Starjemza Injection
Product Images NDC 0143-9168

Product Visual Gallery

This gallery contains 46 technical images submitted to the FDA as part of the official labeling for Starjemza (NDC 0143-9168). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hikma Pharmaceuticals Usa 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.

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Table 1 (Starjemz Ustekinumab Hmny Injection 1)

A table titled 'Recommended Dose of STARJEMZA for Subcutaneous Injection in Pediatric Patients (6-17 years old) with Plaque Psoriasis' showing dosing guidelines based on patient body weight. It lists doses of 0.75 mg/kg for patients under 60 kg, 45 mg for 60 to 100 kg, and 90 mg for over 100 kg.*

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Table 7 (Starjemz Ustekinumab Hmny Injection 10)

A table titled 'Common Adverse Reactions Through Week 44 in Trial CD-3 Occurring in ≥3% of Ustekinumab-Treated Subjects and Higher Than Placebo.' It compares the incidence of specific adverse reactions between placebo (N=133) and ustekinumab 90 mg subcutaneous maintenance dose every 8 weeks (N=131), including nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis.*

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Table 8 (Starjemz Ustekinumab Hmny Injection 11)

A clinical outcomes data table from Ps STUDY 1 and Ps STUDY 2 showing results at week 12 for adults with plaque psoriasis. It compares placebo and ustekinumab at 45 mg and 90 mg doses, displaying subjects randomized and percentages achieving PASI 75 response and PGA of Cleared or Minimal.*

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Table 9 (Starjemz Ustekinumab Hmny Injection 12)

Data table presenting clinical outcomes by weight at Week 12 in adults with plaque psoriasis from two studies (Ps STUDY 1 and Ps STUDY 2). It compares placebo and ustekinumab (45 mg and 90 mg) groups, showing PASI 75 response rates and PGA of cleared or minimal skin by weight categories (≤100 kg and >100 kg).*

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Table 10 (Starjemz Ustekinumab Hmny Injection 13)

A data table titled 'Efficacy Results at Week 12 in Pediatric Subjects 12 to 17 years with Plaque Psoriasis in Ps STUDY 3.' It compares placebo and ustekinumab treatment groups (N=37 and 36) on efficacy measures including PGA of cleared or minimal, PASI 75 responders, and PASI 90 responders, showing higher response rates for ustekinumab.*

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Table 11 (Starjemz Ustekinumab Hmny Injection 14)

A data table titled 'ACR 20, ACR 50, ACR 70 and PASI 75 responses in PsA STUDY 1 and PsA STUDY 2 at Week 24' comparing responses to Ustekinumab 45 mg and 90 mg versus placebo in two Psoriatic Arthritis studies. It presents numbers and percentages of subjects randomized, and subjects with ≥3% BSA experiencing PASI 75 response.*

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Fig 1 (Starjemz Ustekinumab Hmny Injection 15)

A line graph titled 'Percent of subjects achieving ACR 20 response through Week 24 PsA STUDY 1' shows the percentage of patients over 24 weeks. The graph compares Placebo, Ustekinumab 45 mg, and Ustekinumab 90 mg groups, illustrating increasing patient response percentages over time with Ustekinumab groups showing higher response rates than placebo.*

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Table 12 (Starjemz Ustekinumab Hmny Injection 16)

Data table titled 'Mean change from baseline in ACR components at Week 24' from PsA Study 1 comparing placebo and ustekinumab at 45 mg and 90 mg dosages. It presents baseline values and mean changes for swollen joints, tender joints, pain assessment, global assessments by subject and physician, disability index (HAQ), and CRP levels in subjects.*

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Table 13 (Starjemz Ustekinumab Hmny Injection 17)

A data table titled 'Induction of Clinical Response and Remission in CD-1 and CD-2' comparing placebo and ustekinumab treatment outcomes for Crohn's disease populations CD-1 (n=741) and CD-2 (n=627). It presents numbers and percentages for clinical response and remission at weeks 3, 6, and 8, including treatment differences with 95% confidence intervals, alongside footnotes defining clinical measures and patient population details.*

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Table 14 (Starjemz Ustekinumab Hmny Injection 18)

