Hulio
Product Images NDC 83257-017

Product Visual Gallery

This gallery contains 27 technical images submitted to the FDA as part of the official labeling for Hulio (NDC 83257-017). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Biocon Biologics 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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Figure 1. Study Ra-iii Acr 20 Responses Over 52 Weeks (Image 01)

A line graph depicting the percentage of ACR20 responders over time in weeks, ranging from 0 to 48 weeks. Two data series are shown: one with solid square markers and another with open circle markers, each representing different response trends over the study period.*

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Figure 2. Asas 20 Response By Visit, Study As-i (Image 02)

A line graph showing the percentage of ASAS 20 response over time in weeks, comparing Adalimumab (N=208) and Placebo (N=107). The vertical axis represents the response percentage, and the horizontal axis represents time up to 24 weeks. Adalimumab shows a higher and sustained response compared to Placebo.*

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Hulio Pen Logo (Image 03)

Label of Hulio Pen showing the proprietary name Hulio Pen (pronounced hue' lee oh) and the active ingredient adalimumab-fkjp labeled as an injection. The labeler is Biocon Biologics Inc.*

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Pen Instructions For Use Figure A (Image 04)

Illustration of a Hulio Pen (adalimumab-fkjp) injection pen showing labeled components including the orange indicator inside the barrel, medicine inside, fill marker, viewing window, orange activator with needle inside, and the needle end. The diagram also depicts the pen's protective clear cap with a small inner gray cap and cautions not to uncap until ready to inject.*

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Pen Instructions For Use Figure B (Image 05)

A partial packaging label for the drug HULIO by Biocon Biologics Inc, showing a barcode and placeholders for expiration date (EXP: YYYY-MM) and lot number (LOT: 0000000000). The label specifies the product is for subcutaneous use only.*

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Pen Instructions For Use Figure C (Image 06)

Illustration of a Hulio Pen injection device, showing the fill marker and medicine indicator. Text notes it is normal to see one or more bubbles inside the medicine chamber. The pen is labeled as containing adalimumab-fkjp injection.*

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Pen Instructions For Use Figure D (Image 07)

An instructional diagram showing injection sites on the body for medication administration. It highlights the abdomen area with a note to stay 2 inches away from the belly button, and the front areas of both thighs as suitable injection locations.*

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Pen Instructions For Use Figure E (Image 08)

Instructional illustration labeled Figure E showing a person holding the Hulio Pen with one hand and pulling off the pen cap with the other hand, indicating preparation steps for injection using the Hulio Pen device by Biocon Biologics Inc.*

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Pen Instructions For Use Figure F (Image 09)

Instructional diagram showing the recommended squeeze site for injection, indicating the abdomen or thighs as appropriate injection areas. The illustration includes a hand pinching the skin to highlight the injection technique for the product HULIO by Biocon Biologics Inc.*

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Pen Instructions For Use Figure G (Image 10)

An instructional illustration depicting a hand holding a syringe at a 90-degree angle to the skin for injection. The image shows the proper site to squeeze for administration, demonstrating the injection technique in a step-by-step manner.*

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Pen Instructions For Use Figure H (Image 11)

An instructional illustration showing a person administering an injection with a pen device into the skin. The image highlights a '1st click' sound indicating a step in using the device, with an arrow pointing downward toward the injection site.*

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Pen Instructions For Use Figure I (Image 12)

An instructional diagram illustrating how to hold down a device for 10 seconds after a second click, accompanied by an orange indicator. The image includes a hand pressing the device and a timeline counting seconds 1 through 10, emphasizing the need to hold down for the full duration.*

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Pen Instructions For Use Figure J (Image 13)

Instructional illustration labeled Figure J for HULIO, showing a hand holding an injection device and an arrow pointing upward, positioned above a second hand pinching skin on an arm, indicating a step in the injection process for HULIO by Biocon Biologics Inc.*

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Hulio Syringe Logo (Image 14)

The image shows part of the packaging label for HULIO (adalimumab-fkjp) injection by Biocon Biologics Inc. It displays the brand name Hulio with a phonetic pronunciation guide and the generic name adalimumab-fkjp indicating it is an injection product.*

