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PATIENT RESOURCES

PATIENT BROCHURE

Information about Addyi and HSDD for your appropriate patients

PHIL PATIENT INSTRUCTIONS

Specialty pharmacy next steps for your patients

HCP RESOURCES

ADDYI ONE PAGER

Information about Addyi and Phil Specialty Pharmacy

PHILRX FAX FORM

Form to fax prescriptions to Phil Specialty Pharmacy

DECREASED SEXUAL DESIRE SCREENER

Use this validated screener to help make an HSDD diagnosis.

General:

844-PINK-PILL (844-746-5745)

info@sproutpharma.com

Medical Info:

844-746-5745 x 3

medicalaffairs@sproutpharma.com

Indication and Important Safety Information including Boxed Warning regarding hypotension and syncope in certain settings

Indication and Important Safety Information including Boxed Warning regarding hypotension and syncope in certain settings

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.
  • 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.

Contraindications

  • Moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors
  • Hepatic impairment

Warnings and Precautions

  • Hypotension and Syncope Due to an Interaction with Alcohol:  Taking ADDYI within two hours after consuming alcohol increases the risk of severe hypotension and syncope. To reduce this risk, counsel patients to wait at least two hours after drinking one or two standard alcoholic drinks before taking ADDYI at bedtime. Patients who drink three or more standard alcoholic drinks should skip their ADDYI dose that evening. After taking ADDYI at bedtime, advise patients to not use alcohol until the following day.
  • Hypotension and Syncope with CYP3A4 Inhibitors: Moderate or strong CYP3A4 inhibitors significantly increase ADDYI concentrations, which can lead to hypotension and syncope. Concomitant use of ADDYI with a moderate or strong CYP3A4 inhibitor is contraindicated. Concomitant use of multiple weak CYP3A4 inhibitors that may include herbal supplements (e.g., ginkgo, resveratrol) or non-prescription drugs (e.g., cimetidine) could also lead to clinically relevant increases in flibanserin concentrations that may increase the risk of hypotension and syncope.
  • Central Nervous System (CNS) Depression (e.g., Somnolence, Sedation):  Can occur with ADDYI alone and is exacerbated by other CNS depressants including alcohol, and in settings where flibanserin concentrations are increased such as CYP3A4 inhibitors. The risk of CNS depression is also increased if ADDYI is taken during waking hours. 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.
  • Hypotension and Syncope with ADDYI Alone:  The use of ADDYI – without other concomitant medications known to cause hypotension or syncope – can cause hypotension and syncope. The risk of hypotension and syncope is increased if ADDYI is taken during waking hours or if higher than the recommend dose is taken. Consider the benefits of ADDYI and the risks of hypotension and syncope in patients with pre-existing conditions that predispose to hypotension. Patients with pre-syncope should immediately lie supine and promptly seek medical help if symptoms do not resolve. Prompt medical attention should also be obtained for patients who experience syncope.
  • Syncope and Hypotension in Patients with Hepatic Impairment: Any degree of hepatic impairment significantly increases flibanserin concentrations, which can lead to hypotension and syncope. ADDYI is contraindicated in patients with hepatic impairment.

Drug Interactions

  • Alcohol: coadministration of ADDYI with alcohol increased the risk of hypotension, syncope, and CNS depression compared to the use of ADDYI alone or alcohol alone. Patients should 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.
  • CNS Depressants: (i.e., diphenhydramine, opioids, hypnotics, benzodiazepines, etc.) Concomitant use with ADDYI may increase the risk of CNS depression compared to use of ADDYI alone.
  • Moderate or Strong CYP3A4 Inhibitors: ADDYI is contraindicated in women taking moderate (e.g., fluconazole, etc.) or strong (e.g., ketoconazole, etc.) CYP3A4 inhibitors
  • Oral Contraceptives and Other Weak CYP3A4 Inhibitors:  In combination with ADDYI may increase the risk of adverse reactions
  • Strong CYP2C19 Inhibitors: (i.e., proton pump inhibitors, SSRI’s, benzodiazepines, antifungals, etc.) Increase flibanserin exposure which may increase risk of hypotension, syncope, and CNS depression
  • CYP3A4 Inducers: (i.e., carbamazepine, phenobarbital, etc.) Concomitant use substantially decreases flibanserin exposure compared to the use of ADDYI alone and is not recommended.
  • Digoxin or other P-glycoprotein (P-gp) substrates:  Increases digoxin concentration, which may lead to digoxin toxicity. Increase monitoring of drugs transported by P-gp that have a narrow therapeutic index.

