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Xolair (Omalizumab) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Xolair (Omalizumab) is indicated for adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions.

DOSAGE AND ADMINISTRATION

Xolair (Omalizumab) 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts below (Table 5 and Table 6) for appropriate dose assignment. Doses of more than 150 mg are divided among more than one injection site to limit injections to not more than 150 mg per site.

Table 5
ADMINISTRATION EVERY 4 WEEKS
Xolair Doses (milligrams) Administered by Subcutaneous
Injection Every 4 Weeks for Adults and Adolescents
(12 Years of Age and Older) with Asthma
Pre-
treatment
Serum IgE
(IU/mL)
Body Weight (kg)
30-60 > 60-70 > 70-90 > 90-150
>/= 30-100 150 150 150 300
> 100-200 300 300 300  
> 200-300 300 SEE TABLE 6
> 300-400  
> 400-500
> 500-600

Table 6
ADMINISTRATION EVERY 2 WEEKS
Xolair Doses (milligrams) Administered by Subcutaneous
Injection Every 2 Weeks for Adults and Adolescents
(12 Years of Age and Older) with Asthma
Pre-
treatment Serum IgE (IU/mL)
Body Weight (kg)
30-60 > 60-70 > 70-90 > 90-150
>/= 30-100
SEE TABLE 5
 
> 100-200 225
> 200-300   225 225 300
> 300-400 225 225 300  
> 400-500 300 300 375
> 500-600 300 375 DO NOT DOSE
> 600-700 375  

DOSING ADJUSTMENTS

Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment. Therefore, re-testing of IgE levels during Xolair treatment cannot be used as a guide for dose determination. Dose determination after treatment interruptions lasting less than 1 year should be based on serum IgE levels obtained at the initial dose determination. Total serum IgE levels may be re-tested for dose determination if treatment with Xolair has been interrupted for one year or more.

Doses should be adjusted for significant changes in body weight. (See Table 5 and Table 6.)

PREPARATION FOR ADMINISTRATION

Xolair for SC administration should be prepared using SWFI, USP, ONLY.

Xolair is for single use only and contains no preservatives. The solution should be used for SC administration within 8 hours following reconstitution when stored in the vial at 2-8°C (36-46°F), or within 4 hours of reconstitution when stored at room temperature.

The lyophilized product takes 15-20 minutes to dissolve. The fully reconstituted product will appear clear or slightly opalescent and may have a few small bubbles or foam around the edge of the vial. The reconstituted product is somewhat viscous; in order to obtain the full 0.6 mL (75 mg) or 1.2 mL (150 mg) dose, ALL OF THE PRODUCT MUST BE WITHDRAWN from the vial before expelling any air or excess solution from the syringe.

