XOLAIR is administered by subcutaneous injection every 4 weeks at 300 mg or 150 mg per dose for CIU*. Because the solution is slightly viscous, the injection may take 5 to 10 seconds to administer.
XOLAIR should be shipped at controlled ambient temperature (≤30°C [≤86°F]). Prior to reconstitution, XOLAIR should be stored under refrigerated conditions (2°C to 8°C [36°F to 46°F]). Do not use beyond the expiration date stamped on the carton.
To learn more, read the administration instructions.
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Once the correct dose has been determined and the necessary supplies have been assembled, you are ready to begin.
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Before reconstitution, determine the number of vials that will need to be reconstituted (each vial delivers 150 mg of XOLAIR).
STEP 1: Remove the plastic cap from the XOLAIR vial.
STEP 2: Remove the plastic cap from the diluent vial containing SWFI, USP.
STEP 3: Using an alcohol swab, wipe the rubber stopper of the XOLAIR vial and the diluent vial.
You are ready to reconstitute and administer the dose of XOLAIR.
* Please refer to the dose and SC injection specifications table to determine the appropriate number of injections and the mL per dose.
Note: The lyophilized product typically takes 15 to 20 minutes to dissolve.
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 XOLAIR vial upright on a flat surface and, using standard aseptic technique, insert the needle and inject the SWFI, USP, directly onto the product. Remove the syringe and needle from the vial.
STEP 3: Keeping the XOLAIR vial upright, gently swirl the vial for approximately 1 minute to evenly wet the powder. Do not shake.
STEP 4: 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.
Each XOLAIR vial delivers 150 mg of XOLAIR per 1.2 mL upon reconstitution with 1.4 mL of SWFI, USP.
Note: The reconstituted product is somewhat viscous; in order to obtain the full 1.2-mL dose, ALL OF THE PRODUCT MUST BE WITHDRAWN from the vial before expelling any air or excess solution from the syringe.
For a 75-mg dose, draw 0.6 mL into the syringe and discard the remaining product.
Please refer to the Dose and SC Injection Specifications table to determine the appropriate number of injections and the mL per dose.
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 just beyond the vial stopper when draining 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.
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 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 only in a healthcare setting by healthcare providers prepared to manage anaphylaxis that can be life-threatening.
Be sure to provide and instruct patients to read the XOLAIR Medication Guide before starting treatment and before each subsequent treatment.
SELECTING THE INJECTION SITE
XOLAIR may be administered anywhere subcutaneous injections are typically given.
For patients requiring more than 1 injection per administration, it is important to choose a different injection site for each injection. This ensures that injections are limited to not more than 150 mg per site. Divide doses of more than 150 mg among two or more injection sites.
STEP 1: Prepare the injection site.
STEP 2: Administer XOLAIR following your facility's standard guidelines for subcutaneous injections.
STEP 3: Because the solution is somewhat viscous, the injection may take 5 to 10 seconds to administer.
STEP 4: When you are finished with administration, immediately discard syringes, needles, and remaining solution (if any) in a container designated for medical waste disposal, in compliance with state and federal regulations.
Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, observe patients closely for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur.
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