Aripiprazole lauroxil long-acting injection (Aristada)

How Medicare covers it

Usual path Part B (long-acting injection given by a clinician — see the Part B basis in this package). The Part D aggregation in this package is carried exactly as computed — the formulary file carries the prefilled-syringe concepts. Part A during a covered inpatient stay.

What it treats

Aristada treats schizophrenia in adults.

What it is for, in depth

The label's Indications section lists one use: treatment of schizophrenia in adults. Schizophrenia is a long-term mental illness, and Aristada is a long-acting form of aripiprazole, so it is prescribed for adults who need ongoing antipsychotic treatment without a daily pill for this drug. The label places it in the treatment path after tolerability is shown first with oral aripiprazole, and the start is paired either with a single Aristada Initio injection plus one oral dose or with 21 days of oral aripiprazole. Aristada comes in single-dose prefilled syringes: 441 mg in 1.6 mL, 662 mg in 2.4 mL, 882 mg in 3.2 mL, and 1064 mg in 3.9 mL. The different strengths match the different schedules — monthly, every 6 weeks, or every 2 months.

How it works

Aristada contains aripiprazole lauroxil, an atypical antipsychotic. After the injection, the body changes aripiprazole lauroxil into aripiprazole. The label says the exact way aripiprazole works in schizophrenia is not known, but it may work through a mix of partial activity at dopamine D2 and serotonin 5-HT1A receptors and blocking activity at 5-HT2A receptors.

How it is taken

A healthcare professional gives Aristada as an injection into a muscle — the deltoid (shoulder) muscle for the 441 mg dose only, or the gluteal (buttock) muscle for 441 mg, 662 mg, 882 mg, or 1064 mg. It can be given monthly at 441 mg, 662 mg, or 882 mg, every 6 weeks at 882 mg, or every 2 months at 1064 mg. People who have never taken aripiprazole should first show they can tolerate oral aripiprazole. There are two ways to start: one 675 mg Aristada Initio injection plus one 30 mg dose of oral aripiprazole with the first Aristada injection, or 21 straight days of oral aripiprazole with the first Aristada injection. The label has special rules for missed doses and for dose changes.

Common side effects

The FDA label extract for Aristada does not list common side effects with how-often numbers. Its Adverse Reactions section instead points readers to the serious problems described in its Warnings section — such as stroke in older patients with dementia-related psychosis, neuroleptic malignant syndrome, tardive dyskinesia, and metabolic changes — which are covered under serious warnings on this page.

Serious warnings

The label warns about stroke and other cerebrovascular problems, including deaths, in elderly patients with dementia-related psychosis. It warns about dosing errors between Aristada and Aristada Initio — one must not be substituted for the other. Other warnings include neuroleptic malignant syndrome (stop the drug at once and monitor closely), tardive dyskinesia (uncontrolled movements; stop if clinically appropriate), metabolic changes (watch for high blood sugar, abnormal lipids, and weight gain), compulsive behaviors such as pathological gambling (consider lowering the dose or stopping), low blood pressure on standing (watch heart rate and blood pressure), falls, low white blood cell counts, seizures, trouble thinking clearly or moving safely, problems controlling body temperature, and trouble swallowing.

Boxed warning

Older patients with dementia-related psychosis who are treated with antipsychotic drugs have a higher risk of death. Aristada is not approved to treat patients with dementia-related psychosis.

Who should be careful

People with a known allergy to aripiprazole must not receive Aristada — reactions have ranged from itching and hives to anaphylaxis. People with heart or blood vessel disease, a risk of dehydration or fainting, a history of a low white blood cell count, or a history of seizures need extra care and monitoring. People who are known CYP2D6 poor metabolizers need dose adjustments. Use in the third trimester of pregnancy may cause withdrawal or movement symptoms in the newborn, and breastfed infants should be watched for dehydration and poor weight gain.

Major interactions

Strong CYP3A4 or CYP2D6 inhibitors — such as itraconazole, clarithromycin, quinidine, fluoxetine, and paroxetine — can raise aripiprazole levels, so the label says to lower the Aristada dose if one is used for more than 2 weeks. Strong CYP3A4 inducers — such as carbamazepine and rifampin — can lower aripiprazole levels, so the label says to consider raising the Aristada dose if one is used for more than 2 weeks. Aripiprazole may strengthen some blood pressure medicines, such as carvedilol, lisinopril, and prazosin, so blood pressure should be watched. Taking it with the benzodiazepine lorazepam caused more sedation and more low blood pressure on standing than either drug alone, so sedation and blood pressure should be watched and doses adjusted as needed.

