ABILIFY (Page 13 of 14)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

ABILIFY^® (aripiprazole) Tablets have markings on one side an are available in the strengths and packages listed in Table 32.

Table 32: ABILIFY Tablet Presentations

Tablet Strength	Tablet Color/Shape	Tablet Markings	Pack Size	NDC Code
2 mg	greenmodified rectangle	“A-006” and “2”	Bottle of 30	59148-006-13
5 mg	bluemodified rectangle	“A-007” and “5”	Bottle of 30Blister of 100	59148-007-1359148-007-35
10 mg	pinkmodified rectangle	“A-008” and “10”	Bottle of 30Blister of 100	59148-008-1359148-008-35
15 mg	yellowround	“A-009” and “15”	Bottle of 30Blister of 100	59148-009-1359148-009-35
20 mg	whiteround	“A-010” and “20”	Bottle of 30Blister of 100	59148-010-1359148-010-35
30 mg	pinkround	“A-011” and “30”	Bottle of 30Blister of 100	59148-011-1359148-011-35

ABILIFY DISCMELT^® (aripiprazole) Orally Disintegrating Tablets are round tablets with markings on either side. ABILIFY DISCMELT is available in the strengths and packages listed in Table 33.

Table 33: ABILIFY DISCMELT Orally Disintegrating Tablet Presentations

Tablet Strength	Tablet Color	Tablet Markings	Pack Size	NDC Code
10 mg	pink (with scattered specks)	“A” and “640””10″	Blister of 30	59148-640-23
15 mg	yellow (with scattered specks)	“A” and “641””15″	Blister of 30	59148-641-23

ABILIFY^® (aripiprazole) Oral Solution (1 mg/mL) is supplied in child-resistant bottles along with a calibrated oral dosing cup. ABILIFY Oral Solution is available as follows:

150 mL bottle

NDC 59148-013-15

ABILIFY^® (aripiprazole) Injection for intramuscular use is available as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) solution in clear, Type 1 glass vials as follows:

9.75 mg/1.3 mL single-dose vial

NDC 59148-016-65

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].

Oral Solution

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. 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. The bottle and its contents should be discarded after the expiration date.

Injection

Store at 25ºC (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light by storing in the original container. Retain in carton until time of use.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Discuss the following issues with patients prescribed ABILIFY:

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 (5.3)].

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.

Pathological Gambling and Other Compulsive Behaviors

Advise patients and their caregivers of the possibility that they may experience compulsive urges to shop, intense urges to gamble, compulsive sexual urges, binge eating and/or other compulsive urges and the inability to control these urges while taking aripiprazole. In some cases, but not all, the urges were reported to have stopped when the dose was reduced or stopped [see Warnings and Precautions (5.7)].

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 ABILIFY 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 ABILIFY therapy does not affect them adversely [see Warnings and Precautions (5.12)].

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)].

Heat Exposure and Dehydration

Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions (5.13)].

Sugar Content

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

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with ABILIFY. Advise patients that ABILIFY may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to ABILIFY during pregnancy [see Use in Specific Populations (8.1)].

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

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

ABILIFY is a registered trademark of Otsuka Pharmaceutical Co., Ltd.

© 2022, Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan

MEDICATION GUIDE
ABILIFY® (a BIL ĭ fī) (aripiprazole) Tablets	ABILIFY® (a BIL ĭ fī) (aripiprazole)Orally Disintegrating Tablets	ABILIFY® (a BIL ĭ fī) (aripiprazole) Oral Solution	ABILIFY® (a BIL ĭ fī)(aripiprazole) Injection, for intramuscular use
This Medication Guide has been approved by the U.S. Food and Drug Administration			Revised: 08/2019
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: 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 take. 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 Oral Tablets, Orally-Disintegrating Tablets, and Oral Solution are prescription medicines used to treat: schizophrenia manic or mixed episodes that happen with bipolar I disorder major depressive disorder (MDD) when ABILIFY is used with antidepressant medicines irritability associated with autistic disorder Tourette’s disorder ABILIFY Injection is a prescription medicine used to treat: agitation associated with schizophrenia or bipolar mania It is not known if ABILIFY is safe or effective in children: under 13 years of age with schizophrenia under 10 years of age with bipolar I disorder under 6 years of age with irritability associated with autistic disorder under 6 years of age with Tourette’s disorder
Do not take ABILIFY if you are allergic to aripiprazole or any of the ingredients in ABILIFY. See the end of this Medication Guide for a complete list of ingredients in ABILIFY.
Before taking ABILIFY, tell your healthcare provider about all your medical conditions, including 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. If you become pregnant while receiving ABILIFY, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ breast-feeding or plans to breast-feed. ABILIFY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive ABILIFY. low white blood cell count. phenylketonuria. ABILIFY DISCMELT Orally Disintegrating Tablets contain phenylalanine. Tell your healthcare provider about all the medicines that you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.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. 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?ABILIFY may cause serious side effects, including: See “What is the most important information I should know about ABILIFY?“ Stroke in elderly people (cerebrovascular problems) that can lead to death 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. Uncontrolled body movements (tardive dyskinesia). ABILIFY may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving ABILIFY. Tardive dyskinesia may also start after you stop receiving ABILIFY. Problems with your metabolism such as: High blood sugar (hyperglycemia) and diabetes. 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 your treatment. Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving 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 Increased fat levels (cholesterol and triglycerides) in your blood. Weight gain. You and your healthcare provider should check your weight regularly. Unusual urges. Some people taking ABILIFY have had unusual urges, such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges.If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider. Orthostatic hypotension (decreased blood pressure). Lightheadedness or fainting may happen when rising too quickly from a sitting or lying position. Falls. ABILIFY may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries. Low white blood cell count Seizures (convulsions) Problems with control of your body temperature especially when you exercise a lot or are in an area that is very hot. It is important for you to drink water to avoid dehydration. See “What should I avoid while receiving ABILIFY?“ Difficulty swallowing that can cause food or liquid to get into your lungs. The most common side effects of ABILIFY in adults include:
nausea vomiting constipation headache blurred vision upper respiratory illness		dizziness anxiety insomnia restlessness inner sense of restlessness/need to move (akathisia)
The most common side effects of ABILIFY in children include:
feeling sleepy headache vomiting fatigue increased or decreased appetite increased saliva or drooling		insomnia nausea stuffy nose weight gain uncontrolled movement such as restlessness, tremor muscle stiffness
These are not all the possible side effects of ABILIFY.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 68°F to 77°F (20°C to 25°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 the safe and effective use of 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 symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about ABILIFY that was written for healthcare professionals.
What are the ingredients in ABILIFY?Active ingredient: aripiprazoleInactive 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 LakeABILIFY 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 LakeABILIFY 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 flavorsFor more information about ABILIFY go to www.abilify.com or call 1-800-438-6055.Tablets manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 JapanOrally Disintegrating Tablets, Oral Solution, and Injection manufactured by Bristol-Myers Squibb Company, Princeton, NJ 08543 USADistributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USAABILIFY is a trademark of Otsuka Pharmaceutical Company.© Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan