
site and wipe the skinwith an alcohol swab.
Let the injection site dry
before you inject yourdose (See Figure K).

How to identify a blocked 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 OZEMPIC® 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”.
Never touch the dose counter when you inject. This canstop the injection.
You may see a drop of OZEMPIC® at the needle tip after injecting.
This is normal and does not affect your dose.

O

Always watch the dose counter to make sure you have
injected your complete dose. Hold the dose button down until
the dose counter shows 0.

• If you do not have a
sharps disposal container,
follow a 1-handed needle
recapping method.
Carefully slip the needle
into the outer needle cap.
Dispose of the needle in a
sharps disposal container
as soon as possible.

S

Never try to put the inner needle cap back on theneedle. You may stick yourself with the needle.
Always remove the needle from your pen.
This will reduce the risk of contamination, infection, leakage ofOZEMPIC®, and blocked needles leading to the wrong dose.
If the needle is blocked, you will not inject any OZEMPIC®.
Always dispose of the needle after each injection.
Disposing of used OZEMPIC® pens and needles:• Put your used OZEMPIC® pen and needle 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 state15

or 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 OZEMPIC® that is out of date or no longer
needed.
Important• Caregivers must be very careful when handling usedneedles to prevent accidental needle stick injuries and prevent
passing (transmission) of infection.
• Never use a syringe to withdraw OZEMPIC® 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.
• 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 OZEMPIC® 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 OZEMPIC® pen?
• Store your new, unused OZEMPIC® pens in the refrigerator
between 36°F to 46°F (2°C to 8°C).
• Store your pen in use for 56 days at room temperature
between 59ºF to 86ºF (15ºC to 30ºC) or in a refrigerator between
36°F to 46°F (2°C to 8°C).
• The OZEMPIC® pen you are using should be disposed of(thrown away) after 56 days, even if it still has OZEMPIC® left init. Write the disposal date on your calendar.
• Do not freeze OZEMPIC®. Do not use OZEMPIC® if it has
been frozen.
• Unused OZEMPIC® pens may be used until the expiration date(“EXP”) printed on the label, if kept in the refrigerator.
• When stored in the refrigerator, do not store OZEMPIC® pensdirectly next to the cooling element.
• Keep OZEMPIC® away from heat and out of the light.
• Keep the pen cap on when not in use.
• Keep OZEMPIC® and all medicines out of the reach ofchildren.

For more information go to www.OZEMPIC.com
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd
Denmark
For information about OZEMPIC® contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-888-693-6742
Version: 2
OZEMPIC® and NovoFine® are registered trademarks of
Novo Nordisk A/S.
PATENT Information: http://novonordisk-us.com/
patients/products/product-patents.html
This Instructions for Use has been approvedby the U.S. Food and Drug Administration.
© 2023 Novo Nordisk All rights reserved.
US23OZM00590 10/2023