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 ()].• 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 (4)]. 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 (4), Warnings and Precautions ()].
Indication and Usage (
) …………………………………………… 1/2025Dosage and Administration (
) ………………………......………. 1/2025Warnings and Precautions,
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. ()• Start at 0.25 mg once weekly. After 4 weeks, increase the dosage to 0.5 mg once weekly. ()• 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. ()• If additional glycemic control is needed, increase the dosage to 2 mg once weekly after at least 4 weeks on the 1 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. (, )• If a dose is missed, administer within 5 days of missed dose. ()• Inject subcutaneously in the abdomen, thigh, or upper arm. ()
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
OZEMPIC is contraindicated in patients with:
• A personal or family history of MTC or in patients with MEN 2[see Warnings and Precautions ()].• A serious hypersensitivity reaction to semaglutide or to any of the excipients in OZEMPIC. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with OZEMPIC[see Warnings and Precautions ()].
Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with OZEMPIC. If hypersensitivity reactions occur, discontinue use of OZEMPIC; treat promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous hypersensitivity to OZEMPIC
Anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to anaphylaxis with OZEMPIC.
The following adverse reactions have been reported during post-approval use of semaglutide, the active ingredient of OZEMPIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
OZEMPIC causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials, semaglutide did not affect the absorption of orally administered medications to any clinically relevant degree
OZEMPIC (semaglutide) injection, for subcutaneous use, contains semaglutide, a human GLP-1 receptor agonist (or GLP-1 analog). The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is C187H291N45O59 and the molecular weight is 4113.58 g/mol.
Structural formula:
OZEMPIC is a sterile, aqueous, clear, colorless solution. Each 3 mL prefilled single-patient-use pen contains semaglutide 2 mg (0.68 mg/mL), 4 mg (1.34 mg/mL), or 8 mg (2.68 mg/mL). Each 1 mL of OZEMPIC solution also contains the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injections. OZEMPIC has a pH of approximately 7.4. Hydrochloric acid or sodium hydroxide may be added to adjust pH. The 2 mg/1.5 mL (1.34 mg/mL) strength is not currently marketed by Novo Nordisk Inc.
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.
GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors.
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.
The mechanism of kidney-related risk reduction has not been established.
In 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.
Human relevance of thyroid C-cell tumors in rats is unknown and could not be determined by clinical studies or nonclinical studies
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.
FLOW (NCT03819153) was a randomized, double-blind, placebo-controlled, event driven trial in adults with type 2 diabetes mellitus and chronic kidney disease (eGFR 25 to 75 mL/min/1.73 m2 with urine albumin-to- creatinine ratio [UACR] >100 mg/g and <5000 mg/g). All patients needed to have an HbA1c ≤10% at screening and be receiving standard of care background therapy, including a maximum tolerated labeled dose of a renin- angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment was contraindicated or not tolerated. The trial excluded patients with congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.
A total of 3,533 patients were randomized to receive OZEMPIC 1 mg once weekly or placebo and were followed for a median of 41 months. The mean age of the study population was 67 years, and 70% of patients were male. Approximately 66% of the trial population was White, 24% Asian, and 5% Black or African American. At baseline, the mean eGFR was 47 mL/min/1.73m2, with 11% of patients having an eGFR <30 mL/min/1.73m2. Median baseline UACR was 568 mg/g with 69% of patients with a UACR >300 mg/g. At baseline, 95% of patients were treated with an ACE inhibitor or ARB, 16% were on sodium-glucose cotransporter 2 (SGLT2) inhibitors, 76% were on a statin, and 50% were on an antiplatelet agent.
OZEMPIC was superior to placebo in reducing the incidence of the primary composite endpoint of a sustained decline in eGFR of ≥50%, sustained eGFR <15 mL/min/1.73 m2, chronic renal replacement therapy, renal death, CV death (HR 0.76 [95% CI 0.66, 0.88], p=0.0003) as shown in
OZEMPIC also reduced the annual rate of change in eGFR (
The treatment effect on the primary composite endpoint was generally consistent across the pre-specified subgroups examined, including age, biological sex, eGFR and UACR. The treatment benefit on the primary composite endpoint was not evident in patients taking SGLT2 inhibitors at baseline, but there were few events in these patients.
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| 0.0289 |
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| 0.0104 |
1 Cox proportional hazards model with treatment as factor and stratified by baseline use of SGLT2-inhibitor at baseline (yes or no).
2 Two-sided p-value for the test of no difference. The significance level was 0.03224.
3 Sustained was defined as having 2 consecutive measurements ≥28 days apart fulfilling the criteria.
Cumulative incidence estimates are based on time from randomization to first composite renal event with non-CV and non-renal death modelled as competing risk. The x-axis is truncated at 52 months where approximately 5% of the population was in the trial.
