Omlyclo Injection
Product Images NDC 72606-036

Product Visual Gallery

This gallery contains 26 technical images submitted to the FDA as part of the official labeling for Omlyclo (NDC 72606-036). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Celltrion 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 (Omlyclo 01)

A dosing table for OMLYCLO (omalizumab-igec) injections showing recommended doses in milligrams based on pretreatment serum IgE levels (IU/mL), dosing frequency (every 2 or 4 weeks), and patient body weight categories (30–60 kg, >60–70 kg, >70–90 kg, >90–150 kg). The table highlights dosing adjustments with gray and black shading and notes insufficient data for some high IgE level and weight combinations.*

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Table 2 (Omlyclo 02)

A dosing table for OMLYCLO (omalizumab-igec) injection showing the recommended subcutaneous dose (mg) based on pre-treatment serum IgE levels (IU/mL) and body weight (kg). The table specifies dosing frequencies every 4 weeks or every 2 weeks, with shaded areas indicating dosing ranges and blacked-out areas indicating insufficient data to recommend a dose.*

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Table 3 (Omlyclo 03)

A dosing table for OMLYCLO (omalizumab-igec) injection showing recommended subcutaneous doses in mg based on pretreatment serum IgE levels (IU/mL) and patient's body weight (kg). The table distinguishes dosing frequency, with shaded areas for every 4 weeks and unshaded for every 2 weeks, and includes a section indicating insufficient data to recommend a dose for higher ranges.*

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Table 4 (Omlyclo 04)

A dosing table for OMLYCLO (omalizumab-igec) showing recommended subcutaneous dose (mg) based on pretreatment serum IgE levels (IU/mL) and body weight (kg). It differentiates dosing frequencies of every 2 weeks or every 4 weeks using shaded boxes to indicate the schedule for each dose recommendation, with some weight and IgE combinations labeled as having insufficient data for dose recommendation.*

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Figure 1 (Omlyclo 05)

Two line graphs showing LS Mean Change from Baseline in Nasal Polyp Score and Nasal Congestion Score over 24 weeks for OMLYCLO (omalizumab-igec) versus placebo in two clinical trials. Data depict trends for omalizumab and placebo groups with secondary and primary efficacy analysis points marked.*

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Figure 2 (Omlyclo 06)

A line graph displaying mean weekly itch scores over 40 study weeks for placebo and three dosages of omalizumab (75 mg, 150 mg, and 300 mg) administered subcutaneously. The x-axis represents study weeks, and the y-axis shows mean weekly itch scores. The graph is divided into treatment and follow-up periods, highlighting primary efficacy analysis at week 12, with distinct trajectories for each treatment group.*

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Figure A (Omlyclo 07)

An instructional diagram showing a syringe labeled with parts Before Use and After Use. Before use markers include Plunger Rod, Finger Flange, Viewing Window, Safety Guard, Needle, Medicine, and Cap. After use markers include Plunger Rod, Finger Flange, Needle, Safety Guard, and Cap. The diagram highlights syringe components and their appearances pre- and post-injection.*

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Figure B (Omlyclo 08)

An illustration showing three OMLYCLO (omalizumab-igec) subcutaneous injection syringes with corresponding packaging boxes. The 75 mg/0.5 mL syringe has a yellow plunger rod and matching yellow-labeled box; the 150 mg/mL syringe has a blue plunger rod and blue-labeled box; the 300 mg/2 mL syringe has a white plunger rod and purple-labeled box. Each syringe and box is labeled with its respective strength.*

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Figure C (Omlyclo 09)

A dosing table for OMLYCLO injection showing the recommended combination of syringes by plunger rod color and strength for various total doses. The yellow plunger rod syringe contains 75 mg, the blue plunger rod syringe contains 150 mg, and the white plunger rod syringe contains 300 mg. Dose increments from 75 mg to 600 mg are listed with corresponding recommended syringe combinations for subcutaneous injection.*

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Figure D (Omlyclo 10)

An illustration showing components of an injection kit, including a carton containing a prefilled syringe, an alcohol swab, cotton ball or gauze, adhesive bandage, and an FDA-cleared sharps disposal container, associated with subcutaneous injection preparation.*

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Figure E (Omlyclo 11)

An illustration shows a rectangular box with a zoomed-in magnifying glass highlighting the expiration date area on the packaging. The expiration date is labeled as "EXP: YYYY/MM" as a placeholder, indicating where the expiration date is located on the package.*