Most Common Adverse Reactions

  • Most common adverse reactions (ADDYI incidence ≥2% and higher than placebo) are dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth.

See Full Prescribing Information and Medication Guide, including Boxed Warning regarding hypotension and syncope in certain settings at addyi.com/pi.

 

Indication

ADDYI (flibanserin) 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.

Acquired HSDD refers to HSDD that develops in a patient who previously had no problem with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation, or partner.

Limitations of Use:

  • ADDYI is not indicated for the treatment of HSDD in postmenopausal women or in men.
  • ADDYI is not indicated to enhance sexual performance.

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This site is intended for residents of the United States.

Addyi is a registered trademark of Sprout Pharmaceuticals, Inc. or its affiliates. All other trademarks are the property of their respective owners.

© 2020 Sprout Pharmaceuticals, Inc. US–1900020.15

References

1. IQVIA Monthly Total Prescriptions Volume Data Comparing Addyi vs Vyleesi in the US. May 2020.
2. Addyi Prescribing Information.
3. Derogatis LR, Komer L, Katz M, et al. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the BEGONIA Study. J Sex Med. 2012;9(4):1074-1085.
4. Thorp J, Simon J, Dattani D, et al. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study. J Sex Med. 2012;9(3):793-804.
5. Katz M, Derogatis LR, Ackerman R, et al. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. J Sex Med. 2013;10(7):1807-1815.
6. Gerstenberger EP, Rosen RC, Brewer JV, et al. Sexual desire and the Female Sexual Function Index (FSFI): a sexual desire cutpoint for clinical interpretation of the FSFI in women with and without hypoactive sexual desire disorder. J Sex Med. 2010;7(9):3096–3103.
7. Rosen R, Brown C, Heiman J, et al. The Female Sexual Function Index (FSFI): A multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2006; 26:2, 191-208.
8. Simon JA, Millheiser L, Clayton AH, et al. Improvements in Female Sexual Function Index (FSFI) domains over time after flibanserin treatment in premenopausal women with hypoactive sexual desire disorder (HSDD). Poster presented at the International Society for the Study of Women’s Sexual Health (ISSWSH) 2020 Annual Meeting; March 5-8, 2020; Orlando, FL.(A084).
9. Kornstein SG, James JA, Apfel SC, et al. Effect of flibanserin treatment on body weight in premenopausal and postmenopausal women with hypoactive sexual desire disorder: A post hoc analysis. J Women’s Health. 2017;26(11):1161-1168.
10. Stahl SM, et al. Mechanism of action of flibanserin, a multifunctional serotonin agonist and antagonist (MSAA), in hypoactive sexual desire disorder, CNS Spectrums. 2015;20:1-6.
11. Arnow BA, Millheiser L, Garrett A et al. Women with hypoactive sexual desire disorder compared to normal females: a functional magnetic resonance imaging study. Neuroscience 2009;158:484-502.
12. Woodard TL, Nowak NT, Balon R et al. Brain activation patterns in women with acquired hypoactive sexual desire disorder and women with normal sexual function: a cross-sectional pilot study. Fertil Steril 2013;100:1068-1076.
13. Bianchi-Demicheli F, Cojan Y, Waber L, et al. Neural basis of hypoactive sexual desire disorder in women: an event-related fmri study.  J Sex Med. 2011;8:2546-2559.
14. Holstege G. How the emotional motor system controls the pelvic organs. Sex Med Rev. 2016: 4;303-328.
15. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed., Text Revision. Washington, DC: American Psychiatric Press; 2000.
16. Association of Reproductive Health Professionals. ARHP and Healthy Women (2009). Women’s Sexual Health Survey (online in the US). Harris Interactive.
17. Clayton AH, Goldfischer ER, Goldstein I,  et al. Validation of the Decreased Sexual Desire Screener (DSDS): a brief diagnostic instrument for generalized acquired female hypoactive sexual desire disorder (HSDD). J Sex Med. 2009;6(3):730-738.