Addyi Flibanserin Medical Information And Safety Considerations

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The source data contains medical and regulatory information about ADDYI (flibanserin), a medication indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). However, there is no information available about free samples, promotional offers, no-cost trials, or sample programs for this medication. The following information is based exclusively on the provided source data.

Indications and Limitations of Use

ADDYI (flibanserin) is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). This condition is 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

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

Contraindications

ADDYI is contraindicated in patients with: - Moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors - Hepatic impairment - Known hypersensitivity to ADDYI or any of its components

Reactions, including anaphylaxis, reactions consistent with angioedema, pruritus, and urticaria have been reported in patients with known hypersensitivity.

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, patients should 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, patients should 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.

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.

Hypersensitivity Reactions

Reactions including anaphylaxis, reactions consistent with angioedema, pruritus, and urticaria have been reported with ADDYI. ADDYI should be immediately discontinued and appropriate treatment initiated if a hypersensitivity reaction occurs.

Drug Interactions

Alcohol

Coadministration of ADDYI with alcohol increases the risk of hypotension, syncope, and CNS depression compared to the use of ADDYI alone or alcohol alone.

CNS Depressants

Concomitant use of ADDYI with CNS depressants (i.e., diphenhydramine, opioids, hypnotics, benzodiazepines, etc.) 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, oral contraceptives and other weak CYP3A4 inhibitors 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

The most common adverse reactions (ADDYI incidence ≥2% and higher than placebo) are: - Dizziness - Somnolence - Nausea - Fatigue - Insomnia - Dry mouth

References to Studies

The source data includes references to several studies about ADDYI/flibanserin and hypoactive sexual desire disorder, including: - 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. - Holstege G. How the emotional motor system controls the pelvic organs. Sex Med Rev. 2016: 4;303-328. - Kingsberg SA. Attitudinal survey of women living with low sexual desire. J Women's Health. 2014;23(10):817-23 - Clayton AH, Brown L, Kim NN. Evaluation of safety for flibanserin. Expert Opin Drug Saf. 2020;19(1):1-8. doi:10.1080/14740338.2020.1707804. - Goldfischer ER, Breaux J, Katz M et al. Continued efficacy and safety of flibanserin in premenopausal women with hypoactive sexual desire disorder (HSDD): Results from a randomized withdrawal trial. J Sex Med.2011; 8:3160-3172. - Jayne C, Simon JA, Taylor LV, Kimura T, Lesko LM; SUNFLOWER study investigators. Open-label extension study of flibanserin in women with hypoactive sexual desire disorder. J Sex Med. 2012;9(12):3180-3188. doi:10.1111/j.1743-6109.2012.02942.x - 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. - 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. - 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. - Clayton AH, Harry AC, Yuan J, et al. Safety of flibanserin in women treated with antidepressants: A randomized, placebo-controlled study. J Sex Med 2018;15(1):43-51. - 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. - 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.

Conclusion

The provided source material contains medical and regulatory information about ADDYI (flibanserin), a medication indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). However, there is no information available about free samples, promotional offers, no-cost trials, or sample programs for this medication. The source data includes details about indications, contraindications, warnings, precautions, drug interactions, and adverse reactions associated with ADDYI. Patients should consult their healthcare providers for personalized medical advice regarding ADDYI/flibanserin.

Sources

1. ADDYI Prescribing Information