See the full Prescribing Information for selection criteria of patients for self-administration of XOLAIR Autoinjector and prefilled syringe.
*Patients who require ≥300 mg. For IgE-mediated food allergy, dosing is based on pretreatment serum total IgE level and body weight.
† Existing dosing options that continue to be available.
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 Autoinjector or prefilled syringe by the patient or caregiver is appropriate, based on careful assessment of risk for anaphylaxis and mitigation strategies.
Do not use XOLAIR for the emergency treatment of any allergic reactions, including anaphylaxis, hives, or sudden breathing problems.
Not actual size
The single-dose prefilled XOLAIR Autoinjector has a staked needle, needle cap, and needle guard.
Patients should be careful not to turn the carton upside down to take out the XOLAIR Autoinjector, as this may damage it. They should also make sure to hold the XOLAIR Autoinjector by the middle and not by the cap.
The XOLAIR Autoinjector is not made with natural rubber latex.
The XOLAIR Autoinjector comes in 3 dosage strengths: 75 mg (blue needle guard), 150 mg (purple needle guard), and 300 mg (gray needle guard).
Watch this supplemental step-by-step video guide on how to properly prepare, inject, store, and dispose of the XOLAIR Autoinjector. This video also contains instructions for caregivers on how to inject another person.
Please review the steps detailed in the FDA-approved Instructions for Use. Afterward, you may use the following summary as a quick reference before injecting.
Preparing for the Injection (Steps 1-7)
Giving the Injection (Steps 8-14)
If your prescribed dose requires more than 1 injection:
After the Injection (Step 15)
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
The XOLAIR Autoinjector will be shipped under refrigerated conditions. It is important to store it as directed below.
DO | DO NOT |
---|---|
Keep unused XOLAIR in the original carton until ready to inject | Do not remove the XOLAIR Autoinjector from its original carton during storage |
Store XOLAIR in the refrigerator between 2 °C to 8 °C (36 °F to 46 °F) | Do not freeze. Do not use if the XOLAIR Autoinjector has been frozen |
Keep XOLAIR out of direct sunlight | Do not open the carton until ready to inject XOLAIR |
Ensure the total combined time out of refrigerator is less than 48 hours (2 days) | Do not take the cap off until ready to inject XOLAIR |
Keep the XOLAIR Autoinjector sharps disposal container and all drugs out of reach of children | Do not use if the carton is damaged or appears to be tampered with |
Do not use if the Autoinjector has been damaged or appears to be tampered with | |
Do not use if the Autoinjector has been dropped on a hard surface or dropped after removing the needle cap | |
Do not clean or touch the needle guard | |
Do not use if XOLAIR Autoinjector is left at temperatures above 77 °F (25 °C) and discard in a sharps disposal container |
DO |
---|
Keep unused XOLAIR in the original carton until ready to inject |
Store XOLAIR in the refrigerator between 2 °C to 8 °C (36 °F to 46 °F) |
Keep XOLAIR out of direct sunlight |
Ensure the total combined time out of refrigerator is less than 48 hours (2 days) |
Keep the XOLAIR Autoinjector sharps disposal container and all drugs out of reach of children |
DO NOT |
Do not remove the XOLAIR Autoinjector from its original carton during storage |
Do not freeze. Do not use if the XOLAIR Autoinjector has been frozen |
Do not open the sealed carton until ready to inject XOLAIR |
Do not take the needle cap off until ready to inject XOLAIR |
Do not use if the carton is damaged or appears to be tampered with |
Do not use if the Autoinjector has been damaged or appears to be tampered with |
Do not use if the Autoinjector has been dropped on a hard surface or dropped after removing the needle cap |
Do not clean or touch the needle guard |
Do not use if XOLAIR Autoinjector is left at temperatures above 77 °F (25 °C) and discard in a sharps disposal container |
The prefilled syringe has a needle shield. This is intended to protect against accidental needle-stick injuries.
Patients should be careful not to touch the needle-shield wings before use; by touching them, the needle shield may be activated too early.
