- Freeze dried powder inside of a sterile 2ml vial.
- Butyl rubber stopper for multiple penetrations while maintaining a secure seal.
- RTF vials are Depyrogenated, and ETO Sterilized.
- Tamper evident aluminum flip top.
Products are furnished for LABORATORY RESEARCH USE ONLY. This product should only be handled by qualified, and licensed professionals. The product may not be used as a drug, agricultural or pesticidal product, food additive or household chemical – and may not be misbranded as such. All information on this website is available for educational purposes only. Bodily introduction of any kind into humans and/or animals is strictly forbidden by law.
Indications and Limitations of Use
Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes mellitus and established CV disease.
- 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 indicated for use in patients with type 1 diabetes mellitus.
Important Safety Information cont.
- Ozempic® is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a hypersensitivity reaction to semaglutide or to any of the excipients in Ozempic®. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with Ozempic®.
Warnings and Precautions
- Risk of Thyroid C-Cell Tumors: Patients should be referred to an endocrinologist for further evaluation if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging.
- Pancreatitis: Acute and chronic pancreatitis have been reported in clinical studies. Observe patients carefully for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back with or without vomiting). If pancreatitis is suspected, discontinue Ozempic® promptly, and if pancreatitis is confirmed, do not restart.
- Diabetic Retinopathy Complications: In a 2-year trial involving patients with type 2 diabetes and high cardiovascular risk, more events of diabetic retinopathy complications occurred in patients treated with Ozempic® (3.0%) compared with placebo (1.8%). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline than among patients without a known history of diabetic retinopathy.
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. The effect of long-term glycemic control with semaglutide on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
- Never Share an Ozempic® Pen Between Patients: Ozempic® pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens.
- Hypoglycemia: Patients receiving Ozempic® in combination with an insulin secretagogue (eg, sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
- Acute Kidney Injury: There have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis, in patients treated with GLP-1 receptor agonists. Some of these events have been reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function when initiating or escalating doses of Ozempic® in patients reporting severe adverse gastrointestinal reactions.
- Hypersensitivity: Serious hypersensitivity reactions (eg, 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. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist.
- Acute Gallbladder Disease: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients treated with Ozempic® 0.5 mg and 1 mg, respectively, and not reported in placebo-treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.
- The most common adverse reactions, reported in ≥5% of patients treated with Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation. Buy semaglutide
- When initiating Ozempic®, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia.
- Ozempic® causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications, so caution should be exercised.
Use in Specific Populations
- There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Discontinue Ozempic® in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.
FDA Approves 2.0 mg Dose of Semaglutide Injection for Type 2 Diabetes
The FDA has approved a 2.0 mg dose of semaglutide as a once-weekly subcutaneous injection for the treatment of adults with type 2 diabetes (T2D).
The action expands the indicated use of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), to include 0.5, 1.0, and 2.0 mg doses for the treatment of T2D, in addition to decreased risk of major adverse cardiovascular events in adults with both T2D and cardiovascular disease.In 2017, the FDA approved semaglutide at doses of up to 1 mg subcutaneously once weekly for the treatment of TD2 mellitus.
“We are pleased with the FDA approval for a higher 2.0 mg dose of Ozempic, which further supports our purpose of driving change in diabetes care,” Martin Lange, executive vice president of development at Novo Nordisk, said in a press release. “The approval of the 2.0 mg dose allows more people with type 2 diabetes to achieve and maintain individualized glycemic targets and remain on the same medication for longer as their needs evolve.”
The approval for T2D was based on results from the SUSTAIN FORTE trial of 2.0 mg semaglutide injection, which found that patients treated with a higher-dose of the GLP-1 RA experienced statistically significant and superior reductions in hemoglobin A1c (HbA1c) at week 40 compared with patients on 1.0 mg semaglutide.
The treatment was found to be as safe and well-tolerated among patients administered the higher dose of semaglutide as the 1.0 mg treatment cohort, with gastrointestinal events being the most common adverse effect reported.
Please click here for Ozempic® Prescribing Information, including Boxed Warning.