Abilify

Abilify is a prescription medication used in treatment of such conditions as schizophrenia, bipolar disorder, and autism. It can also be used in combination with an antidepressant to treat depression. Abilify belongs to a group of drugs called atypical antipsychotics. These medications work by altering the activity of certain natural substances in the brain.

This medication comes in tablet and oral solution form and is usually taken once a day, with or without food.

This medication is also available in immediate injectable form to be given directly into the muscle (IM) by a healthcare professional.

Common side effects of Abilify include insomnia, fatigue, and an inner sense of restlessness or need to move.

Oral and Immediate-Release Injectable:

Abilify is a prescription medication 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 depression 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

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

• Otsuka America Pharmaceutical, Inc.

Oral and Immediate-Release Injectable:

Common side effects in adults include the following:

• nausea
• vomiting
• constipation
• headache
• dizziness
• an inner sense of restlessness/the need to move (akathisia)
• anxiety
• insomnia
• restlessness
• pain at injection site

Common side effects in children include the following:

• sleepiness
• headache
• vomiting
• tiredness
• increased appetite
• insomnia
• nausea
• stuffy nose
• weight gain
• uncontrolled movement (restlessness, tremor, muscle stiffness)
• pain at injection site

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

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

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

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antidepressants (mood elevators)
• antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• antihistamines
• bupropion (Wellbutrin)
• carbamazepine (Tegretol)
• clarithromycin (Biaxin)
• fluoxetine (Prozac, Sarafem)
• HIV protease inhibitors such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• ipratropium (Atrovent)
• medications for anxiety, high blood pressure, irritable bowel syndrome, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems
• nefazodone (Serzone)
• paroxetine (Paxil, Pexeva)
• quinidine (Cardioquine, Quinact, Duraquin)
• rifampin (Rifadin, Rimactane)
• sedatives
• sleeping pills
• telithromycin (Ketek)
• tranquilizers

This is not a complete list of Abilify drug interactions. Ask your doctor or pharmacist for more information.

Oral/Injectable:

Serious side effects have been reported with Abilify including the following

• neuroleptic malignant syndrome (NMS). Tell your healthcare provider right away if you have some or all of the following symptoms of this life-threatening nervous system disorder:
  • high fever
  • stiff muscles
  • confusion
  • sweating
  • changes in pulse, heart rate, and blood pressure
• high blood sugar. Increases in blood sugar can happen in some people who take Abilify.
  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
• Increase in weight. Weight gain has been reported in patients taking medicines like Abilify, so you and your healthcare provider should check your weight regularly. For children and adolescent patients (6 to 17 years of age) weight gain should be compared against that expected with normal growth.
• difficulty swallowing. This 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 can occur when rising too quickly from a sitting or lying position.
• Low white blood cell count
• Seizures (convulsions)
• Problems controlling your body temperature so that you feel too warm. 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 while taking Abilify.

Important information 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.

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.

Grapefruit and grapefruit juice may interact with Abilify and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before you receive Abilify, tell your healthcare provider if you:

• have never taken Abilify before
• have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start receiving Abilify and during your treatment.
• have or had seizures (convulsions)
• have or had low or high blood pressure
• have or had heart problems or a stroke
• have or had a low white blood cell count
• have any other medical problems including problems that may affect you receiving an injection in your buttocks
• are pregnant or plan to become pregnant. It is not known if Abilify will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Abilify can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive Abilify.

Tell your doctor about all the medicines that you take including prescription medicines, non-prescription medicines, herbal supplements, and vitamins.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

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

Abilify has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Abilify, 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.

Oral:

• Take Abilify exactly as prescribed. Do not change the dose or stop taking Abilify without talking to your doctor.
• Abilify is available in a tablet and oral solution.
• Abilify can be taken with or without food.
• Swallow Abilify tablets whole.
• If you miss a dose of Abilify, take it 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.

Immediate-Release Injectable:

• This medication is also available in an immediate-release injectable forms to be given directly into the muscle (IM) by a healthcare professional.

Take Abilify exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The recommended dose varies depending upon which condition is being treated as well as other factors.

Abilify tablets and oral solution

The recommended dose range for Abilify is 5 mg -15 mg per day. The maximum dose per day is 30 mg.

The target dose for adolescents is 10 mg/day.

Your doctor will start you on a smaller dose and then increase the dose to a target dose.

Abilify immediate release injection

The recommended dose is 9.75 mg injected into the muscle (IM) once. If another dose is needed, the second dose can be administered 2 hours later. The maximum dose of Abilify per day is 30 mg.

If you take too much Abilify call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Abilify 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.
 

• Store Abilify at 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.
• Keep Abilify and all medicines out of the reach of children.

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 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 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.