Vyleesi (Bremelanotide) Safety for Young Adults Ages 18 to 29

Is Vyleesi approved for women in their 20s?

Yes, provided the woman is premenopausal and meets the diagnosis. The label covers premenopausal women with acquired, generalized hypoactive sexual desire disorder — low desire that causes marked distress or interpersonal difficulty and is not explained by another medical or psychiatric condition, relationship problems, or a medication or drug [1]. Acquired means it developed in a woman who previously had no problem with desire; generalized means it occurs regardless of stimulation, situation or partner [1].

The label is explicit about who is outside it: Vyleesi is not indicated for HSDD in postmenopausal women or in men, and not to enhance sexual performance [1]. Bremelanotide was approved as Vyleesi on June 21, 2019 (NDA 210557) and is a 1.75 mg subcutaneous injection from a prefilled autoinjector, prescription only [1][2].

The dose is 1.75 mg injected into the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity, with no more than one dose in 24 hours; more than 8 doses per month is not recommended [1]. The label says to stop after 8 weeks if there has been no improvement in symptoms, and that how long a single dose works is unknown [1]. There is no boxed warning and no REMS program [1][2].

How much of the safety data comes from women aged 18 to 29?

Less than the age-based question implies. The two 24-week placebo-controlled trials randomized 1,267 women; 1,247 were included in the safety analysis, which had an age range of 19 to 56 and a mean age of 39; 86% were White and 12% Black [1][3]. The label gives the age range and the mean age but no results by age group, and an age range starting at 19 means 18-year-olds were not in the safety analysis [1]. A 22-year-old's safety profile therefore rests on the full premenopausal group rather than on data from her age band.

Efficacy followed the same pattern. Bremelanotide improved the FSFI desire domain score over placebo by 0.30 points in study 301 and 0.42 points in study 302, an integrated difference of 0.35 points (all P<0.001), and lowered desire-related distress by 0.37, 0.29 and 0.33 points across the two studies and the integrated analysis (P<0.001, P=0.005 and P<0.001) [3]. Neither trial found a significant difference in the number of satisfying sexual events [3].

Nausea

Nausea was reported by 40.0% of women on Vyleesi versus 1.3% on placebo in the pooled trials [1]. It was highest after the first dose, reported by 21% of patients, then fell to about 3% with later doses; median onset was within one hour and it lasted about two hours [1]. Thirteen percent of treated women used an anti-nausea medicine and 8% stopped the trials because of nausea [1].

In a single-dose study, 8 mg of oral ondansetron taken 30 minutes before a 1.75 mg Vyleesi dose did not reduce nausea; the label does not recommend that pre-treatment [1]. The study randomized 228 healthy women to ondansetron or placebo 30 minutes before the dose and found no significant difference in nausea between groups [1]. Overall, 18% of women on Vyleesi stopped the trials for adverse reactions versus 2% on placebo; the leading reasons were nausea (8%), headache (2%), vomiting (1%), flushing (1%) and injection site reactions (1%) [1].

Blood pressure and heart rate

Each dose produces a transient rise in blood pressure and a small drop in heart rate. In clinical studies the maximal increases were 6 mmHg systolic and 3 mmHg diastolic, peaking 2 to 4 hours after the dose, with heart rate down up to 5 beats per minute; values usually returned to baseline within 12 hours [1]. Those are maximal, not average, figures. In an open-label ambulatory monitoring study of 127 premenopausal women dosed once daily for 8 days, mean daytime blood pressure rose 1.9 mmHg systolic (95% CI 1.0 to 2.7) and 1.7 mmHg diastolic (95% CI 0.9 to 2.4), with a mean heart rate decrease of 0.5 beats per minute [1].

Vyleesi is contraindicated in uncontrolled hypertension or known cardiovascular disease, and the label says it is not recommended in patients at high risk of cardiovascular disease; it also says to weigh cardiovascular risk and confirm blood pressure is well controlled before starting and periodically during treatment [1].

Pregnancy, contraception and breastfeeding

The label advises women of reproductive potential to use effective contraception while taking Vyleesi and to discontinue it if pregnancy is suspected [1]. In dogs, daily bremelanotide during organogenesis at exposures at least 16 times the maximum recommended human dose by AUC produced fetal harm, and the lowest dose associated with fetal harm has not been identified [1]. FDA approved a labeling supplement (S-005) on October 22, 2026 that revises Section 8, Use in Specific Populations, and the patient information; that text was not yet in DailyMed on October 28, 2026, so this section describes the label version effective November 13, 2025 [1][5].

Human data are thin but are spelled out in the label: seven pregnancies occurred across the clinical trials of more than 1,057 patients treated for up to 12 months, with no major congenital anomalies reported, one miscarriage, five full-term live births and one unknown outcome [1]. The label states that it is not known whether bremelanotide or its metabolites appear in human milk, or what the effects would be on a breastfed infant or on milk production [1].

Interactions

Vyleesi may slow stomach emptying and reduce the rate and extent of absorption of oral medicines. The label says to avoid it with oral drugs that depend on threshold blood concentrations, such as antibiotics, and says patients should consider discontinuing Vyleesi if an oral medicine's effect is delayed when a quick onset is desired, with indomethacin for pain relief as its example [1]. In clinical pharmacology studies, only naltrexone and indomethacin were meaningfully affected [1].

Oral naltrexone used for alcohol or opioid addiction has a specific avoidance warning. Because Vyleesi may significantly lower exposure to oral naltrexone, the label says to avoid using it with an oral naltrexone-containing product intended to treat alcohol or opioid addiction, given the consequences of naltrexone treatment failure [1].

Oral contraceptives are not named in the label's interactions section [1]. Its contraception instruction is the one in the pregnancy section: use effective contraception while taking Vyleesi [1].

In a study using a 20 mg intranasal dose of bremelanotide, alcohol at 0.6 g/kg did not change bremelanotide blood levels. That study did not use the Vyleesi injection; the 20 mg intranasal dose gives a mean peak blood concentration (Cmax) about 2.5-fold that of Vyleesi [1]. Flushing and headache rates with the combination were similar to the higher of the two single-agent rates [1].

Skin darkening

Focal hyperpigmentation — darkening of the face, gums or breasts — was reported by 1% of women given up to 8 doses a month in the placebo-controlled trials, versus none on placebo [1]. The label says more frequent dosing raises the risk: in another study, 38% of patients developed focal hyperpigmentation after daily dosing for 8 days, and a further 14% developed new pigmentary changes after 8 more consecutive days [1]. Patients with dark skin were more likely to develop it, resolution was not confirmed in all patients after stopping, and the label says to consider discontinuing Vyleesi if hyperpigmentation develops [1].

Compounded PT-141 is not Vyleesi

Bremelanotide sold as PT-141 in compounded or research-use form is not the FDA-approved product, and compounded drugs are not reviewed by FDA for safety, effectiveness or quality before marketing [4][1].