Flibanserin | Addyi
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
- 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)
Flibanserin | Addyi Prescribing Information Highlights
The following points are shortened, highlighted information from prescribing information for this drug. For the full prescribing information PDF, click the button below to be directed to the FDA PDF label for this drug.
—–INDICATIONS AND USAGE—–
- See description above.
—–DOSAGE AND ADMINISTRATION—–
- See description above.
- Alcohol (4, 5.1)
- Moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors (4, 5.3)
- Hepatic impairment (4
- Hypotension and Syncope with ADDYI Alone: Patients with pre-syncope should immediately lie supine and promptly seek medical help if symptoms do not resolve. (5.5)
- 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 6 hours after each dose and until they know how ADDYI affects them. (5.4)
- Most common adverse reactions (incidence ≥2%) are dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth.
- 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)