### MT2MED (melanotan 2) for Injection
**HIGHLIGHTS OF PRESCRIBING INFORMATION**
These highlights do not include all the information needed to use MT2MED safely and effectively. See full prescribing information for MT2MED.
MT2MED injection, for subcutaneous use
**INDICATIONS AND USAGE**
MT2MED is a peptide indicated for investigational use in stimulating melanin production for tanning, suppressing appetite, and boosting libido in performance enhancement settings. Not approved for human therapeutic use in many jurisdictions; consult local regulations (1).
**DOSAGE AND ADMINISTRATION**
– Reconstitute lyophilized powder with bacteriostatic water.
– Adult males: 0.5 mg to 1 mg per day (loading phase), then maintenance.
– Adult females: 0.3 mg to 0.7 mg per day (loading phase), then maintenance (2.1).
– Cycle duration: Loading phase 1-2 weeks, maintenance as needed.
**DOSAGE FORMS AND STRENGTHS**
Lyophilized powder: 10 mg per vial (3).
**CONTRAINDICATIONS**
– Hypersensitivity to melanotan 2 or any component of the formulation (4).
**WARNINGS AND PRECAUTIONS**
– Nausea: Common side effect; monitor patient comfort (5.1).
– Injection site reactions: Monitor for irritation or swelling (5.2).
– Skin pigmentation: May cause uneven tanning; monitor skin changes (5.3).
**ADVERSE REACTIONS**
Common adverse reactions include nausea, flushing, and injection site reactions (6).
**DRUG INTERACTIONS**
– Limited known interactions; monitor with other peptides (7.1).
**USE IN SPECIFIC POPULATIONS**
– Pregnancy: Insufficient data; avoid use (8.1).
– Lactation: Excretion unknown; not recommended (8.2).
– Pediatric use: Safety not established (8.4).
– Geriatric use: Monitor for organ dysfunction (8.5).
Revised: 08/2025
**FULL PRESCRIBING INFORMATION**
**1 INDICATIONS AND USAGE**
MT2MED is indicated for investigational use in adults to induce skin tanning with minimal sun exposure, reduce appetite for weight loss, increase libido and sexual function, protect against UV damage, and improve mood and energy. It is commonly used for aesthetic enhancement and performance settings. This product is not approved for clinical use and should be administered under medical supervision.
**2 DOSAGE AND ADMINISTRATION**
**2.1 Recommended Dosage**
Reconstitute 10 mg vial with 1-2 mL bacteriostatic water. Administer subcutaneously, preferably in the abdomen or thigh.
– Males: 0.5 mg to 1 mg daily during loading phase (1-2 weeks), then 0.25-0.5 mg weekly for maintenance.
– Females: 0.3 mg to 0.7 mg daily during loading phase, then 0.1-0.3 mg weekly for maintenance.
– Cycle duration: Loading phase 1-2 weeks, maintenance as needed for tanning or other effects. Discontinue if adverse effects occur.
**2.2 Preparation and Handling**
Use sterile technique to reconstitute and draw doses. Inspect reconstituted solution for clarity; do not use if discolored or particulate matter is present.
**3 DOSAGE FORMS AND STRENGTHS**
Supplied as lyophilized powder containing 10 mg melanotan 2 per single-use vial.
**4 CONTRAINDICATIONS**
MT2MED is contraindicated in:
– Patients with known hypersensitivity to melanotan 2 or excipients (e.g., mannitol).
**5 WARNINGS AND PRECAUTIONS**
**5.1 Nausea**
Nausea is a common side effect, particularly during the loading phase. Monitor patient comfort and reduce dose if nausea is severe.
**5.2 Injection Site Reactions**
May cause localized pain, redness, or swelling at the injection site. Rotate injection sites and monitor for signs of infection or severe reactions.
**5.3 Skin Pigmentation**
May cause uneven tanning or hyperpigmentation, particularly in areas with existing moles or freckles. Monitor skin changes and discontinue if unwanted pigmentation occurs.
**6 ADVERSE REACTIONS**
Reported adverse reactions include:
– Gastrointestinal: Nausea, vomiting, abdominal discomfort.
– General: Flushing, warmth sensation.
– Local: Injection site pain, erythema, or swelling.
– Dermatologic: Uneven tanning, hyperpigmentation.
Serious reactions may include hypersensitivity responses.
**7 DRUG INTERACTIONS**
**7.1 Other Peptides**
Concurrent use with other melanocortin peptides may alter effects. Monitor for unexpected interactions and adjust therapy as needed.
**8 USE IN SPECIFIC POPULATIONS**
**8.1 Pregnancy**
No adequate studies in pregnant women; potential risks to the fetus are unknown. Avoid use during pregnancy.
**8.2 Lactation**
Excretion in breast milk is unknown; breastfeeding is not recommended due to potential risks to the infant.
**8.4 Pediatric Use**
Safety and efficacy not established in pediatric patients; use is not recommended.
**8.5 Geriatric Use**
Limited data available; monitor for age-related organ dysfunction, particularly skin or cardiovascular issues.
**9 DRUG ABUSE AND DEPENDENCE**
No evidence of abuse or dependence potential with melanotan 2, but misuse for aesthetic purposes may occur. Monitor for inappropriate use.
**10 OVERDOSAGE**
Symptoms of overdose may include severe nausea, flushing, or hyperpigmentation. Treat symptomatically and discontinue use immediately.
**11 DESCRIPTION**
MT2MED contains melanotan 2, a synthetic peptide that stimulates melanin production and other melanocortin effects. It is supplied as a white lyophilized powder, soluble in bacteriostatic water for injection. Each vial contains 10 mg melanotan 2, with mannitol as a stabilizer. Half-life: Approximately 33 hours. Note: Ethyl oleate and ricinus oil are not used in this formulation, as it is water-based.
**12 CLINICAL PHARMACOLOGY**
**12.1 Mechanism of Action**
Melanotan 2 stimulates melanocortin receptors, increasing melanin production, suppressing appetite, and enhancing libido.
**12.3 Pharmacokinetics**
Absorbed after subcutaneous injection; half-life approximately 33 hours; metabolized and excreted primarily via urine.
**13 NONCLINICAL TOXICOLOGY**
Limited data available; animal studies suggest low toxicity. No human carcinogenicity data available.
**16 HOW SUPPLIED/STORAGE AND HANDLING**
10 mg lyophilized powder in single-use vials. Store refrigerated at 2°-8°C (36°-46°F). Reconstituted solution stable for up to 14 days refrigerated. Protect from light. Keep out of reach of children.
*Manufactured by: Medi Pharma*
