Starjemza Injection
Product Images NDC 0143-9170

Product Visual Gallery

This gallery contains 46 technical images submitted to the FDA as part of the official labeling for Starjemza (NDC 0143-9170). 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)

This text provides the recommended dose of STARJEMZA for subcutaneous injection in pediatric patients aged 6-17 years with plaque psoriasis based on their body weight. For patients weighing less than 60 kg, the recommended dose is 0.75 mg/kg. Patients weighing between 60 kg and 100 kg should receive 45 mg, while those weighing more than 100 kg should receive 90 mg. This information can help healthcare professionals accurately determine the appropriate dosage for pediatric patients with plaque psoriasis.*

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Table 7 (Starjemz Ustekinumab Hmny Injection 10)

This text provides information on common adverse reactions observed in a clinical trial (CD-3) up to week 44 for subjects treated with Ustekinumab compared to placebo. Adverse reactions occurring in more than 3% of Ustekinumab-treated subjects and higher than placebo include nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. The table shows the percentage of subjects experiencing each adverse reaction for Ustekinumab and placebo groups.*

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Table 8 (Starjemz Ustekinumab Hmny Injection 11)

This table presents clinical outcomes at Week 12 for adults with Plaque Psoriasis in two studies (Ps STUDY 1 and Ps STUDY 2). The outcomes include PASI 75 response and PGA of Cleared or Minimal for subjects receiving different doses of Ustekinumab compared to a placebo. The data shows the percentage of subjects who achieved these outcomes in each treatment group.*

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Table 9 (Starjemz Ustekinumab Hmny Injection 12)

This is a comparison of clinical outcomes at week 12 in adults with Plaque Psoriasis in two studies (Ps STUDY 1 and Ps STUDY 2) after being treated with Ustekinumab at different doses (Placebo, 45 mg, 90 mg). The table shows the response rates in terms of PASI 75 (Psoriasis Area and Severity Index reduction by 75%) and Physician's Global Assessment of cleared or minimal disease. The outcomes are categorized by weight (<100 kg and >100 kg). This data helps in understanding the effectiveness of Ustekinumab in treating Plaque Psoriasis based on weight and dosage.*

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Table 10 (Starjemz Ustekinumab Hmny Injection 13)

This text provides efficacy results at Week 12 for pediatric subjects aged 12 to 17 years with plaque psoriasis in Ps STUDY 3. The table compares the percentage of patients in the placebo group versus the ustekinumab group who achieved certain response levels in terms of Physician Global Assessment (PGA) and Psoriasis Area Severity Index (PASI) scores. The data suggests a significant improvement in PGA and PASI scores with ustekinumab treatment compared to placebo. It also mentions the use of weight-based dosage regimen as specified in Table 1 and Table 2 for this study.*

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Table 11 (Starjemz Ustekinumab Hmny Injection 14)

This data table shows the ACR 20, ACR 50, ACR 70, and PASI 75 responses in Psoriatic Arthritis (PsA) Study 1 and PsA Study 2 at Week 24. The table includes information on the number of subjects randomized for each treatment group, as well as the percentage of subjects who achieved different levels of response based on the specified criteria. Additionally, it highlights the number of subjects with more than 3% Body Surface Area (BSA) involvement at baseline for psoriasis skin.*

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Fig 1 (Starjemz Ustekinumab Hmny Injection 15)

This is data from PsA Study 1 showing the percentage of subjects achieving ACR 20 response through Week 24. The study includes three groups: Placebo (n=206), Ustekinumab 45 mg (n=205), and Ustekinumab 90 mg (n=204). The x-axis represents time points, and the y-axis shows the percentage of subjects.*

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Table 12 (Starjemz Ustekinumab Hmny Injection 16)

This text appears to be a table summarizing the mean change from baseline in different components related to arthritis (ACR components) at Week 24 for a study comparing the effects of Ustekinumab versus Placebo (45mg and 90mg). It includes data on swollen joints, tender joints, pain assessment, global assessments by subjects and physician, disability index, and CRP levels. The table also provides a description of the measurement scales used in the study.*

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Table 13 (Starjemz Ustekinumab Hmny Injection 17)

This text presents data on the induction of clinical response and remission in patients with CD-1 and CD-2 through treatment with Ustekinumab compared to placebo. It includes information such as sample sizes, percentages of response and remission, and definitions of clinical response and remission based on CDAI scores. The patient population consisted of those who failed or were intolerant to TNF blocker therapy or corticosteroids/immunomodulators. The infusion dose of ustekinumab was weight-based. The data supports the effectiveness of ustekinumab in inducing clinical response and remission in these patients.*

