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Viibryd

Generic Name: Vilazodone
Drug Category: SSRI
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old and under the age of 70 years old for a maximum duration of 10 weeks.

Approved Uses

• Indicated for the treatment of major depressive disorder (MDD) in adults.

Antidepressants increase the risk of suicidal thoughts and behaviors in patients aged 24 years and younger. Monitor for clinical worsening and emergence of suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes.

Safety and effectiveness of VIIBRYD have not been established in pediatric patients.

In patients with bipolar disorder, treating a depressive episode with VIIBRYD or another antidepressant may precipitate a mixed/manic episode. Prior to initiating treatment with VIIBRYD, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.

Adverse reactions may occur upon discontinuation of VIIBRYD. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible.

Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including VIIBRYD.

VIIBRYD has not been systematically evaluated in patients with a seizure disorder. Patients with a history of seizures were excluded from clinical studies. VIIBRYD should be prescribed with caution in patients with a seizure disorder.

The pupillary dilation that occurs following use of many antidepressant drugs including VIIBRYD may trigger an angle closure attack. In a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including VIIBRYD, in patients with untreated anatomically narrow angles.

Use of SSRIs, including VIIBRYD, may cause symptoms of sexual dysfunction. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.

SNRIs and SSRIs, including VIIBRYD, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs. 

Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including VIIBRYD. Elderly patients, patients taking diuretics, and those who are volume depleted may be at greater risk of developing hyponatremia with SSRIs and SNRIs.

Consider increasing the dosage of VIIBRYD by 2-fold, up to a maximum 80 mg once daily, over 1 to 2 weeks in patients taking strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) for greater than 14 days. If CYP3A4 inducers are discontinued, gradually reduce the VIIBRYD dosage to its original level over 1 to 2 weeks.

During concomitant use of a strong CYP3A4 inhibitor (e.g., itraconazole, clarithromycin, voriconazole), the VIIBRYD dose should not exceed 20 mg once daily. The original VIIBRYD dose level, can be resumed when the CYP3A4 inhibitor is discontinued.

Drugs that interfere with serotonin reuptake inhibition, including VIIBRYD, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk.

Do not use MAOIs intended to treat psychiatric disorders with VIIBRYD or within 14 days of stopping treatment with VIIBRYD. Do not use VIIBRYD within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start VIIBRYD in a patient who is being treated with linezolid or intravenous methylene blue.

Concomitant use of VIIBRYD increased digoxin concentrations.

Exposure to SSRIs and SNRIs, including VIIBRYD, in late pregnancy may lead to an 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 VIIBRYD in the third trimester of pregnancy for PPHN and drug discontinuation syndrome.

There are no data on the presence of vilazodone in human milk, the effects of vilazodone on the breastfed infant, or the effects of the drug on milk production. However, vilazodone is excreted in rat milk.

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Off-label Uses

• Dosage greater than 40 mg per day. GoToSource

• Obsessive compulsive disorder, social anxiety and generalized anxiety disorder. GoToSource

• Use in patients under the age of 18. GoToSource

• Premature ejaculation, migraine headaches, diabetic neuropathy, fibromyalgia and neurocardiogenic syncope. GoToSource 

• Post-traumatic stress disorder, eating disorders, premenstrual disorders and alcohol dependence. GoToSource

Adverse Events

Suicidal ideation and behavior. GoToSource

Increased risk of bleeding. GoToSource

Serotonin syndrome (life-threatening drug reaction), abnormal dreams, decreased libido, arthralgia (joint pain) and palpitations. GoToSource

Pancreatitis (inflammation of the pancreas). GoToSource

Angle-closure glaucoma. GoToSource

Birth defects. GoToSource  

Activation of mania or hypomania, hyponatremia (low sodium level in the blood) and discontinuation syndrome (dysphoric mood, irritability, agitation, anxiety, and confusion). GoToSource

Seizures. GoToSource

Litigation

Lawsuits filed for birth defects. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 28, 2024