Aripiprazole, Injection

________________________________________________________________________

KEY POINTS

• This medicine is given by injection to treat the symptoms of schizophrenia.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: antipsychotic

Generic and brand names: aripiprazole, injection; Abilify Maintena; Aristada

What is this medicine used for?

This medicine is given by injection to treat the symptoms of schizophrenia.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A low white blood cell count
• A stroke or transient ischemic attack (TIA)
• Alzheimer's disease or dementia
• Diabetes
• Heart or blood vessel disease or a heart attack
• High or low blood pressure
• High cholesterol or triglyceride levels in the blood
• Seizures
• Thoughts of suicide
• Trouble swallowing

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Taking this medicine during the last 3 months of pregnancy may cause problems for the baby. Symptoms the baby may have include agitation, tight muscles, floppy muscles, shaking, trouble breathing, or trouble feeding. Talk with your provider about this. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package before you receive your first injection and each time you get an injection.

These shots are given by your healthcare provider every 4 to 6 weeks. You must have all the shots your healthcare provider prescribes or your symptoms may return. Keep all of your appointments for these shots. If you miss a shot, contact your healthcare provider right away to reschedule.

What should I watch out for?

Older adults with dementia are at greater risk for severe side effects or death if they take this medicine. Talk with your provider about this.

Newborn babies may have trouble breathing or feeding, or other symptoms, if the mother takes this medicine in the last 3 months of pregnancy. This medicine should be used during pregnancy only if the benefit is greater than the possible risk to your baby. Talk with your provider about this.

This medicine may cause strong urges to gamble, shop, binge eat, or have sex. Talk with your provider if you have any unusual urges while taking this medicine.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help.

This medicine may cause dizziness, drowsiness, or blurred vision. Do not drive or operate machinery until you are fully alert and can see clearly.

Using this medicine for a long time may cause muscle spasms, twitching in the face and body, and uncontrolled tongue or jaw movement. Talk to your healthcare provider about this.

While taking this medicine, be careful when you exercise, especially when it is hot. This medicine affects your body's ability to cool down, and you may get too hot. If you get too hot, you might vomit, feel dizzy, have a fast heartbeat, get very stiff muscles, or be confused. Contact your provider right away if you have these symptoms.

You may need blood tests regularly to see how this medicine affects you. Keep all appointments.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

This medicine may increase the risk of developing diabetes, especially if you are overweight or have a family history of diabetes. If you have diabetes, this medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Chest pain; high fever; irregular or fast heartbeat; loss of balance; trouble walking; movements that you can’t control; muscle twitching, shaking, or stiffness; seizures; symptoms of high blood sugar (confusion, shaking, weakness, strong hunger, urinating more than usual, nausea, breath that smells fruity); trouble swallowing; vision changes; yellowing of eyes or skin; dark urine; light-colored bowel movements; unusual bruising or bleeding; depression or thoughts of suicide.

Other: Headache, pain at the spot where an injection has been given, fainting, weakness, trouble sleeping, nausea, vomiting, drowsiness, diarrhea, constipation, lightheadedness, dizziness, restlessness, runny nose, loss of appetite, dry skin, dry mouth, weight gain, back pain, muscle or joint pain, sweating.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as captopril, enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), and terazosin
• Angiotensin receptor blockers (ARBs) such as candesartan (Atacand), irbesartan (Avapro), losartan (Cozaar), valsartan (Diovan), and others
• Antianxiety medicines such as alprazolam (Xanax), buspirone, diazepam (Valium), lorazepam (Ativan), and others
• Antibiotics such as clarithromycin (Biaxin), isoniazid, rifampin (Rifadin), telithromycin (Ketek), and others
• Antidepressants such as fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, and others
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), voriconazole (Vfend), and others
• Antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), thioridazine, ziprasidone (Geodon), and others
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline), and others
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), and simeprevir (Olysio)
• Aprepitant (Emend)
• Beta blockers such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), sotalol (Betapace, Sorine), and others
• Bosentan (Tracleer)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as arsenic trioxide (Trisenox), enzalutamide (Xtandi), imatinib (Gleevec), nilotinib (Tasigna), and others
• Celecoxib (Celebrex)
• Cimetidine (Tagamet)
• Cinacalcet (Sensipar)
• Clonidine (Catapres, Kapvay)
• Conivaptan (Vaprisol)
• Dexamethasone
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as glipizide (Glucotrol), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), and others
• Diphenhydramine (Benadryl)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), nicardipine (Cardene), quinidine, and others
• HIV medicines such as atazanavir (Reyataz), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and others
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, and quinine
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Metoclopramide (Metozolv, Reglan)
• Milnacipran (Savella)
• Pain medicines such as codeine, hydrocodone (Hysingla, Zohydro), oxycodone (OxyContin, Roxicodone), tramadol (ConZip, Ultram), and others
• Parkinson’s disease medicines such as apomorphine (Apokyn), bromocriptine (Cycloset, Parlodel), levodopa/carbidopa (Duopa, Rytary, Sinemet), ropinirole (Requip), and others
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• St. John's wort
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Suvorexant (Belsomra)

Do not drink alcohol while taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.