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Table 14 (Starjemz Ustekinumab Hmny Injection 18)

This text presents data from a clinical trial evaluating the treatment response and remission in patients with Crohn's disease after 44 and 52 weeks from the initiation of induction therapy with 90 mg Ustekinumab compared to a placebo group. The results show the percentages of clinical remission, clinical response, and clinical remission in patients who were already in remission at the start of maintenance therapy. Clinical remission is defined as a CDAI score of less than 150, while clinical response is defined as a reduction in CDAI of at least 100 points or being in clinical response. The placebo group consisted of subjects who responded to Ustekinumab and were switched to placebo at the start of maintenance therapy. The data provided includes specific percentages, confidence intervals, and definitions used in the trial.*

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Table 15 (Starjemz Ustekinumab Hmny Injection 19)

This text provides data on the outcomes related to the treatment of Ustekinumab compared to placebo in a study with 319 and 322 participants. It includes statistics on clinical remission, endoscopic improvement, clinical response, and histologic-endoscopic mucosal improvement for both treatment groups. The outcomes are presented for participants who are treatment-naive and those who have experienced prior biologic failure.*

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Table 2 (Starjemz Ustekinumab Hmny Injection 2)

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Table 16 (Starjemz Ustekinumab Hmny Injection 20)

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Fig A (Starjemz Ustekinumab Hmny Injection 21)

This description is not available.*

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Fig B (Starjemz Ustekinumab Hmny Injection 22)

This text provides guidance on recommended injection sites highlighted in gray areas in Figure B.*

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Fig C (Starjemz Ustekinumab Hmny Injection 23)

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Fig D (Starjemz Ustekinumab Hmny Injection 24)

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Fig E (Starjemz Ustekinumab Hmny Injection 25)

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Fig F (Starjemz Ustekinumab Hmny Injection 26)

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Fig G (Starjemz Ustekinumab Hmny Injection 27)

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Fig H (Starjemz Ustekinumab Hmny Injection 28)

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Fig I (Starjemz Ustekinumab Hmny Injection 29)

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Table 3 (Starjemz Ustekinumab Hmny Injection 3)

This is a table listing the recommended doses of STARJEMZA for subcutaneous injection in pediatric patients aged 6 to 17 years old with Psoriatic Arthritis. The doses are categorized based on the body weight of the patient at the time of dosing, with different doses specified for patients weighing less than 60 kg, 60 kg or more, and greater than 100 kg with co-existent moderate-to-severe plaque psoriasis. Additionally, instructions are provided on the administration volume for patients weighing less than 60 kg.*

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Fig J (Starjemz Ustekinumab Hmny Injection 30)

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Figure A And B (Starjemz Ustekinumab Hmny Injection 31)

This is a description of a prefilled syringe with a plunger needle guard. The syringe includes features like plunger, needle guard, viewing window, activation clips, and wings label. The text also mentions a diagram with different components labeled like body, needle, and head.*

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Figure C (Starjemz Ustekinumab Hmny Injection 32)

This is a description of a figure denoting areas in gray that are suggested for injection sites. This information is likely to be related to medical or healthcare procedures.*

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Figure D (Starjemz Ustekinumab Hmny Injection 33)

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Figure E (Starjemz Ustekinumab Hmny Injection 34)

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Figure F (Starjemz Ustekinumab Hmny Injection 35)

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Figure G (Starjemz Ustekinumab Hmny Injection 36)

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Figure H (Starjemz Ustekinumab Hmny Injection 37)

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Figure I (Starjemz Ustekinumab Hmny Injection 38)

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45 mg/0.5 mL (Syringe Label)

This is a description of a medication called Starjemza (ustekinumab-hmny) in a 45mg/0.5 mL injection form for subcutaneous use. The medication comes in a single-dose prefilled syringe and should be stored refrigerated at 2°C to 8°C in the original carton to protect from light. It is important not to freeze or shake the medication. The manufacturing information indicates that it is made by Bio-Thera Solutions, Ltd. in China and distributed in the USA by Hikma Pharmaceuticals.*

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Table 4 (Starjemz Ustekinumab Hmny Injection 4)

This text provides information about the initial intravenous dosage of STARJEMZA based on the body weight of the patient. It indicates the number of 130 mg/26 mL STARJEMZA vials required for different weight categories, such as less than 55 kg, between 55 kg to 85 kg, and more than 85 kg. The dosage ranges from 260 mg for patients weighing less than 55 kg to 520 mg for patients weighing more than 85 kg.*

