Generic drug: bremelanotide
Brand name: Vyleesi
What is Vyleesi (bremelanotide), and how does it work?
Vyleesi (bremelanotide) injection 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.
Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner.
Limitations Of Use
- Vyleesi is not indicated for the treatment of HSDD in postmenopausal women or in men.
- Vyleesi is not indicated to enhance sexual performance.
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Is Vyleesi safe to use while pregnant or breastfeeding?
- The few pregnancies in women exposed to Vyleesi in clinical trials are insufficient for determining whether there is a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes.
- There is no information on the presence of bremelanotide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
- The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for
Vyleesi and any potential adverse effects on the breastfed child from
Vyleesi or from the underlying maternal condition.