On this page
- Quick reference
- Dosage chart and four steps
- Supplies needed
- Peptide Reconstitution Simulator
- Vial and research context
- Melanotan I Human-Study Context
- 10 mg Vial and Weight-Based Calculation
- Afamelanotide Implant vs. Research Vial
- Pigmentation, UV Exposure, and Evidence Limits
- References
- Related research, protocols, and guides
Melanotan I Quick Reference (10 mg Vial)
- Vial contents
- 10 mg Melanotan I
- Final volume
- 1 mL
- Concentration
- 10 mg/mL
- One U-100 unit
- 100 mcg in 0.01 mL
Melanotan I Dosage Chart
Dosage & Reconstitution Guide
Lowest Published Subcutaneous Amount: 154.3 lb (70 kg) Worked Example
Lowest Published Subcutaneous Amount: 154.3 lb (70 kg) Worked Example
| Research Period | Amount per Administration | U-100 Units (mL) |
|---|---|---|
| 5 consecutive days per week for 2 weeks (10 administrations) | 5.6 mg at 154.3 lb (70 kg) (0.0363 mg/lb (0.08 mg/kg)) | 56 units (0.56 mL) |
Frequency: Once daily for five consecutive days, repeated for a second week, in the cited pharmacokinetic study.[2]
Research reference only: The 0.0363 mg/lb (0.08 mg/kg) amount is the low end of a published 0.0363–0.0953 mg/lb (0.08–0.21 mg/kg) study range. The 154.3 lb (70 kg) body mass is an arithmetic example, not a participant-specific instruction. A research vial is not equivalent to the study formulation or the approved implant.
Reconstitution Steps
- Clean the vial stopper and diluent stopper with alcohol; allow both to dry.
- Draw exactly 1.0 mL of bacteriostatic water with a new sterile syringe, then inject it slowly down the inside wall of the vial.
- Gently swirl or roll until dissolved. Do not shake.
- Label the vial with the compound, concentration, and reconstitution date. Refrigerate at 2–8 °C (36–46 °F) and protect from light.
Storage note: No compound-specific post-reconstitution stability or discard period has been established for this worked research-vial preparation. Follow the lot-specific product documentation for any shorter limit.
Supplies Needed
This list covers the single 154.3 lb (70 kg), 0.0363 mg/lb (0.08 mg/kg), ten-administration worked example.
- Peptide Vials (Melanotan I, 10 mg each):
- Ten 5.6 mg calculated administrations: 10 vials
- Insulin Syringes (U-100):
- Ten calculated administrations: 10 syringes
- Bacteriostatic Water (10 mL bottle):
- Ten vials at 1.0 mL each: 10 mL total
- Alcohol Swabs:
- Ten calculated administrations at 2 swabs each: 20 swabs
Sharps safety: Place used needles and syringes immediately in an approved sharps container.
Peptide Reconstitution Simulator
Practice preparing this vial with the verified strength and final volume from this protocol.
Melanotan I Vial and Research Context
- Reconstitute: Add 1.0 mL bacteriostatic water for a worked concentration of 10 mg/mL.
- Vial contents: 10 mg Melanotan I.
- U-100 conversion: 1 unit = 0.01 mL = 100 mcg.
- Storage: Refrigerate at 2–8 °C and protect from light.
The chart uses the lowest published amount, 0.0363 mg/lb (0.08 mg/kg), as a 154.3 lb (70 kg) worked example. It is not a universal dose and is not interchangeable with the later 16 mg afamelanotide implant.[2][4][7]
Melanotan I Human-Study Context
Early human research evaluated a synthetic melanotropin analog by subcutaneous injection.[1] A pharmacokinetic study used 0.0363–0.0953 mg/lb (0.08–0.21 mg/kg) subcutaneously on five consecutive days for two weeks.[2] The chart uses only the lowest 0.0363 mg/lb (0.08 mg/kg) published amount and a clearly stated 154.3 lb (70 kg) arithmetic example.
Later afamelanotide research used controlled implants rather than reconstituted injection vials.[4][5][6] Those implant studies are useful clinical context but are not formulation equivalents.
10 mg Vial and Weight-Based Calculation
- 10 mg divided by 1.0 mL equals 10 mg/mL.
- One U-100 unit equals 0.01 mL or 100 mcg.
- At 154.3 lb (70 kg), the published 0.0363 mg/lb (0.08 mg/kg) amount equals 5.6 mg. Pound equivalents are rounded for display; the calculation uses 70 kg × 0.08 mg/kg.
- 5.6 mg at 10 mg/mL equals 56 units (0.56 mL).
- Ten calculated administrations total 56 mg. Each 10 mg vial provides one complete 5.6 mg withdrawal, so ten separate-vial withdrawals require ten vials. This count does not assume pooling vial remnants.
Afamelanotide Implant vs. Research Vial
The approved SCENESSE product is a 16 mg implant with formulation-specific administration, warnings, and monitoring.[7] Trials in erythropoietic protoporphyria and vitiligo evaluated implants, not a reconstituted 10 mg vial.[4][5][9] Early afamelanotide research in erythropoietic protoporphyria also used a sustained-release implant, not a reconstituted vial.[8]
Pigmentation, UV Exposure, and Evidence Limits
Melanocortin research involving pigmentation does not eliminate ultraviolet risk, and a research vial cannot be assumed equivalent to material used in a controlled trial.[3][7] Product identity, impurities, sterility, stability, exposure, and pharmacokinetics require formulation-specific evidence.[10][11]
References
- 1Levine et al., 1991, PMID 1658407 – Randomized human study using ten subcutaneous melanotropin analog injections over 12 days.
- 2Ugwu et al., 1997, PMID 9113347 – Human pharmacokinetic and tanning study using 0.0363–0.0953 mg/lb (0.08–0.21 mg/kg) subcutaneous doses on five consecutive days for two weeks.
- 3Dorr et al., 2004, PMID 15262693 – Phase 1 studies examining an alpha-MSH analog with ultraviolet exposure.
- 4Langendonk et al., 2015, PMID 26132941 – Randomized trials of afamelanotide implants in erythropoietic protoporphyria.
- 5Lim et al., 2015, PMID 25230094 – Randomized trial of monthly afamelanotide implants with narrowband UV-B in vitiligo.
- 6Biolcati et al., 2015, PMID 25494545 – Long-term observational study of afamelanotide implants in erythropoietic protoporphyria.
- 7U.S. FDA, SCENESSE label (2024) – Official labeling for the 16 mg afamelanotide implant. The implant is not interchangeable with a 10 mg lyophilized vial.
- 8Harms et al., 2009, PMID 19656325 – Small clinical study of a sustained-release afamelanotide implant in erythropoietic protoporphyria.
- 9Langendonk et al., 2015, ClinicalTrials.gov NCT01605136 – Registry record for an afamelanotide erythropoietic protoporphyria study.
- 10U.S. FDA, Clinical Pharmacology Considerations for Peptide Drug Products – Regulatory guidance on formulation-specific evidence expected for peptide drug development.
- 11European Medicines Agency, synthetic peptide guideline – Guideline addressing identity, quality, and impurity control for synthetic peptides.