vortioxetine

vortioxetine

(vor-tye-ox-e-teen),

Brintellix

(trade name)

Classification

Therapeutic: antidepressants
Pharmacologic: selective serotonin reuptake inhibitors ssris
Pregnancy Category: C

Indications

Treatment of major depressive disorder.

Action

Selectively inhibits the reuptake of serotonin in the CNS.

Therapeutic effects

Antidepressant action.

Pharmacokinetics

Absorption: Well absorbed (75%) following oral administration.
Distribution: Extensive extravascular distribution
Protein Binding: 98%.
Metabolism and Excretion: Extensively metabolized, primarily by the CYP2D6 enzyme system, 59% excreted in urine as metabolites, 26% in feces as metabolites, minimal renal excretion of unchanged drug.
Half-life: 66 hr.

Time/action profile (antidepressant effect)

ROUTEONSETPEAKDURATION
PO1–2 wk4–8 wkunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Concurrent or recent MAOIs for psychiatric use, linezolid or IV methylene blue; Obstetric: May cause fetal harm (third trimester use may result in respiratory distress, cyanosis, apnea, seizures, temperature instability feeding difficulties and behavioral issues infants, may also be associated with persistent pulmonary hypertension of the newborn [PPHN]); Lactation: Discontinue drug or discontinue breast feeding.
Use Cautiously in: History of bipolar disorder (may activate mania/hypomania);History of suicide attempt/ideation; genetic implication Poor CYP2D6 metabolizers will have ↑ blood levels; Geriatric: ↑ risk of hyponatremia; Pediatric: Safe and effective use in children has not been established.

Adverse Reactions/Side Effects

Gastrointestinal

  • constipation (most frequent)
  • nausea (most frequent)

Fluid and Electrolyte

  • hyponatremia

Genitourinary

  • sexual dysfunction (most frequent)

Hematologic

  • bleeding

Miscellaneous

  • allergic reactions including angioedema
  • serotOnin syndrome (life-threatening)

Interactions

Drug-Drug interaction

Concurrent use of MAOIs for psychiatric conditions or within 21 days of discontinuing vorioxetine is contraindicated; do not use vorioxetine within 14 days of discontinuing MAOIs used for psychiatric conditions, nor should vorioxetine be started in patients receiving linezolid or intravenous methylene blue due to risk of serious adverse reactions including serotonin syndrome.↑ risk of serotonin syndrome with other SSRIs, SNRIs, buspirone, fentanyl, lithium, tramadol, tricyclic antidepressants, triptans and tryptophan.Strong inhibitors of CYP2D6bupropion, fluoxetine, paroxetine, or quinidine ↑ blood levels and effects (decrease dose by 50%).Strong inducers of CYP2D6carbamazepine, phenytoin, rifampin ↓ blood levels and effectiveness, consider larger doses of vorioxetine if used for longer than 14 days (not to exceed three times original dose).↑ risk of bleeding with aspirin, NSAIDs, anticoagulants, thrombolytics, antiplatelet agents and other drugs affecting coagulation.↑ risk of serotonin syndrome with St. John's wort.

Route/Dosage

Oral (Adults) 10 mg once daily initially, may be increased to 20 mg once daily; some patients may only tolerate daily doses of 5 mg; CYP2D6 poor metabolizers—daily dose should not exceed 10 mg; concurrent use of inhibitors of CYP2D6—reduce dose by 50%; concurrent use of strong inducers of CYP2D6 for more than 14 days—consider increased dose (not to exceed three times original dose). If daily dose 15–20 mg/day, do not discontinue abruptly; taper to 10 mg/day for one week before discontinuing.

Availability

Immediate-release tablets: 5 mg, 10 mg, 15 mg, 20 mg

Nursing implications

Nursing assessment

  • Monitor mood changes. Inform health care professional if patient demonstrates significant increase in anxiety, nervousness, or insomnia.
  • Assess for suicidal tendencies, especially during early therapy. Restrict amount of drug available to patient. Risk may be increased in children, adolescents, and adults ≤24 yr. After starting therapy, children, adolescents, and young adults should be seen by health care professional at least weekly for 4 wk, every 3 wk for next 4 wk, and on advice of health care professional thereafter.
  • Monitor for signs and symptoms of hypersensitivity reactions (rash, hives, swelling, difficulty breathing). Stop vortioxetine and treat symptomatically.
  • Assess for sexual side effects (erectile dysfunction; decreased libido).
  • Monitor for serotonin syndrome (mental changes [agitation, hallucinations, coma], autonomic instability [tachycardia, labile BP, hyperthermia], neuromuscular aberrations [hyperreflexia, incoordination], and/or GI symptoms [nausea, vomiting, diarrhea]), especially in patients taking other serotonergic drugs (SSRIs, SNRIs, triptans).
  • Lab Test Considerations: May cause hyponatremia.

