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Important Risk Information About VIIBRYD

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, teens, and young adults. 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. VIIBRYD is not approved for use in patients under 18. See additional risk information below. For more information on this risk, please read the VIIBRYD Medication Guide in the accompanying full Prescribing Information.

Depressed? You Have Options

It's important to know that you're not alone. Depression affects approximately 16 million people in the United States.

Talking to your doctor is the first important step in learning about depression and available treatment options.

VIIBRYD® (vilazodone HCl) is one possible treatment option. It's the first drug of its kind approved by the FDA for treating depression in adults. Only you and your doctor can decide if VIIBRYD is right for you.

Continue to:

  • Learn more about the signs and symptoms of depression
  • Find out how VIIBRYD may work to relieve these symptoms
  • Download a guide to help you discuss your depression with your doctor

Depression affects approximately 16 million people in the United States

Get Started Now

What Is Depression?

Everyone can feel blue or sad sometimes, but these feelings may only last for a short period of time. However, when a person has depression, it's more than just a feeling of being sad.

Depression is a mood disorder in which feelings of sadness, along with other symptoms, can interfere with a person's normal day-to-day activities for a long period of time.

Next:
Learn about the Symptoms of Depression

What Are the Symptoms of Depression?

An episode of major depression lasts for at least 2 weeks. Symptoms include a depressed mood and/or a loss of interest or pleasure in daily activities, along with at least 4 of the following:

  • Increased irritability
  • Feelings of worthlessness or guilt
  • Agitation or restlessness
  • Fatigue and loss of energy
  • Trouble thinking, making decisions, or concentrating
  • Disturbed sleep, such as insomnia
  • Changes in appetite or weight
  • Thoughts of death or suicide, suicide attempts
Download a Guide to Help You Prepare for Your Next Doctor Appointment
Next:
How VIIBRYD May Help

VIIBRYD® (vilazodone HCl) Is Proven to Relieve Symptoms of Depression

In two 8-week studies, patients who took VIIBRYD experienced significant improvement in their symptoms of depression compared with those who took placebo ("sugar pills"). In these studies, the effect of VIIBRYD was measured on a scale that evaluated symptoms of depression, including:

  • Apparent or reported sadness
  • Inner tension
  • Reduced sleep
  • Reduced appetite
  • Difficulty concentrating
  • Difficulty performing daily activities
  • Reduced interest in daily activities
  • Negative thoughts
  • Thoughts of suicide

How Does VIIBRYD Work?

While the exact way VIIBRYD — or any other medication for depression — works is unknown, it is thought to affect the activity of serotonin in the brain.

Download a Guide to Help You Prepare for Your Next Doctor Appointment
Next:
What Are the Most Common Side Effects of VIIBRYD?

What Side Effects May
Occur with VIIBRYD® (vilazodone HCl)?

All antidepressants have side effects. The most common side effects of VIIBRYD include:

  • Diarrhea
  • Nausea
  • Vomiting
  • Trouble sleeping

Diarrhea and/or nausea were common in clinical studies of VIIBRYD, but most cases were either mild or moderate. They appeared during the first 2 weeks of treatment, and resolved in 5 to 8 days on average.

VIIBRYD was not shown to affect weight in two 8-week studies. In these studies, no more than 5% of patients reported any one sexual side effect. Sexual side effects reported included: decreased sexual desire, abnormal orgasm, delayed ejaculation, erectile dysfunction, or sexual dysfunction.

Next:
Talking to Your Doctor about Depression

Find Out if VIIBRYD® (vilazodone HCl) Is Right for You

If you're experiencing symptoms of depression, ask your doctor about available treatment options.

Start by telling your doctor about your history of symptoms and other medications you're taking. He or she can help you gain a better understanding of the nature of depression, as well as the various treatments available.

Remember, VIIBRYD is one possible treatment option, and only you and your doctor can decide if VIIBRYD is right for you.

Talk to your doctor today to learn more about depression and if VIIBRYD is right for you. To help you prepare for a productive conversation, download a Doctor Discussion Guide and bring it with you to your next appointment.

Get the Guide Now

VIIBRYD® (vilazodone HCl) is indicated for the treatment of major depressive disorder (MDD) in adults.

Important Risk Information

What is the most important information I should know about VIIBRYD?

VIIBRYD and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the symptoms described below, or call 911 if there is an emergency.

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, teens, and young adults. 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. VIIBRYD is not approved for use in patients under 18. For more information on this risk, please read the VIIBRYD Medication Guide in the accompanying full Prescribing Information.

Serotonin Syndrome: Agitation, hallucinations, coma or other changes in mental status; coordination problems or muscle twitching; fast heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting or diarrhea; muscle stiffness or tightness.

Abnormal bleeding: VIIBRYD and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAID), or aspirin.

Seizures or convulsions.

Manic episodes: Greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual.

Low salt (sodium) levels in the blood: Elderly people may be at greater risk for this. Symptoms may include headache; weakness or feeling unsteady; confusion, problems concentrating or thinking or memory problems.

Who should not take VIIBRYD?

  • Do not take any drugs known as MAOIs within 14 days of stopping VIIBRYD
  • Do not start VIIBRYD if you stopped taking an MAOI in the last 14 days
  • Do not start VIIBRYD if you are taking linezolid (a specific antibiotic) or are receiving intravenous methylene blue

People who take VIIBRYD close in time to taking an MAOI may have serious or even life-threatening side effects.

What should I tell my healthcare provider before starting VIIBRYD?

  • Tell your healthcare provider about all prescription, over-the-counter medications, vitamins and herbal supplements you are taking or plan to take, including:
    • Triptans used to treat migraine headaches; medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, buspirone, or antipsychotics; tramadol, mephenytoin (Mesantoin) or over-the-counter supplements such as tryptophan or St. John’s Wort; this is necessary to avoid a potentially life-threatening condition
    • Aspirin, NSAID pain relievers, or blood thinners (warfarin, Coumadin or Jantoven) because they may increase the risk of bleeding
  • Speak with your doctor if you:
    • Have kidney or liver problems
    • Have or had mania, bipolar disorder (manic depression), seizures or convulsions
    • Have or had bleeding problems. VIIBRYD may increase your risk of bleeding or bruising
    • Have low salt (sodium) levels in your blood, or are taking diuretics (water pills)
    • Are nursing, pregnant, or are planning to become pregnant or to breastfeed

Do not stop VIIBRYD without first talking to your healthcare provider.

  • Stopping VIIBRYD suddenly may cause serious symptoms including: anxiety, irritability, high or low mood, feeling restless or sleepy; headache, sweating, nausea, dizziness; electric shock-like sensations, tremor, and confusion.

What should I avoid when taking VIIBRYD?

  • Until you know how VIIBRYD affects you, you should not drive, operate heavy machinery, or engage in other dangerous activities. Avoid drinking alcohol while taking VIIBRYD.

What are the most common side effects of VIIBRYD?

  • The most common side effects in people taking VIIBRYD include diarrhea, nausea or vomiting, and trouble sleeping.
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of VIIBRYD. For more information, ask your healthcare provider or pharmacist.


Call your doctor for medical advice about side effects.


Please also see Medication Guide within the full Prescribing Information.


© 2013 Forest Laboratories, Inc.


VIIBRYD is a registered trademark of Forest Laboratories, Inc.

All other trademarks are the property of their respective owners.


047-12000223-R1     04/13



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