Cost and saving notes

Aristada is a brand-name injection given by a healthcare professional, so what you pay can depend on whether your coverage treats it under your medical benefit or your drug benefit, as well as on your own plan. Costs vary by plan — check with your plan and the clinic that will give the injection to confirm how it is covered and what you will pay before treatment starts. If you have limited income, ask whether you qualify for help with your Medicare costs.

Why it is in its tier

Aripiprazole lauroxil long-acting injection (Aristada) sits on Tier 5 in 94.75% of the plans that list it (4767 of 5031 listing plans). Tier 5 is the specialty tier — instead of a flat copay, patients usually pay a percentage of the drug's cost (coinsurance), which is why specialty drugs feel expensive even with coverage. The data-visible drivers: It is a brand-only product with no generic version in the formulary data, and the CMS dashboard puts its average Part D spending at about $20,537 per beneficiary for 2024 — among the highest-cost drugs in the program, which matches where plans place it. It is listed by 91.56% of Part D plans. The tier shown is the most common one; individual plans vary.

Sources

• ARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.] — DailyMed
• MedlinePlus — National Library of Medicine
• MedlinePlus

What official patient guides say

MedlinePlus's Aripiprazole Injection page, which lists Aristada among its brand names, says the extended-release injection is usually given once every 4, 6, or 8 weeks, depending on the product, by a healthcare provider. It may help control symptoms but will not cure the condition, so keep your injection appointments even if you feel well. If you miss an appointment for an injection, call your doctor to schedule another appointment as soon as possible. MedlinePlus also advises drinking plenty of water every day, and getting up slowly if you feel dizzy or drowsy after an injection.

Source: MedlinePlus

Part D formulary coverage

Source: CMS Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files — Monthly file 2026-10-15 (plan year 2027), file 2027_20261008.zip (data.cms.gov dataset ed1496ea-23e7-41f1-9292-172fa842ccfb): basic drugs formulary file + plan information file, both dated 20261031 inside the zip; downloaded and aggregated 2026-10-30. Medication RxCUI sets resolved through the NLM RxNav (RxNorm) API.

What you pay

Without insurance, the cash benchmark is 994.16843 per unit (ARISTADA ER 1,064 MG/3.9 ML SYR) — about nan for 30 units. NADAC benchmark — the average price pharmacies pay (CMS, as of 2026-11-04). Pharmacy shelf prices vary.

A tier is not a price; what you pay depends on your plan, pharmacy, and benefit stage; Extra Help or Medicaid can lower it further.

Sources: CMS Plan Benefit Package + formulary data; CMS NADAC · Checked 2026-11-07

Coverage by plan and tier

Of the 5,495 Medicare drug plans we track for 2027, 5,031 list Aripiprazole lauroxil long-acting injection (Aristada) — 91.6% of plans. Most of those plans put it on Tier 5: 4,767 plans, 94.8% of the plans that list it. Other plans place it on Tier 4 (150 plans), Tier 1 (113 plans) or Tier 2 (1 plans). For example: Aetna Medicare Dual Extra (HMO D-SNP) puts it on Tier 5; Aetna Medicare Dual Extra Care (PPO D-SNP) puts it on Tier 5; Aetna Medicare Value Plus (PPO) puts it on Tier 5. You can compare these plans side by side on our Medicare Advantage hub. A tier is not a price. What you pay also depends on whether you have met your plan';s deductible, whether the drug costs a flat copay or a share of the price, and whether you get Extra Help or Medicaid.

Read next

• Part D in 2027: The $700 Deductible, the $2,400 Cap, and the $35 Insulin Rule
• Extra Help in 2027: Lower Drug Copays and Who Qualifies
• Checking Medicare Savings Programs and Extra Help

Part D spending averages (2024)

Source: CMS Medicare Part D Spending by Drug (Drug Spending Dashboard), release RY26 P04 V10, data through 2024 (DSD_PTD_RY26_P04_V10_DY24_BGM.csv), downloaded 2026-10-30

Companies covering this drug

Part D and Medicare Advantage plan sponsors that list this drug on a formulary, 50 at a time.