Flibanserin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Martin Nino [2]
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Black Box Warning
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HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS
See full prescribing information for complete Boxed Warning.
======Contraindicated with Alcohol======
The use of Flibanserin tablets and alcohol increases the risk of severe hypotension and syncope. Therefore, alcohol use is contraindicated in patients taking Flibanserin. Before prescribing Flibanserin, assess the likelihood of the patient abstaining from alcohol, taking into account the patient’s current and past drinking behavior, and other pertinent social and medical history. Counsel patients who are prescribed Flibanserin about the importance of abstaining from alcohol use. Because of the increased risk of hypotension and syncope due to an interaction with alcohol, Flibanserin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Flibanserin REMS Program. Contraindicated with Strong or Moderate CYP3A4 InhibitorsThe concomitant use of Flibanserin and moderate or strong CYP3A4 inhibitors increases Flibanserin concentrations, which can cause severe hypotension and syncope. Therefore, the use of moderate or strong CYP3A4 inhibitors is contraindicated in patients taking Flibanserin. Contraindicated in Patients with Hepatic ImpairmentThe use of Flibanserin in patients with hepatic impairment increases Flibanserin concentrations, which can cause severe hypotension and syncope. Therefore, Flibanserin is contraindicated in patients with hepatic impairment. |
Overview
Flibanserin is a tablet for oral administration that is FDA approved 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.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth (incidence ≥2%).
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Flibanserin FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Flibanserin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Flibanserin Contraindications in the drug label.
Warnings
|
HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS
See full prescribing information for complete Boxed Warning.
======Contraindicated with Alcohol======
The use of Flibanserin tablets and alcohol increases the risk of severe hypotension and syncope. Therefore, alcohol use is contraindicated in patients taking Flibanserin. Before prescribing Flibanserin, assess the likelihood of the patient abstaining from alcohol, taking into account the patient’s current and past drinking behavior, and other pertinent social and medical history. Counsel patients who are prescribed Flibanserin about the importance of abstaining from alcohol use. Because of the increased risk of hypotension and syncope due to an interaction with alcohol, Flibanserin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Flibanserin REMS Program. Contraindicated with Strong or Moderate CYP3A4 InhibitorsThe concomitant use of Flibanserin and moderate or strong CYP3A4 inhibitors increases Flibanserin concentrations, which can cause severe hypotension and syncope. Therefore, the use of moderate or strong CYP3A4 inhibitors is contraindicated in patients taking Flibanserin. Contraindicated in Patients with Hepatic ImpairmentThe use of Flibanserin in patients with hepatic impairment increases Flibanserin concentrations, which can cause severe hypotension and syncope. Therefore, Flibanserin is contraindicated in patients with hepatic impairment. |
There is limited information regarding Flibanserin Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Flibanserin Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Flibanserin Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Flibanserin Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Flibanserin in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Flibanserin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Flibanserin during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Flibanserin in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Flibanserin in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Flibanserin in geriatric settings.
Gender
There is no FDA guidance on the use of Flibanserin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Flibanserin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Flibanserin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Flibanserin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Flibanserin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Flibanserin in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Flibanserin Administration in the drug label.
Monitoring
There is limited information regarding Flibanserin Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Flibanserin and IV administrations.
Overdosage
There is limited information regarding Flibanserin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Flibanserin Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Flibanserin Mechanism of Action in the drug label.
Structure
There is limited information regarding Flibanserin Structure in the drug label.
Pharmacodynamics
There is limited information regarding Flibanserin Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Flibanserin Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Flibanserin Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Flibanserin Clinical Studies in the drug label.
How Supplied
There is limited information regarding Flibanserin How Supplied in the drug label.
Storage
There is limited information regarding Flibanserin Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Flibanserin Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Flibanserin interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Flibanserin Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Flibanserin Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.