Dosage & Administration
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Ozempic Prescribing Information
• In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined[see Warnings and Precautions (.), Nonclinical Toxicology (5.1 Risk of Thyroid C-Cell TumorsIn mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures
[see Nonclinical Toxicology ]. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including MTC, in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.
OZEMPIC is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of OZEMPIC and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).
Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with OZEMPIC. Such monitoring may increase the risk of unnecessary procedures, due to the low-test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
)]13.1 Carcinogenesis, Mutagenesis, Impairment of FertilityIn a 2-year carcinogenicity study in CD-1 mice, subcutaneous doses of 0.3, 1 and 3 mg/kg/day [2-, 11-, and 30-fold the maximum recommended human dose (MRHD) of 2 mg/week, based on AUC] were administered to the males, and 0.1, 0.3 and 1 mg/kg/day (1-, 2-, and 7-fold MRHD) were administered to the females. A statistically significant increase in thyroid C-cell adenomas and a numerical increase in C-cell carcinomas were observed in males and females at clinically relevant exposures.
In a 2-year carcinogenicity study in Sprague Dawley rats, subcutaneous doses of 0.0025, 0.01, 0.025 and 0.1 mg/kg/day were administered (below quantification, 0.2-, 0.5-, and 3-fold the exposure at the MRHD). A statistically significant increase in thyroid C-cell adenomas was observed in males and females at all dose levels, and a statistically significant increase in thyroid C-cell carcinomas was observed in males at ≥0.01 mg/kg/day, at clinically relevant exposures.
Human relevance of thyroid C-cell tumors in rats is unknown and could not be determined by clinical studies or nonclinical studies
[see Boxed Warning, Warnings and Precautions ].Semaglutide was not mutagenic or clastogenic in a standard battery of genotoxicity tests (bacterial mutagenicity (Ames), human lymphocyte chromosome aberration, rat bone marrow micronucleus).
In a combined fertility and embryo-fetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.06-, 0.2-, and 0.6-fold the MRHD) were administered to male and female rats. Males were dosed for 4 weeks prior to mating, and females were dosed for 2 weeks prior to mating and throughout organogenesis until Gestation Day 17. No effects were observed on male fertility. In females, an increase in estrus cycle length was observed at all dose levels, together with a small reduction in numbers of corpora lutea at ≥0.03 mg/kg/day. These effects were likely an adaptive response secondary to the pharmacological effect of semaglutide on food consumption and body weight.
• OZEMPIC is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)[see Contraindications ]. Counsel patients regarding the potential risk for MTC with the use of OZEMPIC and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with OZEMPIC[see Contraindications , Warnings and Precautions (.)]5.1 Risk of Thyroid C-Cell TumorsIn mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures
[see Nonclinical Toxicology ]. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including MTC, in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.
OZEMPIC is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of OZEMPIC and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).
Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with OZEMPIC. Such monitoring may increase the risk of unnecessary procedures, due to the low-test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
Indication and Usage (
OZEMPIC is indicated:
• as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.• to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.• to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.
OZEMPIC 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.• to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.• to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.
Dosage and Administration (
Initiate OZEMPIC with a dosage of 0.25 mg injected subcutaneously once weekly for 4 weeks. Follow the dosage escalation below to reduce the risk of gastrointestinal adverse reactions
After 4 weeks on the 0.25 mg dosage, increase the dosage to 0.5 mg once weekly.
The recommended maintenance dosage is 0.5 mg, 1 mg, or 2 mg, injected subcutaneously once weekly, based on glycemic control.
If additional glycemic control is needed after at least 4 weeks on the:
• 0.5 mg dosage, the dosage may be increased to 1 mg once weekly.• 1 mg dosage, the dosage may be increased to 2 mg once weekly.
The maximum recommended dosage is 2 mg once weekly.
Warnings and Precautions,
5.7 Severe Gastrointestinal Adverse ReactionsUse of OZEMPIC has been associated with gastrointestinal adverse reactions, sometimes severe [seeAdverse Reactions(6.1)]. In OZEMPIC clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving OZEMPIC (0.5 mg 0.4%, 1 mg 0.8%) than placebo (0%).Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists.OZEMPIC is not recommended in patients with severe gastroparesis.5.10 Pulmonary Aspiration During General Anesthesia or Deep SedationOZEMPIC delays gastric emptying [seeClinical Pharmacology (12.2)]. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking OZEMPIC, including whether modifying preoperative fasting recommendations or temporarily discontinuing OZEMPIC could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking OZEMPIC.
