Semaglutide subcutaneous

In the U.S.

• Ozempic

Available Dosage Forms:

• Solution

Therapeutic Class: Antidiabetic

Pharmacologic Class: Glucagon-Like Peptide-1 Receptor Agonist

Semaglutide injection 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.

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 injection in the pediatric population. 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 injection in the elderly. However, elderly patients are more sensitive to the effects of semaglutide than younger adults.

Breast Feeding

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

• 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.

• Diabetic retinopathy, history of or
• Digestion problems or
• Kidney disease—Use with caution. May make these conditions worse.

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.

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.

semaglutide may cause diabetic retinopathy. Check with your doctor if you have blurred vision or any other changes in vision.

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 (convulsions) 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 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.

semaglutide may cause 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.

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, troubled 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.

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:

• Gaseous abdominal pain
• recurrent fever
• stomach fullness
• yellow eyes or skin

• Burning feeling in the chest or stomach
• indigestion
• stomach upset
• tenderness in the stomach area

• Anxiety
• blurred vision
• chills
• cold sweats
• confusion
• cool, pale skin
• discouragement
• dizziness
• fast heartbeat
• feeling sad or empty
• headache
• increased heart rate
• increased hunger
• irritability
• lack of appetite
• loss of consciousness
• loss of interest or pleasure
• nausea
• nervousness
• nightmares
• seizures
• shakiness
• slurred speech
• tiredness
• trouble concentrating
• trouble sleeping
• unusual tiredness or weakness

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:

• Diarrhea
• stomach pain
• vomiting

• Belching
• bloated, full feeling
• constipation
• excess air or gas in the stomach or intestines
• heartburn
• passing gas
• stomach discomfort or upset

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• change in taste
• loss of taste

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.