HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ADDYI safely and effectively. See full prescribing information for ADDYI. ADDYI (flibanserin) tablets, for oral use Initial U.S. Approval: 2015 WARNING: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS See full prescribing information for complete boxed warning.  Use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope. 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. (4, 5.1)  Severe hypotension and syncope can occur when ADDYI is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment; therefore, ADDYI use in these settings is contraindicated. (4, 5.2, 5.5) ----------------------------RECENT MAJOR CHANGES-------------------------- Contraindications, Hypersensitivity Reactions (4) 09/2021 Warnings and Precautions, Hypersensitivity Reactions (5.6) 09/2021 ----------------------------INDICATIONS AND USAGE--------------------------- ADDYI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:  A co-existing medical or psychiatric condition,  Problems within the relationship, or  The effects of a medication or other drug substance. (1) Limitations of Use:  ADDYI is not indicated for the treatment of HSDD in postmenopausal women or in men. (1)  ADDYI is not indicated to enhance sexual performance. (1) ----------------------DOSAGE AND ADMINISTRATION-----------------------  Recommended dosage is 100 mg taken once daily at bedtime (2.1)  ADDYI is dosed at bedtime because administration during waking hours increases risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression (2.1)  Discontinue treatment after 8 weeks if no improvement (2.3) ---------------------DOSAGE FORMS AND STRENGTHS---------------------- Tablets: 100 mg (3) -------------------------------CONTRAINDICATIONS------------------------------  Moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors (4, 5.2)  Hepatic impairment (4, 5.5)  Known hypersensitivity to ADDYI or its components (4, 5.6, 6.2) -----------------------WARNINGS AND PRECAUTIONS------------------------  Hypotension and Syncope due to an Interaction with Alcohol: After taking ADDYI at bedtime, advise patients to avoid alcohol until the following day. (5.1)  Hypotension and Syncope with ADDYI Alone: Patients with pre-syncope should immediately lie supine and promptly seek medical help if symptoms do not resolve. (5.4)  Hypersensitivity Reactions, including anaphylaxis, angioedema, pruritus, urticaria: Avoid in women with known hypersensitivity to ADDYI or any of its components (5.6)  Central Nervous System (CNS) Depression (e.g., Somnolence, Sedation): Can occur with ADDYI alone. Exacerbated by other CNS depressants, and in settings where flibanserin concentrations are increased. Patients should avoid activities requiring full alertness (e.g., operating machinery or driving) until at least six hours after each dose and until they know how ADDYI affects them. (5.3) ------------------------------ADVERSE REACTIONS------------------------------- Most common adverse reactions (incidence ≥2%) are dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sprout Pharmaceuticals, Inc. at 1-844-746-5745, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ------------------------------DRUG INTERACTIONS-------------------------------  Oral Contraceptives and Other Weak CYP3A4 Inhibitors: Increases flibanserin exposures and incidence of adverse reactions (6.1, 7)  Strong CYP2C19 Inhibitors: Increases flibanserin exposure which may increase risk of hypotension, syncope, and CNS depression (7)  CYP3A4 Inducers: Use of ADDYI not recommended; flibanserin concentrations substantially reduced (7)  Digoxin: Increases digoxin concentrations, which may lead to digoxin toxicity. Increase monitoring of digoxin concentrations (7) -----------------------USE IN SPECIFIC POPULATIONS------------------------  Nursing Mothers: ADDYI is not recommended. (8.2)  CYP2C19 Poor Metabolizers: Increases flibanserin exposure which may increase risk of hypotension, syncope, and CNS depression (8.7) See 17 for PATIENT COUNSELING INFORMATION and FDA- approved patient labeling. Revised: 09/2021 _______________________________________________________________________________________________________________________________________ FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Hypotension and Syncope due to an Interaction with Alcohol 5.2 Hypotension and Syncope with CYP3A4 Inhibitors 5.3 Central Nervous System Depression 5.4 Hypotension and Syncope with ADDYI Alone 5.5 Syncope and Hypotension in Patients with Hepatic Impairment 5.6 Hypersensitivity Reactions 5.7 Mammary Tumors in Female Mice 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 8.7 CYP2C19 Poor Metabolizers 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 12.5 Pharmacogenomics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Studies in Premenopausal HSDD Patients 14.2 Effects on Driving 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. Reference ID: 4865026