Xolair Pfs Injection, Solution
Product Images NDC 50242-214

Product Visual Gallery

This gallery contains 45 technical images submitted to the FDA as part of the official labeling for Xolair Pfs (NDC 50242-214). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Genentech, 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

Table 1 (Xolair 01)

A dosing chart for Xolair PFS (omalizumab) showing dose amounts in mg based on pretreatment serum IgE levels (IU/mL) and body weight categories (30-60 kg, >60-70 kg, >70-90 kg, >90-150 kg). It differentiates dosing frequency as every 4 weeks or every 2 weeks, with some areas marked as "Insufficient Data to Recommend a Dose."*

FDA Label Image

Table 2 (Xolair 02)

A dosing guidance table for Xolair PFS (omalizumab) injection based on pre-treatment serum IgE levels (IU/mL) and patient body weight (kg). The table lists recommended subcutaneous dose amounts in mg, with dosing frequency options of every 2 weeks or every 4 weeks. It includes dosing ranges for IgE levels from 30 to 1300 IU/mL and weight categories from 20 kg to over 125 kg, noting where data is insufficient to recommend a dose.*

FDA Label Image

Table 3 (Xolair 03)

A dosing chart for Xolair PFS (omalizumab) injection solution showing recommended dose (mg) based on pretreatment serum IgE levels (IU/mL), body weight categories (kg), and dosing frequency (every 2 or 4 weeks). The table uses shading to differentiate dosing intervals and includes a note on dosing frequencies.*

FDA Label Image

Table 4 (Xolair 04a)

A dosing table for Xolair PFS (omalizumab) injection indicating dose (mg) based on pretreatment serum IgE levels (IU/mL) and patient body weight (kg). It also denotes dosing frequency, with subcutaneous injections administered every 2 or 4 weeks depending on specific IgE ranges and weight. The table includes a range of doses from 75 mg to 600 mg and notes areas with insufficient data for dose recommendation.*

FDA Label Image

Figure 1 (Xolair 04)

Two line graphs depicting LS mean change from baseline in nasal symptoms over 24 weeks. The left graph shows nasal polyp score changes, while the right displays nasal congestion score changes. Both compare Xolair (omalizumab) treatment groups versus placebo across two clinical trials, indicating efficacy trends over time with standard error bars.*

FDA Label Image

Figure 2 (Xolair 05)

A line graph depicting the mean weekly itch score over a 40-week study period comparing placebo and three omalizumab dose groups (75 mg, 150 mg, 300 mg) in a treatment and follow-up period. The x-axis represents study weeks, with injection times noted, while the y-axis shows itch score values. The chart includes legend symbols differentiating placebo and omalizumab doses.*

FDA Label Image

Image (Xolair 21a)

An instructional diagram showing the parts of a pre-filled syringe before and after use. The 'Before Use' side labels the needle cap, expiration date location, plunger rod, and plunger rod head. The 'After Use' side shows the needle shield in place, the needle, and safety guard wings, illustrating the syringe safety features after injection.*

FDA Label Image

Image (Xolair 21b)

An instructional illustration showing components related to Xolair Prefilled Syringe use, including the syringe itself, an alcohol swab, a sterile cotton ball or gauze, a bandage, and a sharps disposal container.*

FDA Label Image

Image (Xolair 21c)

Illustration showing Xolair prefilled syringes with color-coded plungers corresponding to doses: blue plunger for 75 mg, purple plunger for 150 mg, and gray plunger for 300 mg. A dosing table indicates combinations of syringes required to achieve doses from 75 mg to 600 mg, specifying the number and color of syringes for each dose amount.*

FDA Label Image

Image (Xolair 21d)

An instructional diagram showing the location of the expiration date on a rectangular drug carton. The expiration date is indicated on the end flap of the box and formatted as MMM YYYY.*

FDA Label Image

Image (Xolair 21e)

An instructional diagram showing a rectangular package with an expiration date format labeled 'MM/YYYY' and a clock icon indicating a time interval of 30 to 45 minutes, suggesting a recommended waiting or observation period.*

FDA Label Image

Image (Xolair 21f)

An instructional line drawing showing a hand lifting the flap of a box, indicated by an upward arrow. The image illustrates the step of opening the package containing the Xolair PFS injection, solution, likely as part of the preparation or administration process.*

FDA Label Image

Image (Xolair 21g)

An instructional diagram showing a blister package with labeled peel tabs and an area indicating the expiration date format (MMM YYYY). The image guides how to access or identify the expiration date on a product package.*