Sustained was defined as having 2 consecutive measurements ≥28 days apart fulfilling the criteria.
Injection: clear, colorless solution of 0.68 mg/mL, 1.34 mg/mL or 2.68 mg/mL of semaglutide available in prefilled, disposable, single-patient-use pens in the following packaging configurations:
Dose per Injection | Use For | Total Strength per Total Volume | Doses per Pen | Carton Contents | NDC |
0.25 mg 0.5 mg | Initiation Maintenance | 2 mg/3 mL | 4 doses of 0.25 mg and 2 doses of 0.5 mg or 4 doses of 0.5 mg | 1 pen 6 NovoFine® Plus needles | 0169-4181-13 |
1 mg | Maintenance | 4 mg/3 mL | 4 doses of 1 mg | 1 pen 4 NovoFine® Plus needles | 0169-4130-13 |
2 mg | Maintenance | 8 mg/3 mL | 4 doses of 2 mg | 1 pen 4 NovoFine® Plus needles | 0169-4772-12 |
The 2 mg/1.5 mL (1.34 mg/mL) strength (NDC 0169-4132-12) is not currently marketed by Novo Nordisk Inc.
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
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.
Prior to first use | After first use | |
Refrigerated 36°F to 46°F (2°C to 8°C) | Room Temperature 59°F to 86°F (15°C to 30°C) | Refrigerated 36°F to 46°F (2°C to 8°C) |
Until expiration date | 56 days | |
INSTRUCTIONS FOR USE OZEMPIC® [oh-ZEM-pick] (semaglutide) injection, for subcutaneous use 2 mg dose (pen delivers doses in 2 mg increments only) | |
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use the OZEMPIC pen.
Supplies you will need to give your OZEMPIC injection:
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Step 1. Prepare your pen with a new needle | |
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 Always use a new needle for each injection. This will reduce the risk of contamination, infection, leakage of OZEMPIC, and blocked needles leading to the wrong dose.Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them. Never use a bent or damaged needle. | |
Step 2. First Time Use for Each New Pen: Check the OZEMPIC flow | |
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 Always make sure that a drop appears at the needle tip before you use a new pen for the first time. This makes sure that OZEMPIC flows. If no drop appears, you will not inject any OZEMPIC, even though the dose counter may move. This may mean that there is a blocked or damaged needle. A small drop may remain at the needle tip, but it will not be injected. Only check the OZEMPIC flow before your first injection with each new pen. | |
Step 3. Select your dose | |
The dashed line in the dose counter |  |
Always use the dose counter and the dose pointer to see that 2 mg has been selected. You will hear a “click” every time you turn the dose selector. Do not set the dose by counting the number of clicks you hear. Only doses of 2 mg can be selected with the dose selector. 2 mg must line up exactly with the dose pointer to make sure that you get a correct dose.The dose selector changes the dose. Only the dose counter and dose pointer will show that 2 mg has been selected. You can only select 2 mg for each dose. When your pen contains less than 2 mg, the dose counter stops before 2 mg is shown. The dose selector clicks differently when turned forward or backward. Do not count the pen clicks. | |
How much OZEMPIC is left? | |
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Step 4. Inject your dose | |
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Always watch the dose counter to make sure you have injected your complete dose. Hold the dose button down until the dose counter shows 0.How to identify a blocked or damaged needle?
How to handle a blocked needle? Change the needle as described in Step 5, and repeat all steps starting with Step 1: “Prepare your pen with a new needle”. Never touch the dose counter when you inject. This can stop the injection.You may see a drop of OZEMPIC at the needle tip after injecting. This is normal and does not affect your dose. | |
Step 5. After your injection | |
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Never try to put the inner needle cap back on the needle. You may stick yourself with the needle. Always remove the needle from your pen. This will reduce the risk of contamination, infection, leakage of OZEMPIC, and blocked needles leading to the wrong dose. If the needle is blocked, you will not inject any OZEMPIC. Always dispose of the needle after each injection. | |
Disposing of used OZEMPIC pens and needles:
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Important | |
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Caring for your pen | |
How should I store my OZEMPIC pen?
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will guide you to 2 mg.
For more information go to
Novo Nordisk A/S
DK-2880 Bagsvaerd
Denmark
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-888-693-6742
Version: 2
OZEMPIC® and NovoFine® are registered trademarks of Novo Nordisk A/S.
© 2023 Novo Nordisk
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: September 2023
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.
GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors.
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.
The mechanism of kidney-related risk reduction has not been established.
