XOLAIR Self-Injection With Prefilled Syringe Now Approved for Appropriate Patients as Determined by a Healthcare Provider
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 by the patient or caregiver is appropriate, based on careful assessment of risk for anaphylaxis and mitigation strategies.
Choose which of your patients may be appropriate for XOLAIR self-injection with prefilled syringe
- When selecting patients or caregivers for self-injection,
patient-specific factors including the following criteria should be
- no prior history of anaphylaxis (including to XOLAIR or other agents, such as foods, drugs, biologics, etc.)
- receipt of at least 3 doses of XOLAIR under the guidance of a healthcare provider, with no hypersensitivity reactions
- ability to recognize symptoms of anaphylaxis
- ability to treat anaphylaxis appropriately
- ability to perform subcutaneous injections with XOLAIR prefilled syringe with proper technique according to the prescribed dosing regimen and Instructions for Use
Instruct Patients or Caregivers to Follow the Directions Provided in the "Instructions for Use" for Preparation and Administration of XOLAIR Prefilled Syringe
- Adolescents 12 years of age and older: XOLAIR prefilled syringe may be self-administered under adult supervision
- Pediatric patients 6 to 11 years of age: XOLAIR prefilled syringe should be administered by a caregiver
XOLAIR self-injection is available for appropriate patients in all approved indications.
There are 2 options in XOLAIR formulation, vial or prefilled syringe.
Initiate XOLAIR only in a healthcare setting by healthcare providers prepared to manage anaphylaxis that can be life-threatening. For more information on anaphylaxis, read Boxed WARNING.
Be sure to review the full Prescribing Information, including Medication Guide, before administering XOLAIR to patients. Also, provide and instruct patients and caregivers to read the XOLAIR Medication Guide and Instructions for Use before starting treatment and before each subsequent treatment.
Option 1: Use a Prefilled Syringe
- No reconstitution required
Preparation & Administration
Click on this video to see instructions on how to prepare and inject XOLAIR prefilled syringe.
Click the tabs below, to learn more about preparing and administering the prefilled syringe
Option 2: Reconstitute From a Vial (only in a healthcare provider office)
Supplies Needed to Reconstitute the Vial and Administer XOLAIR
Once the correct dose has been determined and the necessary supplies have been assembled, you are ready to begin.
Click the tabs below to learn more about how to prepare the XOLAIR vial, reconstitute the dose, and administer the injection.
After reconstitution, the 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.
Stability After Reconstitution
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.
XOLAIR is for single use only and contains no preservatives.
Note: Each XOLAIR vial delivers 150 mg of XOLAIR per 1.2 mL upon reconstitution with 1.4 mL of SWFI, USP.
Spoilage Replacement Program
If the XOLAIR prescribed for a labeled indication was spoiled and unable to be administered, the product might be eligible for replacement through the Genentech Spoilage Replacement Program.*
*Subject to certain limitations and conditions. The Spoilage Replacement Program covers infused or injected Genentech products.
Contact a Representative
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