Aristada vs Abilify Maintena

Aristada and Abilify Maintena are brand names for prescription drugs used for the treatment of schizophrenia. Both are aripiprazole long-acting injections (LAIs). Here we will explain what they are, how they work, their similarities and differences, their side effects, and more. This should provide you with the basics to better understand your options.

What is Aristada?

Aristada is an FDA (Food and Drug Administration)-approved medication manufactured by Alkermes, Inc. Aristada is an atypical antipsychotic medication indicated for the treatment of schizophrenia. Aristada Initio in combination with oral aripiprazole is indicated for the initiation of Aristada when used for the treatment of the symptoms of schizophrenia in adults.

Elderly patients with dementia-related psychosis being treated with antipsychotic drugs are at an increased risk of death. Aristada is not approved for the treatment of patients with dementia-related psychosis.

Aristada contains aripiprazole lauroxil (a prodrug of aripiprazole) as the active ingredient.

Aristada dosage

Aristada is an extended-release injectable suspension, available in the following doses: 441 mg, 662 mg, or 882 mg single-use pre-filled syringe.

Administer Aristada as an intramuscular injection into the deltoid (Aristada 441 mg dose only) or gluteal muscle (441 mg, 662 mg, or 882 mg) by a healthcare professional.

Patients new to aripiprazole will need to have their tolerability determined with oral aripiprazole before taking the first dose of Aristada.

Aristada can be started at a dose of 441 mg, 662 mg, or 882 mg. Administered as a monthly injection, or 882 mg dose every 6 weeks. The first Aristada injection should be administered with oral aripiprazole for 21 consecutive days. Dosing adjustments may be required for missed doses.

Patients who have monthly intramuscular injections of Abilify Maintena 400 mg, and have maintained steady-state concentrations, can switch to Aristada 882 mg injection four weeks after their last Abilify Maintena injection.

Please refer to the prescribing information including the boxed warning of oral aripiprazole for the recommended dosage and administration of the oral formulation, and always speak with your healthcare provider about any changes to your dose so they can monitor and evaluate your condition.

What is Abilify Maintena?

Abilify Maintena is an FDA (U.S. Food and Drug Administration) approved medication manufactured by Otsuka America Pharmaceutical, Inc. Abilify Maintena contains aripiprazole, which is classed as an atypical antipsychotic medication. It is used for the treatment of schizophrenia, and the maintenance monotherapy treatment of bipolar I disorder in adult patients.

Aripiprazole’s exact mechanism of action is not fully understood. It is thought that aripiprazole improves the action of dopamine and serotonin receptors but also blocks 5HT2A receptors. Aripiprazole may also affect other receptors in your body resulting in orthostatic hypotension.

Abilify Maintena dosage

Abilify Maintena is available as an extended-release injectable suspension formulation, in the following doses: 300-mg and 400-mg strength lyophilized powder for reconstitution in single-use pre-filled, dual-chamber syringes, or single-dose vials.

You should use the correct aseptic techniques for the reconstitution of Abilify Maintena at room temperature. If you do not use the injection immediately keep the vial at room temperature. Shake the vial for at least 60 seconds to re-suspend before use.

Abilify Maintena is given by intramuscular injection in the deltoid or gluteal muscle, by a healthcare professional only. If you are new to aripiprazole, your tolerability must be established with oral aripiprazole before starting treatment.

The recommended starting and maintenance dose is 400 mg monthly (no sooner than 26 days after the previous injection) as a single injection. If you have adverse reactions to Abilify Maintena, your dose can be reduced to a 300 mg dose. You must take 14 consecutive days of concurrent oral aripiprazole (10 mg to 20 mg) or current oral antipsychotic with your first injection. If you are known to be a CYP2D6-poor metabolizer your recommended starting and maintenance treatment dose will be 300 mg monthly as a single injection.

Abilify Maintena can make you become dehydrated, so make sure you drink plenty of water. Your recommended dose will depend on the condition you are being treated for, your age, weight, and your renal function.

Please see the complete prescribing information, including the medication guide and boxed warning for complete drug information. Always speak with your healthcare provider for medical advice about any changes to your dose so they can monitor and evaluate your condition. Dosage adjustments are required for missed doses.

