“'Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals & certified pharmacies,' continued Dr. Woodcock. 'Patients & prescribers should fully understand the risks associated with the use of Addyi before considering treatment.'
Addyi can cause severely low blood pressure (hypotension) and loss of consciousness (syncope). These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body. Because of the alcohol interaction, the use of alcohol is contraindicated while taking Addyi. Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi.
Addyi is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The FDA is requiring this REMS because of the increased risk of severe hypotension & syncope due to the interaction between Addyi and alcohol. The REMS requires that prescribers be certified with the REMS program by enrolling and completing training. Certified prescribers must counsel patients using a Patient-Provider Agreement Form about the increased risk of severe hypotension and syncope & about the importance of not drinking alcohol during treatment with Addyi. Additionally, pharmacies must be certified with the REMS program by enrolling & completing training. Certified pharmacies must only dispense Addyi to patients with a prescription from a certified prescriber. Additionally, pharmacists must counsel patients prior to dispensing not to drink alcohol during treatment with Addyi.
Addyi is also being approved with a (BLACK) Boxed Warning to highlight the risks of severe hypotension & syncope in patients who drink alcohol during treatment with Addyi, in those who also use moderate or strong CYP3A4 inhibitors, & in those who have liver impairment. Addyi is contraindicated in these patients. In addition, the FDA is requiring the company that owns Addyi to conduct 3 well-designed studies in women to better understand the known serious risks of the interaction between Addyi & alcohol.
Addyi is a serotonin 1A receptor agonist & a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is NOT known. Addyi is taken once daily. It is dosed at bedtime to help decrease the risk of adverse events occurring due to possible hypotension, syncope & central nervous system depression (such as sleepiness & sedation). Patients should discontinue treatment after 8 weeks if they do not report an improvement in sexual desire & associated distress."