Omalizumab

Administration Overview Administer XOLAIR by subcutaneous injection. XOLAIR is intended for use under the guidance of a healthcare provider. Initiate therapy in a healthcare setting and once therapy has been safely established, the healthcare provider may determine whether self-administration of XOLAIR prefilled syringe or autoinjector by the patient or caregiver is appropriate, based on careful assessment of risk for anaphylaxis and mitigation strategies.

Selection of Patients for Self-Administration of XOLAIR Prefilled Syringe or Autoinjector Healthcare providers should consider known risk factors for anaphylaxis to XOLAIR [see Warnings and Precautions ] and mitigation strategies when selecting patients for self-administration. Patient-specific factors including the following criteria should be considered: 1a) Asthma, CRSwNP and CSU : Patient should have no prior history of anaphylaxis to XOLAIR or other agents, such as foods, drugs, biologics, etc. 1b) IgE-Mediated Food Allergy : Patient should have no prior history of anaphylaxis to XOLAIR or other agents (except foods), such as drugs, biologics, etc. 2) Patient should receive at least 3 doses of XOLAIR under the guidance of a healthcare provider with no hypersensitivity reactions 3) Patient or caregiver is able to recognize symptoms of anaphylaxis 4) Patient or caregiver is able to treat anaphylaxis appropriately 5) Patient or caregiver is able to perform subcutaneous injections with XOLAIR prefilled syringe or autoinjector with proper technique according to the prescribed dosing regimen and Instructions for Use

Preparation for Use and Injection of XOLAIR Lyophilized Powder XOLAIR lyophilized powder should only be prepared and injected by a healthcare provider. The supplied XOLAIR lyophilized powder must be reconstituted with Sterile Water for Injection (SWFI) USP, using the following instructions: 1) 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 6 ) . [See table below.] 2) Draw 1.4 mL of SWFI, USP, into a 3 mL syringe equipped with a 1-inch, 18-gauge needle. 3) 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. 4) Keeping the vial upright, gently swirl the upright vial for approximately 1 minute to evenly wet the powder.

Do not shake. 5) 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. 6) 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. 7) Invert the vial for 15 seconds in order to allow the solution to drain toward the stopper. 8) 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. 9) 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. 10) Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection. 11) 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. 12) 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 between two or more injection sites. Choose a different injection site for each new injection at least 1 inch from the area used for other injections.