Aristada contains aripiprazole lauroxil, which is an atypical antipsychotic. It is formulated as a white to off-white sterile aqueous extended-release injectable suspension for intramuscular use with a dosage strength of 675 mg. Key inactive ingredients include polysorbate 20, sodium chloride, sodium citrate dihydrate, sodium phosphate dibasic anhydrous, and sodium phosphate monobasic dihydrate.

How should I use this medication?

This medication is injected into a muscle. It is given by your care team in a hospital or clinic. A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision -High fever, stiff muscles, increased sweating, fast or irregular heartbeat, and confusion, which may be signs of neuroleptic malignant syndrome -Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision -Pain or trouble swallowing -Prolonged or painful erection -Seizures -Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision -Uncontrolled and repetitive body movements, muscle stiffness or spasms, tremors or shaking, loss of balance or coordination, restlessness, shuffling walk, which may be signs of extrapyramidal symptoms (EPS) -Thoughts of suicide or self-harm, worsening mood, feelings of depression -Urges to engage in impulsive behaviors such as gambling, binge eating, sexual activity, or shopping in ways that are unusual for you Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Constipation -Drowsiness -Pain, redness, or irritation at injection site -Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Dementia -Diabetes -Difficulty swallowing -Have trouble controlling your muscles -Heart disease -History of irregular heartbeat -History of stroke -Low blood cell levels (white cells, red cells, and platelets) -Low blood pressure -Parkinson disease -Seizures -Suicidal thoughts, plans, or attempt by you or a family member -Urges to engage in impulsive behaviors in ways that are unusual for you -An unusual or allergic reaction to aripiprazole, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following: -Brexpiprazole -Cisapride -Dextromethorphan; quinidine -Dronedarone -Metoclopramide -Pimozide -Quinidine -Thioridazine This medication may also interact with the following: -Alcohol -Benzodiazepines, such as alprazolam, diazepam, or lorazepam -Certain antihistamines -Certain medications for depression, such as amitriptyline or trazodone -Certain medications for seizures, such as phenobarbital or primidone -Carbamazepine -Certain medications for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole -Clarithromycin -Medications for blood pressure -Medications for Parkinson disease, such as levodopa -Medications that cause drowsiness before a procedure, such as propofol -Medications that help you fall asleep -Medications that relax muscles -Opioids for pain or cough -Other medications that cause heart rhythm changes -Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine -Rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication. Tell your care team if your symptoms do not start to get better or if they get worse. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects. This medication can cause problems with controlling your body temperature. It can lower the response of your body to cold temperatures. If possible, stay indoors during cold weather. If you must go outdoors, wear warm clothes. It can also lower the response of your body to heat. Do not overheat. Do not over-exercise. Stay out of the sun when possible. If you must be in the sun, wear cool clothing. Drink plenty of water. If you have trouble controlling your body temperature, call your care team right away. This medication may cause dry eyes and blurred vision. If you wear contact lenses, you may feel some discomfort. Lubricating eye drops may help. See your care team if the problem does not go away or is severe. This medication may increase blood sugar. Ask your care team if changes in diet or medications are needed if you have diabetes. There have been reports of increased sexual urges or other strong urges such as gambling while taking this medication. If you experience any of these while taking this medication, you should report this to your care team as soon as possible.

What are the most serious risks of this medication?

This medication should not be used to treat mood and behavior changes caused by dementia. It may increase the risk of death in older adults with dementia.