ABILIFY (Page 15 of 15)

16.2 Storage

Tablets

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

See Medication Guide

17.1 Information for Patients

Physicians are advised to discuss the following issues with patients for whom they prescribe ABILIFY:

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Patients and caregivers should be advised that elderly patients with dementia-related psychoses treated with antipsychotic drugs are at increased risk of death. ABILIFY is not approved for elderly patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS (5.1)].

Clinical Worsening of Depression and Suicide Risk

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see WARNINGS AND PRECAUTIONS (5.2)].

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with ABILIFY and should counsel them in its appropriate use. A patient Medication Guide including information about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for ABILIFY. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. It should be noted that ABILIFY is not approved as a single agent for treatment of depression and has not been evaluated in pediatric major depressive disorder.

Use of Orally Disintegrating Tablet

Do not open the blister until ready to administer. For single tablet removal, 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 tablet.

Interference with Cognitive and Motor Performance

Because aripiprazole may have the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that aripiprazole therapy does not affect them adversely [see WARNINGS AND PRECAUTIONS (5.9)].

Pregnancy

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with ABILIFY [see USE IN SPECIFIC POPULATIONS (8.1)].

Nursing

Patients should be advised not to breast-feed an infant if they are taking ABILIFY [see USE IN SPECIFIC POPULATIONS (8.3)].

Concomitant Medication

Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions [see DRUG INTERACTIONS (7)].

Alcohol

Patients should be advised to avoid alcohol while taking ABILIFY [see DRUG INTERACTIONS (7.2)].

Heat Exposure and Dehydration

Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see WARNINGS AND PRECAUTIONS (5.10)].

Sugar Content

Patients should be advised that each mL of ABILIFY Oral Solution contains 400 mg of sucrose and 200 mg of fructose.

Phenylketonurics

Phenylalanine is a component of aspartame. Each ABILIFY DISCMELT Orally Disintegrating Tablet contains the following amounts: 10 mg — 1.12 mg phenylalanine and 15 mg — 1.68 mg phenylalanine.

Tablets manufactured by Otsuka Pharmaceutical Co, Ltd, Tokyo, 101-8535 Japan or Bristol-Myers Squibb Company, Princeton, NJ 08543 USA

Orally Disintegrating Tablets, Oral Solution, and Injection manufactured by
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

©2011, Otsuka Pharmaceutical Co, Ltd, Tokyo, 101-8535 Japan

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146

MEDICATION GUIDE

ABILIFY ® (a BIL ĭ fī)

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 “What are the possible side effects of ABILIFY? ”).

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:
    1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
    2. 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.
    3. 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’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 “What is the most important information I should know about ABILIFY?” 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:

• nausea • inner sense of restlessness/need to move (akathisia)
• vomiting • anxiety
• constipation • insomnia
• headache • restlessness
• dizziness

Common side effects with ABILIFY in children include:

• feeling sleepy • insomnia
• headache • nausea
• vomiting • stuffy nose
• fatigue • weight gain
• increased appetite • uncontrolled movement such as restlessness, tremor, muscle stiffness

These are not all the possible side effects of ABILIFY. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ABILIFY?

  • Store ABILIFY at room temperature, between 59°F to 86°F (15°C to 30°C).
  • Opened bottles of ABILIFY Oral Solution can be used for up to 6 months after opening, but not beyond the expiration date on the bottle.

Keep ABILIFY and all medicines out of the reach of children.

General information about ABILIFY

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ABILIFY for a condition for which it was not prescribed. Do not give ABILIFY to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about ABILIFY. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ABILIFY that was written for healthcare professionals. For more information about ABILIFY visit www.abilify.com.

What are the ingredients in ABILIFY?

Active ingredient: aripiprazole

Inactive ingredients:

Tablets: cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.

ABILIFY DISCMELT Orally Disintegrating Tablets: acesulfame potassium, aspartame (which contains phenylalanine), calcium silicate, croscarmellose sodium, crospovidone, crème de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.

ABILIFY Oral Solution: disodium edetate, fructose (200 mg per mL), glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose (400 mg per mL), and purified water. The oral solution is flavored with natural orange cream and other natural flavors.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

ABILIFY is a trademark of Otsuka Pharmaceutical Company.

1287307A1 03US11L-0137C Rev February 2011

©2011, Otsuka Pharmaceutical Co, Ltd, Tokyo, 101-8535 Japan

———————————————
REPRESENTATIVE PACKAGING

See How Supplied section for a complete list of available packages of ABILIFY®


ABILIFY®
(aripiprazole)
TABLETS
2 mg
DISPENSE WITH MEDICATION GUIDE
Rx only

ABILIFY 2-mg Tablets
(click image for full-size original)


ABILIFY®
(aripiprazole)
TABLETS
10 mg
DISPENSE WITH MEDICATION GUIDE
Rx only

ABILIFY 10-mg Tablets
(click image for full-size original)

ABILIFY aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6280(NDC:59148-006)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 2 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
ALUMINUM OXIDE
Product Characteristics
Color GREEN Score no score
Shape RECTANGLE (modified rectangle) Size 8mm
Flavor Imprint Code A;006;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6280-0 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021436 07/18/2011
ABILIFY aripiprazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5202(NDC:59148-008)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
ALUMINUM OXIDE
Product Characteristics
Color PINK Score no score
Shape RECTANGLE (modified rectangle) Size 8mm
Flavor Imprint Code A;008;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5202-0 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021436 01/31/2006
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 02/2011 Physicians Total Care, Inc.

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