Bremelanotide (PT-141)
Bremelanotide is a melanocortin receptor agonist. A branded FDA-approved version of bremelanotide exists for a specific indication.
When prescribed through our practice, bremelanotide is compounded by a licensed 503A pharmacy pursuant to an individual patient-specific prescription.
Compounded bremelanotide is not an FDA-approved finished drug product.
Quick Reference
How Prescribing Works
Prescribing decisions are made only after a thorough clinical evaluation.
Review of medical history
Assessment of current medications
Evaluation of contraindications
Asynchronous telemedicine visit
Determination of medical necessity
Off-Label Use
Use outside of an FDA-approved indication is considered off-label and is a clinical decision made by the treating provider based on patient-specific medical factors.
Patient Monitoring
Patients receiving therapy are monitored as clinically appropriate and may require follow-up evaluation.
Regulatory Disclosure
Important information about compounded medications
Bremelanotide prescribed through this practice is compounded by a licensed 503A pharmacy pursuant to an individual prescription. Compounded medications are not reviewed or approved by the U.S. Food and Drug Administration as finished drug products.
Prescriptions are issued only after establishment of a valid patient-practitioner relationship and determination of medical necessity.
Frequently Asked Questions
What is bremelanotide (PT-141)?
Bremelanotide is a melanocortin receptor agonist. A branded version is FDA-approved for a specific indication. When prescribed through our practice, it is compounded by a licensed 503A pharmacy.
Is compounded bremelanotide FDA-approved?
No. Compounded bremelanotide is not an FDA-approved finished drug product. It is prepared by a licensed 503A pharmacy pursuant to an individual prescription.
How is bremelanotide prescribed?
Prescribing requires a review of medical history, assessment of current medications, evaluation of contraindications, an asynchronous telemedicine visit, and determination of medical necessity.
What does off-label use mean?
Off-label use means prescribing a medication for a purpose other than its FDA-approved indication. This is a clinical decision made by the treating provider based on patient-specific factors.
Is ongoing monitoring required?
Patients are monitored as clinically appropriate and may require follow-up evaluation.
How is bremelanotide dispensed?
Bremelanotide is compounded and dispensed by a licensed 503A pharmacy pursuant to an individual patient-specific prescription.
Interested in a Medical Evaluation?
All prescribing decisions are made after a thorough clinical evaluation by a licensed provider.