Abilify

Abilify information
These highlights do not include all the information needed to use ABILIFY safely and effectively. ABILIFY&#174; (aripiprazole) Tablets

ABILIFY DISCMELT&#174; (aripiprazole) Orally Disintegrating Tablets

ABILIFY&#174; (aripiprazole) Oral Solution

ABILIFY&#174; (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY

Initial FDA approval
Initial U.S. Approval: 2002 PD-Rx Pharmaceuticals, Inc.PD-Rx Pharmaceuticals, Inc.PD-Rx Pharmaceuticals, Inc.ABILIFY ARIPIPRAZOLEARIPIPRAZOLEARIPIPRAZOLESTARCH, CORNHYDROXYPROPYL CELLULOSELACTOSE MONOHYDRATEMAGNESIUM STEARATECELLULOSE, MICROCRYSTALLINEFERRIC OXIDE REDFERRIC OXIDE YELLOWFD&amp;C BLUE NO. 2ALUMINUM OXIDEmodified rectangle A;008;10WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDALITY AND ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. ABILIFY (aripiprazole) is not approved for the treatment of patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS (5.1)]. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of adjunctive ABILIFY or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo 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 appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. ABILIFY is not approved for use in pediatric patients with depression [see WARNINGS AND PRECAUTIONS (5.2)]. WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDALITY AND ANTIDEPRESSANT DRUGS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis. (5.1)Children, adolescents, and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders are at increased risk of suicidal thinking and behavior. (5.2) Indications and Usage, Bipolar I Disorder, &#160;&#160;&#160;Adjunctive Therapy (1.2) &#160;&#160;&#160;02/2011

Dosage and Administration, Bipolar I Disorder
&#160;&#160;&#160; Adjunctive Therapy (2.2) &#160;&#160;&#160;02/2011 Dosage and Administration, Dosage Adjustment (2.6) &#160;&#160;&#160;02/20111 INDICATIONS AND USAGE ABILIFY is an atypical antipsychotic indicated &#160;&#160;as oral formulations for the: Treatment of schizophrenia (1.1) Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in patients with schizophrenia (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1) Acute treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy and as an adjunct to lithium or valproate (1.2) Adults: Efficacy was established in four 3-week monotherapy trials and one 6-week adjunctive trial in patients with manic or mixed episodes (14.2) Pediatric Patients (ages 10-17): Efficacy was established in one 4-week monotherapy trial in patients with manic or mixed episodes (14.2) Maintenance treatment of bipolar I disorder, both as monotherapy and as an adjunct to lithium or valproate (1.2) Adults: Efficacy was established in one maintenance monotherapy trial and in one maintenance adjunctive trial (14.2) Adjunctive treatment of major depressive disorder (MDD) (1.3) Adults: Efficacy was established in two 6-week trials in patients with MDD who had an inadequate response to antidepressant therapy during the current episode (14.3) Treatment of irritability associated with autistic disorder (1.4) Pediatric Patients (ages 6-17 years): Efficacy was established in two 8-week trials in patients with autistic disorder (14.4)

&#160;&#160;as an injection for the: Acute treatment of agitation associated with schizophrenia or bipolar I disorder (1.5) Adults: Efficacy was established in three 24-hour trials in agitated patients with schizophrenia or manic/mixed episodes of bipolar I disorder (14.5) 1.1 Schizophrenia ABILIFY is indicated for the treatment of schizophrenia. The efficacy of ABILIFY was established in four 4-6 week trials in adults and one 6-week trial in adolescents (13 to 17 years). Maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to adolescents [see CLINICAL STUDIES (14.1)].1.2 Bipolar I Disorder Acute Treatment of Manic and Mixed Episodes ABILIFY is indicated for the acute treatment of manic and mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or valproate. Efficacy as monotherapy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy trial in pediatric patients (10 to 17 years). Efficacy as adjunctive therapy was established in one 6-week adjunctive trial in adults [see CLINICAL STUDIES (14.2)].Maintenance Treatment of Bipolar I Disorder ABILIFY is indicated for the maintenance treatment of bipolar I disorder, both as monotherapy and as an adjunct to either lithium or valproate. Maintenance efficacy was demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trial in adults [see CLINICAL STUDIES (14.2)].1.3 Adjunctive Treatment of Major Depressive Disorder ABILIFY is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode [see CLINICAL STUDIES (14.3)].1.4	Irritability Associated with Autistic Disorder ABILIFY is indicated for the treatment of irritability associated with autistic disorder. Efficacy was established in two 8-week trials in pediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods) [see CLINICAL STUDIES (14.4)].1.5	Agitation Associated with Schizophrenia or Bipolar Mania ABILIFY Injection is indicated for the acute treatment of agitation associated with schizophrenia or bipolar disorder, manic or mixed. &#8220;Psychomotor agitation&#8221; is defined in DSM-IV as &#8220;excessive motor activity associated with a feeling of inner tension&#8221;. Patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care (eg, threatening behaviors, escalating or urgently distressing behavior, or self-exhausting behavior), leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation. Efficacy was established in three short-term (24-hour) trials in adults [see CLINICAL STUDIES (14.5)].1.6	Special Considerations in Treating Pediatric Schizophrenia, Bipolar I Disorder, and Irritability Associated with Autistic Disorder Psychiatric disorders in children and adolescents are often serious mental disorders with variable symptom profiles that are not always congruent with adult diagnostic criteria. It is recommended that psychotropic medication therapy for pediatric patients only be initiated after a thorough diagnostic evaluation has been conducted and careful consideration given to the risks associated with medication treatment. Medication treatment for pediatric patients with schizophrenia, bipolar I disorder, and irritability associated with autistic disorder is indicated as part of a total treatment program that often includes psychological, educational, and social interventions.

