Flibanserin

Flibanserin
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

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 Inhibitors: The 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 Impairment: The 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 Inhibitors: The 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 Impairment: The 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.