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Xolair

"March 16, 2011 -- The asthma drug Xolair (omalizumab) improves asthma control, nearly eliminates seasonal flare-ups, and allows reductions in the doses of other asthma control medications in children as young as 6, according to a new study.

"...

Xolair

INDICATIONS

Allergic Asthma

Xolair 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.

Chronic Idiopathic Urticaria (CIU)

Xolair is indicated for the treatment of adults and adolescents (12 years of age and above) with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment.

Important Limitations Of Use

  • Xolair is not indicated for treatment of other allergic conditions or other forms of urticaria.
  • Xolair is not indicated for the relief of acute bronchospasm or status asthmaticus.
  • Xolair is not indicated for use in pediatric patients less than 12 years of age.

DOSAGE AND ADMINISTRATION

Dose For Allergic Asthma

Administer Xolair 150 to 375 mg by subcutaneous (SC) injection every 2 or 4 weeks. Determine doses (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts below (Table 1 and Table 2) for appropriate dose assignment.

Periodically reassess the need for continued therapy based upon the patient's disease severity and level of asthma control.

Table 1: Administration Every 4 Weeks Xolair Doses (milligrams) Administered by Subcutaneous Injection Every 4 Weeks for Adults and Adolescents 12 Years of Age and Older for Allergic 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
> 300-400 SEE TABLE 2
> 400-500
> 500-600

Table 2: Administration Every 2 Weeks Xolair Doses (milligrams) Administered by Subcutaneous Injection Every 2 Weeks for Adults and Adolescents 12 Years of Age and Older for Allergic Asthma

Pre-treatment Serum IgE (IU/mL) Body Weight (kg)
30-60 > 60-70 > 70-90 > 90-150
≥ 30-100 SEE TABLE 1
> 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 For Allergic Asthma

Adjust doses for significant changes in body weight (see Table 1 and Table 2).

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.

  • Interruptions lasting less than one year: Dose based on serum IgE levels obtained at the initial dose determination.
  • Interruptions lasting one year or more: Re-test total serum IgE levels for dose determination.

Dose For Chronic Idiopathic Urticaria

Administer Xolair 150 or 300 mg by subcutaneous injection every 4 weeks.

Dosing of Xolair in CIU patients is not dependent on serum IgE (free or total) level or body weight.

The appropriate duration of therapy for CIU has not been evaluated. Periodically reassess the need for continued therapy.

Preparation And Administration

Prepare Xolair for subcutaneous injection using Sterile Water for Injection (SWFI), USP, ONLY. Each vial of Xolair is for single use only and contains no preservatives.

Reconstitution

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

Use the solution 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 sunlight.

Preparation

Step 1: Draw 1.4 mL of SWFI, USP into a 3 mL 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: If it takes longer than 20 minutes to dissolve completely, repeat STEP 4 until there are no visible gel-like particles in the solution. 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 mL 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.

Administration

Administer Xolair by subcutaneous injection. The injection may take 5-10 seconds to administer because the solution is slightly viscous. Each vial delivers 1.2 mL (150 mg) of Xolair. Do not administer more than 150 mg per injection site. Divide doses of more than 150 mg among two or more injection sites (Table 3).

Table 3: Number of Injections and Total Injection Volumes

Xolair Dose (mg)* Number of Injections Total Volume Injected (mL)
150 1 1.2
225 2 1.8
300 2 2.4
375 3 3
*All doses in the table are approved for use in allergic asthma patients. The 150 mg and 300 mg Xolair doses are intended for use in CIU patients.

HOW SUPPLIED

Dosage Forms And Strengths

150 mg of omalizumab as lyophilized, sterile powder in a single-use 5 mL vial.

Storage And Handling

Xolair is supplied as a lyophilized, sterile powder in a single-use, 5 mL vial without preservatives. Each vial delivers 150 mg of Xolair upon reconstitution with 1.4 mL SWFI, USP. Each carton contains one single-use vial of Xolair® (omalizumab) NDC 50242-04062.

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

Use the solution for subcutaneous 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.

Manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 940804990, Jointly marketed by: Genentech USA, Inc. A Member of the Roche Group, 1 DNA Way South San Francisco, CA 940804990 Novartis Pharmaceuticals Corporation One Health Plaza East Hanover, NJ 07936-1080. Revision Date: March 2014

Last reviewed on RxList: 4/10/2014
This monograph has been modified to include the generic and brand name in many instances.

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