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

Figure (Ari05 0017 01)

An illustration of a syringe with a plunger, shown horizontally. The syringe is labeled with the letter "A" near the needle end. This diagram likely relates to administration or handling instructions for an injection suspension.*

FDA Label Image

Figure (Ari05 0017 02)

Illustration showing a sequence of three diagrams labeled B, C, and D, each depicting a hand holding and using a device that appears to be a safety or activation mechanism for an injection syringe, likely related to aripiprazole lauroxil extended-release suspension injection preparation or administration steps.*

FDA Label Image

Figure (Ari05 0017 03)

An instructional illustration showing how to prepare an aripiprazole lauroxil injection suspension. It depicts a hand tapping the vial 10 times, followed by vigorously shaking it for 30 seconds, then shows the injection being drawn into a syringe.*

FDA Label Image

Figure (Ari05 0017 04)

An instructional line drawing showing hands preparing an injection vial, with a cap being removed from a suspension injection vial. The image depicts safe handling before administering an aripiprazole lauroxil extended-release injectable suspension.*

FDA Label Image

Figure (Ari05 0017 05)

An instructional line drawing showing two hands preparing an injection syringe. One hand holds the syringe barrel, while the other hand adjusts the plunger, with a needle attached at the top. This likely illustrates part of the medication preparation or administration process for an injectable drug.*

FDA Label Image

Figure (Ari05 0017 06)

An instructional illustration showing hands holding a syringe with the cap being removed by pulling upwards. This diagram demonstrates how to prepare the syringe for use, likely related to the administration of an injectable medication.*

FDA Label Image

Figure (Ari05 0017 07)

An instructional illustration showing a hand holding a syringe barrel near a plunger with an arrow indicating the direction to pull or push the plunger. This likely depicts part of the process for preparing or administering an injection.*

FDA Label Image

Figure (Ari05 0017 08)

An instructional illustration depicting a hand holding a syringe with a needle, showing the process of removing a cap or protective cover from the needle prior to injection. The image is related to injection preparation or administration, corresponding to an extended-release suspension drug form.*

FDA Label Image

Figure (Ari05 0017 09)

Chemical structure of the active ingredient aripiprazole lauroxil. The structural formula depicts the molecular arrangement, including aromatic rings, nitrogen atoms, and ester linkages characteristic of this extended-release injectable drug.*

FDA Label Image

Figure 1 (Ari05 0017 10)

A pharmacokinetic plot showing aripiprazole fold change with 90% confidence intervals in AUC and Cmax when co-administered with various interacting drugs, including CYP3A4 and CYP2D6 inhibitors and inducers, gastric acid blockers, and others like valproate and lithium, relative to a reference without interacting drugs.*

FDA Label Image

Figure 2 (Ari05 0017 11)

A pharmacokinetic chart showing the fold change and 90% confidence interval of dehydro-aripiprazole levels in the presence of various interacting drugs (CYP3A4 inhibitor ketoconazole, CYP2D6 inhibitor quinidine, CYP3A4 inducer carbamazepine, gastric acid blocker famotidine, and other drugs valproate, lithium, lorazepam) relative to a reference without interacting drug. The x-axis represents the change relative to reference, and the y-axis lists the interacting drugs with AUC and Cmax measures.*

FDA Label Image

Figure 3 (Ari05 0017 12)

A forest plot chart showing the fold change and 90% confidence intervals of various drugs' pharmacokinetic parameters (such as AUC and Cmax) relative to a reference without interacting drug. Drugs listed include dextromethorphan, warfarin, R-warfarin, omeprazole, lamotrigine, valproate, lithium, lorazepam, venlafaxine, O-desmethylvenlafaxine, and escitalopram, with corresponding enzymes CYP2D6, CYP2C9, CYP2C19, UGT1A4, and their relevant PK metrics.*

FDA Label Image

Figure 4 (Ari05 0017 13)

A pharmacokinetic chart displaying the aripiprazole fold change and 90% confidence intervals for various factors, including CYP2D6 metabolizer status, gender, age groups, hepatic impairment, and renal impairment. The chart compares changes in AUC and Cmax relative to reference values, with a horizontal axis ranging from 0.5 to 3.0 fold change.*

FDA Label Image

Figure 5 (Ari05 0017 14)

A pharmacokinetic chart showing the fold change and 90% confidence interval of Dehydro-Aripiprazole levels for various patient factors including CYP2D6 metabolizer status, gender, age groups, hepatic impairment levels, and severe renal impairment. The plot uses AUC and Cmax as pharmacokinetic parameters.*

FDA Label Image

Principal Display Panel (Aristada Initio Carton Label)

Folded carton packaging of Aristada Initio 675 mg aripiprazole lauroxil extended-release injectable suspension starter dose. The label includes dosing information emphasizing use for initiation only, injection route (gluteal or deltoid intramuscular), and highlights it is not interchangeable with Aristada due to different pharmacokinetic profiles. Manufactured by Alkermes, Inc., NDC 65757-500-03.*

* 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.