FDA Boxed Warning — Risk of Thyroid C-Cell Tumors
Semaglutide causes thyroid C-cell tumors in rodents. It is unknown whether it causes medullary thyroid carcinoma (MTC) in humans. Contraindicated in anyone with a personal or family history of MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Other labeled risks: pancreatitis, gallbladder disease, acute kidney injury, diabetic retinopathy complications, hypoglycemia when combined with insulin/sulfonylureas, hypersensitivity reactions. Discontinue at least 2 months before a planned pregnancy (long washout). See the full FDA label on DailyMed.
Semaglutide Protocol Guide
Semaglutide is a GLP-1 receptor agonist studied for metabolic research. It mimics incretin hormone GLP-1 released after eating, influencing glucose regulation and appetite signaling.
Protocol Overview
- Compound
- Semaglutide (Research Peptide for Metabolic Studies)
- Category
- GLP-1 Receptor Agonist
- Vial Size
- 5mg (5,000mcg)
- Reconstitution
- 2mL bacteriostatic water (2.5mg/mL)
- Route
- Subcutaneous injection
- Frequency
- Once weekly
Reconstitution Instructions
Using 2mL of bacteriostatic water results in a concentration of 2.5mg/mL. Start low and titrate up. Always use sterile techniques.
Materials Needed
- Semaglutide 5mg vial (lyophilized powder)
- 2mL bacteriostatic water (sterile, preserved with 0.9% benzyl alcohol)
- Sterile syringe and needle (18-22 gauge for drawing)
- Alcohol swabs
- Clean workspace
Step-by-Step Process
- Preparation: Allow the Semaglutide 5mg vial and bacteriostatic water to reach room temperature. Wipe the rubber stoppers of both vials with an alcohol swab.
- Draw the Water: Using a sterile syringe, draw up exactly 2mL of bacteriostatic water. Expel any air bubbles.
- Inject into Vial: Insert the needle through the rubber stopper at a slight angle, aiming toward the glass wall. Slowly inject the water down the side of the vial to avoid foaming.
- Mix Gently: Remove the needle. Gently swirl or roll the vial between your hands. Do not shake vigorously.
- Check for Clarity: The solution should be clear once fully reconstituted. Do not use if cloudy.
Weekly Dosing Schedule (Titration Protocol)
Semaglutide requires a gradual dose escalation to minimize GI side effects. Increase every 4 weeks as tolerated.
| Weeks | Dose | Units (at 2.5mg/mL) | Frequency |
|---|---|---|---|
| Weeks 1–4 | 0.25mg (250mcg) | 10 units (0.1mL) | Once weekly |
| Weeks 5–8 | 0.5mg (500mcg) | 20 units (0.2mL) | Once weekly |
| Weeks 9–12 | 1mg (1,000mcg) | 40 units (0.4mL) | Once weekly |
| Weeks 13–16 | 1.7mg (1,700mcg) | 68 units (0.68mL) | Once weekly |
| Weeks 17+ | 2.4mg (2,400mcg) max | 96 units (0.96mL) | Once weekly |
Starting dose: 0.25mg once weekly • Max dose: 2.4mg once weekly • Vial Duration: ~5 weeks at 0.25mg or ~2 doses at 2.4mg (5mg vial)
Quick Dosing Reference (at 2.5mg/mL)
| Units (Ticks) | Dose (mcg) | Dose (mg) |
|---|---|---|
| 10 | 250 | 0.25mg |
| 20 | 500 | 0.5mg |
| 40 | 1,000 | 1mg |
| 68 | 1,700 | 1.7mg |
| 96 | 2,400 | 2.4mg |
Administration Guidelines
- Administer subcutaneously once weekly on the same day each week
- Rotate injection sites between abdomen, thigh, and upper arm
- Start at lowest dose and titrate up every 4 weeks
- Store reconstituted peptide refrigerated at 36-46F (2-8C)
- Use reconstituted solution within 30 days
- Never freeze reconstituted peptides
- Document administration times and observations
Storage Requirements
| State | Storage Conditions |
|---|---|
| Lyophilized (powder) | Room temperature or refrigerated, protect from light |
| Reconstituted | Refrigerated 36-46F (2-8C), use within 30 days |