Hypotension and Syncope in Certain Settings, Interaction with Alcohol

Interaction with Alcohol

• The use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope [see WARNINGS AND PRECAUTIONS (5.1)]. Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more alcoholic drinks that evening.

Contraindicated with Strong or Moderate CYP3A4 Inhibitors

• The concomitant use of ADDYI and moderate or strong CYP3A4 inhibitors increase s flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.3)]. Therefore, the use of moderate or strong CYP3A4 inhibitors is contraindicated in patients taking ADDYI [see Contraindications (4)].

Contraindicated in Patients with Hepatic Impairment

• The use of ADDYI in patients with hepatic impairment increases flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.6)]. Therefore, ADDYI is contraindicated in patients with hepatic impairment [see Contraindications (4)].

Hypersensitivity Reactions

• Hypersensitivity reactions, including anaphylaxis, reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth), pruritus, and urticaria have been reported with ADDYI. ADDYI is contraindicated in women with known hypersensitivity to ADDYI or any of its components.
• Immediately discontinue ADDYI and initiate appropriate treatment if a hypersensitivity reaction occurs.