Abilify Maintena

Name: Abilify Maintena

What are some other side effects of Abilify Maintena?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling sleepy.
  • Feeling tired or weak.
  • Restlessness.
  • Anxiety.
  • Headache.
  • Upset stomach or throwing up.
  • Weight gain.
  • Hard stools (constipation).
  • Not able to sleep.
  • Feeling more or less hungry.
  • Nose and throat irritation.
  • Dry mouth.
  • Shakiness.
  • Drooling.
  • Stuffy nose.
  • Pain where the shot was given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Dosage Forms and Strengths

For extended-release injectable suspension: 300 mg and 400 mg of lyophilized powder for reconstitution in:

• single-dose pre-filled dual chamber syringe • single-dose vial

The reconstituted extended-release injectable suspension is a uniform, homogeneous suspension that is opaque and milky-white in color.

PRINCIPAL DISPLAY PANEL - 300 mg Syringe Label

NDC 59148-045-80

300 mg

Abilify Maintena®
(aripiprazole)

for extended release
injectable suspension
Single use only.

Sterile. Discard any
unused portion.

For deltoid or gluteal
intramuscular
injection only.

Usual Dosage:
See package insert.

Rx only

Store below
30°C [86°F].
Protect from light.

Mfd. by:
Otsuka Pharmaceutical
Co., Ltd.

PRINCIPAL DISPLAY PANEL - 300 mg Syringe Carton

For deltoid or gluteal intramuscular injection only

NDC 59148-045-80

Abilify Maintena®
(aripiprazole) for extended release injectable suspension

300 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

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What side effects can this medication cause?

Aripiprazole injection and aripiprazole extended-release injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • pain, swelling, redness at injection site
  • weight gain
  • increased appetite
  • extreme tiredness
  • stomach pain
  • constipation
  • vomiting
  • dry mouth
  • back, muscle, or joint pain
  • difficulty falling asleep or staying asleep
  • dizziness, feeling unsteady, or having trouble keeping your balance

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

  • rash
  • itching
  • hives
  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, and/or lower legs
  • difficulty swallowing or breathing
  • muscle stiffness
  • excessive sweating
  • irregular heartbeat
  • confusion
  • falling
  • unusual movements of the face or body that you cannot control
  • uncontrollable shaking of a part of the body
  • restlessness
  • need to get up and move
  • slow movements
  • sore throat, fever, chills, or other signs of infection
  • seizures

Aripiprazole injection and aripiprazole extended-release injection may cause other side effects. Call your doctor if you have any unusual problems while you are receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

How supplied

Dosage Forms And Strengths

For extended-release injectable suspension: 300 mg and 400 mg of lyophilized powder for reconstitution in:

  • single-dose pre-filled dual chamber syringe
  • single-dose vial

The reconstituted extended-release injectable suspension is a uniform, homogeneous suspension that is opaque and milky-white in color.

Storage And Handling

Pre-filled Dual Chamber Syringe

ABILIFY MAINTENA (aripiprazole) pre-filled dual chamber syringe for extended-release injectable suspension in single-use syringes is available in 300 mg or 400 mg strength syringes. The pre-filled dual chamber syringe consists of a front chamber that contains the lyophilized powder of aripiprazole monohydrate and a rear chamber that contains sterile water for injection.

The 300 mg kit includes ( 59148-045-80):

  • 300 mg single-dose pre-filled dual chamber syringe containing ABILIFY MAINTENA (aripiprazole) for extended-release injectable suspension lyophilized powder and Sterile Water for Injection
  • One 23 gauge, 1 inch (25 mm) hypodermic safety needle with needle protection device for deltoid administration in non-obese patients
  • One 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for gluteal administration in non-obese patients or deltoid administration in obese patients
  • One 21 gauge, 2 inch (50 mm) hypodermic safety needle with needle protection device for gluteal administration in obese patients

The 400 mg kit includes ( 59148-072-80):

  • 400 mg single-dose pre-filled dual chamber syringe containing ABILIFY MAINTENA (aripiprazole) for extended-release injectable suspension lyophilized powder and Sterile Water for Injection
  • One 23 gauge, 1 inch (25 mm) hypodermic safety needle with needle protection device for deltoid administration in non-obese patients
  • One 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for gluteal administration in non-obese patients or deltoid administration in obese patients
  • One 21 gauge, 2 inch (50 mm) hypodermic safety needle with needle protection device for gluteal administration in obese patients

Single-Use Vial:

ABILIFY MAINTENA (aripiprazole) extended-release injectable suspension in single-use vials is available in 300 mg or 400 mg strength vials.

The 300 mg kit includes ( 59148-018-71):

  • 300 mg single-use vial of ABILIFY MAINTENA (aripiprazole) extended-release injectable suspension lyophilized powder
  • 5 mL single-use vial of Sterile Water for Injection, USP
  • One 3 mL luer lock syringe with pre-attached 21 gauge, 1.5 inch hypodermic safety needle with needle protection device
  • One 3 mL luer lock disposable syringe with luer lock tip
  • One vial adapter
  • One 23 gauge, 1 inch (25 mm) hypodermic safety needle with needle protection device for deltoid administration in non-obese patients
  • One 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for gluteal administration in non-obese patients or deltoid administration in obese patients
  • One 21 gauge, 2 inch (50 mm) hypodermic safety needle with needle protection device for gluteal administration in obese patients

The 400 mg kit includes ( 59148-019-71):

  • 400 mg single-use vial of ABILIFY MAINTENA (aripiprazole) extended-release injectable suspension lyophilized powder
  • 5 mL single-use vial of Sterile Water for Injection, USP
  • One 3 mL luer lock syringe with pre-attached 21 gauge, 1.5 inch hypodermic safety needle with needle protection device
  • One 3 mL luer lock disposable syringe with luer lock tip
  • One vial adapter
  • One 23 gauge, 1 inch (25 mm) hypodermic safety needle with needle protection device for deltoid administration in non-obese patients
  • One 22 gauge, 1.5 inch (38 mm) hypodermic safety needle with needle protection device for gluteal administration in non-obese patients or deltoid administration in obese patients
  • One 21 gauge, 2 inch (50 mm) hypodermic safety needle with needle protection device for gluteal administration in obese patients

Storage

Pre-Filled Dual Chamber Syringe

Store below 30°C [86°F]. Do not freeze. Protect the syringe from light by storing in the original package until time of use.

Vial

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

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 Company. Revised: Aug 2016

Uses of Abilify Maintena

Abilify Maintena is a prescription medication used to treat schizophrenia and is also used for acute schizophrenia relapse in adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Side Effects of Abilify Maintena

The most common side effect of Abilify Maintena includes:

  • feeling like you need to move to stop unpleasant feelings in your legs (restless leg syndrome or akathisia)
  • weight increase
  • injection site pain
  • sedation (makes you sleepy)

This is not a complete list of Abilify Maintena side effects. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Abilify Maintena. See "Abilify Maintena" section.

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

Abilify Maintena FDA Warning

Talk to your doctor or your pharmacist about the following black box warning for this medication:

WARNINGS: 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 Maintena is not approved for the treatment of patients with dementia-related psychosis.

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 Maintena 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 Maintena is not approved for use in pediatric patients with depression.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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