• Aristada is a brand (trade) name for aripiprazole lauroxil - a prodrug of aripiprazole - which may be used as a long-acting treatment for schizophrenia in adults.
• Experts aren't sure exactly how Aristada (aripiprazole lauroxil) works to relieve the symptoms of schizophrenia but suggest it may partially activate dopamine D2 and serotonin 5-hydroxytryptamine (5-HT) 1A receptors and has antagonist activity at serotonin 5-HT2A receptors. It does appear to have some activity at other receptors, which may account for its side effects (for example its tendency to cause low blood pressure on standing may be due to its blocking effect on adrenergic alpha1 receptors). Aripiprazole lauroxil is converted into aripiprazole by the body.
• Aristada belongs to the class of medicines known as atypical antipsychotics.

• Used to treat schizophrenia in adults.
• Aristada is an extended-release (depot) injection that is administered by a healthcare professional into the deltoid or gluteal muscle.
• Can be administered every month, every 6 weeks, or every 2 months. But tolerability to oral aripiprazole needs to be established first. Up to 2 weeks may be required to fully assess the tolerability to aripiprazole.
• Used alone or in addition to other medications for the treatment of schizophrenia.
• Aristada is an atypical antipsychotic. This means it is less likely than older antipsychotics to cause side effects, such as extrapyramidal symptoms (EPS). EPS are drug-induced movement disorders and include tremors, Parkinson's-like symptoms (walking with a shuffle, mask-like facial features), and tardive dyskinesia (this describes abnormal, repetitive facial movements such as lip-smacking or poking the tongue out).
• Available as a ready-to-use, prefilled syringe but must be administered by a healthcare professional.
• Available in 3 strengths: 441 mg in 1.6 mL, 662 mg in 2.4 mL, and 882 mg in 3.2 mL. Each kit contains a 5-mL prefilled syringe containing aripiprazole lauroxil in a sterile aqueous suspension, as well as safety needles.
• Aristada is administered via an intramuscular (IM) injection into the deltoid muscle (441mg dose only) or the gluteal muscle (441mg, 662mg, 882mg, or 1064mg)
• Can be administered as 441mg, 662mg, or 882mg given every 4 weeks: 882mg given every 6 weeks; or 1064mg given once every 2 months.
• When switching from Abilify Maintena start Aristada 882mg four weeks after the last Abilify Maintena 400mg IM injection.
• Oral aripiprazole should be given in conjunction with the first injection of Aristada for 21 consecutive days unless Aristada Initio is used (this contains one loading-dose injection of aripiprazole lauroxil which is given in conjunction with one 30mg aripiprazole tablet. An injection of Aristada is given at the same time or within 10 days.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Akathisia (an inner restlessness), headache, injection site pain, insomnia, increased blood creatine phosphokinase levels, and increased weight are the most common side effects reported.
• Research has also shown that some patients can experience intense urges, particularly for gambling, while taking Aristada. Some patients may not recognize these urges as abnormal so prescribers should ask them or their caregivers about them.
• Other side effects including changes in white blood cell counts have also been reported. Discontinue Aristada in those with severe neutropenia (absolute neutrophil count < 1000/mm^3>/sup>).
• Can only be administered by a health professional.
• Not approved for and should not be used to treat dementia-related psychosis in elderly people as associated with a higher risk of death.
• Monitor for any adverse mood effects, such as worsening depression, agitation, or mood changes. May increase the risk of suicidal thoughts or behavior (similar to other antidepressants and antipsychotics).
• May cause a drop in blood pressure on standing, particularly during the initial dose-titration period, which may increase the risk of falls; and the dosage of Aristada may need to be reduced. May not be suitable for people with known cardiovascular disease (history of a heart attack, angina, heart failure, or arrhythmia), stroke, seizure disorders, and people at risk of dehydration.
• Blood levels may need monitoring as Aristada can cause numbers of white blood cells to decrease.
• May increase blood sugar levels. People with a history of diabetes or at risk of diabetes should be monitored closely. Less likely than some other antipsychotics to cause undesirable changes in blood cholesterol and lipid levels or to cause weight gain.
• Potentially irreversible tardive dyskinesia can develop, even with low dosages used short-term. Symptoms include facial grimacing, repetitive chewing, and tongue thrusting.
• Rarely, may cause Neuroleptic Malignant Syndrome; symptoms include high body temperature, muscle rigidity, and mental disturbances; discontinue immediately and seek urgent medical advice.
• May interact with several drugs, including benzodiazepines, carbamazepine, fluoxetine, and itraconazole. See prescribing information for a full list of interactions. Dosage adjustments may be necessary for strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or CYP3A4 inducers. No dosage adjustments are recommended for Aristada if CYP450 modulators are added for less than 2 weeks.
• There have been several substitution and dispensing errors reported between the two different extended-release IM forms of aripiprazole lauroxil, Aristada Initio, and Aristada. Aristada Initio is for single-dose administration only at the start of treatment and is administered with ONE aripiprazole tablet. An injection of Aristada is given at the same time or within 10 days of an Aristada Initio injection. Do not substitute Aristada Initio for Aristada.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Aristada is a long-acting injection that is usually administered into the muscle of your buttocks, although the lowest dose (441mg) may be given into the deltoid muscle of your upper arm.
• Do not miss a dose of Aristada. If you miss a dose, contact your healthcare provider right away to discuss what you should do next.
• May cause sedation or impair judgment skills and affect your ability to drive or operate machinery. Avoid alcohol.
• Avoid becoming too hot or dehydrated while taking Aristada. Do not exercise too much. Aristada may make it difficult to regulate your body temperature. In hot weather, stay out of the sun and do not wear too much heavy clothing. Drink lots of water.
• Seek urgent medical advice if you develop unusual body movements, confusion, high fever, lightheadedness, fainting, seizures, have problems controlling your body temperature, or difficulty swallowing.
• Aristada may make you feel dizzy when going from a sitting or lying down position to standing. This may increase your risk of falls. Stand up slowly and remove any fall hazards from your home (such as loose rugs).
• Aristada may give you an intense urge to gamble, shop, eat, or partake excessively in some other activity
• Talk with your doctor if you develop any worrying side effects such as uncontrollable facial grimacing, restlessness, severe dizziness, or severe abdominal discomfort.
• Tell your doctor if you take any other medications or supplements, or drink alcohol or use recreational drugs.
• Tell your doctor if you are intending to become pregnant and you are taking Aristada as your doctor may wish to change you to a different medication. Aristada is incompatible with breastfeeding. If you inadvertently become pregnant, there is a pregnancy registry that monitors pregnancy outcomes of women exposed to Aristada. Visit www.Aristada.com or ring 1-866-274-7823 for more information.

