Semaglutide (Rybelsus and Ozempic)

 

Generic name: semaglutide (oral/injection) (SEM a GLOO tide)
Brand name: Ozempic, Ozempic (1 mg dose), Rybelsus, Wegovy (0.25 mg dose), Wegovy (0.5 mg dose), Wegovy (1 mg dose), Wegovy (1.7 mg dose), Wegovy (2.4 mg dose), Ozempic (0.25 mg or 0.5 mg dose)
Dosage forms: oral tablet (14 mg; 3 mg; 7 mg); subcutaneous solution (0.25 mg/0.5 mL (0.25 mg dose); 0.5 mg/0.5 mL (0.5 mg dose); 1 mg/0.5 mL (1 mg dose); 1.7 mg/0.75 mL (1.7 mg dose); 2 mg/1.5 mL (0.25 mg or 0.5 mg dose); 2 mg/1.5 mL (1 mg dose); 2.4 mg/0.75 mL (2.4 mg dose); 4 mg/3 mL)
Drug class: Incretin mimetics

Semaglutide (Rybelsus and Ozempic) is used with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus (not for type 1 diabetes).

Wegovy is used with diet and exercise to manage weight in overweight adults who also have least one weight-related medical condition such as type 2 diabetes, high blood pressure, or high cholesterol.

Semaglutide may also be used for purposes not listed in this medication guide.

Warnings

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.

You should not use semaglutide if you have multiple endocrine neoplasia type 2 (tumors in your glands), or a personal or family history of medullary thyroid cancer.

Before taking this medicine

You should not use semaglutide if you are allergic to it, 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).

Tell your doctor if you have ever had:

  • 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 semaglutide 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.

Ask a doctor if it is safe to breastfeed while using this Ozempic or Wegovy.

You should not breastfeed while using Rybelsus.

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

How should I use semaglutide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Semaglutide 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.

Rybelsus (oral) is taken by mouth, usually once per day when you first wake up and at least 30 minutes before you eat or drink anything. Take with no more than 4 ounces of water. Swallow the tablet whole and do not crush, chew, or break it.

Eat within 30 to 60 minutes after taking Rybelsus.

Ozempic and Wegovy are 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 semaglutide. 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 Rybelsus in the original package at room temperature, away from moisture and heat.

Store unopened Ozempic or Wegovy 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.

If needed, you may store an unopened Wegovy pen at cool room temperature for up to 28 days. Do not remove the cap until you are ready to use the injection pen. The pen contains a single dose. Throw the pen away after one use, even if there is still medicine left inside.

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.

What happens if I miss a dose?

For Rybelsus: Skip the missed dose and use your next dose at the regular time.

For Ozempic: 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.

For Wegovy: Use the medicine as soon as you can and then go back to your regular schedule. If your next dose is due in less than 2 days (48 hours), skip the missed dose and return to your regular schedule.

Do not use two doses of semaglutide at one time.

Call your doctor if you miss more than 2 doses in a row of Wegovy. You may need to restart the medicine at a lower dose to avoid stomach problems.

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 semaglutide?

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

Semaglutide side effects

Get emergency medical help if you have signs of an allergic reaction: 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 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 semaglutide?

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 affect semaglutide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.