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45 mg Syringe Carton (Starjemz Ustekinumab Hmny Injection 40)

This text is a medication label for Starjemza, ustekinumab-hmny injection for subcutaneous use. The medication comes in a single-dose prefilled syringe to be discarded if unused. It should be stored refrigerated at 2°C to 8°C and protected from light. The prefilled syringe can be stored at room temperature up to 30°C for up to 30 days. Once stored at room temperature, it should not be placed back in the refrigerator. The medication contains natural rubber latex which may cause allergic reactions. There are no preservatives in the product. The label also contains information on the NDC number, distributor details, storage instructions, and disposal guidelines.*

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

This text appears to contain information related to a medication or injection called ustekinumab, likely used for a specific medical condition. It includes details on administration and storage recommendations, along with instructions regarding dosage and usage. The product seems to be distributed by Bio-Thera Solutions, Ltd., and Hikma Pharmaceuticals USA Inc. The provided U.S. License No. 2218 indicates that this medication has been approved for use in the United States.*

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45 mg/0.5 mL (Vial Carton Label)

This text provides information about a medication called Stelara (ustekinumab), which is an injection used for subcutaneous administration. It comes in single-dose vials containing 0.5 mL. The medication should be stored refrigerated at a temperature between 2°C to 8°C (36°F to 46°F) in the original carton to protect it from light. Each vial contains a specific amount of solution with active ingredients like ustekinumab and excipients. It is important to carefully follow the dosage instructions provided by the prescribing healthcare professional and to disperse the enclosed Medication Guide to each patient.*

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90 mg/ml (Syringe Label)

This is product information for ustekinumab-hmny, an injection used for subcutaneous administration. The medication comes in a single-dose prefilled syringe and should be stored refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. It should not be frozen or shaken. The manufacturer is Bio-Thera Solutions in Guangzhou, China, and it is distributed by Hikma Pharmaceuticals USA Inc. in Berkeley Heights, NJ. The provided lot number is (01)00301439170013.*

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90 mg/ml (Syringe Carton Label)

Dosage information and details about the medication Starjemza (ustekinumab-hmny) for subcutaneous use are provided, including the contents of each prefilled syringe. It contains 90 mg of ustekinumab-hmny along with other ingredients. The medication guide should be dispensed to each patient. The NDC number is also mentioned for reference.*

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

This is information about a medication labeled as "NDC0143-9171-01" with the dosage to be checked in the Prescribing Information. It should be stored in a refrigerated environment at 2°C to 8°C (36°F to 46°F) in the original carton to protect it from light, and must not be frozen. The medication is ustekinumab-hmny by Injection Bio-Thera Solutions, Ltd., located in Guangzhou, China, with a strength of 130 mg/26 mL. The product is distributed by Hikma Pharmaceuticals USA Inc. in Berkeley Heights, NJ 07922. It is indicated for intravenous infusion only and must be diluted before use. The product comes in a Single-Dose Vial, and any unused portion should be discarded.*

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130 mg/26 mL (Vial Carton Label)

The text is not readable.*

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Syringe Image 1 (Starjemz Ustekinumab Hmny Injection 5)

This text seems to describe a medical device or tool that includes components such as a plunger, needle guard, body, viewing needle, activation clips, window cover, wings, label, and head. The device likely serves a specific medical or laboratory purpose where precision and safety are important.*

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Syringe Image 2 (Starjemz Ustekinumab Hmny Injection 6)

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Syringe Image 3 (Starjemz Ustekinumab Hmny Injection 7)

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Table 5 (Starjemz Ustekinumab Hmny Injection 8)

This is a table presenting adverse reactions reported by more than 1% of subjects with Plaque Psoriasis and at higher rates in the Ustekinumab groups compared to the Placebo through Week 12 in Ps STUDY 1 and Ps STUDY 2. Adverse reactions include Nasopharyngitis, Upper respiratory tract infection, Headache, Fatigue, Back pain, Dizziness, Pharyngolaryngeal pain, Pruritus, Injection site erythema, Myalgia, and Depression. The data is categorized based on the number of subjects treated with Ustekinumab 45 mg, Ustekinumab 90 mg, and Placebo, with specific percentages for each adverse reaction.*

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Table 6 (Starjemz Ustekinumab Hmny Injection 9)

This text provides information on common adverse reactions occurring in more than 3% of subjects treated with Ustekinumab compared to those on placebo. The specific adverse reactions mentioned in the table are vomiting with a frequency of 3% for those on Ustekinumab and 4% for those on placebo.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.