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Semaglutide Tablets RYBELSUS® For Diabetes

What is Semaglutide Tablets RYBELSUS®?

Semaglutide tablets are a type of medication used to treat type 2 diabetes. They belong to a class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists. Semaglutide works by mimicking the effects of a naturally occurring hormone called GLP-1, which helps regulate blood sugar levels.

GLP-1 receptor agonists like semaglutide stimulate the release of insulin from the pancreas and reduce the amount of glucose produced by the liver. Additionally, they slow down the rate at which food is absorbed in the stomach, leading to a decrease in post-meal blood sugar levels. This class of medications also helps in promoting a feeling of fullness, which can contribute to weight loss.

Semaglutide is often prescribed to people with type 2 diabetes when lifestyle changes and other medications have not effectively controlled blood sugar levels.

Weight Management: In addition to its use in diabetes, Semaglutide has also been found to be effective in weight management. It can help reduce body weight in individuals when used alongside a reduced-calorie diet and increased physical activity.

Semaglutide Tablets RYBELSUS® 7 mg or 14 mg is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.
•It is not known if Semaglutide Tablets RYBELSUS® can be used in people who have had pancreatitis.
•Semaglutide Tablets RYBELSUS® is not for use in patients with type 1 diabetes.
It is not known if Semaglutide Tablets RYBELSUS® is safe and effective for use in children under 18 years of age.

Highlights Of Semaglutide Tablets RYBELSUS® Prescribing Information

——— INDICATIONS AND USAGE ———
Semaglutide Tablets RYBELSUS® is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1).
Limitations of Use
•Has not been studied in patients with a history of pancreatitis (1, 5.2).
•Not for treatment of type 1 diabetes mellitus (1).
——— DOSAGE AND ADMINISTRATION ———
•Instruct patients to take RYBELSUS® at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only. Waiting less than 30 minutes, or taking with food, beverages (other than plain water) or other oral medications
will lessen the effect of Semaglutide Tablets RYBELSUS®. Waiting more than 30 minutes to eat may increase the absorption of RYBELSUS® (2.1).
•Swallow tablets whole. Do not split, crush, or chew tablets (2.1).
•Start Semaglutide Tablets RYBELSUS® with 3 mg once daily for 30 days. After 30 days on the 3 mg dosage, increase the dosage to 7 mg once daily (2.2).
•Dosage may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dosage (2.2).
•See the Full Prescribing Information for instructions on switching between OZEMPIC® and Semaglutide Tablets RYBELSUS® (2.3).

RYBELSUS® (semaglutide) tablets
Semaglutide Tablets RYBELSUS®

——— DOSAGE FORMS AND STRENGTHS ———
Tablets: 3 mg, 7 mg and 14 mg (3).
——— CONTRAINDICATIONS ———
•Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (4).
•Prior serious hypersensitivity reaction to semaglutide or any of the excipients in Semaglutide Tablets RYBELSUS® (4).
——— WARNINGS AND PRECAUTIONS ———
•Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed (5.2).
•Diabetic Retinopathy Complications: Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored (5.3).
•Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin secretagogue or insulin may be necessary (5.4).
•Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions (5.5).
•Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue Semaglutide Tablets RYBELSUS® if suspected and promptly seek medical advice (5.6).
•Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated (5.7).

——— ADVERSE REACTIONS ———
Most common adverse reactions (incidence ≥5%) are nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation (6.1).
——— DRUG INTERACTIONS ———
Oral Medications: Semaglutide Tablets RYBELSUS® delays gastric emptying. Instruct patients to closely follow Semaglutide Tablets RYBELSUS® administration instructions (7.2).
——— USE IN SPECIFIC POPULATIONS ———
•Pregnancy: May cause fetal harm (8.1).
•Lactation: Breastfeeding not recommended (8.2).
•Females and Males of Reproductive Potential: Discontinue RYBELSUS® in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide (8.3).

Semaglutide Tablets RYBELSUS®

How Semaglutide Tablets Treats Diabetes

Semaglutide is a medication used to treat type 2 diabetes, and it belongs to a class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists. Here’s how semaglutide works in treating diabetes:

Mimicking GLP-1 Hormone: GLP-1 is a natural hormone produced by the intestines in response to food intake. It plays a crucial role in regulating blood sugar levels. Semaglutide mimics the action of GLP-1.

Stimulating Insulin Release: One of the primary actions of semaglutide is to stimulate the release of insulin from the pancreas. Insulin is a hormone that helps cells in the body absorb glucose (sugar) from the bloodstream, thus lowering blood sugar levels.

Inhibiting Glucagon: Semaglutide also reduces the production of glucagon, another hormone released by the pancreas. Glucagon normally signals the liver to release glucose into the bloodstream. By inhibiting glucagon, semaglutide helps decrease the amount of glucose produced by the liver.

Slowing Gastric Emptying: Semaglutide slows down the rate at which food is emptied from the stomach into the small intestine. This delay in gastric emptying helps to control the rise in blood sugar levels after meals.

Promoting Weight Loss: GLP-1 receptor agonists, including semaglutide, can contribute to weight loss. They may reduce appetite and promote a feeling of fullness, leading to decreased food intake and, consequently, weight loss.

Improving Beta Cell Function: Semaglutide may also have a positive impact on the function and survival of beta cells in the pancreas. Beta cells are responsible for producing insulin, and their proper function is essential for maintaining blood sugar control.

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Semaglutide Tablets RYBELSUS® Medication Guide

What should you do before using Semaglutide Tablets 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 Semaglutide Tablets RYBELSUS® will harm your unborn baby. You should stop using Semaglutide Tablets 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 Semaglutide Tablets RYBELSUS®.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Semaglutide Tablets RYBELSUS® may affect the way some medicines work and some medicines may affect the way Semaglutide Tablets RYBELSUS® works. Before using Semaglutide Tablets RYBELSUS®, 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.

Semaglutide Tablets

When Do not use Semaglutide Tablets RYBELSUS®

When Do not use Semaglutide Tablets 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 have had a serious allergic reaction to semaglutide or any of the ingredients in Semaglutide Tablets RYBELSUS®. See the end of this Medication Guide for a complete list of ingredients in Semaglutide Tablets RYBELSUS®. Symptoms of a serious allergic reaction include:

  • • swelling of your face, lips, tongue or throat
  • • problems breathing or swallowing
  • • severe rash or itching
  • • fainting or feeling dizzy
  • • very rapid heartbeat
Semaglutide Tablets RYBELSUS®
Semaglutide Tablets RYBELSUS®

How should I take Semaglutide Tablets RYBELSUS®?

•Take Semaglutide Tablets RYBELSUS® exactly as your healthcare provider tells you to.
•Take Semaglutide Tablets RYBELSUS® by mouth on an empty stomach when you first wake up.
•Take Semaglutide Tablets RYBELSUS® with a sip of plain water (no more than 4 ounces).
•Do not split, crush or chew. Swallow Semaglutide Tablets RYBELSUS® whole.
•After 30 minutes, you can eat, drink, or take other oral medicines.
•If you miss a dose of Semaglutide Tablets RYBELSUS®, skip the missed dose and go back to your regular schedule.
Your dose of Semaglutide Tablets 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.

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What are the possible side effects of Semaglutide Tablets RYBELSUS®?

Semaglutide Tablets RYBELSUS® may cause serious side effects, including:
•See “What is the most important information I should know about Semaglutide Tablets RYBELSUS®?”
•inflammation of your pancreas (pancreatitis). Stop using Semaglutide Tablets 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 Semaglutide Tablets RYBELSUS®.
•low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Semaglutide Tablets 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
  • • blurred vision
  • • anxiety, irritability, or mood changes
  • •sweating
  • • slurred speech
  • • hunger
  • •confusion or drowsiness
  • • shakiness
  • • weakness
  • •headache
  • • fast heartbeat
  • • feeling jittery

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•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:

  • •swelling of your face, lips, tongue or throat
  • • problems breathing or swallowing
  • •severe rash or itching
  • • fainting or feeling dizzy
  • •very rapid heartbeat
  • Gallbladder problems: Gallbladder problems have happened in some people who take RYBELSUS®. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include:
  • •pain in your upper stomach (abdomen)
  • • yellowing of skin or eyes (jaundice)
  • • fever
  • • clay-colored stools
    The most common side effects of Semaglutide Tablets RYBELSUS® may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting and constipation. Nausea, vomiting and diarrhea are most common when you first start Semaglutide Tablets 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 Semaglutide Tablets RYBELSUS®.
Semaglutide Tablets

How should I store Semaglutide Tablets RYBELSUS®?

•Store Semaglutide Tablets RYBELSUS® at room temperature between 68°F and 77°F (20°C to 25°C).
•Store in a dry place away from moisture.
•Store tablets in the original closed Semaglutide Tablets RYBELSUS® bottle until you are ready to take one. Do not store
in any other container.

•Keep RYBELSUS® and all medicines out of the reach of children.

General information about the safe and effective use of Semaglutide Tablets RYBELSUS®.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
Do not use Semaglutide Tablets RYBELSUS® for a condition for which it was not prescribed. Do not give Semaglutide Tablets RYBELSUS® 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 about RYBELSUS® that is written for health professionals.

What are the ingredients in RYBELSUS®?

Active Ingredient: semaglutide
Inactive Ingredients: magnesium stearate, microcrystalline cellulose, povidone and salcaprozate sodium (SNAC).

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