Aristada Initio Injection, Suspension, Extended Release
Product Images NDC 65757-500

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Aristada Initio (NDC 65757-500). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alkermes, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Ari05 0012 01

An illustration showing a syringe with a plunger and a needle cover labeled 'A'. This image likely depicts the injection device for aripiprazole lauroxil suspension extended release, 675 mg/2.4 mL.*

FDA Label Image

Ari05 0012 02

An instructional diagram illustrating steps B, C, and D of a procedure involving a device or applicator, likely for preparing or administering an aripiprazole lauroxil extended-release injection suspension. The diagram shows sequential positioning of the device handle or lever in various angled positions.*

FDA Label Image

Ari05 0012 03

An instructional illustration showing two hands with syringes demonstrating the preparation of an injection. It includes text directing to tap the syringe 10 times and vigorously shake it for 30 seconds, accompanied by a stopwatch icon and arrows indicating shaking motion.*

FDA Label Image

Ari05 0012 04

An instructional line drawing showing a pair of hands opening a vial or ampule, with one hand holding the vial and the other hand breaking or twisting the top off. The image is likely related to preparation of the aripiprazole lauroxil injection, suspension, extended release 675 mg/2.4 mL.*

FDA Label Image

Ari05 0012 05

An instructional line drawing illustrating the preparation of an injection using a syringe and vial. The image shows one hand holding the syringe attached to a needle and the other hand stabilizing the vial, demonstrating the process of drawing medication into the syringe.*

FDA Label Image

Ari05 0012 06

An instructional diagram showing hands holding a syringe with the needle cap being removed by pulling upward. The illustration depicts the correct method to prepare the syringe for an injection using aripiprazole lauroxil extended-release suspension.*

FDA Label Image

Ari05 0012 07

An instructional drawing depicting a hand holding a syringe, with an arrow indicating the direction of plunger movement, likely demonstrating how to prepare or administer an injection.*

FDA Label Image

Ari05 0012 08

An instructional line drawing showing a hand holding a syringe-like device with a curved, toothed blade attached to the tip. The image appears to demonstrate a step in the preparation or administration process of the product aripiprazole lauroxil injection, suspension, extended release.*

FDA Label Image

Ari05 0012 09

Chemical structure diagram of aripiprazole lauroxil showing its molecular framework with chlorine atoms highlighted and multiple ring structures linked by chains.*

FDA Label Image

Ari05 0012 10

A pharmacokinetic chart showing aripiprazole fold change with 90% confidence intervals for various interacting drugs. The horizontal axis represents change relative to reference without interacting drug, ranging from 0.5 to 3.0. The chart compares effects of CYP3A4 inhibitors, CYP2D6 inhibitors, CYP3A4 inducers, gastric acid blockers, and other drugs on aripiprazole AUC and Cmax values.*

FDA Label Image

Ari05 0012 11

A PK chart illustrating the fold change and 90% confidence interval of Dehydro-Aripiprazole levels (AUC and Cmax) relative to reference without interacting drugs. It compares the effects of various inhibitors, inducers, gastric acid blockers, and other drugs on aripiprazole metabolism.*

FDA Label Image

Ari05 0012 12

A forest plot chart showing the fold change and 90% confidence intervals for pharmacokinetic parameters AUC and Cmax of various drugs relative to reference values without interacting drugs. Included drugs are dextromethorphan, warfarin (R- and S-), omeprazole, lamotrigine, valproate, lithium, lorazepam, venlafaxine, O-desmethylvenlafaxine, and escitalopram. The chart visualizes the impact on these pharmacokinetic metrics with a baseline of 1.0 representing no change.*

FDA Label Image

Ari05 0012 13

A pharmacokinetic chart showing aripiprazole fold change with 90% confidence intervals comparing various conditions: CYP2D6 metabolism status, gender, age groups, hepatic and renal impairment severity. It depicts changes in AUC and Cmax relative to a reference value on a horizontal axis from 0.5 to 3.0.*

FDA Label Image

Ari05 0012 14

A forest plot chart showing the fold change and 90% confidence intervals of dehydro-aripiprazole pharmacokinetic parameters (AUC and Cmax) comparing various factors: CYP2D6 metabolizer status, gender, age groups, hepatic impairment levels, and severe renal impairment. The x-axis represents the fold change on a logarithmic scale from 0.5 to 3.0.*

FDA Label Image

Ari05 0012 15

Aristada Initio starter dose 675 mg extended-release injectable suspension of aripiprazole lauroxil by Alkermes, Inc. The packaging is a folded carton label with warnings including 'DO NOT store this end up,' single-dose syringe instructions, and noting the product is only for initiation or re-initiation of Aristada treatment, not for repeated dosing. The label emphasizes professional administration via gluteal or deltoid intramuscular injection.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.