Ozempic (semaglutide)

Generic name: semaglutide injection (SEM a GLOO tide)
Brand name: Ozempic
Drug class: Incretin mimetics

Ozempic (semaglutide) is similar to a hormone that occurs naturally in the body and helps control blood sugar, insulin levels, and digestion.

Ozempic is a pre-filled, disposable, single-patient-use injection pen used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Ozempic is usually given after other diabetes medicines have been tried without success.

Ozempic is also used 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.

This medicine is not for treating type 1 diabetes.

Warnings

You should not use Ozempic if you have multiple endocrine neoplasia type 2 (tumors in your glands), a personal or family history of medullary thyroid cancer, insulin-dependent diabetes, or diabetic ketoacidosis.

Call your doctor at once if you have signs of a thyroid tumor, such as swelling or a lump in your neck, trouble swallowing, a hoarse voice, or shortness of breath.

Before taking this medicine

You should not use Ozempic if you are allergic to semaglutide, or if you have:

  • multiple endocrine neoplasia type 2 (tumors in your glands);
  • a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer); or
  • diabetic ketoacidosis (call your doctor for treatment).

To make sure Ozempic is safe for you, tell your doctor if you have:

  • a stomach or intestinal disorder;
  • pancreatitis;
  • kidney disease; or
  • eye problems caused by diabetes (retinopathy).

In animal studies, semaglutide caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people. Ask your doctor about your risk.

Stop using this medicine at least 2 months before you plan to get pregnant. Ask your doctor for a safer medicine to use during this time. Controlling diabetes is very important during pregnancy, as is gaining the right amount of weight. Even if you are overweight, losing weight during pregnancy could harm the unborn baby.

It is not known if semaglutide passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Ozempic.

Ozempic is not approved for use by anyone younger than 18 years old.

How should I use Ozempic?

Take Ozempic exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Ozempic is usually started at a low dose that is gradually increased every 4 weeks to 30 days. Follow your doctor's dosing instructions very carefully.

Ozempic is injected under the skin, usually once per week at any time of the day, with or without food. Use an injection on the same day each week.

Read and follow all Instructions for Use. Ask your doctor or pharmacist if you need help.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Your healthcare provider will show you where to inject this medicine. Do not inject into the same place two times in a row.

If you choose a different weekly injection day, start your new schedule after at least 2 days have passed since the last injection you gave.

Do not use different brands of semaglutide at the same time.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia) such as increased thirst or urination. Ask your doctor before changing your dose or medication schedule.

Your treatment may also include diet, exercise, weight control, medical tests, and special medical care.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

Store unopened Ozempic injection pens in the original carton in a refrigerator, protected from light. Do not use past the expiration date. Throw away an injection pen that has been frozen.

The Ozempic injection pen contains more than one dose. After your first use, store the pen with the needle removed in a refrigerator or at room temperature. Protect from heat and light. Keep the cap on when not in use. Throw the pen away 56 days after the first use, or if less than 0.25 mg is shown on the dose counter.

Do not reuse a needle. Place it in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Dosing information

Usual Adult Dose for Diabetes Type 2:

Subcutaneous Administration:
Initial dose: 0.25 mg subcutaneously once a week for 4 weeks, then 0.5 mg subcutaneously once a week
-If additional glycemic control is needed after at least 4 weeks receiving 0.5 mg dose subcutaneously once a week, may increase to 1 mg subcutaneously once a week
Maintenance dose: 0.5 to 1 mg subcutaneously once a week
Maximum dose: 1 mg/week.

Usual Adult Dose for Cardiovascular Risk Reduction:

Subcutaneous Administration:
Initial dose: 0.25 mg subcutaneously once a week for 4 weeks, then 0.5 mg subcutaneously once a week
-If additional glycemic control is needed after at least 4 weeks receiving 0.5 mg dose subcutaneously once a week, may increase to 1 mg subcutaneously once a week
Maintenance dose: 0.5 to 1 mg subcutaneously once a week
Maximum dose: 1 mg/week.

Uses:
-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.

What happens if I miss a dose?

Use the medicine as soon as you can and then go back to your regular schedule. If you are more than 5 days late for the injection, skip the missed dose and return to your regular schedule.

Do not use two doses of Ozempic at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause severe nausea, vomiting, or low blood sugar.

What should I avoid while using Ozempic?

Never share an injection pen, even if you changed the needle. Sharing this device can pass infection or disease from person to person.

Ozempic side effects

Get emergency medical help if you have signs of an allergic reaction to Ozempic: hives, itching; dizziness, fast heartbeats; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • vision changes;
  • unusual mood changes, thoughts about hurting yourself;
  • pounding heartbeats or fluttering in your chest;
  • a light-headed feeling, like you might pass out;
  • signs of a thyroid tumor - swelling or a lump in your neck, trouble swallowing, a hoarse voice, feeling short of breath;
  • symptoms of pancreatitis - severe pain in your upper stomach spreading to your back, nausea with or without vomiting, fast heart rate;
  • gallbladder problems - upper stomach pain, fever, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • low blood sugar - headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;
  • kidney problems - swelling, urinating less, feeling tired or short of breath; or
  • stomach flu symptoms - stomach cramps, vomiting, loss of appetite, diarrhea (may be watery or bloody).

Common Ozempic side effects may include:

  • low blood sugar (in people with type 2 diabetes);
  • upset stomach, heartburn, burping, gas, bloating;
  • nausea, vomiting, stomach pain, loss of appetite;
  • diarrhea, constipation;
  • stomach flu symptoms; o
  • headache, dizziness, tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ozempic?

Semaglutide can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

Tell your doctor about all your other medicines, especially insulin or other diabetes medicine, such as dulaglutide, exenatide, liraglutide, Byetta, Trulicity, Victoza, and others.

Other drugs may interact with semaglutide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.