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Vyleesi Generic Name & Formulations
Legal Class
Rx
General Description
Bremelanotide acetate 1.75mg/0.3mL; soln for SC inj.
Pharmacological Class
Melanocortin receptor agonist.
How Supplied
Single-dose prefilled autoinjectors—4
Manufacturer
Generic Availability
NO
Vyleesi Indications
Indications
Acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women and is not due to a coexisting medical or psychiatric condition, problems within the relationship, or adverse effect of a medication or other drug substance.
Limitations of Use
Not for HSDD in postmenopausal women or in men. Not for sexual performance enhancement.
Vyleesi Dosage and Administration
Adult
Give by SC inj in abdomen or thigh as needed, at least 45mins before sexual activity. 1.75mg as a single daily dose. Max 1 dose per 24hrs or 8 doses per month. Discontinue if no improvement after 8 weeks.
Children
Not established.
Vyleesi Contraindications
Contraindications
Uncontrolled hypertension. Known cardiovascular disease.
Vyleesi Boxed Warnings
Not Applicable
Vyleesi Warnings/Precautions
Warnings/Precautions
Consider patient’s cardiovascular risk before initiating and periodically during treatment, and ensure BP is well-controlled. High risk for cardiovascular disease: not recommended. Consider discontinuing if hyperpigmentation develops. Severe hepatic or renal impairment. Pregnancy: not recommended; discontinue if suspected. Nursing mothers.
Vyleesi Pharmacokinetics
See Literature
Vyleesi Interactions
Interactions
Avoid concomitant oral drugs that depend on threshold concentrations for efficacy (eg, antibiotics). Consider discontinuing if there is a delayed effect of concomitant oral drug when a quick onset is desired (eg, indomethacin). Avoid use with oral naltrexone-containing products intended to treat alcohol or opioid addiction.
Vyleesi Adverse Reactions
Adverse Reactions
Nausea, flushing, inj site reactions, headache, vomiting, cough, fatigue, hot flush, paraesthesia, dizziness, nasal congestion; focal hyperpigmentation (esp. with dark skin), transient increases in BP and reduction in HR.
Vyleesi Clinical Trials
See Literature
Vyleesi Note
Not Applicable
Vyleesi Patient Counseling
See Literature
