Xolair Pfs Injection, Solution
Product Images NDC 50242-215

Product Visual Gallery

This gallery contains 24 technical images submitted to the FDA as part of the official labeling for Xolair Pfs (NDC 50242-215). 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

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 06)

An instructional illustration showing the parts of a prefilled syringe before and after use, including the needle cap, expiration date, plunger, and needle-shield wings with a warning not to touch the wings early. After use, the needle-shield is shown extended and locked over the needle.*

FDA Label Image

Image (Xolair 07)

An instructional diagram showing components for subcutaneous injection with Xolair Prefilled Syringe. Includes drawings of an alcohol swab, a sterile cotton ball or gauze, a bandage, the syringe itself labeled as Xolair Prefilled Syringe, and a sharps disposal container for used needles.*

FDA Label Image

Image (Xolair 08)

This illustration depicts Xolair prefilled syringes showing two strengths: 75 mg with a blue needle-shield and 150 mg with a purple needle-shield. Each syringe is shown next to its corresponding box, highlighting color-coded needle-shields to distinguish between doses of omalizumab injection solution for subcutaneous use.*

FDA Label Image

Image (Xolair 09)

A dosage table for Xolair PFS (omalizumab) showing the number and color of syringes needed per dose ranging from 75 mg to 600 mg. Blue syringes deliver 75 mg each, while purple syringes deliver 150 mg each. The table details combinations of blue and purple syringes for incrementing doses.*

FDA Label Image

Image (Xolair 10)

An instructional illustration showing the location of the expiration date on the packaging box for Xolair PFS injection. The expiration date is printed on the end flap of the carton labeled as 'MMM YYYY'.*

FDA Label Image

Image (Xolair 11)

An instructional illustration showing a hand peeling back a protective seal or cover from a box or container. The image includes an arrow indicating the direction to lift the cover upwards. This likely demonstrates how to open packaging or access the product inside.*

FDA Label Image

Image (Xolair 12)

Illustration showing a blister pack with a peel tab and location designated for the expiration date in the format MMM YYYY. The diagram highlights where to find the expiration date on the blister packaging.*

FDA Label Image

Image (Xolair 13)

An instructional illustration showing a hand holding and pushing the plunger of a prefilled syringe, positioned above a molded tray. The image appears to demonstrate removal or activation of the syringe component, related to Xolair PFS injection, solution for subcutaneous use.*

FDA Label Image

Image (Xolair 14)

An instructional illustration showing a hand holding a prefilled syringe, positioning it near an eye with a line indicating the injection site on the eye. The syringe appears to be for subcutaneous injection, relevant to omalizumab (Xolair PFS). The image likely demonstrates or emphasizes the correct injection technique or site visibility for administration.*

FDA Label Image

Image (Xolair 15)

An instructional illustration depicting preferred injection sites for Xolair PFS (omalizumab) subcutaneous injection. The front view highlights the abdomen near the navel and the front thighs, while the back view highlights areas on the upper arms. A label indicates that injections at the upper arm sites are for caregiver use only.*

FDA Label Image

Image (Xolair 16)

An instructional illustration showing a hand wiping a surface with a cloth or wipe, likely depicting a cleaning or preparation step prior to injection or other medical procedure.*

FDA Label Image

Image (Xolair 17)

An instructional illustration showing how to remove a needle cap from a prefilled syringe before injection. It depicts one hand holding the syringe and the other hand pulling the needle cap off, indicated by an arrow pointing away from the needle.*

FDA Label Image

Image (Xolair 18)

An instructional diagram showing the proper technique for subcutaneous injection using the Xolair PFS prefilled syringe. The image depicts the syringe held at a 90-degree angle for injection, with an inset illustrating an alternative 45-degree angle positioning.*

FDA Label Image

Image (Xolair 19)

An instructional illustration showing a hand holding an Xolair PFS prefilled syringe with an emphasis on the needle shield wings. The diagram highlights how to grip the needle shield wings and points to removing the shield before use, demonstrating preparation for subcutaneous injection.*

FDA Label Image

Image (Xolair 20)

An instructional illustration showing a hand holding a prefilled syringe and preparing to insert the needle into the skin for a subcutaneous injection. The image features an upward-pointing arrow indicating the direction of needle insertion for administering Xolair PFS injection.*

FDA Label Image

Image (Xolair 21)

An instructional illustration showing a hand holding a syringe above a disposal container, depicting the safe disposal of a syringe after use, typically associated with injection procedures like subcutaneous administration.*

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)

Xolair (omalizumab) Injection 75 mg/0.5 mL single-dose prefilled syringe packaging label. It is indicated for subcutaneous use and contains one prefilled syringe. The label includes a caution about natural rubber latex in the needle cap and directs patients to the accompanying Medication Guide. Labeler names Genentech and Novartis appear on the label.*

FDA Label Image

Principal Display Panel (150 mg/mL Syringe Carton)

Label for Xolair (omalizumab) Injection 150 mg/mL, a subcutaneous single-dose prefilled syringe. The label includes a caution about natural rubber latex in the needle cap, advises dispensing the Medication Guide to patients, and notes dosage may require more than one injection. Manufactured by Genentech, Inc., part of Novartis.*

* 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.