Semaglutide
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sonya Gelfand
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Black Box Warning
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Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
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Overview
Semaglutide is a Acetylcholine release inhibitor, Adrenergic receptor agonist that is FDA approved for the (type of indication of drug) of a list of indications, separated by commas.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include a list of adverse reactions, separated by commas..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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Off-Label Use and Dosage (Adult)
Guideline-Supported Use
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- Strength of Evidence: (Category A/B/C) (Link)
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Condition 2
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Non–Guideline-Supported Use
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Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
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Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
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- Strength of Evidence: (Category A/B/C) (Link)
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Condition 2
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Non–Guideline-Supported Use
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Contraindications
CONTRAINDICATIONS
Warnings
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Warning Title
See full prescribing information for complete Boxed Warning.
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Conidition 1
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Conidition 2
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Conidition 3
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Adverse Reactions
Clinical Trials Experience
Central Nervous System
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Cardiovascular
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Respiratory
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Gastrointestinal
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Hypersensitive Reactions
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Miscellaneous
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Condition 2
Central Nervous System
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Cardiovascular
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Respiratory
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Gastrointestinal
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Hypersensitive Reactions
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Postmarketing Experience
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Drug Interactions
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Use in Specific Populations
Pregnancy
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Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Semaglutide in women who are pregnant.
Labor and Delivery
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Nursing Mothers
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Pediatric Use
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Geriatic Use
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Gender
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Race
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Renal Impairment
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Hepatic Impairment
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Females of Reproductive Potential and Males
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Immunocompromised Patients
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Others
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Administration and Monitoring
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Monitoring
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IV Compatibility
There is limited information regarding the compatibility of Semaglutide and IV administrations.
Overdosage
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Chronic Overdose
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Pharmacology
Semaglutide
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Nonclinical Toxicology
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Clinical Studies
Overview of Clinical Studies
- OZEMPIC has been studied as monotherapy and in combination with metformin, metformin and sulfonylureas, metformin and/or thiazolidinedione, and basal insulin in patients with type 2 diabetes mellitus. The efficacy of OZEMPIC was compared with placebo, sitagliptin, exenatide extended-release (ER), and insulin glargine.
- Most trials evaluated the use of OZEMPIC 0.5 mg, and 1 mg, with the exception of the trial comparing OZEMPIC and exenatide ER where only the 1 mg dose was studied.
- In patients with type 2 diabetes mellitus, OZEMPIC produced clinically relevant reduction from baseline in HbA1c compared with placebo.
- The efficacy of OZEMPIC was not impacted by age, gender, race, ethnicity, BMI at baseline, body weight (kg) at baseline, diabetes duration and level of renal function impairment.
Monotherapy Use of OZEMPIC in Patients with Type 2 Diabetes Mellitus
- In a 30-week double-blind trial (NCT02054897), 388 patients with type 2 diabetes mellitus inadequately controlled with diet and exercise were randomized to OZEMPIC 0.5 mg or OZEMPIC 1 mg once weekly or placebo. Patients had a mean age of 54 years and 54% were men. The mean duration of type 2 diabetes was 4.2 years, and the mean BMI was 33 kg/m2. Overall, 64% were White, 8% were Black or African American, and 21% were Asian; 30% identified as Hispanic or Latino ethnicity.
- Monotherapy with OZEMPIC 0.5 mg and 1 mg once weekly for 30 weeks resulted in a statistically significant reduction in HbA1c compared with placebo (see Table 3).
Combination Therapy Use of OZEMPIC in Patients with Type 2 Diabetes Mellitus
Combination with metformin and/or thiazolidinediones
- In a 56-week, double-blind trial (NCT01930188), 1231 patients with type 2 diabetes mellitus were randomized to OZEMPIC0.5 mg once weekly, OZEMPIC1 mg once weekly, or sitagliptin 100 mg once daily, all in combination with metformin (94%) and/or thiazolidinediones (6%). Patients had a mean age of 55 years and 51% were men. The mean duration of type 2 diabetes was 6.6 years, and the mean BMI was 32 kg/m2. Overall, 68% were White, 5% were Black or African American, and 25% were Asian; 17% identified as Hispanic or Latino ethnicity.
- Treatment with OZEMPIC0.5 mg and 1 mg once weekly for 56 weeks resulted in a statistically significant reduction in HbA1c compared to sitagliptin (see Table 4 and Figure 5).
Combination with metformin or metformin with sulfonylurea
- In a 56-week, open-label trial (NCT01885208), 813 patients with type 2 diabetes mellitus on metformin alone (49%), metformin with sulfonylurea (45%), or other (6%) were randomized to OZEMPIC1 mg once weekly or exenatide 2 mg once weekly. Patients had a mean age of 57 years and 55% were men. The mean duration of type 2 diabetes was 9 years, and the mean BMI was 34 kg/m2. Overall, 84% were White, 7% were Black or African American, and 2% were Asian; 24% identified as Hispanic or Latino ethnicity.