OZEMPIC is indicated:
• as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.• to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.• to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.
• Administer once weekly at any time of day, with or without meals. ()2.1 Important Administration Instructions• Inspect OZEMPIC visually before use. It should appear clear and colorless. Do not use OZEMPIC if particulate matter and coloration is seen.• Administer OZEMPIC once weekly, on the same day each week, at any time of the day, with or without meals.• Inject OZEMPIC subcutaneously in the abdomen, thigh, or upper arm. Instruct patients to use a different injection site each week when injecting in the same body region.• When using OZEMPIC with insulin, instruct patients to administer as separate injections and to never mix the products. It is acceptable to inject OZEMPIC and insulin in the same body region, but the injections should not be adjacent to each other.• The day of weekly administration can be changed if necessary as long as the time between two doses is at least 2 days (>48 hours).• If a dose is missed, administer OZEMPIC as soon as possible within 5 days after the missed dose. If more than 5 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.
• Start at 0.25 mg once weekly. After 4 weeks, increase the dosage to 0.5 mg once weekly. ()2.2 Recommended DosageRecommended Initiation DosageInitiate OZEMPIC with a dosage of 0.25 mg injected subcutaneously once weekly for 4 weeks. Follow the dosage escalation below to reduce the risk of gastrointestinal adverse reactions
[see Warnings and Precautions , Adverse Reactions ].After 4 weeks on the 0.25 mg dosage, increase the dosage to 0.5 mg once weekly.
Recommended Maintenance and Maximum Dosages for Glycemic ControlThe recommended maintenance dosage is 0.5 mg, 1 mg, or 2 mg, injected subcutaneously once weekly, based on glycemic control.
If additional glycemic control is needed after at least 4 weeks on the:
• 0.5 mg dosage, the dosage may be increased to 1 mg once weekly.• 1 mg dosage, the dosage may be increased to 2 mg once weekly.
The maximum recommended dosage is 2 mg once weekly.
Recommended Maintenance Dosage in Patients with Type 2 Diabetes Mellitus and Chronic Kidney DiseaseIncrease the dosage to the maintenance dosage, 1 mg once weekly, after at least 4 weeks on the 0.5 mg dosage.• If additional glycemic control is needed, increase the dosage to 1 mg once weekly after at least 4 weeks on the 0.5 mg dose. ()2.2 Recommended DosageRecommended Initiation DosageInitiate OZEMPIC with a dosage of 0.25 mg injected subcutaneously once weekly for 4 weeks. Follow the dosage escalation below to reduce the risk of gastrointestinal adverse reactions
[see Warnings and Precautions , Adverse Reactions ].After 4 weeks on the 0.25 mg dosage, increase the dosage to 0.5 mg once weekly.
Recommended Maintenance and Maximum Dosages for Glycemic ControlThe recommended maintenance dosage is 0.5 mg, 1 mg, or 2 mg, injected subcutaneously once weekly, based on glycemic control.
If additional glycemic control is needed after at least 4 weeks on the:
• 0.5 mg dosage, the dosage may be increased to 1 mg once weekly.• 1 mg dosage, the dosage may be increased to 2 mg once weekly.
The maximum recommended dosage is 2 mg once weekly.
Recommended Maintenance Dosage in Patients with Type 2 Diabetes Mellitus and Chronic Kidney DiseaseIncrease the dosage to the maintenance dosage, 1 mg once weekly, after at least 4 weeks on the 0.5 mg dosage.• If additional glycemic control is needed, increase the dosage to 2 mg once weekly after at least 4 weeks on the 1 mg dosage. ()2.2 Recommended DosageRecommended Initiation DosageInitiate OZEMPIC with a dosage of 0.25 mg injected subcutaneously once weekly for 4 weeks. Follow the dosage escalation below to reduce the risk of gastrointestinal adverse reactions
[see Warnings and Precautions , Adverse Reactions ].After 4 weeks on the 0.25 mg dosage, increase the dosage to 0.5 mg once weekly.
Recommended Maintenance and Maximum Dosages for Glycemic ControlThe recommended maintenance dosage is 0.5 mg, 1 mg, or 2 mg, injected subcutaneously once weekly, based on glycemic control.