Common side effects of Aristada and Abilify Maintena

The most common side effects caused by Aristada in clinical trials with placebo include:

• Akathisia (feeling restless)
• Pain or redness at the injection site
• Weight gain
• Drowsiness

More serious side effects of Aristada include:

• Neuroleptic malignant syndrome (NMS) – very stiff muscles, high fever, sweating, confusion, memory impairment, irregular heartbeats, tremors, feeling faint
• Tardive dyskinesia – uncontrolled muscle movements in your face, chewing, lip-smacking, frowning, tongue movement, blinking, or eye movement
• Problems controlling your body temperature – feeling uncomfortably warm or hot
• Orthostatic hypotension (decreased blood pressure) – lightheaded or faint when you rise too quickly from a sitting or lying position
• Difficulty swallowing
• Seizures
• Low blood cell counts – sudden weakness or ill feeling, fever, chills, sore throat, painful mouth sores, swollen gums, skin sores, cold or flu symptoms, cough, trouble breathing
• High blood sugar – increased thirst or urination, hunger, dry mouth, fruity breath odor
• Increased sexual urges, unusual urges to gamble, or other intense urges while using this medicine

The most common side effects of Abilify Maintena in clinical trials include:

• Somnolence, sedation
• Injection site pain or reaction
• Weight gain
• Constipation, dry mouth, diarrhea, vomiting, abdominal discomfort

More serious side effects of Abilify Maintena include

• Risk of extrapyramidal symptoms (EPS) (eg, pseudoparkinsonism, acute dystonic reactions, akathisia, and tardive dyskinesia
• Hyperglycemia (high blood sugar)
• Anemia (low red blood cells)
• Serotonin syndrome especially in cases of concomitant use with other serotonergic medicinal products, such as SSRI/SNRI, or with medicinal products that are known to increase aripiprazole concentrations
• Dysphagia
• Seizures
• Elevated hepatic enzymes
• Cerebrovascular adverse reactions in elderly patients with dementia-related psychosis. Increased incidence of stroke, transient ischemic attack, including fatalities
• Neuroleptic malignant syndrome (NMS)
• High cholesterol
• High blood sugar
• High blood pressure
• Fast or slow heart rate
• Orthostatic hypotension
• Suicidal thoughts, or worsening depression
• Dyslipidemia
• Leukopenia, neutropenia, and agranulocytosis – check blood counts in patients with a history of low white blood cell count (WBC)
• Cognitive and motor impairment

These aren’t all the side effects Aristada or Abilify Maintena can cause. You can find more details in the patient leaflet that comes with your medication. Talk to your physician or pharmacist if you have any concerns about side effects.

Aristada and Abilify Maintena drug interactions

Aristada can interact with other medications. These include:

• Strong CYP3A4 Inhibitors – itraconazole, clarithromycin
• Strong CYP2D6 inhibitors – quinidine, fluoxetine, paroxetine
• Strong CYP3A4 inducers – carbamazepine, rifampin
• Antihypertensive drugs
• Benzodiazepines – lorazepam

Abilify Maintena can interact with other medications. These include:

• Strong CYP3A4 inhibitors – ketoconazole
• Strong CYP2D6 inhibitors – quinidine, paroxetine, fluoxetine
• CYP3A4 inducers – carbamazepine
• Opioid painkillers – alfentanil, buprenorphine, codeine, morphine, tramadol
• Other treatments for schizophrenia – clozapine
• Anesthetics – ketamine
• Antiemetics to prevent sickness – metoclopramide

Aristada and Abilify Maintena can interact with other medications. This can change how Aristada and Abilify Maintena and other medications work and can make adverse effects more likely. Tell your prescribing physician about all your drugs, including vitamins and dietary supplements.

Aristada and Abilify Maintena contraindications

You should not use Aristada if you:

• Are allergic to the active ingredient aripiprazole lauroxil
• Are allergic to any of the other ingredients in Aristada

Talk to your doctor before using Aristada if you:

• Are taking any of the medications that could interact with Aristada
• Have had heart disease, heart attack, or stroke
• Have high or low blood pressure
• Have high blood sugar – Aristada can cause high blood sugar (hyperglycemia)
• Suffer from seizures
• Have low white blood cell counts – this may increase your risk of leukopenia or neutropenia
• Are pregnant or are planning to become pregnant – your name may be listed on a pregnancy registry
• Are breastfeeding or are planning to breastfeed – Aristada can pass into your breast milk

You should not use Abilify Maintena if you:

• Have a known hypersensitivity to the active ingredient aripiprazole
• Have an allergy to any of the other ingredients in Abilify Maintena
• Are an older adult with dementia-related psychosis
• Are under 18 years of age

It is important to talk to your physician before taking Abilify Maintena if you have other risk factors such as:

• Heart disease, heart attack, or stroke
• High or low blood pressure
• Diabetes or a family history of diabetes
• Seizures
• Low white blood cell counts
• If you are pregnant or are planning to become pregnant, or are breastfeeding or are planning to breastfeed

Other drugs for schizophrenia

• Latuda (lurasidone)
• Zyprexa (olanzapine)
• Symbyax (olanzapine/fluoxetine)
• Invega Sustenna (paliperidone palmitate)
• Seroquel (quetiapine)
• Risperdal (risperidone)

If you have any concerns about Aristada or Abilify Maintena side effects, talk to your physician, or pharmacist for medical advice. Also inform your healthcare provider about any medical conditions, supplements, and over-the-counter meds you are taking. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.