2 DOSAGE AND ADMINISTRATION

Formulations
Oral formulations: Administer once daily without regard to meals (2)  IM injection: Wait at least 2 hours between doses. Maximum daily dose 30 mg (2.5)   2.1	Schizophrenia       Adults   Dose Selection:  The recommended starting and target dose for ABILIFY is 10 mg/day or 15 mg/day administered on a once-a-day schedule without regard to meals. ABILIFY has been systematically evaluated and shown to be effective in a dose range of 10 mg/day to 30 mg/day, when administered as the tablet formulation; however, doses higher than 10 mg/day or 15 mg/day were not more effective than 10 mg/day or 15 mg/day. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state [see CLINICAL STUDIES (14.1)]. Maintenance Treatment: Maintenance of efficacy in schizophrenia was demonstrated in a trial involving patients with schizophrenia who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer. These patients were discontinued from those medications and randomized to either ABILIFY 15 mg/day or placebo, and observed for relapse [see CLINICAL STUDIES (14.1)]. Patients should be periodically reassessed to determine the continued need for maintenance treatment. Adolescents  Dose Selection:  The recommended target dose of ABILIFY is 10 mg/day. Aripiprazole was studied in adolescent patients 13 to 17 years of age with schizophrenia at daily doses of 10 mg and 30 mg. The starting daily dose of the tablet formulation in these patients was 2 mg, which was titrated to 5 mg after 2 days and to the target dose of 10 mg after 2 additional days. Subsequent dose increases should be administered in 5 mg increments. The 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose. ABILIFY can be administered without regard to meals [see CLINICAL STUDIES (14.1)]. Maintenance Treatment: The efficacy of ABILIFY for the maintenance treatment of schizophrenia in the adolescent population has not been evaluated. While there is no body of evidence available to answer the question of how long the adolescent patient treated with ABILIFY should be maintained on the drug, maintenance efficacy can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment. Switching from Other Antipsychotics  There are no systematically collected data to specifically address switching patients with schizophrenia from other antipsychotics to ABILIFY or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. 2.2	Bipolar I Disorder      Acute Treatment of Manic and Mixed Episodes     Adults:  The recommended starting dose in adults is 15 mg given once daily as monotherapy and 10 mg to 15 mg given once daily as adjunctive therapy with lithium or valproate. ABILIFY can be given without regard to meals. The recommended target dose of ABILIFY is 15 mg/day, as monotherapy or as adjunctive therapy with lithium or valproate. The dose may be increased to 30 mg/day based on clinical response. The safety of doses above 30 mg/day has not been evaluated in clinical trials. Pediatrics: The recommended starting dose in pediatric patients (10 to 17 years) as monotherapy is 2 mg/day, with titration to 5 mg/day after 2 days, and a target dose of 10 mg/day after 2 additional days. Recommended dosing as adjunctive therapy to lithium or valproate is the same. Subsequent dose increases, if needed, should be administered in 5 mg/day increments. ABILIFY can be given without regard to meals [see CLINICAL STUDIES (14.2)]. Maintenance Treatment    The recommended dose for maintenance treatment, whether as monotherapy or as adjunctive therapy, is the same dose needed to stabilize patients during acute treatment, both for adult and pediatric patients. Patients should be periodically reassessed to determine the continued need for maintenance treatment [see CLINICAL STUDIES (14.2)]. 2.3 Adjunctive Treatment of Major Depressive Disorder   Adults  Dose Selection:  The recommended starting dose for ABILIFY as adjunctive treatment for patients already taking an antidepressant is 2 mg/day to 5 mg/day. The efficacy of ABILIFY as an adjunctive therapy for major depressive disorder was established within a dose range of 2 mg/day to 15 mg/day. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week [see CLINICAL STUDIES (14.3)]. Maintenance Treatment: The efficacy of ABILIFY for the adjunctive maintenance treatment of major depressive disorder has not been evaluated. While there is no body of evidence available to answer the question of how long the patient treated with ABILIFY should be maintained, patients should be periodically reassessed to determine the continued need for maintenance treatment. 