1 INDICATIONS AND USAGE

VYLEESI 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.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dosage of VYLEESI is 1.75 mg administered subcutaneously in the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity. The duration of efficacy after each dose is unknown and the optimal window for VYLEESI administration has not been fully characterized. Patients may decide the optimal time for VYLEESI administration based on how they experience the duration of effect on desire and any adverse reactions such as nausea [see Warnings and Precautions (5.3)].

Patients should not administer more than one dose within 24 hours. The efficacy of consecutive doses within 24 hours has not been established and administering doses close together may increase the risk of additive effects on blood pressure [see Warnings and Precautions (5.1)].

Administering more than 8 doses per month is not recommended. Few patients in the phase 3 program received more than 8 doses per month. Also, more frequent dosing increases the risk for focal hyperpigmentation and the length of time per month when blood pressure is increased [see Warnings and Precautions (5.1, 5.2)].

VYLEESI is self-administered via a prefilled autoinjector pen. Visually inspect the drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if the solution is cloudy, discolored, or visible particles are observed.

2.2 Discontinuation of VYLEESI

Discontinue VYLEESI after 8 weeks if the patient does not report an improvement in her symptoms.

3 DOSAGE FORMS AND STRENGTHS

Subcutaneous injection: 1.75 mg/0.3 mL clear solution in a single-dose autoinjector.