- Treatment with OZEMPIC 1 mg once weekly for 56 weeks resulted in a statistically significant reduction in HbA1c compared to exenatide 2 mg once weekly (see Table 5).
Combination with metformin or metformin with sulfonylurea
- In a 30-week, open-label trial (NCT02128932), 1089 patients with type 2 diabetes mellitus were randomized to OZEMPIC 0.5 mg once weekly, OZEMPIC 1 mg once weekly, or insulin glargine once daily on a background of metformin (48%) or metformin and sulfonylurea (51%). Patients had a mean age of 57 years and 53% were men. The mean duration of type 2 diabetes was 8.6 years, and the mean BMI was 33 kg/m2. Overall, 77% were White, 9% were Black or African American, and 11% were Asian; 20% identified as Hispanic or Latino ethnicity.
- Patients assigned to insulin glargine had a baseline mean HbA1c of 8.1% and were started on a dose of 10 U once daily. Insulin glargine dose adjustments occurred throughout the trial period based on self-measured fasting plasma glucose before breakfast, targeting 71 to <100 mg/dL. In addition, investigators could titrate insulin glargine at their discretion between study visits. Only 26% of patients had been titrated to goal by the primary endpoint at week 30, at which time the mean daily insulin dose was 29 U per day.
- Treatment with OZEMPIC 0.5 mg and 1 mg once weekly for 30 weeks resulted in a statistically significant reduction in HbA1c compared with the insulin glargine titration implemented in this study protocol (see Table 6).
Combination with basal insulin
- In a 30-week, double-blind trial (NCT02305381), 397 patients with type 2 diabetes mellitus inadequately controlled with basal insulin, with or without metformin, were randomized to OZEMPIC0.5 mg once weekly, OZEMPIC1 mg once weekly, or placebo. Patients with HbA1c ≤ 8.0% at screening reduced their insulin dose by 20% at start of the trial to reduce the risk of hypoglycemia. Patients had a mean age of 59 years and 56% were men. The mean duration of type 2 diabetes was 13 years, and the mean BMI was 32 kg/m2. Overall, 78% were White, 5% were Black or African American, and 17% were Asian; 12% identified as Hispanic or Latino ethnicity.
- Treatment with OZEMPICresulted in a statistically significant reduction in HbA1c after 30 weeks of treatment compared to placebo (see Table 7).
Cardiovascular Outcomes Trial of OZEMPIC in Patients with Type 2 Diabetes Mellitus
- SUSTAIN 6 (NCT01720446) was a 104-week, double-blind trial in which 3,297 patients with type 2 diabetes and high risk of cardiovascular events were randomized to OZEMPIC0.5 mg once weekly, OZEMPIC 1 mg once weekly, or placebo in addition to standard-of-care. In total, 2,735 (83%) of the patients had a history of cardiovascular disease and 562 (17%) were at high risk but without known cardiovascular disease. The mean age at baseline was 65 years, and 61% were men. The mean duration of diabetes was 13.9 years, and mean BMI was 33 kg/m2. Overall, 83% were White, 7% were Black or African American, and 8% were Asian; 16% identified as Hispanic or Latino ethnicity. Concomitant diseases of patients in this trial included, but were not limited to, heart failure (24%), hypertension (93%), history of ischemic stroke (12%) and history of a myocardial infarction (33%).
- In total, 98.0% of the patients completed the trial and the vital status was known at the end of the trial for 99.6%. The primary composite endpoint was the time from randomization to first occurrence of a major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. The secondary endpoint was time from randomization to first occurrence of an expanded composite cardiovascular outcome, defined as MACE, revascularization (coronary and peripheral), unstable angina requiring hospitalization or hospitalization for heart failure. The total number of primary component MACE endpoints was 254 (108 [6.6%] with OZEMPIC and 146 [8.9%] with placebo). No increased risk for MACE was observed with OZEMPIC.
How Supplied
- OZEMPIC injection is supplied as a clear, colorless solution that contains 2 mg of semaglutide in a 1.5 mL (1.34 mg/mL) pre-filled, disposable, single-patient-use pen injector in the following packaging configurations:
Carton of 1 Pen (NDC 0169-4132-12)
- Pen delivers doses of 0.25 mg or 0.5 mg per injection.
- 6 NovoFine ® Plus needles.
- Intended for treatment initiation at the 0.25 mg dose and maintenance treatment at the 0.5 mg dose.
Carton of 2 Pens (NDC 0169-4136-02)
- Pen delivers doses of 1 mg per injection.
- 4 NovoFine ® Plus needles.
- Intended for maintenance treatment at the 1 mg dose only.
- Each OZEMPIC pen is for use by a single patient. An OZEMPIC pen must never be shared between patients, even if the needle is changed.
Storage
- Prior to first use, OZEMPIC should be stored in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC) (Table 8). 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.