Potential Nursing Diagnoses

Ineffective coping (Indications)
Risk for injury (Side Effects)
Sexual dysfunction (Side Effects)

Implementation

  • To avoid serotonin syndrome, allow at least 14 days between discontinuation of an MAO inhibitor and starting vortioxetine. Allow at least 21 days after stopping vortioxetine before starting an MAO inhibitor.
  • Oral: Administer once daily at the same time each day without regard to meals.

Patient/Family Teaching

  • Instruct patient to take vortioxetine at the same time each day as directed. Advise patient taking 15 mg/day or 20 mg/day of vortioxetine not to stop abruptly; may cause headache, muscle tension, mood swings, sudden outburst of anger, dizziness, and runny nose. Instruct patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
  • Inform patient that nausea is common in first wk of therapy and is dose related. Usually decreases in frequency after first wk, but may persist.
  • Caution patient to report signs and symptoms of hyponatremia (headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, and may worsen to hallucinations, syncope, seizures, coma, respiratory arrest, death) to health care professional promptly.
  • Advise patient, family and caregivers to look for suicidality, especially during early therapy or dose changes. Notify health care professional immediately if thoughts about suicide or dying, attempts to commit suicide, new or worse depression or anxiety, agitation or restlessness, panic attacks, insomnia, new or worse irritability, aggressiveness, acting on dangerous impulses, mania, or other changes in mood or behavior or if symptoms of serotonin syndrome occur.
  • Caution patient and caregiver to look for signs of activation of mania/hypomania (greatly increased energy, severe sleeping problems, racing thoughts, reckless behavior, unusually grand ideas, excessive happiness or irritability, talking more or faster than usual), especially in patients with a history or family history of bipolar disorder, mania, or hypomania.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications. Advise patient to avoid taking other CNS depressants or alcohol. Also taking aspirin, NSAIDs, warfarin, or other anticoagulants may increase risk of bleeding.
  • Inform patient that medication may cause decreased libido.
  • Advise patient to notify health care professional if symptoms of hypersensitivity reaction or serotonin syndrome occur or if nausea persists.
  • Instruct female patients to inform health care professional if pregnancy is planned or suspected, or if breastfeeding.
  • Emphasize the importance of follow-up exams to monitor progress.

Evaluation/Desired Outcomes

  • Increased sense of well-being.
    • Renewed interest in surroundings. May require 1–4 wk of therapy to obtain antidepressant effects.
References in periodicals archive ?
Vortioxetine also has an inhibitory effect on 5-HT7 and 5-HT1D receptors and partial agonism of 5-HT1B receptors.
Lurasidone * Latuda Mirtazapine * Remeron Moclobemide * Amira, Aurorix, Clobemix, Depnil, Manerix Modafinil * Provigil Olanzapine/fluoxetine * Symbyax Paroxetine * Paxil Phenelzine * Nardil Pramipexole * Mirapex Quetiapine * Seroquel Riluzole * Rilutek Sertraline * Zoloft Vortioxetine * Brintellix
Vortioxetine is FDA-approved to treat major depressive disorder (MDD) (Table 1), having shown efficacy in relieving depressive symptoms in clinical trials.
Vortioxetine hydrobromide is the antidepressant's brand name.
Table 1 Medications that can cause serotonin syndrome Action Medications Increases serotonin Tryptophan formation Increases release of Amphetamines and amphetamine derivatives serotonin Cocaine MDMA Impairs serotonin Cocaine, MDMA, meperidine, reuptake tramadol, pentazocine SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) SNRIs (desvenlafaxine, duloxetine, milnacipran, venlafaxine, levomilnacipran) Dopamine-norepinephrine reuptake inhibitors (bupropion) Serotonin modulators (nefazodone, trazodone, vilazodone, vortioxetine) TCAs (amitriptyline, amoxapine, clomipramine, desipramine, doxepin) St.
In the head-to-head analysis, vortioxetine emerged as the top-rated antidepressant, both in efficacy, with an odds ratio of 2.0, as well as in acceptability.
Speaking about the safety and efficacy of Vortioxetine (Brintellix), he said its use results in significant improvement in depression symptoms.
Vortioxetine is approved in 77 countries and available in more than 60 countries to date.
Acute dosing of vortioxetine strengthens event-related brain activity associated with engagement of attention and cognitive functioning in rats.
Pharmacology and clinical potential of vortioxetine in the treatment of major depressive disorder.
Lundbeck reports positive clinical phase III results of vortioxetine in Japanese adults with Major Depressive Disorder
Lundbeck A/S (Lundbeck)(CPH:LUN), a global pharmaceutical company specialised in psychiatric and neurological disorders, announced on Wednesday the approval by the US Food and Drug Administration (FDA) of a supplemental new drug application for Trintellix (vortioxetine).