Viibryd (vilazodone hydrochloride) Medication Guide

Viibryd Patient Counseling Information

Viibryd Patient Information

Information for Patients

Advise patients and their caregivers about the benefits and risks associated with treatment with VIIBRYD and counsel them in its appropriate use. Advise patients and their caregivers to read the Medication Guide and assist them in understanding its contents. The complete text of the Medication Guide is reprinted at the end of this document.

Suicide Risk

Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dose is adjusted up or down [see Box Warning and Warnings and Precautions].

Dosing and Administration

Instruct patients to take VIIBRYD with food. When initiating treatment with VIIBRYD the dose should be titrated, starting with a dose of 10 mg once daily for 7 days, followed by 20 mg once daily for an additional 7 days, and then increased to 40 mg once daily.

Concomitant Medication

Instruct patients not to take VIIBRYD with an MAOI or within 14 days of stopping an MAOI and to allow 14 days after stopping VIIBRYD before starting an MAOI [see Contraindications].

Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions

Caution patients about the risk of serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions, particularly with the concomitant use of VIIBRYD and triptans, tramadol, tryptophan supplements, other serotonergic agents, or antipsychotic drugs [see Warnings and Precautions and Drug Interactions].

Seizures

Caution patients about using VIIBRYD if they have a history of a seizure disorder [see Warnings and Precautions]. Patients with a history of seizures were excluded from clinical studies.

Abnormal Bleeding

Caution patients about the concomitant use of VIIBRYD and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of abnormal bleeding [see Warnings and Precautions].

Activation of Mania/Hypomania

Advise patients and their caregivers to observe for signs of activation of mania/hypomania [see Warnings and Precautions].

Discontinuation

Advise patients not to stop taking VIIBRYD without talking first with their healthcare provider. Patients should be aware that discontinuation effects may occur when suddenly stopping VIIBRYD [see Warnings and Precautions].

Hyponatremia

Advise patients that if they are treated with diuretics, or are otherwise volume depleted, or are elderly, they may be at greater risk of developing hyponatremia while taking VIIBRYD [see Warnings and Precautions].

Alcohol

Advise patients to avoid alcohol while taking VIIBRYD [see Drug Interactions].

Allergic Reactions

Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing.

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with VIIBRYD [see Use in Specific Populations].

Nursing Mothers

Advise patients to notify their healthcare provider if they are breastfeeding an infant and would like to continue or start VIIBRYD [see Use in Specific Populations].

Interference with Cognitive and Motor Performance

Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that VIIBRYD therapy does not adversely affect their ability to engage in such activities.

Distributed by

Trovis Pharmaceuticals LLC
New Haven, CT 06511

877-878-7200
viibryd.com

Licensed from Merck KGaA,
Darmstadt, Germany

Product protected by U.S. Patent No. 5,532,241 and U.S. Patent No. 7,834,020.

VZ59PI0000

VIIBRYD™ is a trademark of Trovis Pharmaceuticals LLC.

© 2011 Trovis Pharmaceuticals LLC.

Last update: January 2011

Viibryd Patient Information

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