- The storage conditions are summarized in Table 8:
Images
Drug Images
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Patient Counseling Information
- Advise the patient to read the FDA-approved patient labeling.
Risk of Thyroid C-cell Tumors
- Inform patients that semaglutide causes thyroid C-cell tumors in rodents and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia, or dyspnea) to their physician.
Pancreatitis
- Inform patients of the potential risk for pancreatitis. Instruct patients to discontinue OZEMPIC promptly and contact their physician if pancreatitis is suspected (severe abdominal pain that may radiate to the back, and which may or may not be accompanied by vomiting).
Diabetic Retinopathy Complications
- Inform patients to contact their physician if changes in vision are experienced during treatment with OZEMPIC.
- Advise patients that they must never share an OZEMPIC pen with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens.
Dehydration and Renal Failure
- Advise patients treated with OZEMPIC of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Inform patients of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs.
Hypersensitivity Reactions
- Inform patients to stop taking OZEMPIC and seek medical advice promptly if symptoms of hypersensitivity reactions occur.
Pregnancy
- Advise a pregnant woman of the potential risk to a fetus. Advise women to inform their healthcare provider if they are pregnant or intend to become pregnant.
Instructions
- Inform patients of the potential risks and benefits of OZEMPIC and of alternative modes of therapy. Inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and A1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. Advise patients to seek medical advice promptly during periods of stress such as fever, trauma, infection, or surgery as medication requirements may change.
- Advise patients that the most common side effects of OZEMPIC are nausea, vomiting, diarrhea, abdominal pain and constipation. Inform patients that nausea, vomiting and diarrhea are most common when first starting OZEMPIC, but decreases over time in the majority of patients.
- Instruct patients to reread the Medication Guide each time the prescription is renewed.
- Inform patients if a dose is missed, it should be administered as soon as possible within 5 days after the missed dose. If more than 5 days have passed, the missed dose should be skipped and the next dose should be administered on the regularly scheduled day. In each case, inform patients to resume their regular once weekly dosing schedule.
- OZEMPIC® (oh-ZEM-pick)
- (semaglutide)
- injection, for subcutaneous use
- 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.
- Read this Medication Guide before you start using OZEMPIC and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
- What is the most important information I should know about OZEMPIC?
- OZEMPIC 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, OZEMPIC and medicines that work like OZEMPIC caused thyroid tumors, including thyroid cancer. It is not known if OZEMPIC will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
- Do not use OZEMPIC 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).
- What is OZEMPIC?
- OZEMPIC is an injectable prescription medicine for adults with type 2 diabetes mellitus that:
- Along with diet and exercise may improve blood sugar (glucose).
- OZEMPIC is not recommended as the first choice of medicine for treating diabetes.
- It is not known if OZEMPIC can be used in people who have had pancreatitis.
- OZEMPIC is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
- It is not known if OZEMPIC is safe and effective for use in children under 18 years of age.
- Do not use OZEMPIC 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 OZEMPIC. See the end of this Medication Guide for a complete list of ingredients in OZEMPIC.
- Before using OZEMPIC, 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 diabetic retinopathy.
- Are pregnant or plan to become pregnant. It is not known if OZEMPIC will harm your unborn baby. You should stop using OZEMPIC 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. It is not known if OZEMPIC passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using OZEMPIC.
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. OZEMPIC may affect the way some medicines work and some medicines may affect the way OZEMPIC works.
- Before using OZEMPIC, 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.
- How should I use OZEMPIC?
- Read the Instructions for Use that comes with OZEMPIC.
- 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.
- Your dose of OZEMPIC 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.
- What are the possible side effects of OZEMPIC?
- OZEMPIC may cause serious side effects, including:
- See “What is the most important information I should know about OZEMPIC?”
- Inflammation of your pancreas (pancreatitis). Stop using OZEMPIC 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 OZEMPIC.
- Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use OZEMPIC 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
- 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 OZEMPIC and get medical help right away, if you have any symptoms of a serious allergic reaction including itching, rash, or difficulty breathing.
- The most common side effects of OZEMPIC may include nausea, vomiting, diarrhea, stomach (abdominal) pain and constipation.
- 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 OZEMPIC.
- Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.
- General information about the safe and effective use of OZEMPIC.
- Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OZEMPIC for a condition for which it was not prescribed. Do not give OZEMPIC 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 OZEMPIC that is written for health professionals.
- For more information, go to OZEMPIC.com or call 1-888-693-6742.
- What are the ingredients in OZEMPIC?
- Active Ingredient: semaglutide.
- Inactive Ingredients: disodium phosphate dihydrate, propylene glycol, phenol and water for injection.
Precautions with Alcohol
Alcohol-Semaglutide interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
- Ozempic
Look-Alike Drug Names
There is limited information regarding Semaglutide Look-Alike Drug Names in the drug label.
Drug Shortage Status
Drug Shortage
Price
References
The contents of this FDA label are provided by the National Library of Medicine.