ARISTADA INITIO 675 mg/2.4mL
aripiprazole lauroxil · INJECTION, SUSPENSION, EXTENDED RELEASE · Alkermes, Inc.
ARISTADA INITIO is a injection, suspension, extended release containing aripiprazole lauroxil at 675 mg/2.4mL, taken intramuscular. Manufactured by Alkermes, Inc..
Key Facts
- Brand Name
- ARISTADA INITIO
- Generic Name
- aripiprazole lauroxil
- NDC Code (Product)
65757-500- Manufacturer
- Alkermes, Inc.
- Strength
- 675 mg/2.4mL
- Dosage Form
- INJECTION, SUSPENSION, EXTENDED RELEASE
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- NDA209830
- Marketing Start
- 06/29/2018
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 INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults. ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA ® when used for the treatment of schizophrenia in adults ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer one 675 mg injection of ARISTADA INITIO and one 30 mg dose of oral aripiprazole in conjunction with the first ARISTADA injection ( 2.1 ). ARISTADA INITIO is only to be used as a single dose and is not for repeated dosing ( 2.1 ). Administer ARISTADA INITIO by intramuscular injection in either the deltoid or gluteal muscle by a healthcare professional ( 2.1 ). For patients naïve to aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ARISTADA INITIO ( 2.1 ). See Dosage and Administration for detailed preparation and administration instructions ( 2.4 ). Avoid use in known CYP2D6 poor metabolizers ( 2.3 , 7.1 ). Avoid use with strong CYP2D6 or CYP 3A4 inhibitors and strong CYP3A4 inducers ( 2.3 , 7.1 ). ARISTADA INITIO is not interchangeable with ARISTADA ( 2.1 , 5.3 ). 2.1 Recommended Dosage ARISTADA INITIO is only to be used as a single dose to initiate ARISTADA treatment or as a single dose to re-initiate ARISTADA treatment following a missed dose of ARISTADA. ARISTADA INITIO is not for repeated dosing. ARISTADA INITIO is not interchangeable with ARISTADA due to differing pharmacokinetic profiles [see …
Contraindications
4 CONTRAINDICATIONS ARISTADA INITIO 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 INITIO Table 4: Clinically Important Drug Interactions with ARISTADA INITIO Strong CYP3A4 Inhibitors and CYP2D6 Inhibitors Clinical Impact: 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: Avoid concomitant use of ARISTADA INITIO with strong CYP3A4 or strong CYP2D6 inhibitors because the dosage of ARISTADA INITIO cannot be modified [see Dosage and Administration ( 2.3 )]. Examples: itraconazole, clarithromycin, quinidine, fluoxetine, paroxetine Strong CYP3A4 Inducers Clinical Impact: 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: Avoid concomitant use of ARISTADA INITIO with strong CYP3A4 inducers because the dosage of ARISTADA INITIO cannot be modified [see Dosage and Administration ( 2.3 )]. Examples: carbamazepine, rifampin Antihypertensive Drugs Clinical Impact: Due to its alpha adrenergi…
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 (incidence ≥5% and at least twice that for placebo) was akathisia ( 6.1 ). To report SUSPECTED ADVERSE RE…
Frequently Asked Questions
What is ARISTADA INITIO used for?
ARISTADA INITIO contains aripiprazole lauroxil. It is a injection, suspension, extended release taken intramuscular. Consult your doctor for specific uses.
Is ARISTADA INITIO a controlled substance?
ARISTADA INITIO is not classified as a controlled substance by the DEA.
What is the generic name for ARISTADA INITIO?
The generic name for ARISTADA INITIO is aripiprazole lauroxil. There are 4 other brand versions of aripiprazole lauroxil.
What is the NDC code for ARISTADA INITIO 675 mg/2.4mL?
The NDC (National Drug Code) for ARISTADA INITIO 675 mg/2.4mL is 65757-500, listed by Alkermes, Inc..