Premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) that is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to a concurrent medical or psychiatric condition, relationship problems, or the effects of a medication or drug substance.
Stimulates various melanocortin receptors, with the most notable being MC4R (present in the CNS) and MC41 (present on melanocytes). The precise mechanism by which this receptor activation improves HSDD is unknown.
PO (Adults): 1.75 mg given on an as-needed basis ≥45 min before anticipated sexual activity (not to exceed one dose/24 hr or 8 doses/mo). Discontinue after 8 wk if no improvement in symptoms.
Assess sexual desire prior to and periodically during therapy.
Assess cardiovascular risk and control of BP periodically during therapy. SBP ↑ 6 mm Hg, DBP ↑ 3 mm Hg, and HR ↓ up to 5 bpm transiently after dose; usually return to normal within 12 hr of dose.
Assess for focal hyperpigmentation of face, gingiva, and breasts periodically during therapy. More common in patients with dark skin or with >8 doses/mo. Consider discontinuation of therapy if hyperpigmentation occurs; may not resolve with discontinuation.
Assess for nausea during therapy; may require antiemetics. Usually improves with 2nd dose; may require discontinuation.
Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Instruct patient to take medication as directed with no more than 1 dose/24 hr or no more than 8 doses/mo. Educate patient on proper self-injection administration.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Inform patient that ↑ in BP and ↓ in HR may occur after each dose; usually resolve within 12 hr.
Inform patient that darkening of the skin of the face, gums, and breasts may occur, especially in patients with darker skin. Risks ↑ with daily use. Advise patient that changes may not resolve after stopping the medication. Contact health care professional for concerns about skin changes.
Inform patient that nausea may occur, especially after first dose, lasting ≥2 hr. May require antiemetics. Advise patient to notify health care professional if nausea is problematic.
Rep: Advise women of reproductive potential to use effective contraception during therapy and to notify health care professional if pregnancy is planned or expected or if breastfeeding. Discontinue bremelanotide if pregnancy is suspected. Encourage pregnant patients exposed to bremelanotide to call the VYLEESI Pregnancy Exposure Registry at 1-877-411-2510.