Safety

Common adverse reactions

MOST COMMON ADVERSE REACTIONS OCCURRING IN ≥4% OF PATIENTS TREATED WITH VYLEESI IN RANDOMIZED, DOUBLE-BLIND CONTROLLED TRIALS¹

Other adverse reactions occurring in >2% of patients were cough, fatigue, hot flush, paresthesia, dizziness, and nasal congestion.

*Includes injection site pain, unspecified injection site reactions, erythema, hematoma, pruritus, hemorrhage, bruising, paresthesia, and hypoesthesia.

The majority of events were reported to be mild to moderate in intensity and transient¹

Talk to your patients about first-dose nausea

Tell her she may experience some nausea after her first dose: it may start during the first hour and last for about 2 hours
Nausea improved for most patients with the second dose, but could occur intermittently with continued use
Some patients prefer to start with their first dose on a day when they don’t have big plans, so they can see how their body responds

Nausea events were mostly mild to moderate and typically resolved without treatment. Consider prescribing an antiemetic for patients who are bothered by nausea but wish to continue with treatment.

Incidences of nausea

21%
first dose

→

3%
second dose

→

2%
third dose

Setting patient expectations

Blood pressure¹

Patients using Vyleesi experienced a transient increase in systolic blood pressure (max increase of 6 mm Hg) and diastolic blood pressure (max increase of 3 mm Hg) that peaked between 2-4 hours post dose; there was a corresponding reduction in heart rate up to 5 beats per minute
Blood pressure and heart rate returned to baseline usually within 12 hours post dose
Vyleesi is contraindicated in women who have uncontrolled hypertension or known cardiovascular disease
Before initiating Vyleesi, consider the patient’s baseline cardiovascular risk and ensure blood pressure is well controlled, and advise patients not to take more than 1 Vyleesi dose within 24 hours

Focal hyperpigmentation¹

In the clinical trials, focal hyperpigmentation of the face, gingiva, and breasts was reported in 1% of patients who received up to 8 doses per month of Vyleesi compared to no placebo-treated patients
In another clinical study, 38% of patients developed focal hyperpigmentation after receiving Vyleesi daily for 8 days; 14% developed new focal pigmentary changes after 8 additional days of treatment
Patients with dark skin were more likely to develop focal hyperpigmentation, which did not always resolve following discontinuation of Vyleesi
Consider discontinuing Vyleesi if hyperpigmentation develops, and advise patients to take no more than 8 doses per month

Drug interactions¹

Vyleesi may reduce the rate and extent of absorption of concomitantly administered oral medications, likely due to slowing gastric motility
However, with the exception of naltrexone and indomethacin, Vyleesi did not affect absorption of the tested oral medications to a clinically relevant degree
Vyleesi may significantly decrease the systemic exposure of orally-administered naltrexone; patients should avoid use with orally administered naltrexone-containing products intended to treat alcohol or opioid addiction
There were no clinically relevant drug interactions between Vyleesi and oral contraceptives or antidepressants; patients are recommended to use contraception while taking Vyleesi
There are no restrictions on alcohol consumption with Vyleesi

Dosing and Administration

INDICATION

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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

VYLEESI is contraindicated in patients who have uncontrolled hypertension or known cardiovascular disease.

WARNINGS AND PRECAUTIONS

Transient Increase in Blood Pressure and Decrease in Heart Rate: VYLEESI transiently increases blood pressure and reduces heart rate after each dose. Advise patients that these changes usually resolve within 12 hours. VYLEESI is not recommended in patients at high risk for cardiovascular disease. Consider the patient’s cardiovascular risk before initiating VYLEESI and periodically during treatment and ensure blood pressure is well-controlled. To minimize the risk of more pronounced blood pressure effects, patients should not take more than one VYLEESI dose within 24 hours. Patients should not use more than 8 VYLEESI doses per month.

Focal Hyperpigmentation: Reported by 1% of patients who received up to 8 doses per month, including involvement of the face, gingiva and breasts. Patients are at higher risk of developing focal hyperpigmentation if they have darker skin and with daily dosing. Resolution of the focal hyperpigmentation was not confirmed in all patients after discontinuation of VYLEESI. Consider discontinuing VYLEESI if hyperpigmentation develops.

Nausea: Reported by 40% of patients who received up to 8 monthly doses, requiring anti-emetic therapy in 13% of patients and leading to premature discontinuation for 8% of patients. Nausea improves for most patients with the second dose. Consider discontinuing VYLEESI or initiating anti-emetic therapy for persistent or severe nausea.

ADVERSE REACTIONS

Most common adverse reactions (incidence >4%) are nausea, flushing, injection site reactions, headache, and vomiting.

DRUG INTERACTIONS

VYLEESI may slow gastric emptying and impact absorption of concomitantly administered oral medications. VYLEESI may significantly decrease the systemic exposure of orally-administered naltrexone; avoid use with orally administered naltrexone-containing products intended to treat alcohol or opioid addiction.

PREGNANCY

Advise patients to discontinue VYLEESI if pregnancy is suspected. Advise patients to use effective contraception while taking VYLEESI.

A pregnancy exposure registry monitors pregnancy outcomes in women exposed to VYLEESI during pregnancy. Pregnant women exposed to VYLEESI and healthcare providers are encouraged to call the VYLEESI Pregnancy Exposure Registry at 1-800-922-1038.

Please see full Prescribing Information.

Reference: 1. VYLEESI [package insert]. Bridgewater, NJ: Cosette Pharmaceuticals, Inc.; 2024.

Common adverse reactions

The majority of events were reported to be mild to moderate in intensity and transient1

Talk to your patients about first-dose nausea

Incidences of nausea

Setting patient expectations

Blood pressure1

Focal hyperpigmentation1

Drug interactions1

Speak with a Rep

The majority of events were reported to be mild to moderate in intensity and transient¹

Blood pressure¹

Focal hyperpigmentation¹

Drug interactions¹