flibanserin (Rx)

Brand and Other Names:Addyi
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 100mg

Hypoactive Sexual Desire Disorder

Indicated for 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 caused by a coexisting medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance

100 mg PO once daily at bedtime

Dosed at bedtime because administration during waking hours increases risks of hypotension, syncope, accidental injury, and CNS depression

Discontinued after 8 weeks if no improvement

Missed dose

  • If a dose 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

CYP3A4 inhibitors

  • Coadministration with moderate or strong CYP3A4 inhibitors is contraindicated
  • 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

Dosing Considerations

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

  • Not indicated for HSDD in postmenopausal women or in men
  • Not indicated to enhance sexual performance

Not indicated

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Interactions

Interaction Checker

and flibanserin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Dizziness (11.4%)

            Somnolence (11.2%)

            Nausea (10.4%)

            1-10%

            Fatigue (9.2%)

            Insomnia (4.9%)

            Dry mouth (2.4%)

            Anxiety (1.8%)

            Constipation (1.6%)

            Abdominal pain (1.5%)

            Metrorrhagia (1.4%)

            Rash (1.3%)

            Sedation (1.3%)

            Vertigo (1%)

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            Warnings

            Black Box Warnings

            Contraindicated with alcohol

            • Use with alcohol increases risk of severe hypotension and syncope; therefore, alcohol use is contraindicated
            • 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 is due to an interaction with alcohol, flibanserin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADDYI REMS Program

            Contraindicated with moderate or strong CYP3A4 inhibitors

            • Coadministration with 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

            Contraindicated in patients with hepatic impairment

            • Contraindicated for use with any degree of hepatic impairment
            • Flibanserin exposure increased 4.5-fold in patients with hepatic impairment, compared with those with normal hepatic function, increasing the risk of hypotension, syncope, and CNS depression

            Contraindications

            Use with alcohol

            Coadministration with moderate or strong CYP3A4 inhibitors

            Any degree of hepatic impairment

            Cautions

            Coadministration with alcohol increases the risk of severe hypotension and syncope (also see Contraindications and Black Box Warnings)

            Coadministration with moderate or strong CYP3A4 inhibitors is significantly increases flibanserin concentrations, which can lead to hypotension and syncope (also see Contraindications, Black Box Warnings, and Dosing)

            Concomitant use of multiple weak CYP3A4 inhibitors that may include herbal supplements (eg, ginkgo, resveratrol) or nonprescription drugs (eg, cimetidine) could also lead to clinically relevant increases in flibanserin concentrations that may increase the risk of hypotension and syncope

            Causes CNS depression (eg, somnolence, sedation); risk of CNS depression is increased if taken during waking hours, or with alcohol or other CNS depressants, or with medications that increase flibanserin concentrations (eg, CYP3A4 inhibitors)

            Hypotension and syncope can also occur with flibanserin taken alone

            The use in patients with any degree of hepatic impairment is contraindicated; hepatic impairment significantly increases flibanserin concentrations, which can lead to hypotension and syncope

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            Pregnancy

            Pregnancy

            There are no studies in pregnant women to inform whether there is a drug-associated risk in humans

            Animal data

            • In animals, fetal toxicity only occurred in the presence of significant maternal toxicity, including reductions in weight gain and sedation
            • Adverse reproductive and developmental effects consisted of decreased fetal weight, structural anomalies, and increases in fetal loss at exposures greater than 15 times exposures achieved with the recommended human dosage

            Lactation

            Unknown if distributed in human breast milk

            Excreted in rat milk

            Unknown whether flibanserin has effects on the breastfed infant or if it affects milk production

            Because of the potential for serious adverse reactions, including sedation, in a breastfed infant, breastfeeding is not recommended during treatment

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Postsynaptic serotonin-1A (5HT-1A) receptor agonist and 5HT-2A receptor antagonist; also elicits moderate antagonist activities at the 5-HT2B, 5-HT2C, and dopamine D4 receptors

            The mechanism of action HSDD is not known; may work by restoring prefrontal cortex control over the brain's motivation/rewards structures, enabling sexual desire to manifest; this may occur by increasing dopamine and norepinephrine while transiently decreasing serotonin in the brain's prefrontal cortex, which may be accomplished by reduced glutamate transmission

            Absorption

            Bioavailability: 33%

            Peak plasma time: 0.75 hr

            Peak plasma concentration: 419 ng/mL

            AUC: 1543 ng·hr/mL

            Food increased the extent of absorption and slowed the rate of absorption

            Distribution

            Protein bound: 98%, primarily to albumin

            Metabolism

            Primarily metabolized by CYP3A4 and, to a lesser extent, by CYP2C19

            Elimination

            Half-life: 11 hr

            Excretion: 51% feces; 44% urine

            Pharmacogenomics

            CYP2C19 poor metabolizers had increased flibanserin exposures compared with CYP2C19 extensive metabolizers

            Additionally, syncope occurred in a subject who was a CYP2C19 poor metabolizer

            The frequencies of poor CYP2C19 metabolizers are ~2–5% among whites and blacks and ~2–15% among Asians

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.