Abilify Asimtufii Injection, Suspension, Extended Release
Product Images NDC 59148-114

Product Visual Gallery

This gallery contains 33 technical images submitted to the FDA as part of the official labeling for Abilify Asimtufii (NDC 59148-114). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Otsuka America Pharmaceutical, 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

Image (Abilify 01)

An instructional diagram showing parts of a syringe used for Abilify Asimtufii injection, suspension, extended release intramuscular. Labeled parts include plunger rod, syringe tip-cap, needle cap, needle safety shield, and needle base.*

FDA Label Image

Figure 1 (Abilify 02)

An instructional illustration showing a person holding and shaking a syringe or vial, presumably to mix the contents before administration. The image likely relates to preparation of the Abilify Asimtufii aripiprazole extended-release intramuscular injection.*

FDA Label Image

Figure 2 (Abilify 03)

An instructional illustration showing a hand holding a syringe-like device. Arrows indicate a back-and-forth motion, and a stopwatch icon indicates a duration of 10 seconds. This likely demonstrates a step for preparing or administering the injection, emphasizing a 10-second motion or wait time.*

FDA Label Image

Figure 3 (Abilify 04)

An instructional illustration showing two syringes. The first syringe has its cap being removed by twisting and pulling upward. The second syringe shows a needle being attached by twisting it onto the syringe tip. No text other than instructional arrows is visible.*

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Figure 4 (Abilify 05)

An instructional illustration showing a syringe with a needle cap being removed by pulling it straight up, depicting preparation for use of the injection device.*

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Figure 5 (Abilify 06)

An instructional illustration showing a hand holding a syringe with a needle attached, poised above the barrel. The syringe appears to be filled with liquid medication, likely demonstrating proper handling or preparation technique for intramuscular injection of Abilify Asimtufii extended-release suspension.*

FDA Label Image

Figure 6 (Abilify 07)

An anatomical illustration showing the human buttocks from the rear, with shaded areas labeled 'gluteal' indicating the gluteal muscle regions where intramuscular injections, such as Abilify Asimtufii injection suspension, extended release, may be administered.*

FDA Label Image

Figure 7 (Abilify 08)

An instructional line drawing showing a hand holding a syringe or similar device, positioned to activate or press down on a surface. The illustration likely depicts a step in the preparation or administration process for an injection.*

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Figure 8 (Abilify 09)

An illustration showing a hand holding a syringe and needle positioned at an angle for an intramuscular injection. The image visually demonstrates technique or positioning for administering a medication via injection.*

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Chemical Structure (Abilify 10)

Chemical structure of Aripiprazole, the active ingredient in Abilify Asimtufii injection. The diagram shows the molecular formula including chlorine atoms, nitrogen atoms, and a water molecule (H2O) associated with the compound.*

FDA Label Image

Figure 9 (Abilify 11)

A line graph comparing aripiprazole plasma concentration (ng/mL) over time (days) for two formulations: Abilify Asimtufii 960 mg and Abilify Maintena 400 mg. The x-axis shows time from 0 to 56 days, and the y-axis shows concentration ranging from 0 to 500 ng/mL. Both formulations show fluctuating plasma levels with Abilify Asimtufii having data represented with triangles and Abilify Maintena with circles.*

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Figure 10 (Abilify 12)

A horizontal bar chart titled 'Effect of Other Drugs on Abilify' showing the fold change and 90% confidence intervals in Aripiprazole pharmacokinetic parameters (AUC and Cmax) caused by various drugs including CYP3A4 inhibitors (ketoconazole), CYP2D6 inhibitor (quinidine), CYP3A4 inducer (carbamazepine), gastric acid blockers (famotidine), and others (valproate, lithium, lorazepam). The x-axis indicates change relative to reference without interacting drug.*

FDA Label Image

Figure 11 (Abilify 13)

A chart depicting the effect of various drugs on the pharmacokinetics of Abilify. The graph shows fold change and 90% confidence intervals for key pharmacokinetic parameters, AUC and Cmax, relative to a reference without interacting drugs. It compares the impact of CYP3A4 inhibitors (ketoconazole), CYP2D6 inhibitors (quinidine), CYP3A4 inducers (carbamazepine), gastric acid blockers (famotidine), and other drugs like valproate, lithium, and lorazepam on Abilify exposure.*

FDA Label Image

Figure 12 (Abilify 14)

A chart illustrating the effect of Abilify (aripiprazole) on the pharmacokinetics of other drugs, showing fold changes and 90% confidence intervals for various drugs such as dextromethorphan, warfarin, omeprazole, lamotrigine, valproate, lithium, lorazepam, venlafaxine, and escitalopram. The x-axis represents change relative to reference without interacting drug.*

FDA Label Image

Figure 13 (Abilify 15)

A pharmacokinetic chart depicting aripiprazole fold change with 90% confidence intervals in special populations. Variables include CYP2D6 metabolizer status, gender, age groups, hepatic impairment severity, and severe renal impairment, showing changes in AUC and Cmax relative to a reference value on the x-axis.*

