Vyleesi (bremelanotide injection; AMAG Pharmaceuticals) is now commercially available through specialty pharmacies, Avella and BioPlus.
Vyleesi, a melanocortin receptor agonist, was initially approved in June 2019. It is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to: a co-existing medical or psychiatric condition; problems with the relationship; or the effects of a medication or drug substance.
The recommended dosage of Vyleesi is 1.75mg administered subcutaneously in the abdomen or thigh by the patient via a prefilled single-dose autoinjector pen as needed, at least 45 minutes prior to anticipated sexual activity; the duration of efficacy after each dose is unknown. Patients should not exceed more than 1 dose within 24 hours and no more than 8 doses per month. Treatment should be discontinued if no improvement in sexual desire and associated distress is noted after 8 weeks.
Vyleesi is contraindicated in patients with uncontrolled hypertension or known cardiovascular disease as it may increase blood pressure (BP) and reduce heart rate after each dose.
Regarding safety, the most common adverse reactions are nausea, flushing, injection site reactions, headache, and vomiting.
The Company is currently offering a copay assistance program that allows eligible patients to obtain their first 4-pack of Vyleesi for $0 and subsequent refills for no more than $99.
Vyleesi is supplied as a single-dose, disposable prefilled autoinjector in a carton of 4 autoinjectors.
For more information visit vyleesi.com.