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Ozempic

Generic Name: semaglutide
Dosage Form: Injection, for Subcutaneous Use
Date of Approval: December 5, 2017
Company: Novo Nordisk

Treatment for: Type 2 Diabetes

FDA Approves Ozempic

The U.S. Food and Drug Administration (FDA) has approved Ozempic (semaglutide) injection 0.5 mg or 1 mg, a once-weekly glucagon-like peptide (GLP-1) receptor agonist for the treatment of adults with type 2 diabetes.

Medication Guide

Read this Medication Guide before you start using treatment 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.

Important 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.

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 other similar medicines 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 this medicine 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 for adults with type 2 diabetes mellitus that along with diet and exercise may improve blood sugar (glucose).
  • It is not recommended as the first choice of medicine for treating diabetes.
  • It is not known if it can be used in people who have had pancreatitis.
  • Ozempic is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
  • It is not known if this medcicine 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 are allergic to semaglutide or any of the ingredients. See the end of this Medication Guide for a complete list of ingredients.

Before you start treatment, 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 two 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 during treatment.

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 vice versa.

Before you start treatment, 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 when you get a new medicine.

How should I use Ozempic?

  • Read the Instructions for Use that comes with your prescription.
  • 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 one time each week, on the same day each week, at any time of the day.
  • You may change the day of the week you use Ozempic as long as your last dose was given two or more days before.
  • If you miss a dose, take the missed dose as soon as possible within five days after the missed dose. If more than five days have passed, skip the missed dose and take your next dose on 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 stomach area), 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 during treatment.
  • 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 your diabetes.
  • Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
  • Do not share your injection 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.

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.

Ozempic side effects

Ozempic may cause serious side effects, including:

  • See Important information.
  • inflammation of your pancreas (pancreatitis). Stop treatment and call your healthcare 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.
  • 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
    • sweating
    • confusion or drowsiness
    • headache
    • blurred vision
    • slurred speech
    • shakiness
    • fast heartbeat
    • anxiety, irritability, or mood changes
    • hunger
    • weakness
    • 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 get worse. 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 itching, rash, or difficulty breathing.

The most common side effects 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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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 this medicine for a condition for which it was not prescribed. Do not give it to other 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 that is written for health professionals.

For more information, go to Ozempic.com or call 1-888-693-6742.

What are the ingredients?

Active Ingredient: semaglutide

Inactive Ingredients: disodium phosphate dihydrate, propylene glycol, phenol and water for injection

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