vilazodone (Rx)

Brand and Other Names:Viibryd
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Dosing & Uses

AdultPediatric

Dosing Form & Strengths

tablet

  • 10mg
  • 20mg
  • 40mg

Major Depressive Disorder

10 mg PO qDay for 7 days with food; THEN increase to 20 mg qDay with food

May increase further up to 40 mg/day after a minimum of 7 days between dosage increases

Target maintenance dose: 20-40 mg/day

Dosing Considerations

Gradually taper dose , upon discontinuation of antidepressant, to minimize withdrawal symptoms and allow for detection of re-emerging symptoms; in patients taking 40 mg/day, taper dose to 20 mg qDay for 4 ddays; follow by reducing dose to 10 mg qDay for 3 days; if patient is taking 20 mg/day, taper dose to 10 mg qDay for 7 days

Changing to or from MAO inhibitor therapy

  • Do not administer vilazodone within 14 days of discontinuing a MAO inhibitor and initiating vilazodone when treating psychiatric disorders
  • Do not administer MAO inhibitor within 14 days of discontinuing vilazodone and initiating MAO therapy when treating psychiatric disorders

Administration of products with MAO inhibitor activity

  • In patients receiving linezolid or IV methylene blue, do not administer vilazodone; use alternate products to treat psychiatric condition
  • If treatment with linezolid or IV methylene blue urgent in patient receiving vilazodone, discontinue vilazodone immediately, if benefits outweigh risks; administer linezolid or IV methylene blue and monitor for serotonin syndrome for 2 weeks or until 24 hr after last dose of linezolid or IV methylene blue, whichever comes first; may resume vilazodone 24 hr after last dose of IV methylene blue or linezolid

Dosing Modifications

Renal impairment (mild/moderate/severe): No dose adjustment recommended

Hepatic impairment (mild/moderate/severe): No dose adjustment recommended

CYP3A4 inhibitors

  • Coadministration with strong CYP3A4 inhibitors (eg, ketoconazole): Not to exceed 20 mg PO qDay
  • Coadministration with moderate CYP3A4 inhibitors (eg, erythromycin): Reduce dose to 20 mg/day if intolerable adverse events emerge

CYP3A4 inducers

  • Coadministration with strong CYP3A4 inducers (eg, carbamazepine) for >14 days: Consider increasing vilazodone dose up to 2-fold (not to exceed 80 mg/day)

Dosing Considerations

Prior to initiating, screen patients for a personal or family history of bipolar disorder, mania, or hypomania

Safety and efficacy not established

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Interactions

Interaction Checker

and vilazodone

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Diarrhea (28%)

            Nausea (23%)

            1-10%

            Dizziness (9%)

            Xerostomia (8%)

            Insomnia (6%)

            Vomiting (5%)

            Fatigue (4%)

            Abnormal dreams (4%)

            Libido decreased (4%)

            Abnormal orgasm (3%)

            Dyspepsia (3%)

            Flatulence (3%)

            Gastroenteritis (3%)

            Somnolence (3%)

            Paresthesia (3%)

            Arthralgia (3%)

            Restlessness/akathisia (3%)

            Jittery sensation (2%)

            Tremor (2%)

            Delayed ejaculation (2%)

            Erectile dysfunction (2%)

            Increased appetite (2%)

            Postmarketing Reports

            General disorders and administrative site conditions: Irritability

            Psychiatric disorders: Hallucinations, suicide attempt, suicidal ideation

            Gastrointestinal disorders: Acute pancreatitis

            Nervous system disorders: Sleep paralysis

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            Warnings

            Black Box Warnings

            Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders

            In children and young adults, the risks must be weighed against the benefits of taking antidepressants

            Patients should be monitored closely for changes in behavior, clinical worsening, and suicidal tendencies; this should be done during the initial 1-2 months of therapy, as well as during dosage adjustments

            The patient’s family should communicate any abrupt changes in behavior to the healthcare provider

            Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy

            May worsen psychosis in some patients or cause a shift to mania or hypomania in bipolar disorder; patients should be screened for bipolar disorder prior to the initiation of therapy

            Not approved for use in pediatric patients

            Contraindications

            Hypersensitivity

            Coadministration with serotonergic drugs

            • Do not use MAOIs concomitantly or within 14 days before initiating vilazodone or within 14 days after discontinuing vilazodone
            • Symptoms include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant syndrome, seizures, rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma
            • Starting vilazodone in a patient who is being treated with linezolid or IV methylene blue is contraindicated because of an increased risk of serotonin syndrome
            • If linezolid or IV methylene blue must be administered, discontinue vilazodone immediately and monitor for CNS toxicity; may resume vilazodone 2 weeks after last linezolid or methylene blue dose