The needle caps on the XOLAIR 75 mg/0.5 mL and 150 mg/mL prefilled syringes contain a type of natural rubber latex. Ask your patients if they have a latex allergy.
Watch this video for XOLAIR prefilled syringe instructions
Please review the steps detailed in the FDA-approved Instructions for Use. Afterward, you may use the following summaries as a quick reference before injecting.
Preparing for the Injection (Steps 1-7)
If the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14) and contact your healthcare provider.
If the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see step 14) and contact your healthcare provider.
Giving the Injection (Steps 8-10)
Inserting the Needle (Steps 11-13)
If your prescribed dose requires more than 1 injection:
After the Injection (Step 14)
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
Preparing for the Injection (Steps 1-7)
If the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container (see Step 14) and contact your healthcare provider.
Giving the Injection (Steps 8-10)
Inserting the Needle (Steps 11-13)
If your prescribed dose requires more than 1 injection:
After the Injection (Step 14)
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
XOLAIR prefilled syringe should be shipped and stored under refrigerated conditions between 2 °C to 8 °C (36 °F to 46 °F) in the original carton. Protect from direct sunlight. XOLAIR prefilled syringe can be removed from and placed back in the refrigerator if needed. The total combined time out of the refrigerator may not exceed 48 hours (2 days). Do not use if prefilled syringe is exposed to temperatures above 25 °C (77 °F). Do not freeze. Do not use if the syringe has been frozen.
The XOLAIR prefilled syringe will be shipped under refrigerated conditions. It is important to store it as directed below.
DO | DO NOT |
---|---|
Keep unused XOLAIR in the original carton until ready to inject | Do not remove the XOLAIR prefilled syringe from its original carton during storage |
Store XOLAIR in the refrigerator between 2 °C to 8 °C (36 °F to 46 °F) | Do not freeze. Do not use if the XOLAIR prefilled syringe has been frozen |
Keep XOLAIR out of direct sunlight | Do not open the sealed carton until ready to inject XOLAIR |
Ensure the total combined time out of refrigerator is less than 48 hours (2 days) | Do not take the needle cap off until ready to inject XOLAIR |
Keep the XOLAIR prefilled syringe sharps disposal container and all drugs out of reach of children | Do not try to take the XOLAIR prefilled syringe apart at any time |
Do not reuse the same XOLAIR prefilled syringe | |
Do not leave the XOLAIR prefilled syringe unattended | |
Do not use if XOLAIR prefilled syringe is left at temperatures above 77 °F (25 °C) and discard in a sharps disposal container |
DO |
---|
Keep unused XOLAIR in the original carton until ready to inject |
Store XOLAIR in the refrigerator between 2 °C to 8 °C (36 °F to 46 °F) |
Keep XOLAIR out of direct sunlight |
Ensure the total combined time out of refrigerator is less than 48 hours (2 days) |
Keep the XOLAIR prefilled syringe sharps disposal container and all drugs out of reach of children |
DO NOT |
Do not remove the XOLAIR prefilled syringe from its original carton during storage |
Do not freeze. Do not use if the XOLAIR prefilled syringe has been frozen |
Do not open the sealed carton until ready to inject XOLAIR |
Do not take the needle cap off until ready to inject XOLAIR |
Do not try to take the XOLAIR prefilled syringe apart at any time |
Do not reuse the same XOLAIR prefilled syringe |
Do not leave the XOLAIR prefilled syringe unattended |
Do not use if XOLAIR prefilled syringe is left at temperatures above 77 °F (25 °C) and discard in a sharps disposal container |
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.
Please review the steps detailed in the FDA-approved Instructions for Use. Afterward, you may use the following summary as a quick reference before injecting.
Preparing the Vial
First, determine the number of vials you will need to reconstitute.
Each vial contains 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.
Reconstituting the Vial Dose of XOLAIR
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.
Preparing the Reconstituted Dose of XOLAIR for Subcutaneous Use
Step 1:
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 in the vial stopper when drawing the solution into the syringe. The reconstituted product is somewhat viscous. Withdraw all 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 2:
Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
Step 3:
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 and 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.
