Glamour The Q and A on bipolar I disorder

VRAYLAR^® (cariprazine) is a prescription medicine approved for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

IMPORTANT RISK INFORMATION

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

Please see additional
Important Risk Information
below.

• Stroke (which can be fatal) in elderly people with dementia
• Neuroleptic malignant syndrome (NMS): 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
• Tardive dyskinesia (TD): 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
• Late-occurring side effects: 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
• Problems with your metabolism, such as:
• High blood sugar and diabetes: 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
• Increased blood cholesterol or triglycerides: Your healthcare provider should check your cholesterol and triglyceride levels before and during treatment
• Weight gain: Weight gain has been reported with VRAYLAR. Your healthcare provider should check your weight before and regularly during treatment
• Low white blood cell count: 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
• Decreased blood pressure: You may feel lightheaded or faint when you rise too quickly from a sitting or lying position
• Falls: VRAYLAR may increase risk of falls, which could cause fractures or other injuries
• Seizures
• Impaired judgement, thinking, and motor skills: Do NOT drive or use dangerous machinery until you know how VRAYLAR affects you. VRAYLAR may make you drowsy
• Increased body temperature: 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
• Difficulty swallowing: VRAYLAR and medicines like it have been associated with difficulty swallowing

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

• The most common side effects were uncontrolled movements of the body and face, muscle stiffness, vomiting, indigestion, sleepiness, and restlessness.