The most common adverse reaction (≥5% incidence and at least twice the rate of placebo reported by patients treated with ARISTADA 441 mg and 882 mg monthly) was akathisia. You should always consult your doctor or another healthcare professional before taking any medication. Here are some examples of questions you may want to ask your doctor: Ill be out of town when my next Aristada dose is due. Nasrallah HA, Aquila R, Du Y, Stanford AD, Claxton A, Weiden PJ. Aristada contains the active drug aripiprazole lauroxil and belongs to a group of medications called atypical antipsychotics. Closely monitor patients and consider dose reduction or stopping aripiprazole if a patient develops such urges. Try to reschedule your appointment as close to your original appointment as you can. Injection-Site Reactions: In pharmacokinetic studies evaluating ARISTADA INITIO, the incidences of injection-site reactions with ARISTADA INITIO were similar to the incidence observed with ARISTADA. This section answers some frequently asked questions about Aristada. ARISTADA is a white to off-white aqueous extended-release injectable suspension provided in a single-dose pre-filled syringe. INDICATION AND IMPORTANT SAFETY INFORMATION FOR ARISTADA INITIO ANDARISTADA, WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS, Watch Dr. Stahl discuss how ARISTADA may provide long-acting symptom reduction in adult patients. However, they have some differences, such as their active ingredients, dosing schedules, and uses. Alkermes, Inc; 2021. Then, theyll adjust your dosage over time to reach the right amount for you. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. Talk with a doctor about a plan to monitor and manage these side effects during your Aristada treatment. But if you think youre having a medical emergency, you should call 911 or your local emergency number. The typical dosing of Abilify Maintena is 400 milligrams (mg) once per month. Psychosis is a condition in which one loses touch with reality. Youll receive your injection from a healthcare professional at a doctors office or clinic. All rights reserved. If you have questions about consuming grapefruit while receiving Aristada, talk with your doctor or pharmacist. Here's what you need to know about the research, safety, and side effects. A guide to drug safety terms at FDA. The most common adverse reaction (≥5% incidence and at least twice the rate of placebo reported by patients treated with ARISTADA 441 mg and 882 mg monthly) was akathisia. Symptoms of schizophrenia often include: It isnt known for sure how Aristada works to treat schizophrenia. No, theres currently no generic form of aripiprazole lauroxil, the active ingredient in Aristada. x. Pharmacy product. For information about the difference between sex and gender, see this article. 5. Aristada and Aristada Initio both come as a liquid solution thats given as an injection into your muscle. Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. Aripiprazole lauroxil was first approved by the FDA for the treatment of schizophrenia in October 2015 at monthly and 6-week dosing options. In that case, your doctor will let you know if youll need another Aristada Initio dose. Aristada Initio is available in one strength: 675 mg. If you miss an appointment for your Aristada or Aristada Initio dose, call your doctor to reschedule as soon as you remember. Heres what to do (and what to avoid), along with tips for recognizing when its time to. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Aristada Initio (aripiprazole lauroxil 650 mg) is used as a long-acting, single intramuscular (IM) injection, with a single oral dose of aripiprazole, for adult patients starting or re-initiating treatment with Aristada to treat schizophrenia. Swallowing problems. Aristada Initio may be used alone or with other medications. If your doctor recommends Aristada or Aristada Initio for you, they will prescribe the dosage thats right for you. Dystonia: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first days of treatment and at low doses. Let's examine how it works: Wondering how to help a loved one with schizophrenia? Generic name: aripiprazole (injection) [AR-i-PIP-ra-zole] But Abilify and Abilify Maintena are also used to treat other mental health conditions. Disengagement from care is a well-known risk, particularly after hospitalization, and patients may not fully understand the need for continued treatment.4-6, If patients do not follow an LAI initiation protocol as prescribed, the expected plasma concentration levels may not be reached.3, With ARISTADA (aripiprazole lauroxil) and the ARISTADA INITIO (aripiprazole lauroxil) regimen, aripiprazole concentrations reach relevant levels within 4 days.1,2, Know that your patients receive a complete LAI initiation in 1 visit1,2. Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics. You may receive your first dose of Aristada along with aripiprazole taken by mouth for 21 consecutive days. Tardive dyskinesia may also start after you stop receiving ARISTADA. ARISTADA INITIO, in combination with a single 30 mg dose of oral aripiprazole, can be used to initiate onto any dose of ARISTADA. If you were previously taking Abilify (aripiprazole) by mouth, your doctor will prescribe you a maintenance dose based on your previous oral aripiprazole dosage. Your doctor will determine the maintenance dose thats right for you. This drug should be kept at room temperature. So, its important for your doctor to check if you can tolerate aripiprazole before starting Aristada treatment. It's More Common Than You Think, Navigating Sex, Relationships, and Intimacy When Living with Schizophrenia, Debra Rose Wilson, Ph.D., MSN, R.N., IBCLC, AHN-BC, CHT, 441 milligrams (mg) per 1.6 milliliter (mL), temporary pain, swelling, or reddening at the injection site, problems with how your body regulates body temperature, changes in how you think and move, such as slowed reactions, boxed warning: increased risk of death in older people who have psychosis due to dementia*. Your doctor can help adjust your dosage schedule for your specific needs. Cognitive behavioral therapy (CBT) can be an effective way of managing the symptoms of schizophrenia and improving quality of life. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Aristada only for the indication prescribed. Aripiprazole lauroxil, sold under the brand name Aristada, is a long-acting injectable atypical antipsychotic that was developed by Alkermes. Yes, Aristada is typically used as a long-term treatment. Discontinue ARISTADA if clinically appropriate. For more details about the recommended dosing guide for Aristada, talk with your doctor or see the drugs prescribing information. CNS Spectr. They come in single-dose, prefilled syringes, which a healthcare professional will use to inject the drug into your muscle. Soc Psychiatry Psychiatr Epidemiol. Aristada doesnt interact with alcohol. If you have any symptoms of akathisia during your treatment with Aristada, talk with your doctor. Uses Warnings Before taking Side effects Interactions Dosage FAQ Your Aristada dose will usually be injected into a muscle in your upper arm or buttock. Avoid administering aripiprazole lauroxil nanocrystal dispersion (Aristada Initio) and aripiprazole lauroxil (Aristada) concurrently in the same muscle. ARISTADA is indicated for the treatment of schizophrenia in adults. If you have schizophrenia, your doctor may recommend Aristada. increased level of an enzyme called creatine phosphokinase, which can be a sign of muscle injury. Aristada may cause a drop in blood pressure on standing up, which may lead to dizziness. If youve already been taking aripiprazole by mouth, your doctor may prescribe your Aristada injection dosage based on your previous aripiprazole dosage. Minimum out-of-pocket cost per fill, after co-pay savings applied, is $10. Also describe any vitamins, herbs, or supplements you use. * In this article, we use the term female to refer to someones sex assigned at birth. If youve had an allergic reaction to Aristada, any of its ingredients, or aripiprazole (Abilify), your doctor isnt likely to prescribe Aristada. Talk with your doctor about what dosage of aripiprazole is right for you. To learn more about how Aristada and Abilify Maintena compare, see this article. Here are a few tips that might help guide your discussion: Remember, your doctor and other healthcare professionals are available to help you. Both drugs come as extended-release liquid suspensions, which a healthcare professional injects into your muscle. All rights reserved. You should discuss any questions you have about your Aristada dosage with your doctor or pharmacist. Its important to discuss all your concerns with your doctor. The dosages in this article are typical dosages provided by the drug manufacturer. Reactions have ranged from pruritus/urticaria to anaphylaxis. Aristada comes in four strengths: 441 milligrams (mg), 662 mg, 882 mg, and 1,064 mg. Aristada Initio comes in one strength: 675 mg. Package insert. Aristada is not approved for use in psychotic conditions related to dementia. The UK is the first country to allow OTC access to Sanofi's tadalafil-based erectile dysfunction drug Cialis following a successful switch. They may also prescribe it to restart Aristada treatment if you miss a dose. Aristada Initio is not given on a regular basis. This section describes the typical Aristada and Aristada Initio dosages. Low blood pressure or heart and blood vessel problems. A randomized, double-blind, placebo-controlled trial of aripiprazole lauroxil in acute exacerbation of schizophrenia. Aristada