Administering the Subcutaneous Injection of XOLAIR
Step 1:
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.
Step 2:
Prepare the injection site by swabbing it with alcohol.
Step 3:
Administer XOLAIR following your facility’s standard guidelines for subcutaneous injections.
Step 4:
Because the solution is somewhat viscous, the injection may take 5 to 10 seconds to administer.
XOLAIR is a viscous liquid. Due to the fluid’s thickness or resistance to flow, there may be added pressure when injecting.
Step 5:
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.
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.
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 sterile water for injection, USP.
If the XOLAIR prescribed for a labeled indication was spoiled or unable to be administered, the Genentech Spoilage Replacement Program might be able to provide you with a new supply. ‡
‡ Subject to certain limitations and conditions. The Spoilage Replacement Program covers infused or injected Genentech products.
The choice is yours: You can offer self-injection for appropriate patients
When selecting patients or caregivers for self-injection, patient-specific factors including all of the following criteria should be considered:
Patient should have no prior history of anaphylaxis to XOLAIR or other agents (except foods), such as drugs, biologics, etc
Patient has received at least 3 doses of XOLAIR under healthcare provider guidance and has displayed no hypersensitivity reactions
XOLAIR self-injection is available for appropriate patients in all approved indications. The XOLAIR Autoinjector (all doses) is not intended for use in pediatric patients under 12 years of age.
Helping patients prepare for injection day
Remind patients to read the Medication Guide and Instructions for Use before every injection.
Patients should know where the injection will be applied so they can wear clothes that offer easy access to the injection site.
If patients are receiving the injection in-office or by a caregiver, encourage them to focus their attention elsewhere with a game, book, or movie.
Representatives are available to answer your questions about XOLAIR for food allergy.
Models are for illustrative purposes only.
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Gevaert P, Calus L, Van Zele T, et al. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol. 2013;131(1):110-6.e1. doi:10.1016/j.jaci.2012.07.047
Gevaert P, Calus L, Van Zele T, et al. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol. 2013;131(1):110-6.e1. doi:10.1016/j.jaci.2012.07.047
Reddel HK, Taylor DR, Bateman ED, et al; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180(1):59-99.
Reddel HK, Taylor DR, Bateman ED, et al; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180(1):59-99.
Zazzali JL, Raimundo K, Trzaskoma B, Rosén KE. Improvements in health-related quality of life from GLACIAL: a phase III, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of omalizumab in patients with chronic idiopathic/spontaneous urticaria (CIU/CSU) receiving concomitant H1 antihistamines, H2 antihistamines, and/or leukotriene receptor antagonist (LTRA) treatment. Poster presented at: the 32nd Anniversary Fall Clinical Dermatology Conference; October 17–20, 2013; Las Vegas, NV.
Zazzali JL, Raimundo K, Trzaskoma B, Rosén KE. Improvements in health-related quality of life from GLACIAL: a phase III, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of omalizumab in patients with chronic idiopathic/spontaneous urticaria (CIU/CSU) receiving concomitant H1 antihistamines, H2 antihistamines, and/or leukotriene receptor antagonist (LTRA) treatment. Poster presented at: the 32nd Anniversary Fall Clinical Dermatology Conference; October 17–20, 2013; Las Vegas, NV.
Finlay AY, Kaplan AP, Beck LA, et al. Omalizumab substantially improves dermatology-related quality of life in patients with chronic spontaneous urticaria. J Eur Acad Dermatol Venereol. 2017;31(10):1715-1721.
Finlay AY, Kaplan AP, Beck LA, et al. Omalizumab substantially improves dermatology-related quality of life in patients with chronic spontaneous urticaria. J Eur Acad Dermatol Venereol. 2017;31(10):1715-1721.
Antonova E, Raimundo K, Trzaskoma B, Solari PG, Omachi T, Zazzali JL. Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria (CIU/CSU) treated with omalizumab: results of a randomized, double-blind, placebo-controlled clinical trial (GLACIAL). Poster presented at: the 2014 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology; November 6–10, 2014; Atlanta, GA.
