Generic Name: aripiprazole (AR i PIP ra zole)
Brand Names: Abilify, Abilify Discmelt
Brand Names: Abilify, Abilify Discmelt
What is Abilify?
Abilify (aripiprazole is an antipsychotic medication. It works by changing the actions of chemicals in the brain.
Abilify is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar I disorder(manic depression). It is not known if aripiprazole is safe or effective in children younger than 13 with schizophrenia, or children younger than 10 with bipolar disorder.
Abilify is also used together with other medicines to treat major depressive disorder in adults.
Abilify is also used in children 6 years or older who have Tourette's disorder, or symptoms of autistic disorder (irritability, aggression, mood swings, temper tantrums, and self-injury).
Important information
Abilify is not approved for use in psychotic conditions related to dementia. Abilify may increase the risk of death in older adults with dementia-related conditions.
Some young people have thoughts about suicide when taking medicine for a major depressive disorder and other psychiatric disorders. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
Some young people have thoughts about suicide when taking medicine for a major depressive disorder and other psychiatric disorders. Your doctor will need to check your progress at regular visits while you are using Abilify. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Stop using Abilify and call your doctor at once if you have the following symptoms: fever with stiff muscles and rapid heart rate; uncontrolled muscle movements; symptoms that come on suddenly such as numbness or weakness, severe headache, and problems with vision, speech, or balance.
Before taking this medicine
You should not take Abilify if you are allergic to aripiprazole.
Abilify is not approved for use in psychotic conditions related to dementia. Aripiprazole may increase the risk of death in older adults with dementia-related conditions.
To make sure Abilify is safe for you, tell your doctor if you have ever had:
- liver or kidney disease;
- heart disease, high or low blood pressure, heart rhythm problems;
- high cholesterol or triglycerides (a type of fat in the blood);
- low white blood cell (WBC) counts;
- a heart attack or stroke;
- seizures or epilepsy;
- trouble swallowing;
- a personal or family history of diabetes; or
- an obsessive-compulsive disorder, impulse-control disorder, or addictive behaviors.
Some young people have thoughts about suicide when taking medicine for a major depressive disorder and other psychiatric disorders. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
The liquid form (oral solution) of this medication may contain up to 15 grams of sugar per dose. Before taking Abilify oral solution, tell your doctor if you have diabetes.
Abilify may cause you to have high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis while you are taking this medicine.
The orally disintegrating tablet form of this medication may contain over 3 milligrams of phenylalanine per tablet. Before taking Abilify Discmelt, tell your doctor if you have phenylketonuria.
Taking antipsychotic medicine in the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant, do not stop taking Abilify without your doctor's advice.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of aripiprazole on the baby.
Aripiprazole can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
How should I take Abilify?
Take Abilify exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Do not take Abilify for longer than 6 weeks unless your doctor has told you to.
Abilify can be taken with or without food.
Swallow the regular tablet whole and do not crush, chew, or break the tablet.
Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
To take the orally disintegrating tablet (Discmelt):
- Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.
- Use dry hands to remove the tablet and place it in your mouth.
- Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.
Use Abilify regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
You should not stop using Abilify suddenly. Stopping suddenly may make your condition worse.
Your doctor will need to check your progress while you are using this medicine.
Store at room temperature away from moisture and heat. Abilify liquid may be used for up to 6 months after opening, but not after the expiration date on the medicine label.
Abilify Dosage
Adults
The recommended starting and target dose for ABILIFY is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals. ABILIFY has been systematically evaluated and shown to be effective in a dose range of 10 to 30 mg/day, when administered as the tablet formulation; however, doses higher than 10 or 15 mg/day were not more effective than 10 or 15 mg/day. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state
Maintenance Treatment: Maintenance of efficacy in schizophrenia was demonstrated in a trial involving patients with schizophrenia who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer. These patients were discontinued from those medications and randomized to either ABILIFY 15 mg/day or placebo and observed for relapse. Patients should be periodically reassessed to determine the continued need for maintenance treatment.
