PEXEVA®

Depression Is Real

Depression is more than feeling "blue" or "down in the dumps" every now and then. It is a serious medical condition that affects millions of people in different ways.

Depression can affect your mood, your body, and your thoughts for long periods of time. It can change how you feel about yourself and others, and how you go about daily living. For some, it means a loss of energy or the ability to concentrate. It can interfere with appetite and sleep habits, but with proper treatment, 4 out of 5 people will improve.

Some people experience depression during or after a major event in their lives. Depression can also be caused by changes in hormone levels. A person's family history may contribute to a risk of depression. Most of the time, a combination of factors leads to a depressive episode. Today, scientists believe that depression may be caused by an imbalance of certain chemicals in the brain that can influence a person's mood.

Depression often occurs with some form of anxiety.
Generalized anxiety disorder can make a person feel irritable or tense, unable to stop worrying. People with panic disorder may suddenly feel panicky, break into a sweat, and feel their heart pounding. Anxiety symptoms, either as part of depression or as a distinct disorder, such as generalized anxiety disorder or panic disorder, can make someone who is experiencing depression feel even worse.

The good news is that depression, generalized anxiety disorder, and panic disorder are treatable.
For people with these disorders, PEXEVA can help resolve symptoms like sadness, low energy, sleep distrubance, irritability, despair, excessive worry, becoming easily fatigued, sudden and intense fear, or an urge to escape from a situation.

Important Safety Information

Suicidal thoughts or behavior and antidepressant drugs
Short-term studies have shown that antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults. When deciding to use PEXEVA® or any other antidepressant in these age groups, people must balance the risk with the potential benefit to the patient. Short-term studies did not show an increased risk of suicidality with antidepressants compared to placebo in adults beyond age 24; the risk decreased 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 by their doctor and watched closely to see if their condition worsens, if they have suicidal thoughts or behavior or if they exhibit any unusual changes in behavior. Families and caregivers need to understand that they should watch the patient closely and tell the doctor if they have any concerns. PEXEVA® is not approved for use in pediatric patients.

The most common side effects that have been reported with PEXEVA® include nausea, dry mouth, constipation, decreased appetite, infection, drowsiness, tremor, sweating, muscle weakness, trouble sleeping, abnormal ejaculation, impotence and other male genital disorders, and female genital disorders.

Please see Important Safety Information, including Black Boxed Warning. Please see accompanying full Prescribing Information including use in Pregnancy. (See WARNINGS-Clinical Worsening and Suicide Risk and Usage in Pregnancy: Teratogenic and Nonteratogenic Effects).

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.


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