Ozempic | Buy Ozempic Online

An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

OZEMPIC is indicated:

• as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies.

• 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 [see Clinical Studies.

Limitations of Use

• OZEMPIC has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.

• OZEMPIC is not a substitute for insulin. OZEMPIC is not indicated for use in patients with type 1 diabetes mellitusor for the treatment of patients with diabetic ketoacidosis, as it would not be effective in these settings.

Ozempic Pen

Dosage and Administration

Important Administration Instructions

  • Inspect OZEMPIC before use: Ensure it is clear and colorless. Do not use if it contains particulate matter or is discolored.
  • Dosage timing: Administer OZEMPIC once weekly on the same day each week, at any time, with or without meals.
  • Injection sites: Inject OZEMPIC subcutaneously into the abdomen, thigh, or upper arm. Rotate injection sites within the same body region each week.
  • Concurrent use with insulin: Administer OZEMPIC and insulin as separate injections. They can be injected in the same body region, but not adjacent to each other.

Recommended Dosage

  • Initial dosage: Start with 0.25 mg injected subcutaneously once weekly for 4 weeks. This dosage is for treatment initiation and is not effective for glycemic control.
  • Increase dosage: After 4 weeks, increase to 0.5 mg once weekly.
  • Further dosage adjustments:
    • If additional glycemic control is needed after at least 4 weeks on 0.5 mg, increase to 1 mg once weekly.
    • If further control is required after at least 4 weeks on 1 mg, increase to a maximum of 2 mg once weekly.
  • Changing the administration day: The weekly administration day can be changed as long as the time between two doses is at least 2 days (more than 48 hours).
  • Missed doses: If a dose is missed, administer OZEMPIC as soon as possible within 5 days. If more than 5 days have passed, skip the missed dose and resume the regular dosing schedule on the next scheduled day.

Description

OZEMPIC (semaglutide) injection, for subcutaneous use, contains semaglutide, a human GLP-1 receptor agonist (or GLP-1 analog). The peptide backbone is produced via yeast fermentation. The primary mechanism of semaglutide is albumin binding, facilitated by modifying position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Additionally, semaglutide is modified at position 8 to stabilize against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification at position 34 ensures the attachment of only one fatty di-acid. The molecular formula is C187H291N45O59, with a molecular weight of 4113.58 g/mol.

OZEMPIC is a sterile, aqueous, clear, colorless solution. Each 3 mL pre-filled, single-patient-use pen contains semaglutide in concentrations of 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 includes the following inactive ingredients: disodium phosphate dihydrate (1.42 mg), propylene glycol (14.0 mg), phenol (5.50 mg), and water for injections. The solution has a pH of approximately 7.4, and hydrochloric acid or sodium hydroxide may be added to adjust the pH. The 2 mg/1.5 mL (1.34 mg/mL) strength is not currently marketed by Novo Nordisk Inc.

How Supplied/Storage and Handling

How Supplied

OZEMPIC is a clear, colorless solution available in pre-filled, disposable, single-patient-use pens with semaglutide concentrations of 0.68 mg/mL, 1.34 mg/mL, or 2.68 mg/mL. The packaging configurations are as follows:

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 | NDC 0169-4181-13
  • 1 mg | Maintenance | 4 mg/3 mL | 4 doses of 1 mg | 1 pen, 4 NovoFine® Plus needles | NDC 0169-4130-13
  • 2 mg | Maintenance | 8 mg/3 mL | 4 doses of 2 mg | 1 pen, 4 NovoFine® Plus needles | NDC 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 intended for single-patient use only and must never be shared, even if the needle is changed [see Warnings and Precautions (5.4)].

Recommended Storage

  • Before first use: Store OZEMPIC in a refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze or store directly adjacent to the refrigerator cooling element. Do not use if frozen.
  • After first use: Store the OZEMPIC pen for up to 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 and protect from excessive heat and sunlight.

Additional Instructions

  • Remove and safely discard the needle after each injection.
  • Store the OZEMPIC pen without an attached needle.
  • Use a new needle for each injection.

Table 10. Recommended Storage Conditions for the OZEMPIC Pen

  • Prior to first use:
    • Refrigerated: 36°F to 46°F (2°C to 8°C)
  • After first use:
    • Room Temperature: 59°F to 86°F (15°C to 30°C) - up to 56 days
    • Refrigerated: 36°F to 46°F (2°C to 8°C) - up to 56 days or until expiration date

Patient Counseling Information

Advise patients to read the FDA-approved patient labeling, including the Medication Guide and Instructions for Use.