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Figure F (Omlyclo 12)

An illustration showing a clock indicating 30 to 45 minutes alongside a closed rectangular box, likely representing a step or instruction related to the product OMLYCLO injection by CELLTRION USA, Inc.*

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Figure G (Omlyclo 13)

An instructional illustration showing hands being washed under running water from a faucet over a sink, depicting a hygiene step likely related to drug preparation or administration procedures.*

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Figure H (Omlyclo 14)

An instructional illustration showing a hand removing a prefilled syringe from a divided tray within an open box. The syringe is designed for subcutaneous injection, consistent with the OMLYCLO omalizumab-igec injection packaging by CELLTRION USA, Inc.*

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Figure I (Omlyclo 15)

An instructional illustration showing a prefilled syringe for subcutaneous injection with a magnified view highlighting the expiration date area on the syringe barrel labeled as 'EXP: YYYY / MM'.*

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Figure J (Omlyclo 16)

An instructional diagram showing a syringe with a close-up magnified view focusing on the needle and internal chamber, likely demonstrating proper visualization of the liquid or device component for the OMLYCLO injection.*

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Figure K (Omlyclo 17)

Illustration showing recommended injection sites on the human body for OMLYCLO (omalizumab-igec) subcutaneous injection. Dark shaded areas on the upper outer arms are designated for caregiver and healthcare professional (HCP) administration only. Unshaded areas on the abdomen and the front of the thighs can be used for self-injection, caregiver, and HCP administration.*

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Figure L (Omlyclo 18)

Illustration showing a person applying or removing a small adhesive patch or bandage on the front of the thigh, dressed in shorts. Likely demonstrating a step related to subcutaneous injection or site care for OMLYCLO (omalizumab-igec) administration.*

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Figure M (Omlyclo 19)

An instructional illustration showing a hand holding a prefilled syringe and another hand removing a small protective cap by pulling it away from the syringe. An inset circle depicts the cap being disposed of into a sharps container.*

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Figure N (Omlyclo 20)

An instructional illustration showing a hand administering a subcutaneous injection at a 45-degree angle into the skin, demonstrating proper technique for injection of OMLYCLO (omalizumab-igec).*

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Figure O (Omlyclo 21)

An instructional diagram showing a hand holding an injection device with a protective shield, positioned for subcutaneous administration. A close-up inset highlights the injection mechanism, illustrating proper alignment and use for subcutaneous injection.*

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Figure P (Omlyclo 22)

An instructional illustration showing the administration of a subcutaneous injection using a prefilled syringe. A hand holds the syringe angled upwards while the other hand rests on the patient's skin, demonstrating correct injection technique.*

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Figure Q (Omlyclo 23)

An instructional illustration showing a hand disposing of a syringe into a sharps disposal container. The syringe appears to be partially filled and is being held by the thumb and forefinger above the opening of the container.*

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Principal Display Panel (75 mg/0.5 mL Syringe Carton)

OMLYCLO 75 mg/0.5 mL injection prefilled syringe carton for subcutaneous use. The label displays the brand name OMLYCLO and generic name omalizumab-igec, highlighting the strength 75 mg/0.5 mL. It includes a syringe illustration with a safety guard and states "1 single-dose prefilled syringe with safety guard." The labeler is CELLTRION USA, Inc. The carton includes usage warnings and storage instructions, and specifies it is for Rx only.*

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Principal Display Panel (150 mg/mL Syringe Carton)

Packaging label for Omlyclo injection containing 150 mg/mL of omalizumab-igec for subcutaneous use. The label shows the product name, strength, dosage form, and includes the instruction to dispense the enclosed medication guide. It features an image of a prefilled syringe with a safety guard, indicating one single-dose syringe per package. Labeler is CELLTRION USA, Inc., with manufacturing by CELLTRION, Inc. in Korea. Additional text includes storage instructions and a warning not to use for emergency treatment.*

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Principal Display Panel (300 mg/2 mL Syringe Carton)

OMLYCLO 300 mg/2 mL (150 mg/mL) Injection prefilled syringe carton for subcutaneous use. The label shows a single-dose prefilled syringe with safety guard, manufactured by CELLTRION USA, Inc. The package includes medication guide, prescribing information, and use instructions. Active ingredient is omalizumab-igec 300 mg per syringe.*

* 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.