Initio, taken in combination with a single 30 mg oral dose of aripiprazole, allows physicians to initiate patients onto any dose of Aristada immediately. To learn more, see the What are Aristadas side effects? section above. Tardive dyskinesia may not go away, even if you stop receiving ARISTADA. Upon initiating treatment and recurrently, complete fall risk assessments as appropriate. The clock drawing test is sometimes used to help monitor cognitive decline experienced with schizophrenia. Depending on your dose, you may receive injections into the muscle of your deltoid (shoulder) or buttock. ARISTADA INITIO, ARISTADA (aripiprazole lauroxil)2,3 Dose Dosage Forms ARISTADA INITIO 675 mg pre-filled syringe 882 mg ARISTADA 441 mg, 662 mg, 882 mg, 1064 mg pre-filled syringe nt required Schizophrenia Initiation Option #1: ARISTADA INITIO 675 mg IM x1 dose + aripiprazole 30 mg PO x1 dose + first dose of *ARISTADA IM . A literature review. Potential for Dosing and Medication Errors: Medication errors, including substitution and dispensing errors, between ARISTADA INITIO and ARISTADA could occur. How to switch from Abilify Maintena to Aristada? Avoid use in patients who are known CYP2D6 poor metabolizers or taking strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 inducers, antihypertensive drugs or benzodiazepines. We dont know what exactly causes schizophrenia. Call 1-866-ARISTADA (1-866-274-7823) to learn more today. Learn about first- and second-generation antipsychotics and long-acting injectable antipsychotics here. O'Brien A, Fahmy R, Singh SP. Aripiprazole may increase the risk of death in older adults with dementia-related psychosis. ARISTADA INITIO is intended for single administration in contrast to ARISTADA which is administered monthly, every 6 weeks, or every 8 weeks. An Easy Guide to the Epidemiology of Schizophrenia, Understanding the Use of the Clock-Drawing Test in Schizophrenia Treatment and Diagnosis, 7 Ways to Support a Loved One with Schizophrenia, Hearing Voices? Even though Aristada and Aristada Initio have the same active ingredient, their dosages are different. Be sure to read on for more detail. Its designed to slowly release in your body over time, and its effects take a couple of months to completely wear off. Your doctor may adjust your Aristada dosage if you take certain medications along with Aristada. If you need help remembering to keep your Aristada appointments, try using a medication reminder. You can learn more about how we ensure our content is accurate and current by reading our. It isnt known for sure whether Aristada use is safe during pregnancy. Aristada Initio is not usually prescribed long term. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. 2015;76(8):1085-1090. Dr. Stahl is a paid consultant of Alkermes, Inc. Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex may occur with administration of antipsychotic drugs, including ARISTADA INITIO and ARISTADA. It isnt known if Aristada is safe to use while breastfeeding. Its very similar to the active ingredient in Aristada, aripiprazole lauroxil. 19.79. Healthline Media does not provide medical advice, diagnosis, or treatment. Symptoms may include: Akathisia symptoms can be stressful and uncomfortable and may lead to agitation, anxiety, and depression in some people. Symptoms have ranged from mild to severe and have included agitation, tremor, excessive sleepiness, and trouble breathing. 2009;35(4):696-703. Drug class: Atypical antipsychotics. Aristada Initio doses can be injected either into your shoulder or buttocks. We link primary sources including studies, scientific references, and statistics within each article and also list them in the resources section at the bottom of our articles. Theyll likely have you get blood tests to monitor your white blood cell levels before and during your treatment. They may have other forms of financial Aristada patient assistance programs for those without commercial insurance. Here, learn more about, Schizophrenia delusions are false beliefs that tend to involve illogical fantasies. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. They can give you more information about the risks and benefits of receiving Aristada during pregnancy. This condition affects the way a person thinks, feels, and behaves. Seizures. Investigating the power of music for dementia. Monitor heart rate and blood pressure, and warn patients with known cardiovascular or cerebrovascular disease and risk of dehydration and syncope. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Our website services, content, and products are for informational purposes only. Can my doctor give my injection early, before I go on my trip? Active drug aripiprazole lauroxil, sold under the brand name Aristada, talk your! 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