Preparation and administration of XOLAIR
XOLAIR is administered subcutaneously every 4 weeks at 150 mg or 300 mg per dose, or every 2 weeks at 225 mg, 300 mg, or 375 mg per dose. Because the solution is slightly viscous, the injection may take 5 to 10 seconds to administer.
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| Supplies needed per vial of XOLAIR |
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- XOLAIR (Omalizumab) vial
- Diluent vial SWFI, USP
- Two 3-cc syringes
- Two 1-inch, 18-gauge needles (for reconstitution)
- One 25-gauge needle (for subcutaneous injection)
- Alcohol swabs
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| Preparing the vials |
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Step 1
Remove the plastic cap from the XOLAIR vial.
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Step 2
Remove the plastic cap from the diluent vial containing SWFI, USP.
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Step 3
Using an alcohol swab, wipe the rubber stopper of the XOLAIR vial and the diluent vial.
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| Reconstituting the dose* |
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| Note: The lyophilized product typically takes 15 to 20 minutes to dissolve. |
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Step 1
Draw 1.4 mL of SWFI, USP, into a 3-cc syringe equipped with a 1-inch, 18- gauge needle.
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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.
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Step 3
Keeping the XOLAIR vial upright, gently swirl the vial for approximately 1 minute to evenly wet the powder. Do not shake.
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*To determine the appropriate number of injections and the milliliters (mL) per dose, please refer to the dose and SC injection specifications table here.
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Preparing the Reconstituted Dose
for Injection |
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Step 1
After reconstituting the dose, gently swirl the vial for 5 to 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 1 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 within 40 minutes.
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Step 2
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 just beyond 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.
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
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Step 3
Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
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Step 4
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. Each XOLAIR vial delivers 150 mg of XOLAIR per 1.2 mL upon reconstitution with 1.4 mL of SWFI, USP. For a 75-mg dose, draw up 0.6 mL into the syringe and discard the remaining product. For more information,
review the Dose and SC Injection Specifications table
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Stability after Reconstruction
XOLAIR is for single use only and contains no preservatives. The solution should be used for subcutaneous administration within 8 hours following reconstitution when refrigerated in the vial at 2°C to 8°C (36°F to 46°F) or within 4 hours of reconstitution when stored at room temperature. Reconstituted XOLAIR vials should be protected from direct sunlight.
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Administering the Subcutaneous
Injection |
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| Seeing the Injection Site |
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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. |
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Step 1
Prepare the injection site.
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Step 2
Administer XOLAIR following your facility’s standard guidelines for subcutaneous injections.
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Step 3
Because the solution is somewhat viscous, the injection may take 5 to 10 seconds to administer.
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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.
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IMPORTANT SAFETY INFORMATION
Injection site reactions of any severity occurred at a rate of 45% in XOLAIR-treated patients compared with 43% in placebo-treated patients. The types of injection site reactions included: bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation.
INDICATION
XOLAIR® (omalizumab) for subcutaneous use 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.
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Important Limitations of Use
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XOLAIR is not indicated for treatment of other allergic conditions |
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XOLAIR is not indicated for the relief of acute bronchospasm or
status asthmaticus |
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XOLAIR is not indicated for use in pediatric patients less than
12 years of age |
IMPORTANT SAFETY INFORMATION
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WARNING: Anaphylaxis
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 (see Warnings and Precautions: Anaphylaxis).
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XOLAIR should only be administered in a healthcare setting by healthcare providers prepared to manage anaphylaxis that can be life-threatening. |
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XOLAIR should not be administered to patients who have experienced a severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR (see Warnings and Precautions). XOLAIR should be discontinued in patients who experience a severe hypersensitivity reaction. |
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Malignant neoplasms were observed in 20 of 4127 (0.5%) XOLAIR-treated patients compared with 5 of 2236 (0.2%) control patients in clinical studies of asthma and other allergic disorders. |
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XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use XOLAIR to treat acute bronchospasm or status asthmaticus. |
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A constellation of signs and symptoms including arthritis/arthralgia, rash (urticaria or other forms), fever and lymphadenopathy similar to serum sickness have been reported in post-approval use of XOLAIR in some patients. Physicians should stop XOLAIR if a patient develops this constellation of signs and symptoms. |
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Patients should be given and instructed to read the accompanying Medication Guide before starting treatment and before each subsequent treatment. |
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Do not abruptly discontinue corticosteroid use upon initiation of XOLAIR therapy. Decrease corticosteroids gradually under the direct supervision of a physician. |
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In patients ≥12 years of age, the most commonly observed adverse reactions (>1% more frequent in XOLAIR-treated patients) from 4 placebo-controlled asthma studies were arthralgia (8%), pain (general) (7%), leg pain (4%), fatigue (3%), dizziness (3%), fracture (2%), arm pain (2%), pruritus (2%), dermatitis (2%), and earache (2%). |
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The adverse events most frequently resulting in clinical intervention (e.g. discontinuation of XOLAIR, or the need for concomitant medication to treat an adverse event), in either placebo-controlled or other controlled asthma studies, were injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). These events were observed at similar rates in XOLAIR-treated patients and control patients. |
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