Bipolar I Disorder – It’s More Common Than You Think

(BPT) – Bipolar I disorder is a condition that equally affects men and women, regardless of age, race, or ethnicity.<sup>1</sup> Approximately 1.5 million adults in America are living with this disease, yet it’s a condition that’s still chronically misunderstood and often misdiagnosed.<sup>2</sup> In fact, people with bipolar disorder may struggle an average of 10 years before they receive an accurate diagnosis.<sup>1</sup> That’s why knowing and understanding the symptoms is so important.

“One of the biggest difficulties with diagnosis is the wide variety of ways in which the disorder can manifest itself,” said Gary Sachs, MD, Associate Clinical Professor of Psychiatry at Harvard Medical School. “Although every person with bipolar I disorder can experience it differently, these experiences do include features that fall into specific categories of identifiable symptoms.”

Whether you’re someone who has a history of mental illness or are concerned about a loved one who is struggling with their mental health, Dr. Sachs sheds light on bipolar I disorder and answers some important questions to help you better understand this condition.

<strong>What is bipolar I disorder?</strong>

Bipolar I disorder is a brain and behavioral disorder that causes unusual changes in mood, activity levels, energy, and judgment, impacting a person’s ability to carry out day-to-day tasks.<sup>3</sup> Everyone has typical ups and downs, but in bipolar I disorder these can be more extreme. People diagnosed with bipolar I disorder have periods called “mood episodes,” which can be either manic, hypomanic, depressive, or mixed.<sup>3</sup> Every patient experiences episodes differently, but it’s important to note that bipolar I patients have had at least one manic or mixed episode. When managing their condition, patients should keep an open dialogue with their healthcare providers.<sup>4</sup>

<strong>Can you tell me more about what it means to experience mania?</strong>

Many people know what it means to be depressed, but fewer understand mania. Someone experiencing manic symptoms of bipolar I disorder may have periods of unusually elevated feelings like extreme happiness, energy, or irritability. Some symptoms of manic episodes may include<sup>3</sup>:

<ul><li>Feeling unusually happy, excited, or energetic</li><li>Feeling restless, irritable, wired, or overreactive</li><li>Having racing thoughts, difficulty concentrating</li><li>Poor judgment with risk taking, indulging in impulsive behaviors, and having a heightened sense of self-importance</li></ul>

<strong>What does it mean to experience a mixed episode? Is it common?</strong>

<a rel=”nofollow” name=”_Hlk498699812″ id=”_Hlk498699812″></a>Someone with bipolar I disorder can have a mixed episode when experiencing symptoms of mania and depression at the same time. Mixed episodes are more common than you may think. In fact, 40% of people living with bipolar I disorder have experienced a mixed episode, sometimes called a “mixed state.”<a rel=”nofollow” name=”_Hlk498699877″ id=”_Hlk498699877″></a><sup>5</sup> Some of these symptoms include<sup>3</sup>:

<ul><li>Feeling overly energized, while feeling very hopeless</li><li>Feeling agitated, while having extreme changes in appetite, and having suicidal thoughts</li><li>Having racing thoughts, while feeling “slowed down” or experiencing a loss of interest in something once enjoyed</li></ul>

<strong>Can you treat bipolar I disorder?</strong>

There is no known cure for bipolar I disorder, but symptoms may be managed through treatment. It is important for patients to partner with their healthcare providers, so that, together, they can determine an appropriate treatment plan. This may include counseling, support groups, and medicine. In fact, recently approved atypical antipsychotics have provided additional options to help people living with bipolar I disorder.

VRAYLAR<sup>®</sup> (cariprazine) is a once-a-day prescription medicine that’s FDA-approved in adults for the acute treatment of manic or mixed episodes of bipolar I disorder.<sup>6</sup> In clinical studies, VRAYLAR<sup>®</sup> was proven to help manage manic symptoms in adults with manic or mixed episodes associated with bipolar I disorder. VRAYLAR<sup>®</sup> showed significant improvement in overall manic symptoms compared to those who took a placebo (sugar pill). VRAYLAR<sup>®</sup> was not studied to measure symptoms individually, and is not approved to treat hypomania, depression, or depressive symptoms.

Every patient experiences symptoms differently and not all patients respond to treatment in the same way. That’s why it’s important for patients suffering from bipolar I disorder to actively engage with their healthcare provider to determine which treatment path is appropriate for them.

