Abilify Maintena

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Difficulty with speaking
• drooling
• loss of balance control
• muscle trembling, jerking, or stiffness
• restlessness
• shuffling walk
• stiffness of the limbs
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back

• Blurred vision
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• headache
• inability to move the eyes
• increased blinking or spasms of the eyelid
• nervousness
• pounding in the ears
• sticking out the tongue
• trouble breathing or swallowing
• unusual facial expressions

• Convulsions
• fast heartbeat
• high fever
• increased sweating
• lip smacking or puckering
• loss of bladder control
• muscle spasm or jerking of all extremities
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• severe muscle stiffness
• sudden loss of consciousness
• tiredness
• uncontrolled chewing movements
• uncontrolled movements of the arms and legs
• unusually pale skin

• Hives or welts, itching, or skin rash
• itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• redness of the skin
• tightness in the chest
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• difficulty having a bowel movement (stool)
• dry mouth
• fear
• fever
• headache
• heartburn
• hyperventilation
• inability to sit still
• indigestion
• irritability
• lightheadedness
• need to keep moving
• runny nose
• shaking
• sore throat
• stomach discomfort, upset, or pain
• trouble sleeping
• weight gain

• Accidental injury
• bloating or swelling of the face, arms, hands, lower legs, or feet
• body aches or pain
• congestion
• coughing
• difficulty with moving
• hoarseness
• increased appetite
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• sneezing
• stuffy nose
• swollen joints
• tender, swollen glands in the neck
• tingling of the hands or feet
• tremor
• unusual weight gain or loss
• voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.
• Drink lots of noncaffeine liquids every day unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
• If you are planning to harm yourself or the want to harm yourself gets worse.
• Strong urges that are hard to control (such as eating, gambling, sex, or spending money).
• Very bad dizziness or passing out.
• Change in balance.
• Feeling very tired or weak.
• Seizures.
• Blurred eyesight.
• A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
• Some people who take Abilify Maintena may get a very bad muscle problem called tardive dyskinesia. This muscle problem may not go away even if this medicine is stopped. Sometimes, signs may lessen or go away over time after Abilify Maintena (aripiprazole injection) is stopped. The risk of tardive dyskinesia may be greater in people with diabetes and in older adults, especially older women. The risk is also greater the longer you take this medicine or with higher doses. Muscle problems may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or if you have muscle problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.

Drugs Having Clinically Important Interactions with Abilify Maintena

Table 8: Clinically Important Drug Interactions with Abilify Maintena:

Drugs Having No Clinically Important Interactions with Abilify Maintena

Based on pharmacokinetic studies with oral aripiprazole, no dosage adjustment of Abilify Maintena is required when administered concomitantly with famotidine, valproate, lithium, lorazepam [see CLINICAL PHARMACOLOGY (12.3)].

In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, paroxetine, or venlafaxine), CYP2C9 (e.g., warfarin), CYP2C19 (e.g., omeprazole, warfarin), or CYP3A4 (e.g., dextromethorphan) when co-administered with Abilify Maintena. Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, lorazepam, or sertraline when co-administered with Abilify Maintena. [see CLINICAL PHARMACOLOGY (12.3)].

Advise the patient to read the FDA-approved patient labeling (MEDICATION GUIDE)

Pathological Gambling and Other Compulsive Behaviors

Advise patients and their caregivers of the possibility that they may experience compulsive urges to shop, increased 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 [seeWARNINGS AND PRECAUTIONS (5.6)].

Neuroleptic Malignant Syndrome

Counsel patients about a potentially fatal adverse reaction referred to as NMS that has been reported in association with administration of antipsychotic drugs. Advise patients, family members, or caregivers to contact a health care provider or report to the emergency room if they experience signs and symptoms of NMS [see WARNINGS AND PRECAUTIONS (5.3)].

Tardive Dyskinesia

Advise patients that abnormal involuntary movements have been associated with the administration of antipsychotic drugs. Counsel patients to notify their health care provider if they notice any movements which they cannot control in their face, tongue, or other body part [see WARNINGS AND PRECAUTIONS (5.4)].

Metabolic Changes (Hyperglycemia and Diabetes Mellitus, Dyslipidemia, and Weight Gain)

Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight [see WARNINGS AND PRECAUTIONS (5.5)].

Orthostatic Hypotension

Educate patients about the risk of orthostatic hypotension and syncope especially early in treatment, and also at times of re-initiating treatment or increases in dosage [see WARNINGS AND PRECAUTIONS (5.7)].

Leukopenia/Neutropenia

Advise patients with a pre-existing low WBC count or a history of drug-induced leucopenia/neutropenia that they should have their CBC monitored while receiving Abilify Maintena [see WARNINGS AND PRECAUTIONS (5.9)].

Interference with Cognitive and Motor Performance

Because Abilify Maintena may have the potential to impair judgment, thinking, or motor skills, instruct patients to be cautious about operating hazardous machinery, including automobiles, until they are reasonably certain that Abilify Maintena therapy does not affect them adversely [see WARNINGS AND PRECAUTIONS (5.11)].

Heat Exposure and Dehydration

Advise patients regarding appropriate care in avoiding overheating and dehydration [see WARNINGS AND PRECAUTIONS (5.12)].

Concomitant Medication

Advise patients to inform their health care providers of any changes to their current prescription or over-the-counter medications since there is a potential for clinically significant interactions [see DRUG INTERACTIONS (7)].

Pregnancy

Advise patients that Abilify Maintena may cause extrapyramidal and/or withdrawal symptoms in a neonate and to notify their healthcare provider with a known or suspected pregnancy. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Abilify Maintena during pregnancy [see USE IN SPECIFIC POPULATIONS (8.1)].

Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USA

Marketed by Lundbeck, Deerfield, IL 60015 USA

Abilify Maintena is a trademark of Otsuka Pharmaceutical Co., Ltd.

07/2017

© 2017, Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan

NDC 59148-018-71

300 mg per vial

Abilify Maintena™

(aripiprazole) for extended release injectable suspension

Store at 25 ºC (77 ºF), excursions permitted
between 15 ºC and 30 ºC (59 ºF to 86 ºF)
[see USP Controlled Room Temperature].

Reconstitute at room temperature.

READ INSTRUCTIONS PRIOR TO USE.

Usual Dosage: Administer once monthly.

See package insert.

NDC 59148-019-71

400 mg per vial

Abilify Maintena™

(aripiprazole) for extended release injectable suspension

Store at 25 ºC (77 ºF), excursions permitted
between 15 ºC and 30 ºC (59 ºF to 86 ºF)
[see USP Controlled Room Temperature].

Reconstitute at room temperature.

READ INSTRUCTIONS PRIOR TO USE.

Usual Dosage: Administer once monthly.

See package insert.

For deltoid or gluteal intramuscular injection only

NDC 59148-072-80

Abilify Maintena®
(aripiprazole) for extended release injectable suspension

400 mg PER PRE-FILLED
DUAL CHAMBER SYRINGE

Attention: Dispense an enclosed Medication Guide to each patient.

Single use only.
Keep out of reach
of children.

Rx Only

Tell your doctor if you are breastfeeding or plan to breastfeed.

Abilify Maintena has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Abilify Maintena, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Since Abilify Maintena is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.