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Semaglutide (Oral)

Oral route(Tablet)

Warning: Risk of Thyroid C-Cell TumorsIn rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.Semaglutide 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 of MTC and symptoms of thyroid tumors

Commonly used brand name(s)

In the U.S.

  • Rybelsus

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antidiabetic

Pharmacologic Class: Glucagon-Like Peptide-1 Receptor Agonist

Uses for semaglutide

Semaglutide is used to treat type 2 diabetes. It is used together with diet and exercise to help control your blood sugar. Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.

Semaglutide is available only with your doctor's prescription.

Before using semaglutide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For semaglutide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to semaglutide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of semaglutide in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of semaglutide in the elderly. However, elderly patients are more sensitive to the effects of semaglutide than younger adults.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking semaglutide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using semaglutide with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Chloroquine
  • Hydroxychloroquine

Using semaglutide with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Levothyroxine
  • Warfarin

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of semaglutide. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diabetic ketoacidosis (ketones in the blood) or
  • Type 1 diabetes—Should not be used in patients with these conditions. Insulin is needed to control these conditions.
  • Diabetic retinopathy, history of or
  • Kidney disease (eg, chronic kidney failure)—Use with caution. May make these conditions worse.
  • Multiple endocrine neoplasia syndrome type 2 (MEN 2) or
  • Thyroid cancer, history of—Should not be used in patients with these conditions.
  • Pancreatitis (inflammation of the pancreas), history of—It is not known if semaglutide will be safe in patients with this condition.

Proper use of semaglutide

Take semaglutide exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Semaglutide should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take semaglutide at least 30 minutes before the first food, drink, or other oral medicines of the day with a sip of plain water only (no more than 4 ounces).

Swallow the tablet whole. Do not cut, break, or chew it.

Dosing

The dose of semaglutide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of semaglutide. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For type 2 diabetes:
    • For oral dosage form (tablets):
      • Adults—At first, 3 milligrams (mg) once a day for 30 days. Your doctor may adjust your dose as needed. However, the dose is usually not more than 14 mg once a day.
      • Children—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of semaglutide, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the tablet in its original blister card.

Precautions while using semaglutide

It is very important that your doctor check your progress at regular visits to make sure that semaglutide is working properly. Blood and urine tests may be needed to check for unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. Do not use semaglutide for at least 2 months before you plan to become pregnant.

It is very important to carefully follow any instructions from your health care team about:

  • Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
  • Other medicines—Do not take other medicines during the time you are using semaglutide unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
  • Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur during pregnancy in patients with diabetes.
  • Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
  • In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Semaglutide may increase the risk of having thyroid tumors. Tell your doctor right away if you have a lump or swelling in your neck or throat, trouble swallowing or breathing, or if your voice gets hoarse.

Pancreatitis (swelling of the pancreas) may occur while you are using semaglutide. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Check with your doctor right away if you have blurred vision or any other changes in vision. These may be symptoms of diabetic retinopathy.

Semaglutide does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you use semaglutide with other medicines, such as insulin or sulfonylureas, that can lower blood sugar. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.

  • Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
  • If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family should also know how to use it.

Semaglutide may cause serious kidney problems, including acute kidney injury. Check with your doctor right away if you have a bloody urine, decreased urine output, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

Semaglutide may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you are using semaglutide.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

  • Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), ketones in the urine, loss of appetite, stomachache, nausea or vomiting, tiredness, trouble breathing (rapid and deep), unconsciousness, or unusual thirst.
  • If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Semaglutide side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Anxiety
  • bloating
  • blurred vision
  • chills
  • cold sweats
  • confusion
  • constipation
  • cool, pale skin
  • cough
  • darkened urine
  • depression
  • diarrhea
  • difficulty swallowing
  • dizziness
  • fast heartbeat
  • fever
  • headache
  • increased hunger
  • indigestion
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • nausea
  • nervousness
  • nightmare
  • pain in the stomach, side, or abdomen, possibly radiating to the back
  • seizures
  • skin rash
  • slurred speech
  • tightness in the chest
  • trouble breathing
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Acid or sour stomach
  • belching
  • excess air or gas in stomach
  • feeling pressure in the stomach
  • heartburn
  • passing gas
  • stomach discomfort, swelling, tenderness, or upset

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.