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)

Flibanserin tablets are 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 problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner.

Limitations of Use

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

Recommended Dosage The recommended dosage of Flibanserin is 100 mg administered orally once per day at bedtime. Flibanserin is dosed at bedtime because administration during waking hours increases the risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression (such as somnolence and sedation).

Missed Dose If a dose of Flibanserin is missed at bedtime, instruct the patient to take the next dose at bedtime on the next day. Instruct the patient to not double the next dose.

Discontinuation of Flibanserin Discontinue Flibanserin after 8 weeks if the patient does not report an improvement in her symptoms.

Initiation of Flibanserin Following Moderate or Strong CYP3A4 Inhibitor Use If initiating Flibanserin following moderate or strong CYP3A4 inhibitor use, start Flibanserin 2 weeks after the last dose of the CYP3A4 inhibitor.

If initiating a moderate or strong CYP3A4 inhibitor following Flibanserin use, start the moderate or strong CYP3A4 inhibitor 2 days after the last dose of Flibanserin

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Flibanserin is not indicated for use in pediatric patients

Off-Label Use and Dosage (Pediatric)

Contraindications

Flibanserin is contraindicated: With use of alcohol. With concomitant use with moderate or strong CYP3A4 inhibitors. In patients with hepatic impairment.

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.

Hypotension and Syncope due to an Interaction with Alcohol Alcohol use is contraindicated in patients taking Flibanserin. Before prescribing Flibanserin, the healthcare provider must assess the likelihood of the patient abstaining from alcohol use, 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.

The use of Flibanserin and alcohol increases the risk of severe hypotension and syncope. In a dedicated alcohol interaction study conducted in 25 subjects (23 men and 2 premenopausal women), hypotension or syncope requiring therapeutic intervention (ammonia salts and/or placement in supine or Trendelenburg position) occurred in 4 (17%) of the 23 subjects co-administered Flibanserin 100 mg and 0.4 g/kg alcohol (equivalent of two 12 ounce cans of beer containing 5% alcohol content, two 5 ounce glasses of wine containing 12% alcohol content, or two 1.5 ounce shots of 80-proof spirit in a 70 kg person, consumed over 10 minutes in the morning). In these four subjects, all of whom were men, the magnitude of the systolic blood pressure reductions ranged from about 28 to 54 mmHg and the magnitude of the diastolic blood pressure reductions ranged from about 24 to 46 mmHg. In addition, 6 (25%) of the 24 subjects co-administered Flibanserin 100 mg and 0.8 g/kg alcohol experienced orthostatic hypotension when standing from a sitting position. The magnitude of the systolic blood pressure reductions in these 6 subjects ranged from 22 to 48 mmHg, and the diastolic blood pressure reductions ranged from 0 to 27 mmHg. One of these subjects required therapeutic intervention (ammonia salts and placement supine with the foot of the bed elevated). There were no events requiring therapeutic interventions when Flibanserin or alcohol were administered alone.

Flibanserin is available only through a restricted program under a REMS.

Flibanserin REMS Program Flibanserin is available only through a restricted program under a REMS called the Flibanserin REMS Program, because of the increased risk of severe hypotension and syncope due to an interaction between Flibanserin and alcohol.

Notable requirements of the Flibanserin REMS Program include the following:

Prescribers must be certified with the program by enrolling and completing training.

Pharmacies must be certified with the program and must only dispense to patients pursuant to a prescription from a certified prescriber.

Further information, including a list of qualified pharmacies, is available at www.AddyiREMS.com or 844-746-5745.

Hypotension and Syncope with CYP3A4 Inhibitors Moderate or Strong CYP3A4 Inhibitors

The concomitant use of Flibanserin with moderate or strong CYP3A4 inhibitors significantly increases Flibanserin concentrations, which can lead to hypotension and syncope. The concomitant use of Flibanserin with a moderate or strong CYP3A4 inhibitor is contraindicated. If the patient requires a moderate or strong CYP3A4 inhibitor, discontinue Flibanserin at least 2 days prior to starting the moderate or strong CYP3A4 inhibitor. In cases where the benefit of initiating a moderate or strong CYP3A4 inhibitor within 2 days of stopping Flibanserin clearly outweighs the risk of Flibanserin exposure related hypotension and syncope, monitor the patient for signs of hypotension and syncope. Discontinue the moderate or strong CYP3A4 inhibitor for 2 weeks before restarting Flibanserin.

Multiple Concomitant Weak CYP3A4 Inhibitors 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 Depression Flibanserin can cause CNS depression (e.g., somnolence, sedation). In five 24-week, randomized, placebo-controlled, double-blind trials of premenopausal women with HSDD, the incidence of somnolence, sedation or fatigue was 21% and 8% in patients treated with 100 mg Flibanserin once daily at bedtime and placebo, respectively. The risk of CNS depression is increased if Flibanserin is taken during waking hours, or if Flibanserin is taken with alcohol or other CNS depressants, or with medications that increase Flibanserin concentrations, such as CYP3A4 inhibitors.

Patients should not drive or engage in other activities requiring full alertness until at least 6 hours after taking Flibanserin and until they know how Flibanserin affects them.

Hypotension and Syncope with Flibanserin Alone The use of Flibanserin − without other concomitant medications known to cause hypotension or syncope − can cause hypotension and syncope. In five 24-week, randomized, placebo-controlled, double-blind trials of premenopausal women with HSDD, hypotension was reported in 0.2% and <0.1% of Flibanserin -treated patients and placebo-treated patients, respectively; syncope was reported in 0.4% and 0.2% of Flibanserin - treated patients and placebo-treated patients, respectively. The risk of hypotension and syncope is increased if Flibanserin is taken during waking hours or if higher than the recommended dose is taken. Consider the benefits of Flibanserin and the risks of hypotension and syncope in patients with pre- existing conditions that predispose to hypotension. Patients who experience pre-syncope should immediately lie supine and promptly seek medical help if the symptoms do not resolve. Prompt medical attention should also be obtained for patients who experience syncope.

Syncope and Hypotension in Patients with Hepatic Impairment The use of Flibanserin in patients with any degree of hepatic impairment significantly increases Flibanserin concentrations, which can lead to hypotension and syncope. Therefore, the use of Flibanserin is contraindicated in patients with hepatic impairment.

Mammary Tumors in Female Mice In a 2-year carcinogenicity study in mice, there was a statistically significant and dose-related increase in the incidence of malignant mammary tumors in female mice at exposures 3 and 10 times the recommended clinical dose. No such increases were seen in male mice or in male or female rats. The clinical significance of these findings is unknown.

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.