If additional glycemic control is needed after at least 4 weeks on the:
• 0.5 mg dosage, the dosage may be increased to 1 mg once weekly.• 1 mg dosage, the dosage may be increased to 2 mg once weekly.
The maximum recommended dosage is 2 mg once weekly.
Recommended Maintenance Dosage in Patients with Type 2 Diabetes Mellitus and Chronic Kidney DiseaseIncrease the dosage to the maintenance dosage, 1 mg once weekly, after at least 4 weeks on the 0.5 mg dosage.• To reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death, increase the dosage to 1 mg once weekly after at least 4 weeks on the 0.5 mg dosage. (,1 INDICATIONS AND USAGEOZEMPIC is indicated:
• as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.• to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.• to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.
OZEMPIC 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.• to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.• to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.
)2.2 Recommended DosageRecommended Initiation DosageInitiate OZEMPIC with a dosage of 0.25 mg injected subcutaneously once weekly for 4 weeks. Follow the dosage escalation below to reduce the risk of gastrointestinal adverse reactions
[see Warnings and Precautions , Adverse Reactions ].After 4 weeks on the 0.25 mg dosage, increase the dosage to 0.5 mg once weekly.
Recommended Maintenance and Maximum Dosages for Glycemic ControlThe recommended maintenance dosage is 0.5 mg, 1 mg, or 2 mg, injected subcutaneously once weekly, based on glycemic control.
If additional glycemic control is needed after at least 4 weeks on the:
• 0.5 mg dosage, the dosage may be increased to 1 mg once weekly.• 1 mg dosage, the dosage may be increased to 2 mg once weekly.
The maximum recommended dosage is 2 mg once weekly.
Recommended Maintenance Dosage in Patients with Type 2 Diabetes Mellitus and Chronic Kidney DiseaseIncrease the dosage to the maintenance dosage, 1 mg once weekly, after at least 4 weeks on the 0.5 mg dosage.• If a dose is missed, administer within 5 days of missed dose. ()2.1 Important Administration Instructions• Inspect OZEMPIC visually before use. It should appear clear and colorless. Do not use OZEMPIC if particulate matter and coloration is seen.• Administer OZEMPIC once weekly, on the same day each week, at any time of the day, with or without meals.• Inject OZEMPIC subcutaneously in the abdomen, thigh, or upper arm. Instruct patients to use a different injection site each week when injecting in the same body region.• When using OZEMPIC with insulin, instruct patients to administer as separate injections and to never mix the products. It is acceptable to inject OZEMPIC and insulin in the same body region, but the injections should not be adjacent to each other.• The day of weekly administration can be changed if necessary as long as the time between two doses is at least 2 days (>48 hours).• If a dose is missed, administer OZEMPIC as soon as possible within 5 days after the missed dose. If more than 5 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.
• Inject subcutaneously in the abdomen, thigh, or upper arm. ()2.1 Important Administration Instructions• Inspect OZEMPIC visually before use. It should appear clear and colorless. Do not use OZEMPIC if particulate matter and coloration is seen.• Administer OZEMPIC once weekly, on the same day each week, at any time of the day, with or without meals.• Inject OZEMPIC subcutaneously in the abdomen, thigh, or upper arm. Instruct patients to use a different injection site each week when injecting in the same body region.• When using OZEMPIC with insulin, instruct patients to administer as separate injections and to never mix the products. It is acceptable to inject OZEMPIC and insulin in the same body region, but the injections should not be adjacent to each other.• The day of weekly administration can be changed if necessary as long as the time between two doses is at least 2 days (>48 hours).• If a dose is missed, administer OZEMPIC as soon as possible within 5 days after the missed dose. If more than 5 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.
Injection: clear, colorless solution available in 3 prefilled, disposable, single-patient-use pens:
Dose per Injection | Total Strength per Total Volume | Strength per mL |
0.25 mg 0.5 mg | 2 mg / 3 mL | 0.68 mg/mL |
1 mg | 4 mg / 3 mL | 1.34 mg/mL |
2 mg | 8 mg / 3 mL | 2.68 mg/mL |
The 2 mg/1.5 mL (1.34 mg/mL) strength is not currently marketed by Novo Nordisk Inc.
No dose adjustment of OZEMPIC is recommended for patients with hepatic impairment. In a study in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics (PK) was observed