PT-141 (Bremelanotide) Autoimmune Disease Considerations

Does bremelanotide carry an autoimmune-specific warning?

No. The label's contraindications are uncontrolled hypertension and known cardiovascular disease [1]. Its warnings cover a transient blood pressure rise with a heart rate fall, focal hyperpigmentation, and nausea [1]. Autoimmune disease is not named in either section, and the drug interactions section names neither methotrexate, biologics nor corticosteroids [1].

The approved use excludes desire caused by illness or medication

Vyleesi is approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder, meaning low desire causing marked distress that is not due to a co-existing medical or psychiatric condition, relationship problems, or a medication or drug [1]. Low desire that is due to a co-existing medical condition is therefore outside the labeled indication. The label also says the drug is not indicated for men, for postmenopausal women, or to enhance sexual performance [1].

Blood pressure and heart rate

Vyleesi is contraindicated in uncontrolled hypertension or known cardiovascular disease, is not recommended for patients at high risk for cardiovascular disease, and the label says to consider cardiovascular risk before starting and periodically during treatment [1]. Maximal increases of 6 mmHg systolic and 3 mmHg diastolic peak 2 to 4 hours after a dose, with a heart rate reduction of up to 5 beats per minute; values usually return to baseline within 12 hours [1]. 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) [1]. No additive effect appeared with daily dosing 24 hours apart for up to 16 days [1].

Oral medicines and naltrexone

The label says Vyleesi may slow gastric emptying and reduce absorption of oral medicines. It says to avoid Vyleesi with oral drugs that depend on threshold blood concentrations, such as antibiotics, and to consider skipping it when a quick effect from an oral medicine such as indomethacin is wanted [1]. In clinical pharmacology studies only naltrexone and indomethacin were meaningfully affected [1]. The label says to avoid Vyleesi with oral naltrexone-containing products intended to treat alcohol or opioid addiction, because of the severe consequence of naltrexone treatment failure [1].

Is the PT-141 sold online the same product?

Vyleesi is the FDA-approved bremelanotide product [1]. PT-141 sold as a compounded or research-use peptide is not Vyleesi and is not an FDA-approved drug; compounded drugs are not reviewed by FDA for safety, effectiveness or quality before marketing [1][3].