Semaglutide

What is Semaglutide?

Semaglutide (OZEMPIC) is a glucagon-like peptide 1 (GLP-1) receptor agonist.

What are the uses of this medicine?

This medicine is used

• along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes mellitus.
• to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease.

Limitations of Use:

• It is not known if OZEMPIC can be used in people who have had pancreatitis.
• OZEMPIC is not for use in people with type 1 diabetes.

How does this medicine work?

• Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1.
• Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1.
• The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation.
• Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme.
• Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner.
• Thus, when blood glucose is high, insulin secretion is stimulated, and glucagon secretion is inhibited.
• The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.

Who Should Not Use this medicine ?

This medcine cannot be used in patients 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 OZEMPIC.

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

What drug interactions can this medicine cause?

• Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin may increase the risk of hypoglycemia.
• OZEMPIC causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications.

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

Recommended Dosage

• Start OZEMPIC with a 0.25 mg subcutaneous injection once weekly for 4 weeks.
• The 0.25 mg dose is intended for treatment initiation and is not effective for glycemic control.
• After 4 weeks on the 0.25 mg dose, increase the dosage to 0.5 mg once weekly.
• If additional glycemic control is needed after at least 4 weeks on the 0.5 mg dose, the dosage may be increased to 1 mg once weekly.
• The maximum recommended dosage is 1 mg once weekly.

Administration

• Use OZEMPIC exactly as your healthcare provider tells you to.
• Your healthcare provider should show you how to use OZEMPIC before you use it for the first time.
• OZEMPIC is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject OZEMPIC into a muscle (intramuscularly) or vein (intravenously).
• Use OZEMPIC 1 time each week, on the same day each week, at any time of the day.
• You may change the day of the week you use OZEMPIC as long as your last dose was given 2 or more days before.
• If you miss a dose of OZEMPIC, take the missed dose as soon as possible within 5 days after the missed dose. If more than 5 days have passed, skip the missed dose and take your next dose on the regularly scheduled day.
• OZEMPIC may be taken with or without food.
• Do not mix insulin and OZEMPIC together in the same injection.
• You may give an injection of OZEMPIC and insulin in the same body area (such as your stomach area), but not right next to each other.
• Change (rotate) your injection site with each injection. Do not use the same site for each injection.
• Check your blood sugar as your healthcare provider tells you to.
• Stay on your prescribed diet and exercise program while using OZEMPIC.
• 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 hemoglobin A1C.
• Do not share your OZEMPIC pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection:

2 mg/1.5 mL (1.34 mg/mL) available in:

• Single-patient-use pen that delivers 0.25 mg or 0.5 mg per injection.
• Single-patient-use pen that delivers 1 mg per injection.

4 mg/3 mL (1.34 mg/mL) available in:

• Single-patient-use pen that delivers 1 mg per injection

This medicine is available in fallowing brand namesː

• OZEMPIC

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• vomiting
• diarrhea
• stomach (abdominal) pain
• constipation

OZEMPIC may cause serious side effects, including:

• inflammation of your pancreas (pancreatitis)
• changes in vision
• low blood sugar (hypoglycemia)
• kidney problems (kidney failure)
• serious allergic reactions

What special precautions should I follow?

• Pancreatitis has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
• Diabetic retinopathy complications has been reported in a clinical trial. Patients with a history of diabetic retinopathy should be monitored.
• Never share an OZEMPIC pen between patients, even if the needle is changed.
• 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.
• Acute kidney injury may occur. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.
• Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue OZEMPIC if suspected and promptly seek medical advice.

What to do in case of emergency/overdose?

• In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.
• A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of OZEMPIC of approximately 1 week.

Can this medicine be used in pregnancy?

• There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.

Can this medicine be used in children?

• Safety and efficacy of OZEMPIC have not been established in pediatric patients (younger than 18 years).

What are the active and inactive ingredients in this medicine?

• Active Ingredient: semaglutide
• Inactive Ingredients: disodium phosphate dihydrate, propylene glycol, phenol and water for injection

Who manufactures and distributes this medicine?

• Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark

OZEMPIC® is a registered trademark of Novo Nordisk A/S.

What should I know about storage and disposal of this medication?

• Prior to first use, OZEMPIC should be stored in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC).
• Do not store in the freezer or directly adjacent to the refrigerator cooling element.
• Do not freeze OZEMPIC and do not use OZEMPIC if it has been frozen.
• After first use of the OZEMPIC pen, the pen can be stored for 56 days at controlled room temperature (59°F to 86°F; 15°C to 30°C) or in a refrigerator (36°F to 46°F; 2°C to 8°C).
• Do not freeze.
• Keep the pen cap on when not in use.
• OZEMPIC should be protected from excessive heat and sunlight.
• Always remove and safely discard the needle after each injection and store the OZEMPIC pen without an injection needle attached.
• Always use a new needle for each injection.

• Dailymed label info on Semaglutide
• FDA Semaglutide

Semaglutide Resources
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