Vyleesi (Bremelanotide) in Adults 65 and Older: What Geriatric Patients and Their Clinicians Need to Know

Does the label cover women 65 and older?

Vyleesi is approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD): low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, relationship problems, or a medication or drug [1]. The label states that it is not indicated for HSDD in postmenopausal women or in men, and not to enhance sexual performance [1]. Because the labeled population is defined by menopausal status, age 65 by itself does not settle whether a woman falls inside it.

FDA approved a labeling supplement (S-005) on October 22, 2026 that updates Section 8 (Use in Specific Populations) and the patient information. That new text was not yet in DailyMed on October 28, 2026, so the DailyMed label effective November 13, 2025 does not reflect it [1][2].

The trials that support approval were two identical 24-week randomized, double-blind, placebo-controlled studies in 1,267 premenopausal women with a mean age of 39 and a range of 19 to 56 [1][3].

What happens to blood pressure and heart rate

Each dose transiently raises blood pressure and lowers heart rate. In clinical studies the maximal increases were 6 mmHg systolic and 3 mmHg diastolic, peaking 2 to 4 hours after the injection, with heart rate down by up to 5 beats per minute. Values usually returned to baseline within 12 hours, and no additive effect appeared with daily dosing 24 hours apart for up to 16 days [1]. Those are maximal figures, not averages. In an open-label ambulatory 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 fall of 0.5 beats per minute [1].

The label contraindicates Vyleesi in patients with uncontrolled hypertension or known cardiovascular disease. It is also not recommended for patients at high risk for cardiovascular disease, and the label says to assess cardiovascular risk and make sure blood pressure is well controlled before treatment and periodically during treatment [1].

Kidney and liver function

Bremelanotide is broken down by hydrolysis of amide bonds, with 64.8% of radioactivity recovered in urine and 22.8% in feces. Mean terminal half-life is about 2.7 hours after a 1.75 mg subcutaneous dose [1]. Exposure (AUC) is 1.5-fold higher in moderate and 2-fold higher in severe renal impairment, and 1.2-fold (mild) to 1.7-fold (moderate) higher in hepatic impairment [1].

Nausea, flushing and anti-nausea drugs

In the pooled phase 3 trials, nausea was reported by 40.0% of women on Vyleesi versus 1.3% on placebo. Thirteen percent needed an anti-nausea medicine and 8% stopped the trials because of it. Nausea was most common after the first dose (21% of patients) and fell to about 3% with later doses [1]. Flushing occurred in 20.3% versus 0.3%, injection site reactions in 13.2% versus 8.4%, and headache in 11.3% versus 1.9% [1].

A phase 4 single-dose study of 228 healthy women randomized them to 8 mg oral ondansetron or placebo 30 minutes before a 1.75 mg dose. Ondansetron did not reduce the nausea, and the label says pre-treatment with oral ondansetron is not recommended [1]. Ondansetron given after Vyleesi, or after nausea has started, has not been formally studied [1].

Focal hyperpigmentation (darkening of skin, gums or breasts, including the face) was reported by 1% of patients using up to 8 doses a month. Risk is higher in darker skin and with daily dosing, and the label says to consider stopping if it develops [1].

Oral medicines worth checking

Vyleesi may slow gastric emptying. The label says to avoid it with oral drugs that depend on threshold blood concentrations for efficacy, such as antibiotics, and to consider skipping it when a quick effect from an oral drug such as indomethacin is wanted [1]. Vyleesi may also significantly decrease the systemic exposure of oral naltrexone. The label says to avoid combining it with oral naltrexone products intended to treat alcohol or opioid addiction because of the severe consequence of naltrexone treatment failure [1]. In clinical pharmacology studies, only naltrexone and indomethacin were meaningfully affected [1].

When a patient who started earlier reaches menopause or turns 65

The indication is premenopausal HSDD, so a woman who has gone through menopause no longer matches the labeled population [1]. The label's dosing, cardiovascular, kidney or liver impairment and oral-medicine interaction information is described above.