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Dosage of Semaglutide

1. Overview of Semaglutide Tablet Formulations

Semaglutide tablets have two formulations (i.e., R1 formulation and R2 formulation) with different recommended dosages. Please refer to the advice on how to switch from one formulation to the other.

Semaglutide tablets (R1 formulation) are available in 3 mg, 7 mg, and 14 mg strengths.

Semaglutide tablets (R2 formulation) are available in 1.5 mg, 4 mg, and 9 mg strengths.

These formulations cannot be substituted on a milligram-to-milligram basis.

Use either Semaglutide tablets R1 formulation or R2 formulation; do not use both formulations simultaneously.

Do not take more than one tablet per day.

2. Important Administration Instructions

Take Semaglutide tablets on an empty stomach in the morning, with water (up to 4 ounces of water). Do not take Semaglutide tablets with any other liquid besides water.

After taking Semaglutide tablets, wait at least 30 minutes before eating, drinking, or taking other oral medications.

Swallow the tablet whole. Do not split, crush, or chew.

If you miss a dose, skip the missed dose and take the next dose as usual the following day.

3. Recommended Starting, Escalation, and Maintenance Dosages for Semaglutide Tablets R1 and R2 Formulations

Semaglutide Tablets (R1 Formulation)

Semaglutide tablets (R1 formulation) are available in the following strengths: 3 mg, 7 mg, and 14 mg.

To reduce the risk of gastrointestinal adverse reactions, the following dosages are recommended for Semaglutide tablets (R1 formulation):

Starting Dose (Initiation Phase) (Days 1 to 30): The recommended starting dose is 3 mg taken orally once daily (this dose is not effective for glycemic control).

Escalation and Maintenance Dose (Days 31 and beyond):

Days 31 to 60: Increase the dose to 7 mg taken orally once daily.

On day 61 or later: If no additional glycemic control is needed, maintain the dose at 7 mg once daily; if additional glycemic control is needed, increase the dose to 14 mg once daily.

Semaglutide Tablets (R2 Formulation)

Semaglutide tablets (R2 formulation) are available in the following strengths: 1.5 mg, 4 mg, and 9 mg.

To reduce the risk of gastrointestinal adverse reactions, the following dosages are recommended for Semaglutide tablets (R2 formulation):

Starting Dose (Initiation Phase) (Days 1 to 30): The recommended starting dose is 1.5 mg taken orally once daily (this dose is not effective for glycemic control).

Escalation and Maintenance Dose (Days 31 and beyond):

Days 31 to 60: Increase the dose to 4 mg taken orally once daily.

On day 61 or later: If no additional glycemic control is needed, maintain the dose at 4 mg once daily; if additional glycemic control is needed, increase the dose to 9 mg once daily.

4. Switching Between Semaglutide Tablets (R1 or R2 Formulations) or from OZEMPIC to Semaglutide Tablets

Switching Between Semaglutide Tablet Formulations

Do not switch between Semaglutide tablet formulations during the initiation phase (Days 1-30).

After 30 days of treatment with Semaglutide tablets (after the initiation phase), patients can switch between Semaglutide tablet formulations.

When switching between formulations, start the other Semaglutide tablet formulation on the day after discontinuing the previous Semaglutide tablet formulation.

Switching recommendations are as follows: When switching from R1 formulation 7 mg once daily, start R2 formulation 4 mg once daily. When switching from R1 formulation 14 mg once daily, start R2 formulation 9 mg once daily. Conversely, switch from R2 formulation 4 mg to R1 formulation 7 mg, and from R2 formulation 9 mg to R1 formulation 14 mg.

Switching from OZEMPIC to Semaglutide Tablets (R1 Formulation) or Semaglutide Tablets (R2 Formulation)

Switching from OZEMPIC to Semaglutide Tablets (R1 Formulation)

After discontinuing subcutaneous OZEMPIC 0.5 mg for one week, start Semaglutide tablets (R1 formulation) 7 mg or 14 mg once daily.

Recommendations for switching from weekly subcutaneous OZEMPIC 0.25 mg, 1 mg, or 2 mg to Semaglutide tablets (R1 formulation) have not been established.

Switching from OZEMPIC to Semaglutide Tablets (R2 Formulation)

After discontinuing subcutaneous OZEMPIC 0.5 mg for one week, start Semaglutide tablets (R2 formulation) 4 mg or 9 mg once daily.

Recommendations for switching from weekly subcutaneous OZEMPIC 0.25 mg, 1 mg, or 2 mg to Semaglutide tablets (R2 formulation) have not been established.

FDA,2025.10

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