Antonova E, Raimundo K, Trzaskoma B, Solari PG, Omachi T, Zazzali JL. Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria (CIU/CSU) treated with omalizumab: results of a randomized, double-blind, placebo-controlled clinical trial (GLACIAL). Poster presented at: the 2014 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology; November 6–10, 2014; Atlanta, GA.
Casale TB, Murphy TR, Holden M, et al. Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: results from XTEND-CIU, a 48-week, randomized, placebo-controlled study. Poster presented at: the American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress; March 2–5, 2018; Orlando, FL.
Casale TB, Murphy TR, Holden M, et al. Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: results from XTEND-CIU, a 48-week, randomized, placebo-controlled study. Poster presented at: the American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress; March 2–5, 2018; Orlando, FL.
Ludmann P. Hives: signs and symptoms. American Academy of Dermatology Association. Updated September 28, 2021. Accessed May 25, 2023. https://www.aad.org/public/diseases/a-z/hives-symptoms
Ludmann P. Hives: signs and symptoms. American Academy of Dermatology Association. Updated September 28, 2021. Accessed May 25, 2023. https://www.aad.org/public/diseases/a-z/hives-symptoms
Hollis K, Proctor C, McBride D, et al. Comparison of Urticaria Activity Score Over 7 Days (UAS7) values obtained from once-daily and twice-daily versions: results from the ASSURE-CSU study. Am J Clin Dermatol. 2018;19(2):267-274.
Hollis K, Proctor C, McBride D, et al. Comparison of Urticaria Activity Score Over 7 Days (UAS7) values obtained from once-daily and twice-daily versions: results from the ASSURE-CSU study. Am J Clin Dermatol. 2018;19(2):267-274.
XOLAIR ® (omalizumab) is indicated for:
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, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis.
XOLAIR is contraindicated in patients with a severe hypersensitivity reaction to XOLAIR or to any ingredient of XOLAIR.
Anaphylaxis: Anaphylaxis has been reported to occur after administration of XOLAIR in premarketing clinical trials and in postmarketing spontaneous reports. In premarketing clinical trials in patients with asthma, anaphylaxis was reported in 3 of 3507 (0.1%) patients. Anaphylaxis occurred with the first dose of XOLAIR in two patients and with the fourth dose in one patient. The time to onset of anaphylaxis was 90 minutes after administration in two patients and 2 hours after administration in one patient.
A case-control study in asthma patients showed that, among XOLAIR users, patients with a history of anaphylaxis to foods, medications, or other causes were at increased risk of anaphylaxis associated with XOLAIR, compared to those with no prior history of anaphylaxis.
In postmarketing spontaneous reports, the frequency of anaphylaxis attributed to XOLAIR use was estimated to be at least 0.2% of patients based on an estimated exposure of about 57,300 patients from June 2003 through December 2006. Approximately 60% to 70% of anaphylaxis cases have been reported to occur within the first three doses of XOLAIR, with additional cases occurring sporadically beyond the third dose.
Initiate XOLAIR only in a healthcare setting equipped to manage anaphylaxis which can be life-threatening. Observe patients closely for an appropriate period of time after administration of XOLAIR, taking into account the time to onset of anaphylaxis seen in premarketing clinical trials and postmarketing spontaneous reports. Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs or symptoms occur.
Once XOLAIR therapy has been established, administration of XOLAIR prefilled syringe or autoinjector outside of a healthcare setting by a patient or a caregiver may be appropriate for selected patients. Patient selection, determined by the healthcare provider in consultation with the patient, should take into account the pattern of anaphylaxis events seen in premarketing clinical trials and postmarketing spontaneous reports, as well as individual patient risk factors (e.g. prior history of anaphylaxis), ability to recognize signs and symptoms of anaphylaxis, and ability to perform subcutaneous injections with XOLAIR prefilled syringe or autoinjector with proper technique according to the prescribed dosing regimen and Instructions for Use.
Discontinue XOLAIR in patients who experience a severe hypersensitivity reaction.
