Vyleesi Cost: $850-$950 per Carton vs. Addyi Pricing

What the label fixes about monthly use

Vyleesi is a single-strength product: 1.75 mg of bremelanotide in a prefilled autoinjector, injected under the skin of the abdomen or thigh [1]. The label directs as-needed use at least 45 minutes before anticipated sexual activity and says not to give more than one dose within 24 hours [1]. More than 8 doses per month is not recommended; the label notes that more frequent dosing raises the risk of focal hyperpigmentation and lengthens the time each month when blood pressure is increased [1].

How often Vyleesi is used

Vyleesi is taken as needed rather than on a daily schedule. In the two 24-week phase 3 trials, most patients used Vyleesi two to three times a month and no more than once a week [1]. The label also says the duration of effect after a dose is unknown and the best timing window has not been fully characterized [1].

Why patients stopped Vyleesi in the trials

In the pooled phase 3 trials, 18% of Vyleesi patients stopped because of adverse reactions versus 2% on placebo [1]. Nausea was reported by 40.0% of Vyleesi patients versus 1.3% on placebo; 13% received anti-nausea medicine and 8% stopped the trials because of nausea [1]. Nausea was most common after the first dose, reported by 21% of patients, and fell to about 3% after later doses [1].

How Addyi's label directs use

The Addyi label directs 100 mg by mouth once a day at bedtime; after a missed dose, the next dose is taken at bedtime the following day, not doubled [3]. Like Vyleesi's label, it says to discontinue after 8 weeks if the patient does not report improvement in HSDD symptoms [3]. Addyi's label has a boxed warning titled hypotension and syncope in certain settings. It includes an alcohol instruction (wait at least two hours after one or two standard drinks before the bedtime dose, and skip the dose after three or more) and lists moderate or strong CYP3A4 inhibitors and hepatic impairment as contraindicated [3]. Vyleesi has no boxed warning [1].

PT-141 sold as a peptide is not Vyleesi

'PT-141' products sold as compounded or research-use peptides are not Vyleesi and are not FDA-approved drugs [2][1]. Compounded drugs are not reviewed by FDA for safety, effectiveness or quality before marketing [2][1].