HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useVYLEESI™ safely and effectively. See full prescribing information forVYLEESI
VYLEESI(bremelanotide injection)for subcutaneous use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
VYLEESI is a melanocortin receptor agonist indicated for the treatment ofpremenopausal women with acquired, generalized hypoactive sexual desiredisorder (HSDD) as characterized by low sexual desire that causes markeddistress 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 (1).
Limitations of Use (1):
• Not indicated for treatment of HSDD in postmenopausal women or in men.
• Not indicated to enhance sexual performance.
DOSAGE AND ADMINISTRATION
• Inject 1.75 mg subcutaneously via the autoinjector to the abdomen or thigh,as needed, at least 45 minutes before anticipated sexual activity. (2.1)
• Do not administer more than one dose within 24 hours. (2.1)
• More than 8 doses per month is not recommended. (2.1)
DOSAGE FORMS AND STRENGTHS
Subcutaneous injection: 1.75 mg/0.3 mL solution. (3)
CONTRAINDICATIONS
Uncontrolled hypertension or known cardiovascular disease. (4)
WARNINGS AND PRECAUTIONS
• Transient increase in blood pressure and decrease in heart rate: Occurs aftereach dose and usually resolves within 12 hours. Consider the patient’scardiovascular risk before initiating VYLEESI and periodically during treatment and ensure blood pressure is well-controlled. VYLEESI is notrecommended in patients at high risk for cardiovascular disease. (5.1)
• Focal hyperpigmentation: Reported by 1% of patients who received up to 8doses per month, including involvement of the face, gingiva and breasts.
Higher risk in patients with darker skin and with daily dosing. Resolutionwas not confirmed in some patients. Consider discontinuing VYLEESI ifhyperpigmentation develops. (5.2)
• Nausea: Reported by 40% of patients who received up to 8 monthly doses,requiring anti-emetic therapy in 13% of patients and leading to prematurediscontinuation for 8% of patients. Improved for most patients with thesecond dose. Consider discontinuing VYLEESI or initiating anti-emetictherapy for persistent or severe nausea. (5.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 4%) are nausea, flushing,injection site reactions, headache, and vomiting. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AMAGPharmaceuticals at 1-877-411-2510 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch
DRUG INTERACTIONS
• VYLEESI may slow gastric emptying and impact absorption ofconcomitantly administered oral medications. (7.1)
• VYLEESI may significantly decrease the systemic exposure of orallyadministerednaltrexone; avoid use with orally administered naltrexonecontainingproducts intended to treat alcohol or opioid addiction. (7.2)
USE IN SPECIFIC POPULATIONS
• Pregnancy: Advise patients to discontinue VYLEESI if pregnancy issuspected. (8.1)
• Females of Reproductive Potential: Advise patients to use effectivecontraception while taking VYLEESI. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and FDAapprovedpatient labeling
Revised: 6/2019
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