ABILIFY

ABILIFY
ABILIFY is added to an antidepressant to help treat unresolved symptoms of depression in adults when an antidepressant alone is not enough.
Treating depressive symptoms can be challenging
For some people, finding the antidepressant that works best for them may take a few tries. A large clinical study showed that approximately 2 out of 3 people being treated for depression are still experiencing depressive symptoms.

Common symptoms of depression include:
Sadness most of the day
Low energy or fatigue
Loss of interest in favorite activities
Feelings of hopelessness and/or pessimism
Difficulty concentrating
Irritability, restlessness, or being slowed down
Feeling worthless or guilty
Trouble sleeping or sleeping too much
Significant weight change
Thoughts about suicide or dying
Adding ABILIFY has been clinically proven to treat unresolved symptoms of depression in adults taking antidepressants including Lexapro® (escitalopram oxalate), Zoloft® (setraline hydrochloride), Prozac® (fluoxetine hydrochloride), Effexor XR® (venlafaxine hydrochloride), and Paxil CR® (paroxetine hydrochloride), or their generic equivalents where available.
Trademarks are of respective companies.
Ask your healthcare professional about the option of adding ABILIFY
If you’re still feeling depressive symptoms even after your doctor has changed your antidepressant, or made adjustments to your dose, and you have been taking the antidepressant for at least six weeks, ask if having ABILIFY added to your antidepressant could be right for you.
How ABILIFY is Thought to Work
ABILIFY is prescribed to adults with depression, in addition to an antidepressant medication such as Lexapro®, Zoloft®, Prozac®, Effexor XR®, and Paxil CR®, or their generic equivalents where available, when an antidepressant alone is not enough.
While the cause of depression is unknown, it is thought to be caused by an imbalance in key brain chemicals called neurotransmitters including dopamine, serotonin, and norepinephrine. Although the exact way ABILIFY or any other medicine for depression works is not known, it is thought that ABILIFY may work by affecting the activity of some key brain chemicals — adjusting dopamine instead of completely blocking it, and by also adjusting serotonin.
Dopamine may contribute to feelings of pleasure and positive mood states, and serotonin may play a role in regulating a person’s moods and emotions. Dopamine and serotonin may be involved in the development of a range of symptoms in depression.
Adding on to your antidepressant medication
Adding ABILIFY has been clinically proven to help relieve depression symptoms in adults taking antidepressants* such as the following for at least six weeks:
Lexapro® (escitalopram oxalate)
Zoloft® (setraline hydrochloride)
Prozac® (fluoxetine hydrochloride)
Effexor XR® (venlafaxine hydrochloride)
Paxil CR® (paroxetine hydrochloride)
Trademarks of respective companies
Clinical studies of adults with depression showed that adding ABILIFY to an antidepressant helped to significantly improve depressive symptoms compared to adults treated with an antidepressant alone.
How to Take ABILIFY with Your Current Antidepressant
It is important to take ABILIFY as prescribed by your healthcare professional.
What to expect with ABILIFY
ABILIFY is meant to be taken in addition to your current antidepressant—not instead of it. For most people, ABILIFY is prescribed as a pill, but other forms are available if you have trouble swallowing. ABILIFY should be taken at the same time each day. It can also be taken with or without food. So, if the medication bothers your stomach, it’s OK to take it with a meal or snack.
If you’ve missed a dose
If you do not take your ABILIFY as scheduled, take your missed dose as soon as you remember. However, if it’s almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose.
Safety Profile and Side Effects for ABILIFY
Below you’ll find answers to some commonly asked questions about taking ABILIFY and possible side effects associated with it.
What common side effects should I know about?
In 6-week clinical studies of adults with Major Depressive Disorder (MDD), the most commonly observed side effects associated with ABILIFY plus antidepressant therapy (ADT) reported in greater than or equal to 5% and twice the rate of placebo plus antidepressant therapy included an inner sense of restlessness or need to move (akathisia), insomnia, fatigue, blurred vision, and constipation. In clinical studies, few patients discontinued the use of ABILIFY due to side effects (6% for ABILIFY + antidepressant vs 2% for placebo + antidepressant).
Will ABILIFY make me feel sleepy or drowsy?
Feeling sleepy or drowsy is defined as somnolence and sedation. 6-week clinical studies of adults with MDD showed a low rate of somnolence and sedation, (10% of patients treated with ABILIFY + ADT felt sleepy or drowsy vs 6% of patients treated with ADT alone). Although you may not feel tired, you should not drive or operate hazardous machinery until you know how ABILIFY affects you.
Will ABILIFY make me gain weight?
In 6-week clinical studies of adults with MDD, ABILIFY plus ADT showed a low rate of significant weight gain. The percentage of people who gained more than or equal to 7% of their baseline body weight was 5% for ABILIFY plus ADT vs 1% for placebo plus ADT. The average weight change at Week 6 with people taking ABILIFY plus ADT was 3.7 lb vs 0.9 lb for placebo plus ADT.
Does ABILIFY affect sexual function?
In 6-week clinical trials of adults with MDD, ABILIFY plus ADT showed a minimal impact on sexual function as measured by the Sexual Function Inventory (SFI) Questionnaire. In addition, the rate of patient-reported adverse reactions related to sexual dysfunction with ABILIFY plus ADT was less than 2%.
Will ABILIFY affect my cholesterol?
In 6-week clinical studies of adults with MDD, ABILIFY plus ADT was not shown to significantly elevate levels of fasting HDL-C, LDL-C, or total cholesterol compared to placebo plus ADT.
The average percent change (median) in triglycerides was 5% in patients treated with ABILIFY plus ADT vs 0% in patients treated with placebo plus ADT.
Will ABILIFY affect my blood sugar?
In 6-week clinical studies of adults with MDD, ABILIFY plus ADT was not shown to significantly elevate levels of fasting glucose. Serious side effects can occur with any antipsychotic medicine, including ABILIFY. Tell your healthcare professional right away if you have any conditions or side effects, including the following:
Diabetes: Risk factors for diabetes include obesity, family history of diabetes, or unexpected increases in thirst, urination, or hunger
