Ozempic^®*

Ozempic®

What is Ozempic®?

Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg and Ozempic® (semaglutide) tablets 4 mg or 9 mg are prescription medicines used:

• along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes

Ozempic® injection is used:

• to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes and 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 and chronic kidney disease

Ozempic® tablets are used:

• to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes who are at high risk for these events

It is not known if Ozempic® injection and Ozempic® tablets are safe and effective for use in children.

Important Safety Information

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.

What is the most important information I should know about Ozempic®?

Ozempic® may cause serious side effects, including:

• Possible thyr oid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyr oid cancer. In studies with rodents, Ozempic® and medicines that work like Ozempic® caused thyr oid tumors, including thyr oid cancer. It is not known if Ozempic® will cause thyr oid tumors or a type of thyr oid cancer called medullary thyr oid carcinoma (MTC) in people.

Do not use Ozempic® if:

• you or any of your family have ever had 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® injection or Ozempic® tablets

Before using Ozempic®, tell your health care 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 vision problems related to your diabetes

• 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® 2 months before you plan to become pregnant

• are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with Ozempic® tablets. It is not known if Ozempic® when received through an injection passes into your breast milk

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.

What are the possible side effects of Ozempic®?

Ozempic® may cause serious side effects, including:

• inflammation of your pancreas (pancreatitis). Stop using Ozempic® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.

• changes in vision. Tell your health care 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 lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.

• dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your health care provider right away if you have nausea, vomiting, or diarrhea that does not go away.

• severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Ozempic®. Tell your health care provider if you have stomach problems that are severe or will not go away.

• 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; or very rapid heartbeat.

• gallbladder problems. Gallbladder problems have happened in some people who take Ozempic®. Tell your health care provider right away if you get symptoms which may include: pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.

• food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Ozempic® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your health care providers that you are taking Ozempic® before you are scheduled to have surgery or other procedures.

The most common side effects of Ozempic® may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation. When taking Ozempic® tablets, they may also include decreased appetite.

Please click here for Prescribing Information and Medication Guide for Ozempic® pen.

Please click here for Prescribing Information and Medication Guide for Ozempic® pill.

Ozempic® injection and Ozempic® tablets are prescription medications.

Novo Nordisk provides patient assistance for those who qualify. Please call 1-866-310-7549 to learn more about Novo Nordisk assistance programs.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This site is intended for US patients only.