A table titled 'Clinical Response and Remission in CD-3 (Week 44; 52 weeks from initiation of the induction dose)' comparing placebo and 90 mg ustekinumab every 8 weeks. It presents clinical remission, clinical response, and remission in patients in remission at the start of maintenance therapy, with treatment differences and confidence intervals.*

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Table 15 (Starjemz Ustekinumab Hmny Injection 19)

A data table comparing clinical outcomes between placebo and ustekinumab groups in a sample of patients (N=319 placebo, N=322 ustekinumab). It summarizes percentages and counts for endpoints including Clinical Remission, Endoscopic Improvement, Clinical Response, and Histologic-Endoscopic Mucosal Improvement, further divided by bio-naïve and prior biologic failure subgroups, along with treatment differences and 97.5% confidence intervals.*

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Table 2 (Starjemz Ustekinumab Hmny Injection 2)

A data table showing injection volumes of STARJEMZA 45 mg/0.5 mL single-dose vials for pediatric patients aged 6-17 years with plaque psoriasis or psoriatic arthritis weighing less than 60 kg. It lists body weight (kg), corresponding dose (mg), and volume of injection (mL) ranging from 11.3 mg to 44.3 mg doses and 0.12 mL to 0.49 mL injection volumes.*

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Table 16 (Starjemz Ustekinumab Hmny Injection 20)

A clinical data table comparing placebo and 90 mg ustekinumab every 8 weeks in various efficacy endpoints such as clinical remission, maintenance of clinical response, endoscopic improvement, and corticosteroid-free clinical remission. The table includes subgroup analyses for bio-naive and prior biologic failure patients, showing treatment differences and 95% confidence intervals.*

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Fig A (Starjemz Ustekinumab Hmny Injection 21)

An instructional illustration depicting the components related to Starjemza (ustekinumab-hmny) injection. Shown are a syringe with attached needle, Starjemza vial, cotton ball or gauze pads, antiseptic wipes, adhesive bandage, and an FDA-cleared sharps disposal container.*

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Fig B (Starjemz Ustekinumab Hmny Injection 22)

An instructional diagram showing recommended subcutaneous injection sites for Starjemza (ustekinumab-hmny). Gray shaded areas on a human figure indicate preferred injection locations on the abdomen, front thighs, and upper buttocks.*

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Fig C (Starjemz Ustekinumab Hmny Injection 23)

An instructional diagram labeled Figure C showing the removal of a vial cap from a vial bottle containing injectable solution. The diagram illustrates lifting the circular cap upward and away from the vial.*

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Fig D (Starjemz Ustekinumab Hmny Injection 24)

An instructional illustration showing hands removing the cap from a vial, presumably for preparing a subcutaneous injection of Starjemza (ustekinumab-hmny). The image demonstrates the step of pulling up and away to remove the vial cap.*

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Fig E (Starjemz Ustekinumab Hmny Injection 25)

An instructional diagram showing two hands holding a syringe and a vial. The image depicts the action of pulling the syringe and vial apart, indicated by arrows pointing in opposite directions. This figure likely illustrates a step in the preparation of the Starjemza subcutaneous injection.*

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Fig F (Starjemz Ustekinumab Hmny Injection 26)

An instructional illustration showing two hands preparing an injection by drawing liquid from a vial using a syringe. The vial is held steady by one hand while the other hand pulls back the syringe plunger to withdraw the medication.*

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Fig G (Starjemz Ustekinumab Hmny Injection 27)

An instructional illustration labeled Figure G showing hands drawing medication from a vial into a syringe. The vial is held upside down with one hand while the other hand pulls back the syringe plunger to withdraw liquid. This image demonstrates drug preparation technique for injection.*

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Fig H (Starjemz Ustekinumab Hmny Injection 28)

An instructional illustration showing two hands demonstrating the preparation of an injection by drawing liquid from a vial into a syringe, likely related to the subcutaneous injection of Starjemza (ustekinumab-hmny).*

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Fig I (Starjemz Ustekinumab Hmny Injection 29)

An instructional diagram showing the correct technique for subcutaneous injection at a 45-degree angle, with one hand pinching the skin and the other hand inserting a syringe needle.*

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Table 3 (Starjemz Ustekinumab Hmny Injection 3)