Adolescents
The recommended target dose of ABILIFY is 10 mg/day. Aripiprazole was studied in adolescent patients 13 to 17 years of age with schizophrenia at daily doses of 10 mg and 30 mg. The starting daily dose of the tablet formulation in these patients was 2 mg, which was titrated to 5 mg after 2 days and to the target dose of 10 mg after 2 additional days. Subsequent dose increases should be administered in 5 mg increments. The 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose. ABILIFY can be administered without regard to meals. Patients should be periodically reassessed to determine the need for maintenance treatment.
Switching from Other Antipsychotics
There are no systematically collected data to specifically address switching patients with schizophrenia from other antipsychotics to ABILIFY or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized.
Bipolar I Disorder
Acute Treatment of Manic and Mixed Episodes
Adults: The recommended starting dose in adults is 15 mg given once daily as monotherapy and 10 mg to 15 mg given once daily as adjunctive therapy with lithium or valproate. ABILIFY can be given without regard to meals. The recommended target dose of ABILIFY is 15 mg/day, as monotherapy or as adjunctive therapy with lithium or valproate. The dose may be increased to 30 mg/day based on clinical response. The safety of doses above 30 mg/day has not been evaluated in clinical trials.
Pediatrics: The recommended starting dose in pediatric patients (10 to 17 years) as monotherapy is 2 mg/day, with titration to 5 mg/day after 2 days, and a target dose of 10 mg/day after 2 additional days. Recommended dosing as adjunctive therapy to lithium or valproate is the same. Subsequent dose increases, if needed, should be administered in 5 mg/day increments. ABILIFY can be given without regard to meals
Adjunctive Treatment of Major Depressive Disorder
Adults
The recommended starting dose for ABILIFY as an adjunctive treatment for patients already taking an antidepressant is 2 to 5 mg/day. The recommended dosage range is 2 to 15 mg/day. Dosage adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week. Patients should be periodically reassessed to determine the continued need for maintenance treatment.
Irritability Associated with Autistic Disorder
Pediatric Patients (6 to 17 years)
The recommended dosage range for the treatment of pediatric patients with irritability associated with autistic disorder is 5 to 15 mg/day.
Dosing should be initiated at 2 mg/day. The dose should be increased to 5 mg/day, with subsequent increases to 10 or 15 mg/day if needed. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week [see Clinical Studies (14.4)] . Patients should be periodically reassessed to determine the continued need for maintenance treatment.
Tourette's Disorder
Pediatric Patients (6 to 18 years)
The recommended dosage range for Tourette's Disorder is 5 to 20 mg/day.
For patients weighing less than 50 kg, dosing should be initiated at 2 mg/day with a target dose of 5 mg/day after 2 days. The dose can be increased to 10 mg/day in patients who do not achieve optimal control of tics. Dosage adjustments should occur gradually at intervals of no less than 1 week.
For patients weighing 50 kg or more, dosing should be initiated at 2 mg/day for 2 days, and then increased to 5 mg/day for 5 days, with a target dose of 10 mg/day on day 8. The dose can be increased up to 20 mg/day for patients who do not achieve optimal control of tics. Dosage adjustments should occur gradually in increments of 5 mg/day at intervals of no less than 1 week.
Patients should be periodically reassessed to determine the continued need for maintenance treatment.
Agitation Associated with Schizophrenia or Bipolar Mania (Intramuscular Injection)
Adults
The recommended dose in these patients is 9.75 mg. The recommended dosage range is 5.25 to 15 mg. No additional benefit was demonstrated for 15 mg compared to 9.75 mg. A lower dose of 5.25 mg may be considered when clinical factors warrant. If agitation warranting a second dose persists following the initial dose, cumulative doses up to a total of 30 mg/day may be given. However, the efficacy of repeated doses of ABILIFY injection in agitated patients has not been systematically evaluated in controlled clinical trials. The safety of total daily doses greater than 30 mg or injections given more frequently than every 2 hours have not been adequately evaluated in clinical trials .
