Generic name: semaglutide (SEM a GLOO tide)
Brand name: Rybelsus
Drug class: Incretin mimetics
Rybelsus (semaglutide) is used with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. .
Rybelsus is usually given after other diabetes medicines have been tried without success.
Rybelsus is not for treating type 1 diabetes.
Rybelsus is supplied as a white to light yellow, oval shaped tablet and is available in 3mg, 7mg, and 14mg strengths.
Warnings
You should not use Rybelsus 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 Rybelsus 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 Rybelsus 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 Rybelsus 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.
You should not breastfeed while using Rybelsus.
Rybelsus is not approved for use by anyone younger than 18 years old.
How should I use Rybelsus?
Take Rybelsus exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Rybelsus 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.
Read and follow all Instructions for Use. Ask your doctor or pharmacist if you need help.
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. Keep out of the reach of children and pets.
Dosing information
Usual Adult Dose for Diabetes Type 2:
Oral Tablets:
Initial dose: 3 mg orally once a day for 30 days; then 7 mg orally once a day
-Titration: If additional glycemic control is needed after receiving 7 mg/day for at least 30 days, may increase to 14 mg orally once a day
Maintenance dose: 7 to 14 mg orally once a day
Maximum dose: 14 mg/day (taking two 7 mg tablets to achieve a 14 mg dose is not recommended).
Usual Adult Dose for Cardiovascular Risk Reduction:
Oral Tablets:
Initial dose: 3 mg orally once a day for 30 days; then 7 mg orally once a day
-Titration: If additional glycemic control is needed after receiving 7 mg/day for at least 30 days, may increase to 14 mg orally once a day
Maintenance dose: 7 to 14 mg orally once a day
Maximum dose: 14 mg/day (taking two 7 mg tablets to achieve a 14 mg dose is not recommended)
What happens if I miss a dose?
Skip the missed dose and use your next dose at the regular time.
Do not use two doses of Rybelsus 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.
Rybelsus side effects
Get emergency medical help if you have signs of an allergic reaction to Rybelsus: 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 Rybelsus 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 Rybelsus?
Rybelsus 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.