Maximum Dosage of Bremelanotide (Vyleesi)
The maximum number of doses of bremelanotide (Vyleesi) that can be used per month is 8 doses, as specified in the FDA-approved drug labeling. 1
Dosing Guidelines
Bremelanotide is administered as a subcutaneous injection for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. The FDA-approved labeling provides clear guidance on the maximum frequency of administration:
- No more than 1 dose should be taken within 24 hours 1
- Maximum of 8 doses per month 1
- Injection should be administered approximately 45 minutes before anticipated sexual activity 2
Rationale for Dosing Limitations
The dosing limitations are based on several important safety considerations:
1. Cardiovascular Effects
Bremelanotide transiently increases blood pressure and reduces heart rate after each dose:
- Maximal increases of 6 mmHg in systolic blood pressure
- Maximal increases of 3 mmHg in diastolic blood pressure
- Reduction in heart rate up to 5 beats per minute 1
Taking doses too close together (less than 24 hours apart) or exceeding the monthly limit could lead to more pronounced cardiovascular effects.
2. Hyperpigmentation Risk
Focal hyperpigmentation is a documented side effect that increases with more frequent dosing:
- In phase 3 trials, 1% of patients who received up to 8 doses per month developed focal hyperpigmentation
- When used daily for 8 consecutive days, 38% of patients developed focal hyperpigmentation
- With continued daily use for 8 more days, an additional 14% developed new pigmentary changes 1
3. Other Common Side Effects
The most common adverse effects include:
- Nausea (40% of patients)
- Facial flushing (20.4%)
- Headache (11%) 2
Clinical Efficacy Considerations
Clinical trials evaluated bremelanotide with the recommended dosing schedule:
- Patients should discontinue use after 8 weeks if no benefit is observed 2
- The medication is administered as needed, not on a regular schedule
- Efficacy was demonstrated across various patient subgroups when used according to the approved dosing guidelines 3
Important Patient Counseling Points
When prescribing bremelanotide, patients should be advised:
- To not take more than one dose in 24 hours
- To not exceed 8 doses per month
- That taking the medication more frequently or too close together may lead to more pronounced increases in blood pressure 1
- To discontinue use and contact their healthcare provider if hyperpigmentation develops 1
Following these dosing guidelines helps maximize the benefit of bremelanotide while minimizing the risk of adverse effects.