• May take up to 21 days to reach stable blood concentrations of Aristada which is why it is either given with oral aripiprazole for the first 21 days or an injection of Aristada Initio is used for the first dose.
• In the event of early dosing, Aristada should not be given earlier than 14 days after the previous injection.
• Dosage reductions may be needed for people known to be poor metabolizers of medicines like aripiprazole, or in people taking other medications known to interfere with the hepatic enzymes CYP2D6 and CYP3A4. Conversely, a dosage increase of Aristada may be needed when given with medications that induce CYP3A4. Do not initiate Aristada Initio and Aristada together if a patient requires dosage adjustments.
• The approval of Aristada was based on the results of an international, placebo-controlled, phase 3 clinical trial, with >600 patients with schizophrenia. This study demonstrated that Aristada offers superior symptom control compared with placebo (an inactive treatment).
• The 441 mg, 662 mg, 882 mg and 1064 mg doses correspond to 300 mg, 450 mg, 600 mg and 724 mg of aripiprazole, respectively.

Medicines that interact with Aristada may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Aristada. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Aristada include:

• anti-anxiety medications such as diazepam and oxazepam
• anticonvulsants, such as phenytoin
• antidepressants, such as amitriptyline, imipramine, nortriptyline
• antifungals, such as itraconazole or ketoconazole
• antihistamines that cause sedation, such as diphenhydramine
• bupropion
• CYP2D6 strong inhibitors (such as bupropion, fluoxetine, paroxetine, quinidine, or terbinafine. Administer half the usual dosage
• CYP3A4 strong inhibitors (such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, or grapefruit). Administer half the usual dosage
• CYP3A4 strong inducers (such as carbamazepine or rifampin). Double the usual dosage over 1 to 2 weeks
• duloxetine
• HIV medications such as indinavir and ritonavir
• ipratropium
• grapefruit juice and products
• lithium
• methylphenidate
• migraine treatments, such as rizatriptan and sumatriptan
• monoamine oxidase inhibitors, such as selegiline, isocarboxazid, or phenelzine
• opioid analgesics such as oxycodone and morphine
• muscle relaxants such as cyclobenzaprine
• quinidine
• serotonin modulators, such as nefazodone and trazodone
• sleeping pills, such as zolpidem
• some chemotherapy treatments
• some heart medications, such as doxazosin and prazosin
• other medications used to treat mental illness, such as clozapine and thioridazine.

Alcohol may worsen the side effects of Aristada such as drowsiness, dizziness, and liver toxicity.

Note that this list is not all-inclusive and includes only common medications that may interact with Aristada. You should refer to the prescribing information for Aristada for a complete list of interactions.