Pharmacokinetics and Safety of Vilazodone in Hepatic Impairment

Boinpally, Ramesh; Henry, Dahlia; Gupta, Samir K.; Edwards, J.B.; Longstreth, James; Periclou, Antonia

doi:10.1097/mjt.0000000000000173

Cited by 7 publications

(5 citation statements)

References 5 publications

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“…As expected, impaired renal function does not affect the pharmacokinetics of vilazodone, while severe hepatic impairment led to vomiting in 4/8 patients treated with vilazodone, as opposed to 0/8 patients with severe hepatic impairment not treated with vilazodone (Boinpally et al 2013;Boinpally et al 2015). It has been reported that polymorphisms or SNP haplotypes affect the therapeutic response and the incidence of nausea and vomiting upon treatment with vilazodone (Rickels et al 2009;Lindsey 2011).…”

Section: Vilazodonesupporting

confidence: 65%

Tools for optimising pharmacotherapy in psychiatry (therapeutic drug monitoring, molecular brain imaging and pharmacogenetic tests): focus on antidepressants

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Gründer

Baumann

et al. 2021

The World Journal of Biological Psychiatry

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Objectives: More than 40 drugs are available to treat affective disorders. Individual selection of the optimal drug and dose is required to attain the highest possible efficacy and acceptable tolerability for every patient. Methods: This review, which includes more than 500 articles selected by 30 experts, combines relevant knowledge on studies investigating the pharmacokinetics, pharmacodynamics and pharmacogenetics of 33 antidepressant drugs and of 4 drugs approved for augmentation in cases of insufficient response to antidepressant monotherapy. Such studies typically measure drug concentrations in blood (i.e. therapeutic drug monitoring) and genotype relevant genetic polymorphisms of enzymes, transporters or receptors involved in drug metabolism or mechanism of action. Imaging studies, primarily positron emission tomography that relates drug concentrations in blood and radioligand binding, are considered to quantify target structure occupancy by the antidepressant drugs in vivo. Results: Evidence is given that in vivo imaging, therapeutic drug monitoring and genotyping and/or phenotyping of drug metabolising enzymes should be an integral part in the development of any new antidepressant drug. Conclusions: To guide antidepressant drug therapy in everyday practice, there are multiple indications such as uncertain adherence, polypharmacy, nonresponse and/or adverse reactions under therapeutically recommended doses, where therapeutic drug monitoring and cytochrome P450 genotyping and/or phenotyping should be applied as valid tools of precision medicine.

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Section: Vilazodonesupporting

confidence: 65%

Tools for optimising pharmacotherapy in psychiatry (therapeutic drug monitoring, molecular brain imaging and pharmacogenetic tests): focus on antidepressants

Eap

Gründer

Baumann

et al. 2021

The World Journal of Biological Psychiatry

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“…We think it is unlikely that metabolites M10 or M13 cross-react with amphetamines immunoassays as these are very close in structure to vilazodone. However, it should be pointed out that the reported metabolic pathway for vilazodone has only been worked out in adults, with essentially no data on the metabolic pathway for vilazodone in young children [4, 13–15]. A number of drug-metabolizing enzymes show significant age-dependent differences in expression and functional activity [41].…”

Section: Discussionmentioning

confidence: 99%

“…Published pharmacokinetic studies of vilazodone in adults show maximum serum/plasma concentrations of approximately 150 ng/mL or below for vilazodone and M17 [4, 13]. A report of two children who experienced seizures following accidental vilazodone ingestion reported serum concentrations of vilazodone [7].…”

Section: Methodsmentioning

confidence: 99%

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Accidental intoxications in toddlers: lack of cross-reactivity of vilazodone and its urinary metabolite M17 with drug of abuse screening immunoassays

