Vyleesi Geriatric (65+) Caregiver Administration Guidance

Is Vyleesi approved for women aged 65 or older?

The label limits Vyleesi to premenopausal women with acquired, generalized HSDD and states it is not indicated for postmenopausal women or for men [1]. Approval rested on two identical phase 3 trials, RECONNECT 301 and 302, which randomized 1,267 premenopausal women; participants were aged 19 to 56, with a mean age of 39 [1][2]. Women aged 65 or older were therefore not part of the studied population.

What the label says about giving a dose

Vyleesi comes as a prefilled autoinjector pen, and the label describes it as self-administered: 1.75 mg under the skin of the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity [1]. The label specifies no more than one dose within 24 hours and does not recommend more than 8 doses per month; more frequent dosing raises the risk of focal hyperpigmentation and lengthens the time each month that blood pressure is increased [1]. How long a dose's effect lasts is unknown, and the label advises stopping after 8 weeks if symptoms have not improved [1].

Blood pressure and what the studies measured

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 dose, with heart rate down by up to 5 beats per minute; values usually returned to baseline within 12 hours [1]. In a separate open-label ambulatory study of 127 premenopausal women dosed daily for 8 days, the mean daytime increase was 1.9 mmHg systolic (95% CI 1.0 to 2.7) and 1.7 mmHg diastolic (95% CI 0.9 to 2.4) [1]. Vyleesi is contraindicated in uncontrolled hypertension and known cardiovascular disease, and the label says it is not recommended for patients at high risk of cardiovascular disease [1].