Malignancy: 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 adults and adolescents (≥12 years of age) with asthma and other allergic disorders. The observed malignancies in XOLAIR-treated patients were a variety of types, with breast, non-melanoma skin, prostate, melanoma, and parotid occurring more than once, and five other types occurring once each. The majority of patients were observed for less than 1 year. The impact of longer exposure to XOLAIR or use in patients at higher risk for malignancy (e.g., elderly, current smokers) is not known.
A subsequent 5-year observational study of 5007 XOLAIR-treated and 2829 non-XOLAIR-treated adolescent and adult patients with moderate to severe persistent asthma and a positive skin test reaction or in vitro reactivity to a perennial aeroallergen found that the incidence rates of primary malignancies (per 1000 patient years) were similar in both groups (12.3 vs 13.0, respectively). Study limitations which include the observational study design, the bias introduced by allowing enrollment of patients previously exposed to XOLAIR (88%), enrollment of patients (56%) while a history of cancer or a premalignant condition were study exclusion criteria, and the high study discontinuation rate (44%) preclude definitively ruling out a malignancy risk with XOLAIR.
Acute Asthma Symptoms and Deteriorating Disease: XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use XOLAIR to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with XOLAIR.
Corticosteroid Reduction: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of XOLAIR therapy for asthma or CRSwNP. Decrease corticosteroids gradually under the direct supervision of a physician.
Eosinophilic Conditions: In rare cases, patients with asthma on therapy with XOLAIR may present with serious systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between XOLAIR and these underlying conditions has not been established.
Fever, Arthralgia, and Rash: In post-approval use, some patients have experienced a constellation of signs and symptoms, including arthritis/arthralgia, rash, fever, and lymphadenopathy with an onset 1 to 5 days after the first or subsequent injections of XOLAIR. These signs and symptoms have recurred after additional doses in some patients. Physicians should stop XOLAIR if a patient develops this constellation of signs and symptoms.
Parasitic (Helminth) Infection: Monitor patients at high risk of geohelminth infection while on XOLAIR therapy. Insufficient data are available to determine the length of monitoring required for geohelminth infections after stopping XOLAIR treatment.
Laboratory Tests: Due to formation of XOLAIR:IgE complexes, serum total IgE levels increase following administration of XOLAIR and may remain elevated for up to 1 year following discontinuation of XOLAIR. Do not use serum total IgE levels obtained less than 1 year following discontinuation to reassess the dosing regimen for asthma or CRSwNP patients, because these levels may not reflect steady state free IgE levels.
Potential Medication Error Related to Emergency Treatment of Anaphylaxis
XOLAIR should not be used for the emergency treatment of allergic reactions, including anaphylaxis. In studies to simulate use, some patients and caregivers did not understand that XOLAIR is not intended for the emergency treatment of allergic reactions, including anaphylaxis. The safety and effectiveness of XOLAIR for emergency treatment of allergic reactions, including anaphylaxis, have not been established. Instruct patients that XOLAIR is for maintenance use to reduce allergic reactions, including anaphylaxis, while avoiding food allergens.
Chronic Rhinosinusitis with Nasal Polyps: The most common adverse reactions (≥3% in XOLAIR-treated patients) included: headache (8.1%), injection site reaction (5.2%), arthralgia (3.0%), upper abdominal pain (3.0%), and dizziness (3.0%).
Injection Site Reactions: Injection site reactions occurred at a rate of 5.2% in XOLAIR-treated patients compared with 1.5% in placebo-treated patients. Injection site reactions were mild to moderate severity and none resulted in study discontinuation.
Injection Site Reactions in Healthy Adults: In an open label trial in healthy adults, in which the 300 mg/2 mL autoinjector was compared to the 300 mg/2 mL prefilled syringe, injection site reactions (e.g., induration, pain, erythema, hemorrhage, swelling, discomfort, bruising, hypoesthesia, edema, pruritus) were observed in 24% (16/66) of subjects treated with the autoinjector compared with 14% (9/64) of subjects treated with the prefilled syringe.