et al. 2019

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Background Vilazodone is an FDA approved medication used to treat major depressive disorder. The authors describe two cases of accidental vilazodone exposure in toddlers who presented with symptoms similar to amphetamine exposure and also with unexplained positive amphetamine urine immunoassay drug screens. Given a lack of published data on cross-reactivity of vilazodone and its metabolites with drug of abuse screening tests, the authors investigated drug of abuse immunoassay cross-reactivity of vilazodone and metabolites using computational and empirical approaches. Methods To ascertain the likelihood that vilazodone would cross-react with drug of abuse screening immunoassays, the authors assessed the two-dimensional (2D) similarity of the vilazodone parent molecule and known metabolites to an array of antigenic targets for urine immunoassay drug screens. To facilitate studies of the commercially unavailable M17 metabolite, it was prepared synthetically through a novel scheme. Urine and serum were spiked with vilazodone and M17 into urine (200–100,000 ng/mL) and serum (20–2000 ng/mL) samples and tested for cross-reactivity. Results Computational analysis using 2D similarity showed that vilazodone and metabolites have generally low similarity to antigenic targets of common drug of abuse screening immunoassays, predicting weak or no cross-reactivity. The M17 metabolite had 2D similarity to amphetamines and tricyclic antidepressants in a range similar to some other compounds exhibiting weak cross-reactivity on these immunoassays. Cross-reactivity testing was therefore performed on two different urine amphetamines immunoassays and a serum tricyclic antidepressant immunoassay. However, actual testing of cross reactivity for vilazodone and the M17 metabolite did not detect cross-reactivity for any urine amphetamines screen at concentrations up to 100,000 ng/mL and for a serum tricyclic antidepressants assays at concentrations up to 2000 ng/mL. Conclusion While the vilazodone metabolite M17 has weak 2D structural similarity to amphetamines and tricyclic antidepressants, the current study did not demonstrate any experimental cross-reactivity with two different urine amphetamines immunoassays and a serum tricyclic antidepressant immunoassay. Vilazodone ingestions in young children present a diagnostic challenge in their similarity to amphetamine ingestions and the lack of routine laboratory tests for vilazodone. Further work is needed to understand the metabolic profile for vilazodone in children versus adults. Electronic supplementary material The online version of this article (10.1186/s12907-019-0084-9) contains supplementary material, which is available to authorized users.

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“…Pharmacokinetics of vilazodone were similar in participants with mild, moderate, or severe hepatic impairment and healthy controls following a single, 20-mg oral dose of vilazodone. 11 Thus, dose adjustment is not needed for patients with major depressive disorder who have mild, moderate, or severe hepatic impairment. Likewise, another study suggested that no dose adjustment was required for patients having mild to moderate renal dysfunction.…”

Section: General Informationmentioning

confidence: 99%

Vilazodone for the Treatment of Depression: An Update

et al. 2016

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Vilazodone is a novel antidepressant having a selective serotonin (5-HT) reuptake inhibitor and 5-HT1A receptor partial agonist profile, so it has been regarded as a serotonin partial agonist-reuptake inhibitor (SPARI). We aimed to provide Vilazodone's clinical implications mainly by reviewing published clinical trials. Vilazodone has been speculated to have three potential benefits including faster onset of action, greater efficacy, and better tolerability owning to its SPARI properties. However, no studies conducted so far have directly proven the above speculations. Five initial phase II trials failed to distinguish vilazodone from placebo in the treatment of MDD, but 4 randomized clinical trials (RCT), 3 post-hoc or pooled analysis, 1 long-term open label study, and a meta-analysis showed vilazodone's superior efficacy over placebo. The studies also showed vilazodone is generally safe and tolerable. However, diarrhea, nausea, headache, dizziness, dry mouth, and insomnia warrant close attention in clinical practice because they have been constantly noted throughout the clinical studies. 2 RCTs recently documented the efficacy and safety of vilazodone in patients with generalized anxiety disorder, which could be a start of broadening vilazodone's usage or FDA approval in diverse anxiety disorders.

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Pharmacokinetics and Safety of Vilazodone in Hepatic Impairment

Cited by 7 publications

References 5 publications

Tools for optimising pharmacotherapy in psychiatry (therapeutic drug monitoring, molecular brain imaging and pharmacogenetic tests): focus on antidepressants

Tools for optimising pharmacotherapy in psychiatry (therapeutic drug monitoring, molecular brain imaging and pharmacogenetic tests): focus on antidepressants

Accidental intoxications in toddlers: lack of cross-reactivity of vilazodone and its urinary metabolite M17 with drug of abuse screening immunoassays

Vilazodone for the Treatment of Depression: An Update

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