Setmelanotide (IMCIVREE): Dosing Protocols
Dosing guidelines, reconstitution, and administration information
๐TL;DR
- โข2 dosing protocols documented
- โขReconstitution instructions included
- โขStorage: Store refrigerated at 2-8 degrees C (36-46 degrees F). Protect from light. Keep in original carton until use. May be stored at room temperature up to 30 degrees C (86 degrees F) for up to 30 days in the original carton. Do not freeze.
Protocol Quick-Reference
Chronic weight management in genetic obesity (POMC, PCSK1, LEPR deficiency)
Dosing
Amount
2-3 mg (adults/adolescents) or 1-3 mg (pediatric)
Frequency
Once daily
Duration
Ongoing (with 12-16 week response assessment)
Administration
Route
SCSchedule
Once daily
Timing
Administer once daily at the start of the day. Inject into the abdomen. Rotate injection sites with each injection.
Cycle
Duration
Ongoing
Repeatable
Yes
โ๏ธ Suggested Bloodwork (4 tests)
Genetic testing
When: Before initiation (required)
Why: Confirm eligible POMC, PCSK1, or LEPR genetic variant
Body weight and BMI
When: Baseline and monthly
Why: Monitor weight loss response
CMP (Comprehensive Metabolic Panel)
When: Baseline
Why: Liver and kidney function baseline
Body weight assessment
When: 12-16 weeks at maintenance dose
Why: Determine if meaningful weight loss achieved; discontinue if not
๐ก Key Considerations
- โRequires genetic testing confirming eligible variant before prescribing; FDA-approved only for specific rare genetic obesity conditions
- โAvailable only through REMS restricted distribution due to risk of sexual adverse reactions
- โSkin hyperpigmentation is common due to MC1R cross-reactivity
Unlock dosing protocols
Free access to research-backed dosing information for all peptides.
150+ peptide profiles ยท 30+ comparisons ยท 18 research tools
| Purpose | Dose | Frequency | Duration | Notes |
|---|---|---|---|---|
| Once daily | Administer once daily at the start of the day. Inject into the abdomen. Rotate injection sites with each injection. | |||
| Once daily | Pediatric dose titration is more gradual (1 mg increments every 2 weeks). Same injection site and rotation guidance as adults. |
Unlock full dosage protocols
Free access to complete dosing tables and protocol details.
150+ peptide profiles ยท 30+ comparisons ยท 18 research tools
๐Reconstitution Instructions
IMCIVREE is supplied as a ready-to-use solution for injection at 10 mg/mL in single-dose vials. No reconstitution is required. The solution should be clear to slightly opalescent. Do not use if particulate matter or discoloration is observed.
Recommended Injection Sites
- โAbdomen (preferred)
๐งStorage Requirements
Store refrigerated at 2-8 degrees C (36-46 degrees F). Protect from light. Keep in original carton until use. May be stored at room temperature up to 30 degrees C (86 degrees F) for up to 30 days in the original carton. Do not freeze.
Community Dosing Protocols
Compare these clinical doses with what 15+ community members report using.
Based on 15+ community reports
View community protocolsResearch Tools
Before You Begin
Review safety warnings and contraindications before starting any protocol.
FDA-Approved Dosing#
Setmelanotide (IMCIVREE) is FDA-approved for chronic weight management in patients aged 6 years and older with obesity due to POMC, PCSK1, LEPR deficiency, or Bardet-Biedl syndrome, confirmed by genetic testing.
Dosing Schedule#
Adults and Adolescents (12 Years and Older)#
| Phase | Dose | Duration |
|---|---|---|
| Starting dose | 2 mg SC once daily | 2 weeks |
| Maintenance dose | 3 mg SC once daily | Ongoing |
| Assessment period | - | 12-16 weeks at maintenance |
Pediatric Patients (6 to Less Than 12 Years)#
| Phase | Dose | Duration |
|---|---|---|
| Starting dose | 1 mg SC once daily | 2 weeks |
| Step-up dose | 2 mg SC once daily | 2 weeks |
| Maintenance dose | 3 mg SC once daily | Ongoing |
| Assessment period | - | 12-16 weeks at maintenance |
Administration#
- Administer subcutaneously once daily, preferably at the start of the day
- Inject into the abdomen; rotate injection sites with each injection
- IMCIVREE is provided as a ready-to-use 10 mg/mL solution; no reconstitution needed
- If a dose is missed, skip the missed dose and administer the next dose at the regularly scheduled time
Response Assessment#
After 12-16 weeks at the maintenance dose, assess whether the patient has achieved meaningful weight loss. If meaningful weight loss has not been achieved, discontinue setmelanotide. Lack of response may indicate that the patient's genetic variant does not affect the MC4R pathway in a manner responsive to MC4R agonism.
Special Populations#
- Genetic testing required: Prescribing requires genetic testing confirming an eligible variant
- Renal impairment: No dose adjustment required for mild to moderate renal impairment; not studied in severe impairment
- Hepatic impairment: No dose adjustment required for mild hepatic impairment; not studied in moderate or severe impairment
- Pregnancy: Not recommended; weight loss offers no benefit during pregnancy
Restricted Distribution#
IMCIVREE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) due to the risk of sexual adverse reactions and the need for genetic testing confirmation.
Dosing Context#
Setmelanotide (IMCIVREE) belongs to the Metabolic category of research peptides. Dosing protocols for Setmelanotide (IMCIVREE) are derived from available clinical trial data. These protocols are provided for research reference only and do not constitute medical advice. Actual dosing decisions should be made by qualified healthcare providers based on individual patient factors.
Research Protocols#
The following dosing protocols have been documented in clinical research for Setmelanotide (IMCIVREE):
undefined#
Dose: undefined
Frequency: Once daily
Duration: undefined
Administer once daily at the start of the day. Inject into the abdomen. Rotate injection sites with each injection.
undefined#
Dose: undefined
Frequency: Once daily
Duration: undefined
Pediatric dose titration is more gradual (1 mg increments every 2 weeks). Same injection site and rotation guidance as adults.
Reconstitution and Preparation#
IMCIVREE is supplied as a ready-to-use solution for injection at 10 mg/mL in single-dose vials. No reconstitution is required. The solution should be clear to slightly opalescent. Do not use if particulate matter or discoloration is observed.
Injection Sites#
Recommended injection sites for Setmelanotide (IMCIVREE) include:
- Abdomen (preferred)
Site rotation is recommended to minimize local tissue reactions and ensure consistent absorption.
Storage Requirements#
Store refrigerated at 2-8 degrees C (36-46 degrees F). Protect from light. Keep in original carton until use. May be stored at room temperature up to 30 degrees C (86 degrees F) for up to 30 days in the original carton. Do not freeze.
Related Reading#
Subscribe to see vendor options
Free access to verified vendor scores, pricing, and suppliers.
150+ peptide profiles ยท 30+ comparisons ยท 18 research tools
Protocol updates
Get notified when we update dosing protocols or publish related comparisons.
Frequently Asked Questions About Setmelanotide (IMCIVREE)
Explore Further
Medical Disclaimer
This website is for educational and informational purposes only. The information provided is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a qualified healthcare professional before using any peptide or supplement.