Cardiovascular and Cerebrovascular Events from Clinical Studies in Patients with Asthma: A 5-year observational study was conducted in 5007 XOLAIR-treated and 2829 non-XOLAIR-treated patients ≥12 years of age with moderate to severe persistent asthma and a positive skin test reaction to a perennial aeroallergen to evaluate the long term safety of XOLAIR, including the risk of malignancy. Similar percentages of patients in both cohorts were current (5%) or former smokers (29%). Patients had a mean age of 45 years and were followed for a mean of 3.7 years. More XOLAIR-treated patients were diagnosed with severe asthma (50%) compared to the non-XOLAIR-treated patients (23%). A higher incidence rate (per 1000 patient-years) of overall cardiovascular and cerebrovascular serious adverse events (SAEs) was observed in XOLAIR-treated patients (13.4) compared to non-XOLAIR-treated patients (8.1). Increases in rates were observed for transient ischemic attack (0.7 vs 0.1), myocardial infarction (2.1 vs 0.8), pulmonary hypertension (0.5 vs 0), pulmonary embolism/venous thrombosis (3.2 vs 1.5), and unstable angina (2.2 vs 1.4), while the rates observed for ischemic stroke and cardiovascular death were similar among both study cohorts. The results suggest a potential increased risk of serious cardiovascular and cerebrovascular events in patients treated with XOLAIR, however the observational study design, the inclusion of patients previously exposed to XOLAIR (88% for a mean of 8 months), baseline imbalances in cardiovascular risk factors between the treatment groups, an inability to adjust for unmeasured risk factors, and the high study discontinuation rate (44%) limit the ability to quantify the magnitude of the risk.
Pregnancy: Data with XOLAIR use in pregnant women are insufficient to inform on drug associated risk.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682 .
Please see full Prescribing Information, including Boxed WARNING and Medication Guide, for additional Important Safety Information.
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, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis.
XOLAIR ® (omalizumab) is indicated for:
XOLAIR is contraindicated in patients with a severe hypersensitivity reaction to XOLAIR or to any ingredient of XOLAIR.
Anaphylaxis: Anaphylaxis has been reported to occur after administration of XOLAIR in premarketing clinical trials and in postmarketing spontaneous reports. In premarketing clinical trials in patients with asthma, anaphylaxis was reported in 3 of 3507 (0.1%) patients. Anaphylaxis occurred with the first dose of XOLAIR in two patients and with the fourth dose in one patient. The time to onset of anaphylaxis was 90 minutes after administration in two patients and 2 hours after administration in one patient.
A case-control study in asthma patients showed that, among XOLAIR users, patients with a history of anaphylaxis to foods, medications, or other causes were at increased risk of anaphylaxis associated with XOLAIR, compared to those with no prior history of anaphylaxis.
In postmarketing spontaneous reports, the frequency of anaphylaxis attributed to XOLAIR use was estimated to be at least 0.2% of patients based on an estimated exposure of about 57,300 patients from June 2003 through December 2006. Approximately 60% to 70% of anaphylaxis cases have been reported to occur within the first three doses of XOLAIR, with additional cases occurring sporadically beyond the third dose.
Initiate XOLAIR only in a healthcare setting equipped to manage anaphylaxis which can be life-threatening. Observe patients closely for an appropriate period of time after administration of XOLAIR, taking into account the time to onset of anaphylaxis seen in premarketing clinical trials and postmarketing spontaneous reports. Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs or symptoms occur.
Once XOLAIR therapy has been established, administration of XOLAIR prefilled syringe or autoinjector outside of a healthcare setting by a patient or a caregiver may be appropriate for selected patients. Patient selection, determined by the healthcare provider in consultation with the patient, should take into account the pattern of anaphylaxis events seen in premarketing clinical trials and postmarketing spontaneous reports, as well as individual patient risk factors (e.g. prior history of anaphylaxis), ability to recognize signs and symptoms of anaphylaxis, and ability to perform subcutaneous injections with XOLAIR prefilled syringe or autoinjector with proper technique according to the prescribed dosing regimen and Instructions for Use.
Discontinue XOLAIR in patients who experience a severe hypersensitivity reaction.