2.4	Irritability Associated with Autistic Disorder    Pediatric Patients   Dose Selection:  The efficacy of aripiprazole has been established in the treatment of pediatric patients 6 to 17 years of age with irritability associated with autistic disorder at doses of 5 mg/day to 15 mg/day. The dosage of ABILIFY should be individualized according to tolerability and response. Dosing should be initiated at 2 mg/day. The dose should be increased to 5 mg/day, with subsequent increases to 10 mg/day or 15 mg/day if needed. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week [see CLINICAL STUDIES (14.4)]. Maintenance Treatment: The efficacy of ABILIFY for the maintenance treatment of irritability associated with autistic disorder has not been evaluated. While there is no body of evidence available to answer the question of how long the patient treated with ABILIFY should be maintained, patients should be periodically reassessed to determine the continued need for maintenance treatment. 2.5	Agitation Associated with Schizophrenia or Bipolar Mania (Intramuscular Injection)   Adults   Dose Selection:  The recommended dose in these patients is 9.75 mg. The effectiveness of aripiprazole injection in controlling agitation in schizophrenia and bipolar mania was demonstrated over a dose range of 5.25 mg to 15 mg. No additional benefit was demonstrated for 15 mg compared to 9.75 mg. A lower dose of 5.25 mg may be considered when clinical factors warrant. If agitation warranting a second dose persists following the initial dose, cumulative doses up to a total of 30 mg/day may be given. However, the efficacy of repeated doses of aripiprazole injection in agitated patients has not been systematically evaluated in controlled clinical trials. The safety of total daily doses greater than 30 mg or injections given more frequently than every 2 hours have not been adequately evaluated in clinical trials [see CLINICAL STUDIES (14.5)]. If ongoing aripiprazole therapy is clinically indicated, oral aripiprazole in a range of 10 mg/day to 30 mg/day should replace aripiprazole injection as soon as possible [see DOSAGE AND ADMINISTRATION (2.1 and 2.2)]. Administration of ABILIFY Injection  To administer ABILIFY Injection, draw up the required volume of solution into the syringe as shown in Table 1. Discard any unused portion. ABILIFY Injection is intended for intramuscular use only. Do not administer intravenously or subcutaneously. Inject slowly, deep into the muscle mass. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 2.6	Dosage Adjustment  Dosage adjustments in adults are not routinely indicated on the basis of age, gender, race, or renal or hepatic impairment status [see USE IN SPECIFIC POPULATIONS (8.4-8.10)]. Dosage adjustment for patients taking aripiprazole concomitantly with strong CYP3A4 inhibitors: When concomitant administration of aripiprazole with strong CYP3A4 inhibitors such as ketoconazole or clarithromycin is indicated, the aripiprazole dose should be reduced to one-half of the usual dose. When the CYP3A4 inhibitor is withdrawn from the combination therapy, the aripiprazole dose should then be increased [see DRUG INTERACTIONS (7.1)]. Dosage adjustment for patients taking aripiprazole concomitantly with potential CYP2D6 inhibitors: When concomitant administration of potential CYP2D6 inhibitors such as quinidine, fluoxetine, or paroxetine with aripiprazole occurs, aripiprazole dose should be reduced at least to one-half of its normal dose. When the CYP2D6 inhibitor is withdrawn from the combination therapy, the aripiprazole dose should then be increased [see DRUG INTERACTIONS (7.1)]. When adjunctive ABILIFY is administered to patients with major depressive disorder, ABILIFY should be administered without dosage adjustment as specified in DOSAGE AND ADMINISTRATION (2.3). Dosing recommendation in patients taking aripiprazole concomitantly with strong CYP3A4 and CYP2D6 inhibitors:  When concomitant administration of aripiprazole with strong inhibitors of CYP3A4 (such as ketoconazole or clarithromycin) and CYP2D6 (such as quinidine, fluoxetine, or paroxetine) is indicated, the aripiprazole dose should be reduced to one-quarter (25%) of the usual dose. When the CYP3A4 and/or CYP2D6 inhibitor is withdrawn from the combination therapy, the aripiprazole dose should be increased [see DRUG INTERACTIONS (7.1)]. Dosing recommendation in patients taking aripiprazole concomitantly with strong, moderate, or weak inhibitors of CYP3A4 and CYP2D6:  Patients who may be receiving a combination of strong, moderate, and weak inhibitors of CYP3A4 and CYP2D6 (eg, a potent CYP3A4 inhibitor and a moderate CYP2D6 inhibitor or a moderate CYP3A4 inhibitor with a moderate CYP2D6 inhibitor), the dosing may be reduced to one-quarter (25%) of the usual dose