Risk of Thyroid C-cell Tumors

Inform patients that semaglutide has caused thyroid C-cell tumors in rodents, although the relevance to humans is unknown. Advise patients to report any symptoms of thyroid tumors (such as a lump in the neck, hoarseness, difficulty swallowing, or shortness of breath) to their physician [see Boxed Warning and Warnings and Precautions (5.1)].

Pancreatitis

Inform patients about the potential risk of pancreatitis. Instruct them to discontinue OZEMPIC immediately and contact their physician if they suspect pancreatitis (severe abdominal pain that may radiate to the back, with or without vomiting) [see Warnings and Precautions (5.2)].

Diabetic Retinopathy Complications

Advise patients to contact their physician if they experience any changes in vision during treatment with OZEMPIC [see Warnings and Precautions (5.3)].

Never Share an OZEMPIC Pen Between Patients

Inform patients that they must never share an OZEMPIC pen with anyone else, even if the needle is changed, as this can transmit blood-borne pathogens [see Warnings and Precautions (5.4)].

Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin

Inform patients that the risk of hypoglycemia increases when OZEMPIC is used with an insulin secretagogue (like a sulfonylurea) or insulin. Educate them on the signs and symptoms of hypoglycemia [see Warnings and Precautions (5.5)].

Acute Kidney Injury

Advise patients of the potential risk of dehydration due to gastrointestinal side effects and to take steps to avoid fluid depletion. Inform them of the potential risk for worsening renal function and explain the signs and symptoms of renal impairment, as well as the possibility of dialysis if acute kidney injury occurs [see Warnings and Precautions (5.6)].

Hypersensitivity Reactions

Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of OZEMPIC. Advise them on the symptoms of hypersensitivity reactions and instruct them to stop taking OZEMPIC and seek medical advice promptly if such symptoms occur [see Warnings and Precautions (5.7)].

Acute Gallbladder Disease

Inform patients of the potential risk for cholelithiasis or cholecystitis. Instruct them to contact their physician if they suspect either condition for appropriate follow-up [see Warnings and Precautions (5.8)].

Pregnancy

Advise pregnant women of the potential risk to a fetus. Instruct women to inform their healthcare provider if they are pregnant or plan to become pregnant [see Use in Specific Populations (8.1), (8.3)].

Missed Doses

Inform patients that 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, they should skip the missed dose and administer the next dose on the regularly scheduled day. They should then resume their regular once-weekly dosing schedule [see Dosage and Administration (2.2)].

Manufactured by:

Novo Nordisk A/S
DK-2880 Bagsvaerd
Denmark

For information about OZEMPIC contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-888-693-6742

Version: 9

OZEMPIC® and NovoFine® are registered trademarks of Novo Nordisk A/S.

Patent Information: http://www.novonordisk-us.com/products/product-patents.html

© 2023 Novo Nordisk

Warnings and Precautions

• 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.

• Hypoglycemia: When OZEMPIC is used with an insulin secretagogue or insulin, consider lowering the dose of the secretagogue or insulin to reduce the risk of hypoglycemia.

• Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.

• Hypersensitivity Reactions: Discontinue OZEMPIC if suspected and promptly seek medical advice.

 

WARNING: RISK OF THYROID C-CELL TUMORS

In rodents, semaglutide has been shown to cause thyroid C-cell tumors in a dose-dependent manner and based on the length of treatment at clinically relevant exposures. It is not known if OZEMPIC leads to thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of these rodent findings is unclear [see Warnings and Precautions and Nonclinical Toxicology].OZEMPIC is contraindicated for individuals with a personal or family history of MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications]. Patients should be advised about the potential risk of MTC with OZEMPIC and informed about symptoms of thyroid tumors, such as a neck mass, difficulty swallowing, shortness of breath, or persistent hoarseness. The value of routine monitoring of serum calcitonin or thyroid ultrasound for early detection of MTC in patients using OZEMPIC is uncertain.

The highlights above do not include all or the complete information needed to use Ozempic safely and effectively. See full prescribing information for Ozempic 

Additional information at https://dailymed.nlm.nih.gov

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