INFORMATION
OZEMPIC® (semaglutide) Indications for Use
OZEMPIC® (semaglutide) is a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Additionally, it is used to reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, in adults with type 2 diabetes and established cardiovascular disease.
Key Indications:
- Type 2 diabetes mellitus: As an adjunct therapy to improve glycemic control.
- Cardiovascular risk reduction: Reduces the risk of MACE in patients with cardiovascular disease.
Not for:
- Patients with a history of pancreatitis.
- Type 1 diabetes mellitus or diabetic ketoacidosis.
OZEMPIC® is administered via a subcutaneous injection. The recommended dosage regimen begins with 0.25 mg once weekly for four weeks. After that, the dosage is increased to 0.5 mg once weekly. If further glycemic control is required, the dosage can be increased to 1 mg once weekly.
Dosage Summary:
- Starting dose: 0.25 mg once weekly for 4 weeks.
- Maintenance dose: 0.5 mg once weekly.
- Maximum dose: 1 mg once weekly if needed.
It should be injected into the abdomen, thigh, or upper arm, with each injection site rotated weekly.
OZEMPIC® (semaglutide) Side Effects and Precautions
OZEMPIC® is generally well tolerated but can cause various side effects, particularly during the initial phase of treatment. Patients should be monitored for symptoms related to pancreatitis, diabetic retinopathy, and kidney function.
Common Side Effects:
- Nausea, vomiting, diarrhea, and abdominal pain are common but tend to diminish with continued use.
- Constipation and indigestion.
- Injection site reactions such as redness or swelling.
Serious Side Effects:
- Pancreatitis: If severe abdominal pain occurs, discontinue OZEMPIC® and evaluate for pancreatitis.
- Diabetic retinopathy complications: Patients with existing retinopathy may experience worsening symptoms.
- Hypoglycemia: When used in combination with insulin or sulfonylureas, the risk of hypoglycemia increases.
- Acute kidney injury: Monitor patients with severe gastrointestinal issues such as dehydration.
Precautions:
- Thyroid tumors: OZEMPIC® has been associated with thyroid C-cell tumors in animal studies. It is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Gallbladder disease: Acute gallbladder disease, such as cholelithiasis, has been reported.
OZEMPIC® (semaglutide) Clinical Studies or Real-World Outcomes
OZEMPIC® has been shown in clinical trials to provide significant benefits in reducing blood glucose and improving overall cardiovascular health.
Efficacy Results:
- In trials, OZEMPIC® significantly reduced HbA1c levels by 1.4% to 1.6% over 30 weeks at doses of 0.5 mg and 1 mg.
- A notable reduction in fasting plasma glucose (FPG) and postprandial glucose was observed, with patients showing an average weight loss of 3.5 kg to 4.7 kg during the study.
Cardiovascular Outcomes:
- In patients with type 2 diabetes and established cardiovascular disease, OZEMPIC® was found to reduce the risk of major cardiovascular events by 26%.
OZEMPIC® (semaglutide) Drug Interactions
OZEMPIC® delays gastric emptying, which may influence the absorption of other oral medications. Caution should be exercised when co-administering drugs that require rapid absorption or have a narrow therapeutic index.
Potential Drug Interactions:
- Insulin or sulfonylureas: Co-administration increases the risk of hypoglycemia. Dose adjustments for insulin may be necessary.
- Oral medications: OZEMPIC® may affect the absorption of oral contraceptives and other oral medications.
OZEMPIC® (semaglutide) Aftercare Instructions
Patients receiving OZEMPIC® injections should follow specific post-administration care guidelines to ensure safety and effectiveness.
Post-Injection Guidelines:
- Ensure the injection site is rotated weekly to avoid irritation.
- Store unused pens in the refrigerator between 2°C and 8°C, but do not freeze. Once in use, pens can be stored at room temperature for up to 6 weeks.
What to Expect:
- Nausea and gastrointestinal discomfort are common but usually diminish after a few weeks of continued use.
- Blood sugar monitoring: Regular monitoring is essential, particularly if the patient is on insulin or other glucose-lowering medications to prevent hypoglycemia.
Follow-Up Treatments
OZEMPIC® is a long-term therapy for patients with type 2 diabetes. Patients should have regular follow-ups with their healthcare provider to evaluate their response to treatment and adjust dosages if necessary.
Maintenance Therapy:
- Treatment effectiveness should be reviewed every 3-6 months. If patients require additional glycemic control after 4 weeks on the 0.5 mg dose, the dose may be increased to 1 mg once weekly.
- Regular eye exams for patients with diabetic retinopathy are recommended.