A data table titled 'Recommended Dose of STARJEMZA for Subcutaneous Injection in Pediatric Patients (6 to 17 years old) with Psoriatic Arthritis,' presenting dosing recommendations based on patient body weight. It lists dosages for weights less than 60 kg, 60 kg or more, and greater than 100 kg with moderate-to-severe plaque psoriasis, specifying corresponding doses of 0.75 mg/kg, 45 mg, and 90 mg respectively.*

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Fig J (Starjemz Ustekinumab Hmny Injection 30)

An instructional illustration showing a hand administering a subcutaneous injection using a syringe. The image appears to demonstrate proper injection technique at an angled position into the skin.*

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Figure A And B (Starjemz Ustekinumab Hmny Injection 31)

Illustrative diagrams of the Starjemza prefilled syringe for subcutaneous injection. Figure A shows the syringe with needle and cap, along with required accessories: adhesive bandage, cotton ball or gauze pads, antiseptic wipes, and FDA-cleared sharps disposal container. Figure B labels syringe components including plunger head, plunger, needle guard activation clips and wings, body, viewing window, label, needle, and needle cover.*

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Figure C (Starjemz Ustekinumab Hmny Injection 32)

An instructional diagram showing recommended injection sites for Starjemza (ustekinumab-hmny) subcutaneous injection. Gray-shaded areas on a front and back outline of a human figure indicate recommended injection sites including the abdomen, front and outer sides of the thighs, and the upper buttocks.*

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Figure D (Starjemz Ustekinumab Hmny Injection 33)

Illustration showing two hands preparing a syringe for use by removing or attaching a protective needle cap. Arrows indicate the motion of pulling the cap off or pushing it on, demonstrating safe handling before injection of Starjemza subcutaneous injection.*

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Figure E (Starjemz Ustekinumab Hmny Injection 34)

An instructional drawing showing a human hand holding a syringe, likely demonstrating how to properly grip the syringe for a subcutaneous injection. The syringe is depicted with a plunger and needle, and the hand is positioned to push the plunger.*

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Figure F (Starjemz Ustekinumab Hmny Injection 35)

An instructional illustration showing the subcutaneous injection technique for Starjemza (ustekinumab-hmny). The diagram depicts a hand holding an injection device at a 45-degree angle to the skin on a person's thigh, demonstrating proper injection angle and positioning.*

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Figure G (Starjemz Ustekinumab Hmny Injection 36)

An instructional diagram showing proper use of a Starjemza subcutaneous injection device. The illustration highlights the needle guard wings and demonstrates placement of the injector in a hand-position aimed for injection, indicating direction with arrows.*

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Figure H (Starjemz Ustekinumab Hmny Injection 37)

An instructional illustration showing hand positioning for holding an injection device, likely for subcutaneous administration. The diagram highlights gripping points with arrows and depicts the needle end directed downward toward the skin, indicating proper handling technique for injection.*

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Figure I (Starjemz Ustekinumab Hmny Injection 38)

An instructional illustration showing a hand gripping a prefilled injection device, presumably for subcutaneous administration, with an arrow indicating the direction of use or removal. The diagram is labeled as Figure I and depicts the injection device in a transparent style revealing internal components.*

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45 mg/0.5 mL (Syringe Label)

Label for Starjemza 45 mg/0.5 mL injection, containing ustekinumab-hmny. It is a single-dose prefilled syringe for subcutaneous use. The label provides storage instructions to keep refrigerated at 2°C to 8°C and avoid freezing or shaking. Manufactured by Bio-Thera Solutions, Ltd., China, and distributed by Hikma Pharmaceuticals USA Inc.*

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Table 4 (Starjemz Ustekinumab Hmny Injection 4)

Data table presenting the initial intravenous dosage of Starjemza, showing dosing amounts based on patient body weight categories and the corresponding number of 130 mg/26 mL (5 mg/mL) Starjemza vials required.*

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45 mg Syringe Carton (Starjemz Ustekinumab Hmny Injection 40)

The packaging label for Starjemza 45 mg/0.5 mL injection in a prefilled syringe, containing ustekinumab-hmny for subcutaneous use. The label includes storage instructions, a caution about natural rubber latex, and details the product is manufactured by Bio-Thera Solutions and distributed by Hikma Pharmaceuticals USA Inc. The label states it is for single-dose use with no preservative.*

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45 mg/0.5 mL Vial Label (Starjemz Ustekinumab Hmny Injection 41)