FDA Label Image

Figure 14 (Abilify 16)

A pharmacokinetic chart titled 'Dehydro-Aripiprazole Fold Change and 90% CI' showing fold changes in AUC and Cmax relative to reference values across different factors: CYP2D6 metabolizer status, gender, age groups, hepatic impairment levels, and severe renal impairment. The x-axis represents change relative to reference from 0.5 to 3.0, with data points and confidence intervals plotted for each factor's comparison.*

FDA Label Image

Figure 15 (Abilify 17)

A line graph showing the change in PANSS total score from baseline over 12 weeks of treatment comparing Abilify Maintena and placebo groups. The graph displays least-square mean changes in PANSS total score on the vertical axis and weeks of treatment on the horizontal axis, with Abilify Maintena showing a greater reduction in score compared to placebo.*

FDA Label Image

Figure 16 (Abilify 18)

A Kaplan-Meier curve chart comparing the proportion of patients with relapse over time (days from randomization) between Abilify Maintena and placebo groups. The x-axis shows time to relapse up to 364 days, and the y-axis shows the proportion of patients with relapse from 0% to 80%. The chart includes numbers of subjects at risk at various time points for both groups.*

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Figure 17 (Abilify 19)

A Kaplan-Meier curve chart showing the proportion of subjects with recurrence over time (days from randomization) comparing Abilify Maintena versus placebo. The chart includes numbers of subjects at risk at various time points and shows separate survival curves for both treatments.*

FDA Label Image

Image (Abilify 22)

An instructional diagram showing parts of a syringe used for Abilify Asimtufii injection. Labeled components include the syringe tip-cap, plunger rod, needle safety shield, needle cap, and needle base, illustrating the proper setup and safety features for intramuscular administration.*

FDA Label Image

Figure 1 (Abilify 23)

An instructional illustration showing hands preparing a syringe, holding the syringe with one hand and shaking it with the other, likely demonstrating proper mixing technique for an injectable suspension.*

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Figure 2 (Abilify 24)

Illustration showing a hand holding a syringe with an extended release injection, demonstrating the action of pulling back or adjusting the syringe plunger. A clock icon indicates to wait 10 seconds, suggesting a timing step in the injection preparation or administration process.*

FDA Label Image

Image (Abilify 25)

FDA Label Image

Image (Abilify 26)

Illustration depicting a simplified human figure, possibly indicating an intramuscular injection site for the medication Abilify Asimtufii (aripiprazole extended-release suspension). The image shows the outline of a person without specific anatomical details.*

FDA Label Image

Figure 3 (Abilify 27)

An instructional illustration showing how to activate a syringe by rotating and pulling off a protective cap. The image depicts step-by-step syringe preparation involving turning and removing the cap before use.*

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Figure 4 (Abilify 28)

An instructional illustration showing the assembly of a syringe with an attached needle cap being removed, demonstrated by an upward arrow. This image likely depicts preparation steps for an intramuscular injection, relevant to Abilify Asimtufii extended-release suspension.*

FDA Label Image

Figure 5 (Abilify 29)

An illustration showing a hand holding a syringe with a needle cap partially removed, prepared for injection. The image relates to administration of an injection, consistent with an intramuscular extended-release suspension drug like Abilify Asimtufii (aripiprazole).*

FDA Label Image

Figure 6 (Abilify 30)

An anatomical illustration highlighting the gluteal areas on a human figure, indicating the recommended injection sites for intramuscular administration, relevant to medications such as Abilify Asimtufii.*

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Figure 7 (Abilify 31)

An instructional illustration showing a hand holding a syringe with the needle cover being peeled away or rotated downward, demonstrating how to prepare the syringe for injection. No product labeling or text is visible in the image.*

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Figure 8 (Abilify 31a)

Illustration showing a hand holding a syringe with the needle tip angled downward toward a surface, demonstrating proper handling or injection technique for an intramuscular injection.*

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Figure 9 (Abilify 32)

A gray, square-shaped container labeled with a prominent black biohazard symbol on a white square background. No additional text or branding is visible on the container. The container appears suitable for medical or hazardous waste use, with no direct reference to Abilify Asimtufii or its pharmaceutical details.*

FDA Label Image

Principal Display Panel (720 mg/2.4 mL Syringe Carton)

Packaging label for Abilify Asimtufii 720 mg/2.4 mL (300 mg/mL) extended-release injectable suspension. The label states the product contains aripiprazole and is for gluteal intramuscular injection only. It includes contents of a single-dose prefilled syringe with two safety needles. Distributed by Otsuka America Pharmaceutical, Inc., the label displays dosing frequency, storage instructions, inactive ingredients, and a barcode.*

FDA Label Image

Principal Display Panel (960 mg/3.2 mL Syringe Carton)

Packaging label for Abilify Asimtufii 960 mg/3.2 mL (300 mg/mL) extended-release injectable suspension of aripiprazole for gluteal intramuscular injection. The box includes one single-dose prefilled syringe with two safety needles and states dosage frequency of once every 2 months. Labeler is Otsuka America Pharmaceutical, Inc.*

* 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.