<strong>IMPORTANT RISK INFORMATION</strong>

<strong>What is the most important information I should know about VRAYLAR?</strong>

<div style=”border: solid 1px black; padding: 8px; margin-bottom: 20px;”><strong>Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking antipsychotic drugs are at an increased risk of death.</strong></div>

<strong>V</strong><strong>RAYLAR may cause serious side effects, including:</strong>

<ul><li><strong>S</strong><strong>troke (which can be fatal) in elderly people with dementia</strong></li><li><strong>N</strong><strong>eu</strong><strong>r</strong><strong>o</strong><strong>l</strong><strong>ep</strong><strong>tic malignant syndrome (NMS):</strong> Call your healthcare provider right away if you have high fever; stiff muscles; confusion; changes in pulse, heart rate, or blood pressure; or sweating. These can be symptoms of a rare but potentially fatal side effect called NMS. VRAYLAR should be stopped if you have NMS</li><li><strong>T</strong><strong>a</strong><strong>r</strong><strong>di</strong><strong>v</strong><strong>e dyskinesia (TD):</strong> Tell your healthcare provider if you cannot control the movements of your face, tongue, or other body parts. These could be signs of a serious and sometimes permanent side effect called TD. Risk of developing TD and the chance that it will become permanent are thought to increase the longer a person takes the medicine and the more medicine a person takes over time. TD can develop even after a person has been taking the medicine for a short time at low doses. TD may partially or completely go away if you stop taking VRAYLAR. TD may also start after you stop taking VRAYLAR</li><li><strong>Late-occurring side effects:</strong> VRAYLAR stays in the body for several weeks, even after you stop taking it, which could affect the timing of when you may experience side effects. Tell your healthcare provider if you have side effects (eg, uncontrolled movements of the body and face, muscle stiffness, or feelings of restlessness) as these may occur several weeks after starting or increasing dose of VRAYLAR</li><li><strong>Problems with your metabolism, such as:</strong><ul style=”list-style-type: square;”><li><strong>High blood sugar and diabetes:</strong> If you have diabetes or risk factors for diabetes (eg, being overweight or family history of diabetes), your blood sugar should be tested before you start VRAYLAR and regularly during treatment. Complications of diabetes can be serious and even life threatening. Tell your healthcare provider if you have symptoms such as feeling very thirsty or very hungry, urinating more than usual, or feeling weak</li><li><strong>I</strong><strong>n</strong><strong>cr</strong><strong>ea</strong><strong>sed blood cholesterol or triglycerides:</strong> Your healthcare provider should check your cholesterol and triglyceride levels before and during treatment</li><li><strong>Wei</strong><strong>g</strong><strong>h</strong><strong>t gain:</strong> Weight gain has been reported with VRAYLAR. Your healthcare provider should check your weight before and regularly during treatment</li></ul></li><li><strong>Low white blood cell count:</strong> Low white blood cell counts have been reported with antipsychotic drugs, including VRAYLAR. This may increase your risk of infection. Very low white blood cell counts, which can be fatal, have been reported with other antipsychotics</li><li><strong>Decreased blood pressure:</strong> You may feel lightheaded or faint when you rise too quickly from a sitting or lying position</li><li><strong>Falls:</strong> VRAYLAR may increase risk of falls, which could cause fractures or other injuries</li><li><strong>Se</strong><strong>iz</strong><strong>u</strong><strong>r</strong><strong>e</strong><strong>s</strong></li><li><strong>I</strong><strong>mpaired judgment, thinking, and motor skills:</strong> Do NOT drive or use dangerous machinery until you know how VRAYLAR affects you. VRAYLAR may make you drowsy</li><li><strong>I</strong><strong>n</strong><strong>cr</strong><strong>ea</strong><strong>sed body temperature:</strong> VRAYLAR may make you more sensitive to heat. You may have trouble cooling off. Be careful when exercising or when doing things likely to cause dehydration or make you warm</li><li><strong>Difficulty swallowing:</strong> VRAYLAR and medicines like it have been associated with difficulty swallowing</li></ul>

<strong>Who should not take VRAYLAR?</strong>

Do not take VRAYLAR if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (eg, rash, itching, hives, swelling of the tongue, lip, face or throat).

<strong>What should I tell my healthcare provider before taking VRAYLAR?</strong>

Tell your healthcare provider about any medical conditions and if you have or have had:

<ul><li>Diabetes or high blood sugar in you or your family</li><li>High levels of total cholesterol, triglycerides, or LDL-cholesterol; or low levels of HDL-cholesterol</li><li>Seizures or conditions that increase your risk for seizures</li><li>Low or high blood pressure</li><li>Low white blood cell count</li></ul>

Tell your healthcare provider if you are pregnant, or if you plan to become pregnant. Using VRAYLAR in the third trimester may cause uncontrolled movements of the body and face, muscle stiffness, or feelings of restlessness and/or withdrawal symptoms in newborn babies. A special program (National Pregnancy Registry for Atypical Antipsychotics) collects information on the safety of antipsychotic drugs, including VRAYLAR, during pregnancy. For information, contact the program at 1-866-961-2388 or visit <a href=”http://www.womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/” target=”_blank” rel=”nofollow noopener”>http://www.womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.</a>

Tell your healthcare provider about all medicines that you take or have recently taken, including prescriptions, over-the-counter medicines, and supplements. VRAYLAR may affect the way other medicines work, and other medicines may affect how VRAYLAR works.