Starjemza 45 mg/0.5 mL injection vial label for subcutaneous use. The single-dose vial contains 0.5 mL of ustekinumab-hmny. Label includes storage instructions to refrigerate at 2°C to 8°C and warnings not to freeze or shake. Manufactured by Bio-Thera Solutions, Ltd. and distributed by Hikma Pharmaceuticals USA Inc.*

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45 mg/0.5 mL (Vial Carton Label)

Carton label for Starjemza 45 mg/0.5 mL subcutaneous injection. The product contains ustekinumab-hmny and is provided in a single-dose vial containing 0.5 mL. Manufactured by Bio-Thera Solutions, Ltd., and distributed by Hikma Pharmaceuticals USA Inc. Instructions note storage refrigeration at 2°C to 8°C and caution to discard unused portions. The label includes dosage instructions, storage conditions, and a barcode.*

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90 mg/ml (Syringe Label)

Starjemza 90 mg/mL injection label for subcutaneous use featuring a single-dose prefilled syringe. The label includes storage instructions to refrigerate at 2°C to 8°C and keep in the original carton, manufacturing information from Bio-Thera Solutions, Ltd. in China, and distribution by Hikma Pharmaceuticals USA Inc.*

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90 mg/ml (Syringe Carton Label)

Starjemza 90 mg/mL injection carton label for subcutaneous use. The label identifies the active ingredient ustekinumab-hmny and states the product as a single-dose prefilled syringe containing 1 mL solution. It includes dosage and dispensing information, warnings, the labeler Hikma Pharmaceuticals USA Inc., and handling instructions.*

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130 mg/26 mL Vial Label (Starjemz Ustekinumab Hmny Injection 45)

Starjemza 130 mg/26 mL (5 mg/mL) injection label for intravenous infusion. It includes storage instructions to keep refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton, with warnings not to freeze or shake. Manufactured by Bio-Thera Solutions, Ltd., Guangzhou, China, and distributed by Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ.*

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130 mg/26 mL (Vial Carton Label)

Starjemza 130 mg/26 mL (5 mg/mL) injection carton label for intravenous infusion only. The label indicates it is a single-dose vial that must be diluted and discarded if unused. Manufactured by Bio-Thera Solutions, Ltd. and distributed by Hikma Pharmaceuticals USA Inc. Storage instructions and ingredient information are also included on the carton.*

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Syringe Image 1 (Starjemz Ustekinumab Hmny Injection 5)

An instructional illustration of a Starjemza subcutaneous injection pen showing labeled parts including the plunger head, plunger, needle activation clips, needle guard wings, body, viewing window with expiration date, label, needle, and needle cover. The diagram visually breaks down the components of the injection device.*

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Syringe Image 2 (Starjemz Ustekinumab Hmny Injection 6)

An instructional illustration showing the proper technique for subcutaneous injection using a prefilled syringe with needle guard wings. The diagram highlights how to hold the syringe and press the plunger while protecting the needle, with emphasis on the needle guard wings for safety during administration.*

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Syringe Image 3 (Starjemz Ustekinumab Hmny Injection 7)

An instructional illustration showing a hand holding a subcutaneous injection device with an arrow indicating upward removal or disconnection of a cap or component. The image likely relates to the administration process of Starjemza (ustekinumab-hmny) injection.*

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Table 5 (Starjemz Ustekinumab Hmny Injection 8)

Table listing adverse reactions reported by 1% or more of subjects with plaque psoriasis in placebo and ustekinumab groups (45 mg and 90 mg doses) up to week 12 from two studies. It details the number and percentage of subjects experiencing various side effects such as nasopharyngitis, upper respiratory tract infection, headache, fatigue, back pain, dizziness, pharyngolaryngeal pain, pruritus, injection site erythema, myalgia, and depression.*

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Table 6 (Starjemz Ustekinumab Hmny Injection 9)

A data table titled 'Common Adverse Reactions Through Week 8 in Trials CD-1 and CD-2 Occurring in ≥3% of Ustekinumab-Treated Subjects and Higher Than Placebo.' The table compares the incidence rates of vomiting between placebo (3%, N=466) and ustekinumab 6 mg/kg single intravenous induction dose (4%, N=470) groups.*

* 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.