If ongoing ABILIFY therapy is clinically indicated, oral ABILIFY in a range of 10 to 30 mg/day should replace ABILIFY injection as soon as possible
Administration of ABILIFY Injection
To administer ABILIFY Injection, draw up the required volume of solution into the syringe as shown in Table 1. Discard any unused portion.
| Single-Dose | Required Volume of Solution |
|---|---|
| 5.25 mg | 0.7 mL |
| 9.75 mg | 1.3 mL |
| 15 mg | 2 mL |
ABILIFY Injection is intended for intramuscular use only. Do not administer intravenously or subcutaneously. Inject slowly, deep into the muscle mass.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dosage Adjustments for Cytochrome P450 Considerations
Dosage adjustments are recommended in patients who are known CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers (see Table 2). When the coadministered drug is withdrawn from the combination therapy, ABILIFY dosage should then be adjusted to its original level. When the coadministered CYP3A4 inducer is withdrawn, ABILIFY dosage should be reduced to the original level over 1 to 2 weeks. Patients who may be receiving a combination of strong, moderate, and weak inhibitors of CYP3A4 and CYP2D6 (e.g., a strong CYP3A4 inhibitor and a moderate CYP2D6 inhibitor or a moderate CYP3A4 inhibitor with a moderate CYP2D6 inhibitor), the dosing may be reduced to one-quarter (25%) of the usual dose initially and then adjusted to achieve a favorable clinical response.
| Factors | Dosage Adjustments for ABILIFY |
|---|---|
| Known CYP2D6 Poor Metabolizers | Administer half of usual dose |
| Known CYP2D6 Poor Metabolizers taking concomitant strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin) | Administer a quarter of usual dose |
| Strong CYP2D6 (e.g., quinidine, fluoxetine, paroxetine) or CYP3A4 inhibitors (e.g., itraconazole, clarithromycin) | Administer half of usual dose |
| Strong CYP2D6 and CYP3A4 inhibitors | Administer a quarter of usual dose |
| Strong CYP3A4 inducers (e.g., carbamazepine, rifampin) | Double usual dose over 1 to 2 weeks |
When adjunctive ABILIFY is administered to patients with major depressive disorder, ABILIFY should be administered without dosage adjustment as specified in Dosage and Administration (2.3).
Dosing of Oral Solution
The oral solution can be substituted for tablets on a mg-per-mg basis up to the 25 mg dose level. Patients receiving 30 mg tablets should receive 25 mg of the solution
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include drowsiness, vomiting, aggression, confusion, tremors, fast or slow heart rate, seizure (convulsions), trouble breathing, or fainting.
What should I avoid while taking Abilify?
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.
Avoid drinking alcohol. Dangerous side effects could occur.
Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Abilify.
Abilify side effects
Get emergency medical help if you have signs of an allergic reaction to Abilify: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- severe agitation, distress, or restless feeling;
- twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
- mask-like appearance of the face, trouble swallowing, problems with speech;
- seizure (convulsions);
- thoughts about suicide or hurting yourself;
- severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
- low blood cell counts--sudden weakness or ill feeling, fever, chills, sore throat, swollen gums, painful mouth sores, red or swollen gums, skin sores, cold or flu symptoms, cough, trouble breathing; or
- high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, weight loss.
You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.
Common Abilify side effects may include:
- weight gain;
- blurred vision;
- nausea, vomiting, changes in appetite, constipation;
- drooling;
- headache, dizziness, drowsiness, feeling tired;
- anxiety, feeling restless;
- sleep problems (insomnia); or
- cold symptoms such as the stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Abilify?
Taking Abilify with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.
Many other drugs can interact with aripiprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Abilify.
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