Generic Name: aripiprazole (AR-i-PIP-ra-zole)
Brand Name: Abilify Maintena
Abilify Maintena is an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Abilify Maintena is not approved to treat mental problems caused by dementia.
Abilify Maintena is used for:
Treating schizophrenia. It may also be used for other conditions as determined by your doctor.
Abilify Maintena is an atypical antipsychotic. Exactly how it works is not known. It affects certain substances in the brain.
Do NOT use Abilify Maintena if:
- you are allergic to any ingredient in Abilify Maintena
- you are taking carbamazepine, enzalutamide, a hydantoin (eg, phenytoin), metoclopramide, phenobarbital, primidone, a rifamycin (eg, rifampin), or St. John's wort
Contact your doctor or health care provider right away if this applies to you.
Before using Abilify Maintena:
Some medical conditions may interact with Abilify Maintena. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of heart problems (eg, heart failure, irregular heartbeat, heart attack), high or low blood pressure, high blood cholesterol or triglyceride levels, blood vessel problems, stroke, or low white blood cell levels
- if you have a history of seizures, neuroleptic malignant syndrome (NMS), dementia, Alzheimer disease, depression or other mental or mood disorders, or suicidal thoughts or attempts
- if you or a family member has a history of diabetes or high blood sugar, or you are very overweight
- if you are dehydrated or have low blood volume, drink alcohol, or smoke, or you will be exposed to high temperatures
- if you have never taken aripiprazole by mouth
Some MEDICINES MAY INTERACT with Abilify Maintena. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticholinergics (eg, benztropine, methscopolamine) because the risk of overheating may be increased
- Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), metoclopramide, perampanel, quinidine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or voriconazole because they may increase the risk of Abilify Maintena's side effects
- Carbamazepine, enzalutamide, hydantoins (eg, phenytoin), phenobarbital, primidone, a rifamycin (eg, rifampin), or St. John's wort because they may decrease Abilify Maintena's effectiveness
- Alpha-blockers (eg, terazosin) or medicine for high blood pressure because the risk of their side effects may be increased by Abilify Maintena
This may not be a complete list of all interactions that may occur. Ask your health care provider if Abilify Maintena may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Abilify Maintena:
Use Abilify Maintena as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Abilify Maintena comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Abilify Maintena refilled.
- Abilify Maintena is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Abilify Maintena at home, a health care provider will teach you how to use it. Be sure you understand how to use Abilify Maintena. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Abilify Maintena is for injection deep into the muscle only. Do NOT inject Abilify Maintena under the skin or into a vein.
- Do not use Abilify Maintena if it contains particles, is discolored, or if the vial is cracked or damaged.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
Ask your health care provider any questions you may have about how to use Abilify Maintena.
Important safety information:
- Abilify Maintena may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Abilify Maintena with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol while you are using Abilify Maintena.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Abilify Maintena; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Abilify Maintena may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor.
- NMS is a possibly fatal syndrome that can be caused by Abilify Maintena. Symptoms may include fever, stiff muscles, confusion, abnormal thinking, fast or irregular heartbeat, and sweating. Contact your doctor at once if you have any of these symptoms.
- Some patients who take Abilify Maintena may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Abilify Maintena in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Abilify Maintena.
- Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
- Abilify Maintena may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection such as fever, sore throat, rash, or chills.
- Abilify Maintena may raise your blood sugar or increase your risk of developing diabetes. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Diabetes patients - Abilify Maintena may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Abilify Maintena may cause weight gain in some patients. You may need regular weight checks while taking Abilify Maintena.
- Lab tests, including fasting blood sugar levels and complete blood cell counts, may be performed while you use Abilify Maintena. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Abilify Maintena with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscle movements or seizures.
- Abilify Maintena should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if Abilify Maintena can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Abilify Maintena while you are pregnant. Using Abilify Maintena during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. Abilify Maintena is found in breast milk. Do not breast-feed while taking Abilify Maintena.
Possible side effects of Abilify Maintena:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; dizziness; drowsiness; headache; light-headedness; nausea; pain, redness, or swelling at the injection site; restlessness; stomach upset; tiredness; trouble sleeping; vomiting; weight gain.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thinking; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; increased sweating; involuntary movements of the tongue, face, mouth, jaw, arms, legs, or back (eg, chewing movements, puckering of mouth, puffing of cheeks); loss of control over urination; loss of coordination; muscle tremor, jerking, or stiffness; new or worsening mental or mood problems (eg, anxiety, depression, agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, inability to sit still); one-sided weakness; seizures; severe or persistent restlessness; shortness of breath; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; symptoms of high blood sugar (eg, increased thirst, urination, or appetite; unusual weakness); trouble swallowing; trouble walking; unusual bruising or bleeding; unusual tiredness or weakness; vision or speech changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include aggression; confusion; fast, slow, or irregular heartbeat; loss of consciousness; seizures; severe drowsiness, dizziness, or vomiting; tremor; trouble breathing; unusual mental changes.Proper storage of Abilify Maintena:
Store Abilify Maintena at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Abilify Maintena out of the reach of children and away from pets.
- If you have any questions about Abilify Maintena, please talk with your doctor, pharmacist, or other health care provider.
- Abilify Maintena is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Abilify Maintena or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Abilify Maintena. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Abilify Maintena. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Abilify Maintena.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.