What is the proper protocol for prescribing Semaglutide (Ozempic)?

From the Guidelines

Semaglutide (Ozempic) should be prescribed starting at 0.25 mg once weekly by subcutaneous injection for the first 4 weeks, which serves as a dose-escalation period to minimize gastrointestinal side effects, as recommended by the most recent and highest quality study 1.

Key Considerations for Prespresing Semaglutide

• The dose can be increased to 0.5 mg once weekly after 4 weeks, and if additional glycemic control is needed, the dose can be further increased to 1 mg weekly, and if necessary, to 2 mg weekly after at least 4 weeks on the previous dose, as indicated in the study 1.
• Patients should inject Ozempic into the abdomen, thigh, or upper arm, rotating injection sites with each dose.
• The medication should be stored in the refrigerator before first use and can be kept at room temperature for up to 56 days after opening.
• Patients should be counseled about common side effects including nausea, vomiting, diarrhea, and potential risk of pancreatitis, as reported in the study 1.

Important Contraindications and Cautions

• Ozempic is contraindicated in patients with personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.
• It should be used cautiously in patients with diabetic retinopathy or history of pancreatitis, as noted in the study 1.

Mechanism of Action

• Ozempic works by mimicking GLP-1, which increases insulin secretion, decreases glucagon secretion, slows gastric emptying, and reduces appetite.

Additional Recommendations

• Gradual dose titration is recommended to minimize the risk of GI adverse effects, as suggested in the study 1.
• Clinical judgment is recommended for adjusting the titration schedule as needed for an individual patient’s response, tolerance, and adverse effects.

From the FDA Drug Label

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage • Start OZEMPIC with a 0.25 mg subcutaneous injection once weekly for 4 weeks. The 0.25 mg dose is intended for treatment initiation and is not effective for glycemic control. • After 4 weeks on the 0.25 mg dose, increase the dosage to 0.5 mg once weekly. • If additional glycemic control is needed after at least 4 weeks on the 0.5 mg dose, the dosage may be increased to 1 mg once weekly. The maximum recommended dosage is 1 mg once weekly. • Administer OZEMPIC once weekly, on the same day each week, at any time of the day, with or without meals. • 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.

2.2 Important Administration Instructions • Administer OZEMPIC subcutaneously to the abdomen, thigh, or upper arm. Instruct patients to use a different injection site each week when injecting in the same body region. • Inspect OZEMPIC visually before use. It should appear clear and colorless. Do not use OZEMPIC if particulate matter and coloration is seen • 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 proper protocol for prescribing Semaglutide (Ozempic) is to:

• Start with a 0.25 mg dose for 4 weeks
• Increase to 0.5 mg after 4 weeks
• Increase to 1 mg if additional glycemic control is needed after at least 4 weeks on the 0.5 mg dose
• Administer once weekly, on the same day each week, at any time of day, with or without meals
• Use a different injection site each week when injecting in the same body region
• Inspect the product visually before use and do not use if particulate matter or coloration is seen
• Administer as separate injections when using with insulin and do not mix the products 2 2

From the Research

Protocol for Prescribing Semaglutide (Ozempic)

• Semaglutide is a once-weekly agonist of glucagon-like peptide-1 receptors (GLP-1 AR) indicated in the treatment of type 2 diabetes (T2D) 3.
• The proper protocol for prescribing semaglutide involves subcutaneous injection of 0.5 or 1.0 mg once weekly, presented as prefilled pens 3.
• Semaglutide can be prescribed as an add-on to SGLT-2 inhibitor therapy in patients with inadequately controlled type 2 diabetes, with a dose-escalation schedule of 4 weeks of 0.25 mg semaglutide or placebo and 4 weeks of 0.5 mg semaglutide or placebo 4.
• Oral semaglutide administration can also be used, with a recommended dose of 14.0 mg, taken on an empty stomach upon waking with a sip (≤120 mL) of plain water and at least 30 minutes before the first food, beverage, or other oral medications of the day 5.

Efficacy and Safety

• Semaglutide has been shown to have efficacy and safety profiles similar to those of other GLP-1RAs, with significant reductions in HbA1c and body weight compared to placebo 6, 7.
• The most common adverse effects of semaglutide are gastrointestinal, including nausea, diarrhea, and vomiting 6, 7, 5.
• Semaglutide can be used in combination with other glucose-lowering medications, including metformin and sulphonylurea 4.

Patient Counseling

• Pharmacists should counsel patients prescribed oral semaglutide about optimal oral dosing, why correct dosing conditions are necessary, expected therapeutic response, and effective strategies to mitigate potential gastrointestinal adverse events 5.
• Patients should be instructed to take oral semaglutide on an empty stomach upon waking with a sip (≤120 mL) of plain water and at least 30 minutes before the first food, beverage, or other oral medications of the day 5.