FDA Label Image

Image (Xolair 21h)

An instructional illustration showing a hand holding a prefilled syringe labeled Xolair PFS (omalizumab) injection, positioned above a molded tray. An arrow indicates the syringe being placed or removed from the tray, likely demonstrating proper handling or storage of the subcutaneous injection solution.*

FDA Label Image

Image (Xolair 21i)

An instructional diagram showing a hand holding a prefilled syringe, pointing it toward an eye. The illustration emphasizes careful handling or aiming, likely related to the use of the injection product Xolair PFS (omalizumab).*

FDA Label Image

Image (Xolair 21j)

An instructional diagram for Xolair PFS injection sites on the human body showing recommended areas for subcutaneous injection. The front view highlights the abdomen and upper thighs, while the back view indicates the upper arms. A note specifies that injections are for caregiver use only.*

FDA Label Image

Image (Xolair 21k)

An instructional diagram showing a hand using a small wipe to clean an area of skin, with an arrow indicating a circular motion. This illustration likely demonstrates skin preparation before an injection.*

FDA Label Image

Image (Xolair 21l)

An instructional illustration showing two hands preparing an injection with a prefilled syringe. The left hand holds a protective cap being removed from the needle, indicated by an arrow pointing upward, while the right hand holds the syringe ready for use.*

FDA Label Image

Image (Xolair 21m)

Instructional illustration showing the administration of Xolair PFS (omalizumab) subcutaneous injection at a 45-degree angle. The image depicts a hand holding a syringe angled toward a finger, demonstrating proper injection technique.*

FDA Label Image

Image (Xolair 21n)

Illustration showing the use of the Xolair PFS prefilled syringe for subcutaneous injection. The diagram highlights the plunger head and safety guard wings on the syringe and depicts a person injecting the solution into the skin of their finger or hand.*

FDA Label Image

Image (Xolair 21o)

An instructional illustration demonstrating the subcutaneous injection technique for Xolair PFS (omalizumab) injection, solution. The image shows a hand holding the prefilled syringe and another hand pinching the skin to administer the injection with an arrow indicating the needle's insertion direction.*

FDA Label Image

Image (Xolair 21p)

An instructional diagram showing a hand holding a syringe with a prefilled syringe design, positioned above a disposal container, demonstrating the proper disposal method for a used needle or syringe.*

FDA Label Image

Image (Xolair 21aa)

An instructional diagram showing a prefilled syringe labeled Xolair PFS before and after use. The 'Before Use' syringe displays the expiration date, viewing window, and cap. The 'After Use' syringe shows a green indicator in the viewing window and a needle guard covering the needle.*

FDA Label Image

Image (Xolair 21bb)

An instructional diagram showing components for use with Xolair autoinjector. It includes an alcohol swab, a sterile cotton ball or gauze, a bandage, and a sharps disposal container, arranged around a line drawing of the Xolair autoinjector injection device.*

FDA Label Image

Image (Xolair 21cc)

An instructional diagram illustrating Xolair autoinjectors by dose and needle guard color. The 75 mg autoinjector has a blue needle guard, the 150 mg autoinjector has a purple needle guard, and the 300 mg autoinjector has a gray needle guard. A table correlates doses from 75 mg to 600 mg with the recommended combination of autoinjectors by color for each dose.*

FDA Label Image

Image (Xolair 21dd)

An illustration depicts a rectangular pharmaceutical carton with an instruction note stating that the expiration date is printed on the back of the box in the format MMM YYYY. The image is likely intended to guide users on where to find the expiration date on the product packaging.*

FDA Label Image

Image (Xolair 21ee)

An instructional illustration showing a box placed on a flat surface and a clock icon indicating a time duration of 30 to 45 minutes, likely representing a recommended waiting or preparation time.*

FDA Label Image

Image (Xolair 21ff)

An instructional illustration showing a hand removing a Xolair PFS prefilled syringe from its packaging box. The syringe is held by the thumb and forefinger, being lifted vertically out of the box.*

FDA Label Image

Image (Xolair 21gg)

Illustration showing a prefilled syringe with labels indicating areas to check for damage and medicine presence, as well as the location of the expiration date formatted as month and year (MMM YYYY).*

FDA Label Image

Image (Xolair 21hh)

An anatomical illustration showing recommended subcutaneous injection sites for Xolair PFS (omalizumab). The front and back views of a human figure highlight injection areas on the abdomen, thighs, and upper arms. A key indicates these shaded areas are designated injection sites for caregiver use only.*

FDA Label Image

Image (Xolair 21ii)

