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INDICATION AND IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

WARNING:RISK OF HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS
See full prescribing information for complete boxed warning.

  • Use of ADDYI and alcohol together close in time increases this risk. 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 standard alcoholic drinks that evening.
  • Use of ADDYI is contraindicated with strong or moderate CYP3A4 inhibitors orin patients with hepatic impairment.

Contraindications

  • Moderate or strong CYP3A4 inhibitors
  • Hepatic impairment
  • Known hypersensitivity to ADDYI or any of its components. Reactions,including anaphylaxis, angioedema, pruritus, and urticaria have been reported.

Warnings and Precautions

  • Hypotension and Syncope Due to Alcohol Interaction: See BoxedWarning.
  • Hypotension and Syncope with CYP3A4 Inhibitors: See Boxed Warning and Contraindications. Concomitant use of multiple weak CYP3A4 inhibitors that may include herbal supplements (e.g., ginkgo, resveratrol) or non-prescription drugs (e.g., cimetidine) may also increase the risk.
  • Central Nervous System (CNS) Depression: The risk is increased if ADDYI is taken during waking hours; with alcohol; with other CNS depressants; or with CYP3A4 inhibitors.Patients should avoid activities requiring full alertness(e.g., driving or operating machinery) until at least 6 hours after taking ADDYI and until they know how it affects them
  • Hypotension and Syncope with ADDYI Alone: The risk is increased if ADDYI is taken during waking hours or if higher than the recommend dose is taken.
  • Syncope and Hypotension in Patients with Hepatic Impairment: See Contraindications.
  • Hypersensitivity Reactions: See Contraindications. Immediately discontinue ADDYI and initiate appropriate treatment if hypersensitivity reaction occurs.

Drug Interactions

  • Oral Contraceptives and Other Weak CYP3A4 Inhibitors: Increases flibanserin exposures and incidence of adverse reactions.
  • Strong CYP2C19 Inhibitors: Increases flibanserin exposure which may increase risk of hypotension, syncope, and CNS depression.
  • Digoxin: Increases digoxin concentrations, which may lead to digoxin toxicity. Increase monitoring of digoxin concentrations.

Most Common Adverse Reactions

  • Most common adverse reactions (≥2% and higher than placebo) are dizziness, somnolence, nausea, fatigue, insomnia, urinary tract infection, anxiety, sinusitis, constipation and dry mouth

[Digital Version: Please see accompanying full Prescribing Information including BOXED WARNING at ADDYI.com/PI]

INDICATION

ADDYI is indicated for the treatment of women<65 years of age with acquired, generalized hypoactive sexual desire disorder (HSDD),characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to: aco-existing medical or psychiatric condition; problems within the relationship; or the effects of a medication or other drug substance.

Limitations of Use:ADDYI is not for use in men or to enhance sexual performance.