Abilify MyCite

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

Abilify MyCite contains a sensor to detect whether the medication is being taken. The Abilify MyCite system also comes with a MyCite Patch, a wearable patch, that detects the sensor after Abilify MyCite has been taken. The MyCite Patch will send data to the MyCite App and a portal where a healthcare provider and caregiver can see the information.

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

Do not chew, divide, or break Abilify MyCite tablets. Swallow tablets whole.

Common side effects of Abilify MyCite include an inner sense of restlessness or need to move and insomnia. Abilify MyCite can also cause drowsiness or dizziness. Do not drive or operate heavy machinery until you know how Abilify MyCite affects you.

Aripiprazole is a prescription medication used to treat:

• adults with schizophrenia
• bipolar I disorder in adults, including:
  • the short-term treatment of manic or mixed episodes. May be used alone or with the medicine lithium or valproate.
  • long-term treatment of bipolar I disorder. May be used alone or with the medicine lithium or valproate.
• major depression in adults, as an add-on treatment to an antidepressant medicine, when you do not get better with an antidepressant alone

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

Serious side effects have been reported with Abilify MyCite. See the “Abilify MyCite Precautions” section.

Common side effects of Abilify MyCite include the following:

• an inner sense of restlessness or need to move
• dizziness 
• nausea
• insomnia
• sedation
• tremor or shaking
• anxiety
• constipation
• tiredness

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

Tell your doctor if you have any side effects that bother you or that do not go away.

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 non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), fluoxetine (Prozac, Sarafem), amitriptyline (Elavil, Amitril, Amitid), and paroxetine (Paxil)
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort
• medications for high blood pressure 
• benzodiazepines like lorazepam (Ativan)

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

Serious side effects have been reported with Abilify MyCite including the following:

• increased risk of death in elderly people with dementia-related psychosis. This medication is not for the treatment of people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
• 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
• changes in the body's metabolic processes, including: 
  • high blood sugar. Increases in blood sugar can happen in some people who take aripiprazole. Call your healthcare provider if you have any of these symptoms of high blood sugar while taking aripiprazole:
    • 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 aripiprazole, 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.
  • increase fat levels (cholesterol and triglycerides in your blood)
• 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 aripiprazole. Tardive dyskinesia may also start after you stop taking aripiprazole.
• unusual urges. Some people receiving this medication have had unusual urges such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges. If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
• 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 overheated 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 aripiprazole.
• increase risk of falls. 

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 aripiprazole affects you. Aripiprazole may make you drowsy.

Do not take Abilify MyCite if you are allergic to Abilify MyCite or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Abilify MyCite, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Abilify MyCite, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Abilify MyCite or to any of its ingredients
• have diabetes or high blood sugar or have a family history of diabetes or high blood sugar
• have or have had low or high blood pressure
• have or have had heart problems or stroke
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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

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

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

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

Take Abilify MyCite exactly as prescribed. 

Abilify MyCite comes in tablet form and is taken once a day. Take with or without food.

Do not chew, divide, or break Abilify MyCite tablets. Swallow tablets whole.

Follow your healthcare provider's instructions on how to apply and wear the MyCite Patch. The MyCite Patch should be placed on the left side of the body just above the lower edge of the rib cage. Do not place the MyCite Patch on skin that is cracked, scraped, or irritated. The MyCite Patch should be kept on when showering, swimming, or exercising and replaced weekly or sooner.

The Abilify MyCite tablet is usually detected by the MyCite Patch within 30 minutes after you take it, but there can be a delay of more than 2 hours for the MyCite App and portal to have the information. Sometimes the Abilify MyCite is not detected. If the tablet is not detected after you take it, do not repeat the dose.

Do not stop or change the way you take Abilify MyCite without talking to your healthcare provider.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Abilify MyCite at the same time.

Take aripiprazole 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.

• The recommended dose range of Abilify MyCite for schizophrenia and in bipolar I disorder is 10 mg to 15 mg. The maximum dose per day is 30 mg.
• The recommended dose range of Abilify MyCite for depression with an antidepressant is 2 mg to 5 mg. The maximum dose per day is 15 mg.

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

• Store Abilify MyCite tablets and MyCite Patches at room temperature, between 68°F to 77°F (20°C to 25°C).
• Keep Abilify MyCite tablets and MyCite Patches dry. Do not store Abilify MyCite tablets and MyCite Patches in humid areas.
• Keep this and all medicines out of the reach of children.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY MYCITE is not approved for the treatment of patients with dementia-related psychosis.  
• Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants. Closely monitor for worsening and emergence of suicidal thoughts and behaviors.
• The safety and effectiveness of ABILIFY MYCITE have not been established in pediatric patients.