  • For Xolair 75 mg vial:
    STEP 1:    Draw 0.9 mL of SWFI, USP into a 3-cc syringe equipped with a 1-inch, 18-gauge needle.
    STEP 2:    Place the vial upright on a flat surface and using standard aseptic technique, insert the needle and inject the SWFI, USP directly onto the product.
    STEP 3:    Keeping the vial upright, gently swirl the upright vial for approximately 1 minute to evenly wet the powder. Do not shake.
    STEP 4:    After completing STEP 3, gently swirl the vial for 5-10 seconds approximately every 5 minutes in order to dissolve any remaining solids. There should be no visible gel-like particles in the solution. Do not use if foreign particles are present.
    Note:   Some vials may take longer than 20 minutes to dissolve completely. If this is the case, repeat STEP 4 until there are no visible gel-like particles in the solution. It is acceptable to have small bubbles or foam around the edge of the vial. Do not use if the contents of the vial do not dissolve completely by 40 minutes.
    STEP 5:    Invert the vial for 15 seconds in order to allow the solution to drain toward the stopper. Using a new 3-cc syringe equipped with a 1-inch, 18-gauge needle, insert the needle into the inverted vial. Position the needle tip at the very bottom of the solution in the vial stopper when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.
    STEP 6:    Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
    STEP 7:    Expel air, large bubbles, and any excess solution in order to obtain the required 0.6 mL dose. A thin layer of small bubbles may remain at the top of the solution in the syringe. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer.
  • For Xolair 150 mg vial:
    STEP 1:    Draw 1.4 mL of SWFI, USP into a 3-cc syringe equipped with a 1-inch, 18-gauge needle.
    STEP 2:    Place the vial upright on a flat surface and using standard aseptic technique, insert the needle and inject the SWFI, USP directly onto the product.
    STEP 3:    Keeping the vial upright, gently swirl the upright vial for approximately 1 minute to evenly wet the powder. Do not shake.
    STEP 4:    After completing STEP 3, gently swirl the vial for 5-10 seconds approximately every 5 minutes in order to dissolve any remaining solids. There should be no visible gel-like particles in the solution. Do not use if foreign particles are present.
    Note:   Some vials may take longer than 20 minutes to dissolve completely. If this is the case, repeat STEP 4 until there are no visible gel-like particles in the solution. It is acceptable to have small bubbles or foam around the edge of the vial. Do not use if the contents of the vial do not dissolve completely by 40 minutes.
    STEP 5:    Invert the vial for 15 seconds in order to allow the solution to drain toward the stopper. Using a new 3-cc syringe equipped with a 1-inch, 18-gauge needle, insert the needle into the inverted vial. Position the needle tip at the very bottom of the solution in the vial stopper when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.
    STEP 6:    Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
    STEP 7:    Expel air, large bubbles, and any excess solution in order to obtain the required 1.2 mL dose. A thin layer of small bubbles may remain at the top of the solution in the syringe. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer.

    A 75 mg vial delivers 0.6 mL (75 mg) of Xolair. A 150 mg vial delivers 1.2 mL (150 mg) of Xolair (see Table 7).

    Table 7
    Number of Vials, Number of Injections and Total Injection Volumes for Asthma
    Dose (mg) Number of Vials  
    75 mg a 150 mg b Number of
    Injections
    Total Volume
    Injected
    (mL)
    150 0 1 1 1.2
    225 1 1 2 1.8
    300 0 2 2 2.4
    375 1 2 3 3.0
    a 0.6 mL maximum delivered volume per vial.
    b 1.2 mL maximum delivered volume per vial.

    STABILITY AND STORAGE

    Xolair should be shipped at controlled ambient temperature (</=30°C [</=86°F]). Xolair should be stored under refrigerated conditions 2-8°C (36-46°F). Do not use beyond the expiration date stamped on carton.

    Xolair is for single-use only and contains no preservatives. The solution may be used for SC administration within 8 hours following reconstitution when stored in the vial at 2-8°C (36-46°F), or within 4 hours of reconstitution when stored at room temperature.

    Reconstituted Xolair vials should be protected from direct sunlight.

  • HOW SUPPLIED

    Xolair (Omalizumab) is supplied as a lyophilized sterile powder in a single-use 5 cc vial.

    The 75 mg vial configuration is designed to deliver 75 mg of Xolair upon reconstitution with 0.9 mL SWFI, USP. Each 75 mg carton contains one single-use vial of Xolair (Omalizumab) NDC 50242-042-01.

    The 150 mg vial configuration is designed to deliver 150 mg of Xolair upon reconstitution with 1.4 mL SWFI, USP. Each 150 mg carton contains one single-use vial of Xolair (Omalizumab). NDC 50242-040-62.

    XOLAIR®

    Omalizumab

    For Subcutaneous Use

    Manufactured by:

    Genentech, Inc.

    1 DNA Way

    South San Francisco, CA 94080-4990         (4821002)

                                         FDA Approval Date: June 2003

                              Code Revision Date: September 2004

    Jointly marketed by:                       ©2004 Genentech, Inc.

    Genentech, Inc.

    1 DNA Way

    South San Francisco, CA 94080-4990

    Novartis Pharmaceuticals Corporation

    One Health Plaza

    East Hanover, NJ 07936-1080

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