Medically reviewed by Drugs.com. Last updated on Dec 9, 2020.
Generic name: OMALIZUMAB 202.5mg in 1.4mL
Dosage form: injection, solution
Overview of Dosage Determination
Asthma and Nasal Polyps
Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL) measured before the start of treatment, and by body weight (kg). For patients with both asthma and nasal polyps, dosing determination should be based on the primary diagnosis for which XOLAIR is being prescribed. Adjust doses for significant changes in body weight during treatment (see Tables 1 and 2 for treatment of asthma and Table 3 for treatment of nasal polyps).
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 (Table 1 or 2 for treatment of asthma, based on the patient's age, and Table 3 for treatment of nasal polyps).
Recommended Dosage for Asthma
The recommended dosage for treatment of asthma is XOLAIR 75 mg to 375 mg by subcutaneous injection every 2 or 4 weeks based on serum total IgE level (IU/mL) measured before the start of treatment and by body weight (kg) [see Dosage and Administration 2.2].
- Adult and adolescent patients 12 years of age and older: Initiate dosing according to Table 1.
- Pediatric patients 6 to <12 years of age: Initiate dosing according to Table 2.
Recommended Dosage for Nasal Polyps
Administer XOLAIR 75 mg to 600 mg by subcutaneous injection every 2 or 4 weeks based on serum total IgE level (IU/mL) measure before the start of treatment and by body weight (kg) [see Dosage and Administration 2.2].
Recommended Dosage for Chronic Idiopathic Urticaria
Administer XOLAIR 150 mg 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.
XOLAIR is available as a prefilled syringe and as a lyophilized powder in vial for reconstitution. Both XOLAIR prefilled syringe and lyophilized powder should be administered by a healthcare professional. Administer XOLAIR by subcutaneous injection. The injection may take 5-10 seconds to administer. Do not administer more than one injection per site. (Table 4, Table 5).
|XOLAIR Dose*||75 mg Syringes||150 mg Syringes||Total Volume Injected|
|75 mg||1||0||0.5 mL|
|150 mg||0||1||1 mL|
|225 mg||1||1||1.5 mL|
|300 mg||0||2||2 mL|
|375 mg||1||2||2.5 mL|
|450 mg||0||3||3 mL|
|525 mg||1||3||3.5 mL|
|600 mg||0||4||4 mL|
|XOLAIR Dose*||Number of Vials||Number of Injections||Total Volume Injected|
|75 mg||1||1||0.6 mL|
|150 mg||1||1||1.2 mL|
|225 mg||2||2||1.8 mL|
|300 mg||2||2||2.4 mL|
|375 mg||3||3||3.0 mL|
|450 mg||3||3||3.6 mL|
|525 mg||4||4||4.2 mL|
Preparation for Use and Injection of XOLAIR Prefilled Syringe
To prepare XOLAIR prefilled syringes for subcutaneous administration, please carefully read and adhere to these instructions for use.
XOLAIR prefilled syringes are available in 2 dose strengths. These instructions are to be used for both dose strengths. You should check the label on the carton that comes with the XOLAIR prefilled syringe to make sure that the dose is correct.
XOLAIR 75 mg prefilled syringe with a blue needle shield
XOLAIR 150 mg prefilled syringe with a purple needle shield
- Keep the unused syringe in the original carton and store the carton in a refrigerator at 36˚F to 46˚F (2˚C to 8˚C). Do not remove the syringe from its original carton during storage.
- Keep the XOLAIR syringe out of direct sunlight.
- Do not freeze.
- Do not use if the syringe has been frozen.
- Always keep the syringe dry.
Important Information about the Prefilled Syringe
- The removable needle cap of XOLAIR solution for injection in prefilled syringe contains a derivative of natural rubber latex [see Description (11)].
- Do not open the sealed outer carton until you are ready to inject XOLAIR.
- Do not take the needle cap off until you are ready to inject XOLAIR.
- Do not try to take the syringe apart at any time.
- Do not reuse the same syringe.
- Do not use if the syringe has been dropped or damaged.
- Do not use if the packaging is damaged or appears to be tampered with.
- Do not leave the syringe unattended.
- Keep the syringe out of the reach of children.
Preparing for the Injection
|Administering the Injection|
|After the Injection
Preparation for Use and Injection of XOLAIR Lyophilized Powder
The supplied XOLAIR lyophilized powder must be reconstituted with Sterile Water for Injection (SWFI) USP, using the following instructions:
- Before reconstitution, determine the number of vials that will need to be reconstituted (each vial delivers 150 mg of XOLAIR in 1.2 mL) (see Table 5).
- Draw 1.4 mL of SWFI, USP, into a 3 mL syringe equipped with a 1-inch, 18-gauge needle.
- 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.
- Keeping the vial upright, gently swirl the upright vial for approximately 1 minute to evenly wet the powder. Do not shake.
- Gently swirl the vial for 5 to 10 seconds approximately every 5 minutes in order to dissolve any remaining solids. The lyophilized product takes 15 to 20 minutes to dissolve. If it takes longer than 20 minutes to dissolve completely, gently swirl the vial for 5 to 10 seconds approximately every 5 minutes 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.
- After reconstitution, XOLAIR solution is somewhat viscous and will appear clear or slightly opalescent. It is acceptable if there are a few small bubbles or foam around the edge of the vial; there should be no visible gel-like particles in the reconstituted solution. Do not use if foreign particles are present.
- Invert the vial for 15 seconds in order to allow the solution to drain toward the stopper.
- Use the XOLAIR solution within 8 hours following reconstitution when stored in the vial at 2ºC to 8ºC (36ºF to 46ºF), or within 4 hours of reconstitution when stored at room temperature. Reconstituted XOLAIR vials should be protected from sunlight.
- 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. The reconstituted product is somewhat viscous. Withdraw all of the product from the vial before expelling any air or excess solution from 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.
- Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
- Expel air, large bubbles, and any excess solution in order to obtain a volume of 1.2 mL corresponding to a dose of 150 mg of XOLAIR. To obtain a volume of 0.6 mL corresponding to a dose of 75 mg of XOLAIR, expel air, large bubbles and discard 0.6 mL from the syringe. A thin layer of small bubbles may remain at the top of the solution in the syringe
- Administer XOLAIR by subcutaneous injection. The injection may take 5-10 seconds to administer because the solution is slightly viscous. Do not administer more than 150 mg (contents of one vial) per injection site. Divide doses of more than 150 mg among two or more injection sites.
Frequently asked questions
- Is Xolair an immunosuppressant?
- How long before Xolair starts working?
- How does Xolair work?
- Does Xolair cause weight gain?
More about Xolair (omalizumab)
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