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Instructions For Use Figure A (Image 15)

An instructional diagram showing the components of a HULIO prefilled syringe, including the plunger, needle safety feature, fill marker, medicine, strength and expiration date label, and needle cap. An inset depicts syringes with different volumes (0.4 mL and 0.8 mL) indicating the syringe volume should match the prescription.*

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Instructions For Use Figure B (Image 16)

The image shows a label on a 40 mg/0.8 mL syringe for HULIO by Biocon Biologics Inc. It includes fields for expiration date (EXP: YYYY-MM) and lot number (LOT: 0000000), along with a barcode beneath the lot number.*

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Instructions For Use Figure C (Image 17)

An instructional diagram labeled Figure C showing a syringe with bars indicating the Fill Marker and Medicine level inside the syringe. The illustration notes that it is normal to see one or more bars in this area. The syringe handle and plunger are also visible. This image is related to the HULIO product by Biocon Biologics Inc.*

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Instructions For Use Figure D (Image 18)

An instructional diagram showing recommended sites for subcutaneous injection, including the abdomen area with specific placement away from the belly button, and the front of both thighs. The diagram is a simplified human figure with labeled areas indicating injection locations.*

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Instructions For Use Figure E (Image 19)

An instructional illustration showing a pair of hands preparing a syringe for injection. One hand is holding the syringe with a needle while the other hand is removing a protective cap from the needle. The figure is labeled as Figure E with an arrow indicating the direction to remove the cap.*

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Instructions For Use Figure F (Image 20)

An instructional illustration for HULIO showing a hand pinching the skin at the injection site. Adjacent diagram highlights possible injection areas on a human body, specifically the abdomen and thighs. The heading reads 'Squeeze Site' with a label indicating 'Abdomen or Thighs.'*

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Instructions For Use Figure G (Image 21)

An instructional diagram illustrating the injection technique for HULIO. It shows a hand holding a syringe at a 45-degree angle to the skin, demonstrating the proper angle for subcutaneous injection.*

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Instructions For Use Figure H (Image 22)

An instructional illustration showing a hand holding an injection device with the needle inserted into the skin. An arrow points to the top of the device, indicating a specific action or component during the injection process. The figure is labeled as Figure H.*

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Instructions For Use Figure I (Image 23)

An instructional diagram showing two steps for preparing an injection using a syringe. The first step depicts pulling back the syringe plunger to draw fluid, and the second step shows removing the needle cap before administration. The figure is labeled as Figure I.*

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Hulio Prefilled Syringe Carton (20 mg/0.4 mL)

Packaging label for HULIO (adalimumab-fkjp) injection, 20 mg/0.4 mL single-dose prefilled syringes. The label indicates for subcutaneous use only and a quantity of 2 syringes per package. Manufacturer is Biocon Biologics Inc. The label includes directions for storage, usage, and dosing warnings.*

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Hulio Prefilled Syringe Carton (40 mg/0.8 mL)

Carton packaging for Hulio (adalimumab-fkjp) injection, 40 mg/0.8 mL syringe, by Biocon Biologics Inc. The label indicates 2 single-dose prefilled syringes for subcutaneous use only, with storage and usage instructions, barcodes, and a variable data area for online printing.*

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Hulio Prefilled Pen (40 mg/0.8 mL)

Packaging label for Hulio Pen (adalimumab-fkjp) injection 40 mg/0.8 mL by Biocon Biologics Inc. This carton contains 2 single-dose prefilled pens intended for subcutaneous use only. The label includes storage instructions, dosing and safety information, and manufacturer details.*

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Figure 3: Kaplan-meier Curves Summarizing Time To Treatment Failure On Or After Week 6 (study Uv I) Or Week 2 (study Uv Ii) (Image 27)

Two line graphs showing treatment failure rates over time (in months) comparing Placebo and Adalimumab groups in Study UV I and Study UV II. The y-axis represents treatment failure rate percentage, while the x-axis shows months of treatment. The graphs include numerical data points under the x-axis for both treatment groups at various time intervals up to 20 months.*

* 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.