            Cautions

            May precipitate mixed/manic episode if initiated for bipolar disorder

            May cause serotonin syndrome or neuroleptic malignant syndrome-like reactions, including agitation, hallucinations, coma, autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (eg, hyperreflexia, incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea)

            Use with caution in patients with history of seizures; has not been systematically evaluated in patients with seizure disorders (caution advised)

            Serotonin reuptake inhibition may increase risk of bleeding (caution with drugs that inhibit platelets or coagulation)

            Decrease dose gradually when discontinuing, to avoid dysphoric mood, irritability, insomnia, agitation, and confusion

            CYP3A4 (major substrate); CYP2C19 (minor substrate, minor inhibitor, minor inducer); CYP2D6 (minor substrate, minor inhibitor); CYP2C8 (moderate inhibitor); increased plasma concentration (by 50%) observed when coadministered with strong CYP3A4 inhibitors (eg, ketoconazole)

            Highly bound to plasma proteins (administration to patient taking another drug that is highly protein bound may increase free concentrations of the other drug)

            Hyponatremia has been reported with other SSRIs, and SNRIs; common adverse effects include diarrhea, nausea, xerostomia, dizziness, and insomnia; can occur in association with syndrome of inappropriate antidiuretic hormone secretion (SIADH)

            Bone fractures reported with antidepressant treatment; consider possibility of fragility fracture if antidepressant treated patient presents with unexplained bone pain, swelling, point tenderness, or bruising;

            May cause sexual dysfunction

            MAOIs (see Contraindications)

            Coadministration with 5HT receptor agonist (ie, triptan), other serotonergic drugs (eg, SSRIs, SNRIs, buspirone, tramadol), or antidopaminergic drugs may increase risk for serotonin syndrome

            Concomitant use with serotonin precursors (eg, tryptophan) not recommended

            Serotonin reuptake inhibition may increase risk of bleeding (caution when coadministered with aspirin, NSAIDs, warfarin, and other anticoagulants)

            Risk of mydriasis; may trigger angle closure attack in patients with angle closure glaucoma with anatomically narrow angles without a patent iridectomy

            There is conflicting evidence regarding use of SSRIs during pregnancy and increased risk of persistent pulmonary hypertension of the newborn (PPHN; see Pregnancy)

            Write prescription for smallest quantity consistent with good patient care

            Abrupt discontinuation or interruption of therapy associated with discontinuation syndrome; antidepressants with shorter half-lives, prolonged treatment, or abrupt discontinuation, associated with increased risk of developing discontinuation syndrome; for antidepressants of short of intermediate hslf-lives, symptoms may emerge within 2-5 days after treatment discontinuation; may last 7-14 days

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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled studies in pregnant women; a prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at beginning of pregnancy; women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants; consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum

            Exposure in late pregnancy may lead to increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN); monitor neonates who were exposed to therapy in third trimester of pregnancy for PPHN and drug discontinuation syndrome

            Persistent pulmonary hypertension of the newborn

            • Potential risk of PPHN when used during pregnancy
            • Initial public health advisory in 2006 was based on a single published study; since then, there have been conflicting findings from new studies, making it unclear whether use of SSRIs during pregnancy can cause PPHN
            • FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN
            • FDA recommendation: FDA advises health-care professionals not to alter their current clinical practice of treating depression during pregnancy and to report any adverse events to the FDA MedWatch program

            Lactation

            There are no data on presence in human milk, effects on breastfed infant, or on milk production; however, drug is excreted in rat milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition

            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

            Mechanism of antidepressant effect is not fully understood, but may be related to serotonergic activity in the CNS through selective inhibition of serotonin reuptake; no effect on norepinephrine or dopamine reuptake

            Partial agonist of serotonergic 5-HT1A receptor whose activity may be altered in depression and anxiety

            Absorption

            Bioavailability: 72% (with food)

            Peak plasma time: 4-5 hr  

            Peak plasma concentration: 156 ng/mL

            AUC: 1645 ng•h/mL

            Distribution

            Protein bound: 96-99%  

            Metabolism

            Extensively metabolized through CYP and non-CYP pathways (possibly by carboxylesterase); CYP3A4 is primarily responsible for its metabolism among CYP pathways, with minor contributions from CYP2C19 and CYP2D6

            Elimination

            Half-life: 25 hr

            Excretion: Feces (2% unchanged), urine (1% unchanged)  

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            Administration

            Instructions

            Take with food

            Administration in fasted state (without food) may decrease blood concentration (AUC) by up to 50% and may result in decreased effectiveness

            Discontinuing

            Gradually reduce dose rather than discontinue abruptly

            Taper from 40 mg/day to 20 mg/day for 4 days, followed by 10 mg/day7 for 3 days

            Patients taking 20 mg/day should be tapered to 10 mg/day for 7 days

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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