initially and then adjusted to achieve a favorable clinical response. Dosing recommendation in patients who are classified as CYP2D6 poor metabolizers (PM):  The aripiprazole dose in PM patients should initially be reduced to one-half (50%) of the usual dose and then adjusted to achieve a favorable clinical response. The dose of aripiprazole for PM patients who are administered a strong CYP3A4 inhibitor should be reduced to one-quarter (25%) of the usual dose [see CLINICAL PHARMACOLOGY (12.3)]. Dosage adjustment for patients taking potential CYP3A4 inducers: When a potential CYP3A4 inducer such as carbamazepine is added to aripiprazole therapy, the aripiprazole dose should be doubled. Additional dose increases should be based on clinical evaluation. When the CYP3A4 inducer is withdrawn from the combination therapy, the aripiprazole dose should be reduced to 10 mg to 15 mg [see DRUG INTERACTIONS (7.1)]. 2.7	Dosing of Oral Solution  The oral solution can be substituted for tablets on a mg-per-mg basis up to the 25 mg dose level. Patients receiving 30 mg tablets should receive 25 mg of the solution [see CLINICAL PHARMACOLOGY (12.3)]. 2.8	Dosing of Orally Disintegrating Tablets  The dosing for ABILIFY Orally Disintegrating Tablets is the same as for the oral tablets [see DOSAGE AND ADMINISTRATION (2.1, 2.2, 2.3, and 2.4)]. 3	DOSAGE FORMS AND STRENGTHS  ABILIFY&#174; (aripiprazole) Tablets are available as described in Table 2. Bristol-Myers Squibb Company, Princeton, NJ 08543 USA Distributed and marketed by Otsuka America Pharmaceutical, Inc, Rockville, MD 20850 USA  Marketed by Bristol-Myers Squibb Company, Princeton, NJ 08543 USA  ABILIFY is a trademark of Otsuka Pharmaceutical Company. 1287307A1	 03US11L-0137	 Rev February 2011 &#169;2011, Otsuka Pharmaceutical Co, Ltd, Tokyo, 101-8535 Japan    MEDICATION GUIDE     ABILIFY  &#174;   (a BIL &#301; f&#299;)     Generic name: aripiprazole   Read this Medication Guide before you start taking ABILIFY and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about ABILIFY? (For other side effects, also see &#8220;What are the possible side effects of ABILIFY?&#8221;). Serious side effects may happen when you take ABILIFY, including:    Increased risk of death in elderly patients with dementia-related psychosis:  Medicines like ABILIFY can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ABILIFY is not approved for the treatment of patients with dementia-related psychosis. Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:                     	  Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:    thoughts about suicide or dying  attempts to commit suicide  new or worse depression  new or worse anxiety  feeling very agitated or restless  panic attacks  trouble sleeping (insomnia)  new or worse irritability  acting aggressive, being angry, or violent  acting on dangerous impulses  an extreme increase in activity and talking (mania)  other unusual changes in behavior or mood     What else do I need to know about antidepressant medicines? Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms. Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child&#8217;s healthcare provider for more information. What is ABILIFY? ABILIFY is a prescription medicine used to treat:    schizophrenia in people age 13 years and older. bipolar I disorder in people age 10 years and older, including:                     	  manic or mixed episodes that happen with bipolar I disorder. manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate. long-term treatment of bipolar I disorder. major depressive disorder in adults, as an add-on treatment to an antidepressant medicine when you do not get better with an antidepressant alone. irritability associated with autistic disorder in children and adolescents ages 6 to 17 years old. agitation associated with schizophrenia or bipolar disorder. The symptoms of schizophrenia include:    losing touch with reality (psychosis)  seeing things or hearing voices that are not there (hallucinations)  believing things that are not true (delusions)  being suspicious (paranoia)  disorganized speech and thinking  bizarre behavior     The symptoms of bipolar I disorder include:     extreme mood swings that include feeling depressed and high or irritable mood  talking too fast and too much  impulsive behavior  having more energy and restlessness than usual  needing less sleep than usual     The symptoms of major depressive disorder (MDD) include:     feeling of sadness and emptiness  loss of interest in activities that you once enjoyed and loss of energy  problems focusing and making decisions  feeling of worthlessness or guilt  changes in sleep or eating patterns  thoughts