<strong>What are the most common side effects of VRAYLAR?</strong>

<ul><li>The most common side effects were uncontrolled movements of the body and face, muscle stiffness, vomiting, indigestion, sleepiness, and restlessness.</li></ul>

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all possible side effects of VRAYLAR.

<strong>Please also see full</strong> <a href=”https://www.allergan.com/assets/pdf/vraylar_pi” rel=”nofollow”><strong>Prescribing Information</strong></a><strong>, including Boxed Warning, which are also available at</strong> <a href=”http://www.vraylar.com/” rel=”nofollow”><strong>www.vraylar.com</strong></a> <strong>and</strong> <a href=”https://www.allergan.com/assets/pdf/vraylar_pi” rel=”nofollow”><strong>https://www.allergan.com/assets/pdf/vraylar_pi</strong></a><strong>.</strong>

<strong><span style=”text-decoration: underline”>References</span></strong>

<ol><li>Depression and Bipolar Support Alliance. Bipolar Disorder Statistics. Available at: <a href=”http://www.dbsalliance.org/site/PageServer?pagename=education_statistics_bipolar_disorder” rel=”nofollow”>http://www.dbsalliance.org/site/PageServer?pagename=education_statistics_bipolar_disorder</a>. Accessed January 31, 2018.</li><li>National Institute of Mental Health. Bipolar Disorder Among Adults. Available at <a href=”https://www.nimh.nih.gov/health/statistics/prevalence/bipolar-disorder-among-adults.shtml” rel=”nofollow”>https://www.nimh.nih.gov/health/statistics/prevalence/bipolar-disorder-among-adults.shtml</a>. Accessed January 31, 2018.</li><li>National Institute of Mental Health. Bipolar Disorder. Available at: <a href=”https://www.nimh.nih.gov/health/topics/bipolar-disorder/index.shtml” rel=”nofollow”>https://www.nimh.nih.gov/health/topics/bipolar-disorder/index.shtml</a>. Accessed January 31, 2018.</li><li>American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.</li><li>Muneer, A. Mixed States in Bipolar Disorder: Etiology, Pathogenesis and Treatment. Chonnam Medical Journal. 2017 Jan; 53(1): 1–13. doi: 10.4068/cmj.2017.53.1.1.</li><li>VRAYLAR<sup>®</sup> (cariprazine) [package insert]. Irvine, CA: Allergan USA, Inc.; 2017.</li></ol>

Allergan<sup>®</sup> and its design are trademarks of Allergan, Inc.

VRAYLAR<sup>®</sup> and its design are registered trademarks of Forest Laboratories Holdings Ltd., an Allergan affiliate.

Licensed from Gedeon Richter Plc.

© 2018 Allergan. All rights reserved.

VRA112771_v2 02/18

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• <strong>Low white blood cell count:</strong> Low white blood cell counts have been reported with antipsychotic drugs, including VRAYLAR. This may increase your risk of infection. Very low white blood cell counts, which can be fatal, have been reported with other antipsychotics

• <strong>Decreased blood pressure:</strong> You may feel lightheaded or faint when you rise too quickly from a sitting or lying position

• <strong>Falls:</strong> VRAYLAR may increase risk of falls, which could cause fractures or other injuries

• <strong>Se</strong><strong>iz</strong><strong>u</strong><strong>r</strong><strong>e</strong><strong>s</strong>

• <strong>I</strong><strong>mpaired judgment, thinking, and motor skills:</strong> Do NOT drive or use dangerous machinery until you know how VRAYLAR affects you. VRAYLAR may make you drowsy

• <strong>I</strong><strong>n</strong><strong>cr</strong><strong>ea</strong><strong>sed body temperature:</strong> VRAYLAR may make you more sensitive to heat. You may have trouble cooling off. Be careful when exercising or when doing things likely to cause dehydration or make you warm

• <strong>Difficulty swallowing:</strong> VRAYLAR and medicines like it have been associated with difficulty swallowing

<strong>Who should not take VRAYLAR?</strong>

Do not take VRAYLAR if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (eg, rash, itching, hives, swelling of the tongue, lip, face or throat).

</div>

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