Risks of Vyleesi (Bremelanotide) in Postmenopausal Women
Vyleesi (bremelanotide) should not be used in postmenopausal women due to lack of safety data and potential cardiovascular risks that may be particularly concerning in this population.
Key Risks and Concerns
Bremelanotide is FDA-approved only for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). Its use in postmenopausal women presents several specific concerns:
Cardiovascular Risks
- Bremelanotide causes transient but statistically significant increases in blood pressure 1
- Postmenopausal women already have increased cardiovascular risk due to estrogen decline
- The American Heart Association specifically cautions against hormone therapies that may increase cardiovascular risk in postmenopausal women 2
Bone Health Concerns
- Postmenopausal women are at increased risk for osteoporosis and bone loss
- The effects of bremelanotide on bone health in postmenopausal women have not been studied
- This population often requires careful management of bone health with calcium, vitamin D, and sometimes bisphosphonates 2
Other Documented Adverse Effects
- Nausea (40% of users) - most common reason for discontinuation
- Flushing (20.3%)
- Headache (11.3%)
- Injection site reactions (5.4%)
- Focal hyperpigmentation (rare with recommended dosing but common with consecutive daily dosing) 1
Clinical Considerations
Drug Interactions
- Potential interactions with medications commonly used by postmenopausal women:
- Indomethacin and naltrexone (reduced plasma concentrations when used with bremelanotide) 1
- Potential interactions with antihypertensives (given bremelanotide's effect on blood pressure)
- Unknown interactions with hormone replacement therapy
Alternative Approaches
For postmenopausal women with HSDD:
- Transdermal testosterone has shown efficacy for HSDD in postmenopausal women 3
- Menopause hormone therapy (systemic and local) is considered the mainstay for individualized management of sexual dysfunction in midlife women 3
Monitoring Requirements
If bremelanotide were to be used (which is not recommended):
- Blood pressure should be well-controlled and regularly monitored during treatment 1
- Careful assessment for cardiovascular risk factors
- Monitoring for nausea and other common side effects
Conclusion
The safety profile of bremelanotide has only been established in premenopausal women 1, 4, 5, 6. The clinical trials specifically excluded postmenopausal women, and the FDA approval is limited to premenopausal women with acquired, generalized HSDD. Given the known cardiovascular effects and the increased baseline cardiovascular risk in postmenopausal women, along with the availability of alternative treatments specifically studied in this population, bremelanotide should be avoided in postmenopausal women.