Rybelsus

Rybelsus is a prescription medication used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes. Rybelsus belongs to a group of drugs called GLP-1 receptor agonists. In addition to slowing the movement of food through the stomach, Rybelsus works by stimulating the pancreas to release insulin when blood sugar levels are high which helps move sugar from the blood into other body tissues where it is used for energy.

This medication comes in tablet form. It is taken on an empty stomach with a sip of plain water, no more than 4 ounces, when you first wake up. Wait at least 30 minutes before eating, drinking, or taking other oral medications. Swallow the tablets whole; do not split, chew, or crush them.

Common side effects include nausea, stomach (abdominal) pain, diarrhea and decreased appetite.

Rybelsus is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.

• Rybelsus is not recommended as the first choice of medicine for treating diabetes.
• It is not known if Rybelsus can be used in people who have had pancreatitis.
• Rybelsus is not for use in patients with type 1 diabetes and people with diabetic ketoacidosis.
• It is not known if Rybelsus is safe and effective for use in children under 18 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

The most common side effects of Rybelsus may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting and constipation. Nausea, vomiting and diarrhea are most common when you first start Rybelsus.

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 of Rybelsus.

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

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Rybelsus may affect the way some medicines work and some medicines may affect the way Rybelsus works. Especially tell your healthcare provider if you take:

• insulin
• levothyroxine (Euthyrox, Levo-T, Levoxyl, Synthroid, Tirosint, others)
• sulfonylureas such as glimepiride (Amaryl, in Duetact)
• glipizide (Glucotrol)
• glyburide (DiaBeta, Glynase)
• tolazamide
• tolbutamide

This is not a complete list of Rybelsus drug interactions. Ask your doctor or pharmacist for more information.

Rybelsus 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, Rybelsus and medicines that work like Rybelsus caused thyroid tumors, including thyroid cancer. It is not known if Rybelsus will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
• Do not use Rybelsus 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).
• Inflammation of your pancreas (pancreatitis). Stop using Rybelsus 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 with Rybelsus.
• Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Rybelsus 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 Rybelsus and get medical help right away, if you have any symptoms of a serious allergic reaction including itching, rash, or difficulty breathing.

Do not use Rybelsus 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 in Rybelsus.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Rybelsus, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using Rybelsus, 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 vision problems related to your diabetes.
• are pregnant or plan to become pregnant. It is not known if Rybelsus will harm your unborn baby. You should stop using Rybelsus 2 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. Breastfeeding is not recommended during treatment with Rybelsus.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Rybelsus may affect the way some medicines work and some medicines may affect the way Rybelsus works.

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Rybelsus will harm your unborn baby. You should stop using Rybelsus 2 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.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with Rybelsus.

It is not known if Rybelsus crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, breastfeeding is not recommended during treatment.

• Take Rybelsus exactly as your healthcare provider tells you to.
• Take Rybelsus by mouth on an empty stomach when you first wake up.
• Take Rybelsus with a sip of water (no more than 4 ounces).
• Do not split, crush or chew. Swallow Rybelsus whole.
• After 30 minutes, you can eat, drink, or take other oral medications. Rybelsus works best if you eat 30 to 60 minutes after taking Rybelsus.
• If you miss a dose of Rybelsus, skip the missed dose and go back to your regular schedule.
• Check your blood sugar as your healthcare provider tells you to.
• Stay on your prescribed diet and exercise program while using Rybelsus.
• 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 A1C.
• Your dose of Rybelsus 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.

Take this medication exactly as prescibed by your doctor. Follow the directions on your prescription label carefully. 

• The recommended starting dose is 3 mg once daily for 30 days. After 30 days on the 3 mg dose, increase the dose to 7 mg once daily (2.2).

• Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose.

If you take too much Rybelsus, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Rybelsus at room temperature between 68°F and 77°F (20°C to 25°C).

Store in a dry place away from moisture.

Store tablet in the original pack.

Keep the tablet in the pack until you are ready to take it.

Keep Rybelsus and all medicines out of the reach of children.

WARNING: RISK OF THYROID C−CELL TUMORS

• In rodents, semaglutide causes dose-dependent and treatment-duration- dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Rybelsus causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.

• Rybelsus is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Rybelsus and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Rybelsus.