ARISTADA 441 mg/1.6mL
aripiprazole lauroxil · INJECTION, SUSPENSION, EXTENDED RELEASE · Alkermes, Inc.
ARISTADA is a injection, suspension, extended release containing aripiprazole lauroxil at 441 mg/1.6mL, taken intramuscular. Manufactured by Alkermes, Inc..
Key Facts
- Brand Name
- ARISTADA
- Generic Name
- aripiprazole lauroxil
- NDC Code (Product)
65757-401- Manufacturer
- Alkermes, Inc.
- Strength
- 441 mg/1.6mL
- Dosage Form
- INJECTION, SUSPENSION, EXTENDED RELEASE
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- NDA207533
- Marketing Start
- 10/05/2015
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ARISTADA is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14 )]. ARISTADA is an atypical antipsychotic indicated for the treatment of schizophrenia in adults ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer ARISTADA by intramuscular injection in the deltoid (441 mg dose only) or gluteal (441 mg, 662 mg, 882 mg or 1064 mg) muscle by a healthcare professional ( 2.1 ). For patients naïve to aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ARISTADA ( 2.1 ). There are two options for initiating treatment with ARISTADA: Option #1: Administer one injection of 675 mg of ARISTADA INITIO ® and one 30 mg dose of oral aripiprazole in conjunction with the first ARISTADA injection. ( 2.1 ). Option #2: Administer 21 consecutive days of oral aripiprazole in conjunction with the first ARISTADA injection ( 2.1 ). ARISTADA can be initiated at a dose of 441 mg, 662 mg or 882 mg administered monthly, 882 mg dose every 6 weeks, or 1064 mg dose every 2 months ( 2.1 ). Dosing regimen adjustments may be required for missed doses ( 2.2 ). Dose adjustments are required for 1) known CYP2D6 poor metabolizers and 2) for patients taking CYP3A4 inhibitors, CYP2D6 inhibitors, or CYP3A4 inducers for more than 2 weeks ( 2.4 ). 2.1 Recommended Dosage ARISTADA is only to be administered as an intramuscular injection by a healthcare profe…
Contraindications
4 CONTRAINDICATIONS ARISTADA is contraindicated in patients with a known hypersensitivity reaction to aripiprazole. Hypersensitivity reactions have ranged from pruritus/urticaria to anaphylaxis [see Adverse Reactions ( 6 )]. Known hypersensitivity to aripiprazole ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Drugs Having Clinically Important Interactions with ARISTADA Table 10: Clinically Important Drug Interactions with ARISTADA Strong CYP3A4 Inhibitors and CYP2D6 Inhibitors Clinical Impact: The concomitant use of oral aripiprazole with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of oral aripiprazole alone [see Clinical Pharmacology ( 12.3 )]. Intervention: With concomitant use of ARISTADA with a strong CYP3A4 inhibitor or CYP2D6 inhibitor for more than 2 weeks, reduce the ARISTADA dose [see Dosage and Administration ( 2.4 )]. Examples: itraconazole, clarithromycin, quinidine, fluoxetine, paroxetine Strong CYP3A4 Inducers Clinical Impact: The concomitant use of oral aripiprazole and carbamazepine decreased the exposure of aripiprazole compared to the use of oral aripiprazole alone [see Clinical Pharmacology ( 12.3 )]. Intervention: With concomitant use of ARISTADA with a strong CYP3A4 inducer for more than 2 weeks consider increasing the ARISTADA dose [see Dosage and Administration ( 2.4 )]. Examples: carbamazepine, rifampin Antihypertensive Drugs Clinical Impact: Due to its alpha adrenergic antagonism, aripipra…
Adverse Reactions
6 ADVERSE REACTIONS The following are discussed in more details in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-related Psychosis [see Boxed Warning , Warnings and Precautions ( 5.1 )] Cerebrovascular Adverse Reactions, Including Stroke [see Boxed Warning , Warnings and Precautions ( 5.2 )] Neuroleptic Malignant Syndrome [see Warnings and Precautions ( 5.4 )] Tardive Dyskinesia [see Warnings and Precautions ( 5.5 )] Metabolic Changes [see Warnings and Precautions ( 5.6 )] Pathological Gambling and Other Compulsive Behaviors [see Warnings and Precautions ( 5.7 )] Orthostatic Hypotension [see Warnings and Precautions ( 5.8 )] Falls [see Warnings and Precautions ( 5.9 )] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.10 )] Seizures [see Warnings and Precautions ( 5.11 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.12 )] Body Temperature Regulation [see Warnings and Precautions ( 5.13 )] Dysphagia [see Warnings and Precautions ( 5.14 )] Most commonly observed adverse reaction with ARISTADA (incidence ≥5% and at least twice that for placebo) was akathisia ( 6.1 ). To report SUSPEC…
Frequently Asked Questions
What is ARISTADA used for?
ARISTADA contains aripiprazole lauroxil. It is a injection, suspension, extended release taken intramuscular. Consult your doctor for specific uses.
Is ARISTADA a controlled substance?
ARISTADA is not classified as a controlled substance by the DEA.
What is the generic name for ARISTADA?
The generic name for ARISTADA is aripiprazole lauroxil. There are 1 other brand versions of aripiprazole lauroxil.
What is the NDC code for ARISTADA 441 mg/1.6mL?
The NDC (National Drug Code) for ARISTADA 441 mg/1.6mL is 65757-401, listed by Alkermes, Inc..