Ozempic semaglutide .68 mg/mL Injection, Solution

1 INDICATIONS AND USAGE OZEMPIC 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 and established cardiovascular disease. • to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.

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 ) • to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.

( 1 )

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 ) • To reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death, increase the dosage to 1 mg once weekly after at least 4 weeks on the 0.5 mg dosage.

( 1 , 2.2 ) • If a dose is missed, administer within 5 days of missed dose. ( 2.1 ) • Inject subcutaneously in the abdomen, thigh, or upper arm. ( 2.1 )

2.1Important 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 or without meals. • Inject OZEMPIC subcutaneously in 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 and to 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. • 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.

2.2Recommended Dosage Recommended Initiation Dosage Initiate OZEMPIC with a dosage of 0.25 mg injected subcutaneously once weekly for 4 weeks. Follow the dosage escalation below to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions ( 5.7 ), Adverse Reactions ( 6.1 )]. After 4 weeks on the 0.25 mg dosage, increase the dosage to 0.5 mg once weekly.

Recommended Maintenance and Maximum Dosages for Glycemic Control The recommended maintenance dosage is 0.5 mg, 1 mg, or 2 mg, injected subcutaneously once weekly, based on glycemic control. 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. • 1 mg dosage, the dosage may be increased to 2 mg once weekly. The maximum recommended dosage is 2 mg once weekly.

Recommended Maintenance Dosage in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease Increase the dosage to the maintenance dosage, 1 mg once weekly, after at least 4 weeks on the 0.5 mg dosage.

3 DOSAGE FORMS AND STRENGTHS Injection: clear, colorless solution available as follows: Single-Patient-Use Pens (with multiple weekly doses) Dose per Injection Total Strength per Total Volume Strength per mL 0.25 mg 0.5 mg 2 mg / 3 mL 0.68 mg/mL 1 mg 4 mg / 3 mL 1.34 mg/mL 2 mg 8 mg / 3 mL 2.68 mg/mL Single-Dose Prefilled Syringes Dose per Injection Total Strength per Total Volume 0.25 mg 0.25 mg / 0.5 mL 0.5 mg 0.5 mg / 0.5 mL 1 mg 1 mg / 0.5 mL • Injection: 2 mg/3 mL (0.68 mg/mL) for 4 doses of 0.25 mg and 2 doses of 0.5 mg or 4 doses of 0.5 mg, 4 mg/3 mL (1.34 mg/mL) for 4 doses of 1 mg, and 8 mg/3 mL (2.68 mg/mL) for 4 doses of 2 mg in single-patient-use pens ( 3 ) • Injection: 0.25 mg, 0.5 mg or 1 mg per 0.5 mL in a single-dose prefilled syringe ( 3 )

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 human relevance 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, Warnings and Precautions ( 5.1 )] .

Acute Pancreatitis Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that may radiate to the back, and which may or may not be accompanied by nausea or vomiting. Instruct patients to discontinue OZEMPIC promptly and contact their physician if pancreatitis is suspected [see Warnings and Precautions ( 5.2 )]. Diabetic Retinopathy Complications Inform patients to contact their physician if changes in vision are experienced during treatment with OZEMPIC [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 the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens [see Warnings 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 of hypoglycemia [see Warnings and Precautions ( 5.5 )].

Acute Kidney Injury Due to Volume Depletion Inform patients of the potential risk of acute kidney injury due to dehydration associated with gastrointestinal adverse reactions. Advise patients to take precautions to avoid fluid depletion. Inform patients of the signs and symptoms of acute kidney injury and instruct them to promptly report any of these signs or symptoms or persistent (or extended) nausea, vomiting, and diarrhea to their healthcare provider [see Warnings and Precautions ( 5.6 )] .

Severe Gastrointestinal Adverse Reactions Inform patients of the potential risk of severe gastrointestinal adverse reactions. Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms [see Warnings and Precautions ( 5.7 )] Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of OZEMPIC. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking OZEMPIC and seek medical advice promptly if such symptoms occur [see Warnings and Precautions ( 5.8 )] .

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 [see Warnings and Precautions ( 5.9 )]. Pulmonary Aspiration During General Anesthesia or Deep Sedation Inform patients that OZEMPIC may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures.

Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking OZEMPIC [see Warnings and Precautions ( 5.10 )]. 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 [s…

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 been changed. 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 lump or 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 like OZEMPIC caused thyroid tumors, including thyroid cancer. It is not known if OZEMPIC will cause 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. • to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes mellitus and chronic kidney disease. It is not known if OZEMPIC is safe and effective for use in children.

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. See “What are the possible side effects of OZEMPIC?” for symptoms of a serious allergic reaction.

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. • have a history of diabetic retinopathy. • have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food. • are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). • are pregnant or plan to become pregnant. It is not known if OZEMPIC will harm your unborn baby.

You should stop using OZEMPIC at least 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 and over-the-counter medicines, vitamins, and herbal supplements. OZEMPIC may affect the way some medicines work and some medicines may affect the way OZEMPIC works.

Before using OZEMPIC, talk to your healthcare provider about low blood sugar and how 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 whe…