Increases in blood sugar levels (hyperglycemia): In some cases, serious risks related to increases in blood sugar associated with coma or death have been reported in patients taking ABILIFY and medicines like it
Ask your healthcare professional about the need to monitor your blood sugar level before and during treatment.
What additional Important Safety considerations should I know about?
Elderly people with psychosis related to dementia (for example, an inability to perform daily activities as a result of increased memory loss), treated with antipsychotic medicines including ABILIFY, are at an increased risk of death compared to placebo. ABILIFY is not approved for the treatment of people with dementia-related psychosis.
Antidepressants may increase suicidal thoughts or behaviors in some children, teenagers and young adults, especially, within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Such symptoms should be reported to the patient’s healthcare professional right away, especially if they are severe or occur suddenly. ABILIFY is not approved for use in pediatric patients with depression.
Serious side effects may also include:
An increased risk of stroke and ministroke have been reported in clinical studies of elderly people with dementia-related psychosis.
Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. These may be signs of a condition called neuroleptic malignant syndrome (NMS), a rare but serious side effect which could be fatal.
Uncontrollable movements of face, tongue, or other parts of body as these may be signs of a serious condition called tardive dyskinesia (TD). TD may become permanent and the risk of TD may increase with the length of treatment and the overall dose. While TD can develop after taking the medicine at low doses for short periods, this is much less common. There is no known treatment for TD, but it may go away partially or completely if the medicine is stopped.
Other risks may include lightheadedness upon standing, decreases in white blood cells (which can be serious), seizures, trouble swallowing and impairment in judgment or motor skills.
IMPORTANT SAFETY INFORMATION and INDICATION for ABILIFY® (aripiprazole)
Elderly people with psychosis related to dementia (for example, an inability to perform daily activities as a result of increased memory loss), treated with antipsychotic medicines including ABILIFY, are at an increased risk of death compared to placebo. ABILIFY is not approved for the treatment of people with dementia-related psychosis (see Boxed WARNING).
Antidepressants may increase suicidal thoughts or behaviors in some children, teenagers, and young adults, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Such symptoms should be reported to the patient’s healthcare professional right away, especially if they are severe or occur suddenly. ABILIFY is not approved for use in pediatric patients with depression (see Boxed WARNING).
Contraindication: Patients should not use ABILIFY if they are allergic to aripiprazole or any of the ingredients in ABILIFY. Allergic reactions have ranged from rash, hives, and itching to anaphylaxis, which may include difficulty breathing, tightness in the chest, and swelling of the mouth, face, lips, or tongue.
Serious side effects may include:
An increased risk of stroke and ministroke have been reported in clinical studies of elderly people with dementia-related psychosis
Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. These may be signs of a condition called neuroleptic malignant syndrome (NMS), a rare but serious side effect which could be fatal
Uncontrollable movements of face, tongue, or other parts of body as these may be signs of a serious condition called tardive dyskinesia (TD). TD may become permanent and the risk of TD may increase with the length of treatment and the overall dose. While TD can develop after taking the medicine at low doses for short periods, this is much less common. There is no known treatment for TD, but it may go away partially or completely if the medicine is stopped
If you have diabetes, or risk factors for diabetes (for example, obesity, family history of diabetes), or unexpected increases in thirst, urination, or hunger, your blood sugar should be monitored. Increases in blood sugar levels (hyperglycemia), in some cases serious and associated with coma or death, have been reported in patients taking ABILIFY and medicines like it
Lightheadedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting or lying position (orthostatic hypotension) has been reported with ABILIFY.
Decreases in white blood cells (infection fighting cells) have been reported in some patients taking antipsychotic agents, including ABILIFY. Patients with a history of a significant decrease in white blood cell (WBC) count or who have experienced a low WBC count due to drug therapy should have their blood tested and monitored during the first few months of therapy.
ABILIFY and medicines like it can affect your judgment, thinking, or motor skills. You should not drive or operate hazardous machinery until you know how ABILIFY affects you.
Medicines like ABILIFY® (aripiprazole) can impact your body’s ability to reduce body temperature; you should avoid overheating and dehydration.

ABILIFY and medicines like it have been associated with swallowing problems (dysphagia). If you had or have swallowing problems, you should tell your healthcare professional.
Tell your healthcare professional if you have a history of, or are at risk for seizures, or are pregnant or intend to become pregnant. Also tell your healthcare professional about all prescription and non-prescription medicines you are taking or plan to take, since there are some risks for drug interactions.
While taking ABILIFY, avoid:
Drinking alcohol
Breast-feeding an infant
Most common side effects (≥10%) from all clinical trials involving adults include:
ADULTS: Nausea, vomiting, constipation, headache, dizziness, an inner sense of restlessness or need to move (akathisia), anxiety, insomnia, and restlessness
It is important to contact your healthcare professional if you experience prolonged, abnormal muscle spasms or contractions which may be signs of a condition called dystonia.
For patients who must limit their sugar intake, ABILIFY Oral Solution contains sugar.
For patients with phenylketonuria or PKU, ABILIFY DISCMELT® (aripiprazole) contains phenylalanine.
If you have any questions about your health or medicines, talk to your healthcare professional.
INDICATION: ABILIFY is indicated for:
Use as an add-on treatment to an antidepressant for adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy.
Source: http://www.abilify.com/

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