An instructional line drawing showing a hand using a cloth or wipe in a circular motion on a surface, likely depicting the step of cleaning or preparing the injection site before administering a subcutaneous injection.*

FDA Label Image

Image (Xolair 21jj)

An instructional illustration showing a person holding a prefilled syringe with one hand and removing the cap from the needle with the other hand, indicating preparation for subcutaneous injection. The syringe design and handling suggest it is related to the Xolair PFS (omalizumab) injection.*

FDA Label Image

Image (Xolair 21kk)

An instructional illustration showing a hand holding a prefilled syringe vertically at a 90-degree angle against a surface, demonstrating the correct technique for subcutaneous injection of Xolair PFS (omalizumab) injection solution.*

FDA Label Image

Image (Xolair 21ll)

An instructional line drawing showing a hand holding a prefilled syringe vertically with the thumb pressing on the plunger. The image includes an arrow pointing downward and instructions to 'Click' and 'Press and Hold,' demonstrating the proper technique for using the injection device.*

FDA Label Image

Image (Xolair 21mm)

An illustration showing a hand holding a pen-like device vertically with the thumb pressing down on the top. A dark arrow points downward, indicating a pressing or injection action. The device includes a visible window with a green indicator, suggesting activation or readiness for use.*

FDA Label Image

Image (Xolair 21nn)

An instructional illustration showing a hand holding an injection device vertically over the skin with the instruction to press until a 'Click' is heard to deploy the subcutaneous injection, likely related to the administration of Xolair PFS (omalizumab) injection solution.*

FDA Label Image

Image (Xolair 21oo)

An instructional illustration showing a hand firmly gripping a prefilled syringe with a green liquid, positioned above a surface. An upward arrow below the syringe indicates the direction to pull or lift it.*

FDA Label Image

Image (Xolair 21pp)

An instructional illustration depicts a hand disposing of a syringe or prefilled syringe into a sharps disposal container. The image emphasizes safe disposal of used injection devices, relevant to products like Xolair PFS (omalizumab) injection, solution for subcutaneous use.*

FDA Label Image

Principal Display Panel (150 mg Vial Carton)

Label for Xolair (omalizumab) single-dose vial, 150 mg strength for subcutaneous injection. The label has a purple background with yellow and white text, highlighting the product name and strength. It includes instructions to keep refrigerated and not freeze. The label also displays the NDC 50242-040-62 and the logos of Genentech and Novartis.*

FDA Label Image

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

Label for Xolair (omalizumab) injection, 75 mg/0.5 mL, a subcutaneous injection solution in a single-dose prefilled syringe. The label includes directions for subcutaneous use, a warning not to use for emergency treatment, and instructions to dispense the accompanying Medication Guide. The labeler is Genentech, Inc., with logos for Genentech and Novartis. The product must be refrigerated.*

FDA Label Image

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

Xolair (omalizumab) Injection 75 mg/0.5 mL label for subcutaneous use featuring a single-dose autoinjector. The label includes a warning not to use for emergency treatment and advises patients needing more than one injection to consult their healthcare provider. It is labeled by Genentech, Inc. and includes an NDC number.*

FDA Label Image

Principal Display Panel (150 mg/mL Syringe Carton)

Xolair (omalizumab) injection 150 mg/mL single-dose prefilled syringe label for subcutaneous use. The label includes warnings not to use for emergency treatment and advises contacting a healthcare provider for dosing questions. It states the product must be refrigerated and is manufactured by Genentech, Inc., Novartis.*

FDA Label Image

Principal Display Panel (150 mg/mL Autoinjector Carton)

Label for Xolair (omalizumab) Injection 150 mg/mL for subcutaneous use in a single-dose autoinjector. The label includes a warning that it is not for emergency treatment and advises contacting a healthcare provider for dose questions. It is labeled by Genentech, Inc. and Novartis, with NDC 50242-215-55.*

FDA Label Image

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

Label for Xolair (omalizumab) Injection, 300 mg/2 mL (150 mg/mL) solution for subcutaneous use. The label indicates a single-dose prefilled syringe and includes a warning not to use for emergency treatment. It states refrigeration is required. Manufactured by Genentech, Inc., a Novartis company.*

FDA Label Image

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

Label for Xolair (omalizumab) Injection 300 mg/2 mL for subcutaneous use. The label specifies a single-dose autoinjector and includes a warning not to use for emergency treatment. It advises contacting a healthcare provider if more than one injection is required. Labeler names Genentech and Novartis appear on the label.*

* 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.