Adverse Events with VIIBRYD®

Adverse reactions occurring in ≥2% of patients treated with VIIBRYD and at a rate greater than in placebo-treated patients*¹

System Organ Class Preferred Term	VIIBRYD 40 mg/day (N=436)	Placebo (N=433)
Gastrointestinal disorders
Diarrhea	28	9
Nausea	23	5
Dry mouth	8	5
Vomiting	5	1
Dyspepsia	3	2
Flatulence	3	2
Gastroenteritis	3	<1
Nervous system disorders
Dizziness	9	5
Somnolence	3	2
Paresthesia	3	1
Tremor	2	0
Psychiatric disorders
Insomnia	6	2
Abnormal dreams	4	1
Libido decreased	4	<1
Restlessness ^†	3	<1
Orgasm abnormal ^‡	3	0
General disorders
Fatigue	4	3
Feeling jittery	2	<1
Cardiac disorders
Palpitations	2	<1
Musculoskeletal and connective tissue disorders
Arthralgia	3	2
Reproductive system and breast disorders
Delayed ejaculation ^§	2	0
Erectile dysfunction ^§	2	1
Metabolism and nutrition disorders
Increased appetite	2	1

*Pooled results from 2 randomized, double-blind, placebo-controlled, multicenter, 8-week studies in adult patients with MDD aged 18 to 70 years. VIIBRYD treatment was initiated once daily at 10 mg for 7 days, followed by 20 mg for another 7 days, and 40 mg thereafter until the end of week 8. VIIBRYD was administered with food.
^†Includes restlessness, akathisia, and restless legs syndrome.
^‡Includes orgasm abnormal and anorgasmia.
^§Male patients only (VIIBRYD, n=170; placebo, n=182).

Diarrhea, nausea, and insomnia were judged to be mild to moderate in severity and did not require concomitant medications in the
majority of patients²

Onset of diarrhea and nausea took place during the initial 2-week titration period
Median duration was short—5 days for nausea and 8 days for diarrhea and insomnia

Sexual adverse reactions*¹

Women

	VIIBRYD (n=266)	Placebo (n=251)
Decreased libido	3%	<1%
Abnormal orgasm*	2%	0%
Sexual dysfunction	<1%	<1%

Men

	VIIBRYD (n=170)	Placebo (n=182)
Decreased libido	5%	0%
Abnormal orgasm*	4%	0%
Delayed ejaculation	2%	0%
Erectile dysfunction	2%	1%
Sexual dysfunction	2%	0%

*Includes anorgasmia

Discontinuation rates due to adverse reactions*¹

7.1% of patients taking VIIBRYD discontinued treatment due to an adverse reaction compared with 3.2% of patients taking placebo
No single adverse reaction led to discontinuation of treatment in >1% of patients

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of VIIBRYD or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. VIIBRYD is not approved for use in pediatric patients.

Contraindications

Serotonin Syndrome and MAOIs: 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.

Warnings and Precautions

All patients treated with antidepressants should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of treatment and when changing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or includes symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or suicidality that are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants should be alerted about the need to monitor patients daily. Prescriptions for VIIBRYD should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including VIIBRYD, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Symptoms of serotonin syndrome may include mental status changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile blood pressure, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms. If symptoms of serotonin syndrome occur, discontinue VIIBRYD and initiate supportive treatment. If concomitant use of VIIBRYD with other serotonergic drugs is clinically warranted, patients should be aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases. Patients should be monitored for the emergence of serotonin syndrome.
Like other antidepressants, VIIBRYD should be prescribed with caution in patients with a seizure disorder.
The use of drugs that interfere with serotonin reuptake, including VIIBRYD, may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of VIIBRYD and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation or bleeding.
Symptoms of mania/hypomania were noted in 0.1% of patients treated with VIIBRYD in clinical studies. As with all antidepressants, VIIBRYD should be used cautiously in patients with a history or family history of bipolar disorder, mania, or hypomania.
Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. VIIBRYD is not approved for use in treating bipolar depression.
Discontinuation symptoms have been reported with discontinuation of serotonergic drugs such as VIIBRYD. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients when discontinuing VIIBRYD. If intolerable symptoms occur following a dose decrease or upon discontinuation of treatment, consider resuming the previously prescribed dose and decreasing the dose at a more gradual rate.
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. Although no cases of hyponatremia resulting from VIIBRYD treatment were reported in the clinical studies, hyponatremia has occurred as a result of treatment with SSRIs and SNRIs. Discontinuation of VIIBRYD in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.

Adverse Reactions

The most commonly observed adverse reactions in MDD patients treated with VIIBRYD in placebo-controlled studies (incidence ≥5% and at least twice the rate of placebo) were: diarrhea (28% vs 9%), nausea (23% vs 5%), insomnia (6% vs 2%), and vomiting (5% vs 1%).

Please also see full Prescribing Information

References:

1. Viibryd (vilazodone HCl) [package insert]. St. Louis, MO: Forest Pharmaceuticals, Inc.; 2012. 2. Data on file. Forest Laboratories, Inc.