Afamelanotide: Dosing Protocols
Dosing guidelines, reconstitution, and administration information
๐TL;DR
- โข1 dosing protocols documented
- โขReconstitution instructions included
- โขStorage: Store refrigerated at 2-8 degrees C (36-46 degrees F). Protect from light. Store in the original carton until use. Do not freeze.
Protocol Quick-Reference
Erythropoietic protoporphyria (EPP) photoprotection
Dosing
Amount
16 mg implant
Frequency
Every 2 months
Duration
Seasonal (spring through fall)
Administration
Route
SCTiming
Administered by certified healthcare provider as a bioresorbable implant above the anterior supra-iliac crest. Typically 5-6 implants per year.
Cycle
Duration
Seasonal treatment (approximately 5-6 months)
Repeatable
Yes
โ๏ธ Suggested Bloodwork (3 tests)
Full-body skin examination
When: Before each implant
Why: Check for suspicious melanocytic lesions
CBC with differential
When: Baseline
Why: Baseline blood cell counts
Liver function tests
When: Baseline
Why: Baseline hepatic function assessment
๐ก Key Considerations
- โFDA-approved prescription medication: must be administered by certified healthcare providers through the Scenesse REMS Program
- โCauses skin darkening (tanning) as an expected pharmacological effect
- โDoes not provide protection against UV damage; sunscreen should still be used
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| Purpose | Dose | Frequency | Duration | Notes |
|---|---|---|---|---|
| EPP Photoprotection (FDA-Approved) | 16 mg subcutaneous implant administered by a healthcare provider every 2 months before and during periods of sun exposure. | Every 2 months (approximately 5-6 implants per year) | Seasonal treatment before and during periods of expected sun exposure. Typically administered from spring through fall. | Must be administered by a certified healthcare provider. The implant is placed subcutaneously above the anterior supra-iliac crest using a provided applicator device. |
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๐Reconstitution Instructions
Not applicable. Afamelanotide is supplied as a pre-formed bioresorbable subcutaneous implant containing 16 mg of afamelanotide in a PLGA matrix. No reconstitution, mixing, or preparation is required beyond removing the implant from its packaging.
Recommended Injection Sites
- โSubcutaneous tissue above the anterior supra-iliac crest (above the hip bone). The implant is placed using a catheter-based applicator provided with the drug. Only this anatomical site is approved.
๐งStorage Requirements
Store refrigerated at 2-8 degrees C (36-46 degrees F). Protect from light. Store in the original carton until use. Do not freeze.
Community Dosing Protocols
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Before You Begin
Review safety warnings and contraindications before starting any protocol.
Important Information#
Afamelanotide (Scenesse) is an FDA-approved prescription medication administered exclusively by certified healthcare providers. It is not a self-administered injection. The drug must be dispensed through the Scenesse REMS Program.
Approved Dosing#
Adults with EPP#
- Dose: One 16 mg subcutaneous implant
- Frequency: Every 2 months (60 days) before and during periods of expected sun exposure
- Typical schedule: 5-6 implants per year, administered from spring through fall in temperate climates
- Administration: By a certified healthcare provider using the provided applicator device
Implant Placement Procedure#
The implant is placed subcutaneously in the following steps:
- Clean the area above the anterior supra-iliac crest
- Apply local anesthesia if needed
- Insert the implant using the catheter-based applicator through a small puncture
- The implant is bioresorbable and does not require removal
- The procedure takes approximately 5-10 minutes
Pre-Treatment Requirements#
Before each implant:
- Full-body skin examination: Check for suspicious melanocytic lesions
- Dermatologic assessment: Document baseline skin color and any existing nevi
- Patient counseling: Remind that afamelanotide does not provide protection against UV damage and sunscreen should still be used
Treatment Schedule#
| Month | Activity |
|---|---|
| March-April | First implant of the season |
| May-June | Second implant |
| July-August | Third implant |
| September-October | Fourth implant |
| November-December | Fifth implant (if needed based on geography) |
The exact timing should be individualized based on geographic location, climate, and the patient's sun exposure patterns.
REMS Program#
In the United States, Scenesse is available only through a restricted distribution program called the Scenesse REMS Program. Healthcare providers must be certified and enrolled in the program before prescribing or administering the drug.
Dosing Context#
Afamelanotide belongs to the Skin category of research peptides. Dosing protocols for Afamelanotide 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 Afamelanotide:
EPP Photoprotection (FDA-Approved)#
Dose: 16 mg subcutaneous implant administered by a healthcare provider every 2 months before and during periods of sun exposure.
Frequency: Every 2 months (approximately 5-6 implants per year)
Duration: Seasonal treatment before and during periods of expected sun exposure. Typically administered from spring through fall.
Must be administered by a certified healthcare provider. The implant is placed subcutaneously above the anterior supra-iliac crest using a provided applicator device.
Reconstitution and Preparation#
Not applicable. Afamelanotide is supplied as a pre-formed bioresorbable subcutaneous implant containing 16 mg of afamelanotide in a PLGA matrix. No reconstitution, mixing, or preparation is required beyond removing the implant from its packaging.
Injection Sites#
Recommended injection sites for Afamelanotide include:
- Subcutaneous tissue above the anterior supra-iliac crest (above the hip bone). The implant is placed using a catheter-based applicator provided with the drug. Only this anatomical site is approved.
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. Store in the original carton until use. Do not freeze.
Related Reading#
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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.