of death or suicide     The symptoms of irritability associated with autistic disorder include:     aggressive behavior towards others  intentionally trying to harm oneself  temper tantrums  quickly changing moods     The symptoms of agitation associated with schizophrenia or bipolar disorder include:     hostility or aggressive behavior  agitation and inner tension  self-exhausting behavior     What should I tell my healthcare provider before taking ABILIFY? Before taking ABILIFY, tell your healthcare provider if you have or had:  diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before you start ABILIFY and also during therapy. seizures (convulsions). low or high blood pressure. heart problems or stroke. pregnancy or plans to become pregnant. It is not known if ABILIFY will harm your unborn baby. breast-feeding or plans to breast-feed. It is not known if ABILIFY will pass into your breast milk. You and your healthcare provider should decide if you will take ABILIFY or breast-feed. You should not do both. low white blood cell count. phenylketonuria. ABILIFY DISCMELT Orally Disintegrating Tablets contain phenylalanine. any other medical conditions. Tell your healthcare provider about all the medicines that you take or recently have taken, including prescription medicines, non-prescription medicines, herbal supplements, and vitamins. ABILIFY and other medicines may affect each other causing possible serious side effects. ABILIFY may affect the way other medicines work, and other medicines may affect how ABILIFY works. Your healthcare provider can tell you if it is safe to take ABILIFY with your other medicines. Do not start or stop any medicines while taking ABILIFY without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. How should I take ABILIFY? Take ABILIFY exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking ABILIFY yourself. ABILIFY can be taken with or without food. ABILIFY tablets should be swallowed whole. If you miss a dose of ABILIFY, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of ABILIFY at the same time. If you have been prescribed ABILIFY DISCMELT, take it as follows:                       Do not open the blister until ready to take the DISCMELT tablet. To remove one DISCMELT tablet, open the package and peel back the foil on the blister to expose the tablet. Do not push the tablet through the foil because this could damage the tablet. Immediately upon opening the blister, using dry hands, remove the tablet and place the entire ABILIFY DISCMELT Orally Disintegrating Tablet on the tongue. Tablet disintegration occurs rapidly in saliva. It is recommended that ABILIFY DISCMELT be taken without liquid. However, if needed, it can be taken with liquid. Do not attempt to split the DISCMELT tablet. If you take too much ABILIFY, call your healthcare provider or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room. What should I avoid while taking ABILIFY? Do not drive, operate heavy machinery, or do other dangerous activities until you know how ABILIFY affects you. ABILIFY may make you drowsy. Do not drink alcohol while taking ABILIFY. Avoid getting over-heated or dehydrated. Do not over-exercise. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much or heavy clothing. Drink plenty of water. What are the possible side effects of ABILIFY? Serious side effects have been reported with ABILIFY including:    Also see &#8220;What is the most important information I should know about ABILIFY?&#8221; at the beginning of this Medication Guide. Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms. High blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take ABILIFY. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start ABILIFY and during therapy. Call your healthcare provider if you have any of these symptoms of high blood sugar while taking ABILIFY:  feel very thirsty  need to urinate more than usual  feel very hungry  feel weak or tired  feel sick to your stomach  feel confused, or your breath smells fruity. Difficulty swallowing: may lead to aspiration and choking. Tardive dyskinesia: Call your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition. Tardive dyskinesia may not go away, even if you stop taking ABILIFY. Tardive dyskinesia may also start after you stop taking ABILIFY. Orthostatic hypotension (decreased blood pressure): lightheadedness or fainting when rising too quickly from a sitting or lying position. Low white blood cell count    Seizures (convulsions)  Common side effects with ABILIFY in adults include: ABILIFY&#174; (aripiprazole) TABLETS 10 mg DISPENSE WITH MEDICATION GUIDE Rx only Otsuka America Pharmaceutical, Inc. Bristol-Myers Squibb PDRx Label   55289251 Label