Malignancy: 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 adults and adolescents (≥12 years of age) with asthma and other allergic disorders. The observed malignancies in XOLAIR-treated patients were a variety of types, with breast, non-melanoma skin, prostate, melanoma, and parotid occurring more than once, and five other types occurring once each. The majority of patients were observed for less than 1 year. The impact of longer exposure to XOLAIR or use in patients at higher risk for malignancy (e.g., elderly, current smokers) is not known.
A subsequent 5-year observational study of 5007 XOLAIR-treated and 2829 non-XOLAIR-treated adolescent and adult patients with moderate to severe persistent asthma and a positive skin test reaction or in vitro reactivity to a perennial aeroallergen found that the incidence rates of primary malignancies (per 1000 patient years) were similar in both groups (12.3 vs 13.0, respectively). Study limitations which include the observational study design, the bias introduced by allowing enrollment of patients previously exposed to XOLAIR (88%), enrollment of patients (56%) while a history of cancer or a premalignant condition were study exclusion criteria, and the high study discontinuation rate (44%) preclude definitively ruling out a malignancy risk with XOLAIR.
Acute Asthma Symptoms and Deteriorating Disease: XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use XOLAIR to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with XOLAIR.
Corticosteroid Reduction: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of XOLAIR therapy for asthma or CRSwNP. Decrease corticosteroids gradually under the direct supervision of a physician.
Eosinophilic Conditions: In rare cases, patients with asthma on therapy with XOLAIR may present with serious systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between XOLAIR and these underlying conditions has not been established.
Fever, Arthralgia, and Rash: In post-approval use, some patients have experienced a constellation of signs and symptoms, including arthritis/arthralgia, rash, fever, and lymphadenopathy with an onset 1 to 5 days after the first or subsequent injections of XOLAIR. These signs and symptoms have recurred after additional doses in some patients. Physicians should stop XOLAIR if a patient develops this constellation of signs and symptoms.
Parasitic (Helminth) Infection: Monitor patients at high risk of geohelminth infection while on XOLAIR therapy. Insufficient data are available to determine the length of monitoring required for geohelminth infections after stopping XOLAIR treatment.
Laboratory Tests: Due to formation of XOLAIR:IgE complexes, serum total IgE levels increase following administration of XOLAIR and may remain elevated for up to 1 year following discontinuation of XOLAIR. Do not use serum total IgE levels obtained less than 1 year following discontinuation to reassess the dosing regimen for asthma or CRSwNP patients, because these levels may not reflect steady state free IgE levels.
Potential Medication Error Related to Emergency Treatment of Anaphylaxis
XOLAIR should not be used for the emergency treatment of allergic reactions, including anaphylaxis. In studies to simulate use, some patients and caregivers did not understand that XOLAIR is not intended for the emergency treatment of allergic reactions, including anaphylaxis. The safety and effectiveness of XOLAIR for emergency treatment of allergic reactions, including anaphylaxis, have not been established. Instruct patients that XOLAIR is for maintenance use to reduce allergic reactions, including anaphylaxis, while avoiding food allergens.
Chronic Rhinosinusitis with Nasal Polyps: The most common adverse reactions (≥3% in XOLAIR-treated patients) included: headache (8.1%), injection site reaction (5.2%), arthralgia (3.0%), upper abdominal pain (3.0%), and dizziness (3.0%).
Injection Site Reactions: Injection site reactions occurred at a rate of 5.2% in XOLAIR-treated patients compared with 1.5% in placebo-treated patients. Injection site reactions were mild to moderate severity and none resulted in study discontinuation.
Injection Site Reactions in Healthy Adults: In an open label trial in healthy adults, in which the 300 mg/2 mL autoinjector was compared to the 300 mg/2 mL prefilled syringe, injection site reactions (e.g., induration, pain, erythema, hemorrhage, swelling, discomfort, bruising, hypoesthesia, edema, pruritus) were observed in 24% (16/66) of subjects treated with the autoinjector compared with 14% (9/64) of subjects treated with the prefilled syringe.
Cardiovascular and Cerebrovascular Events from Clinical Studies in Patients with Asthma: A 5-year observational study was conducted in 5007 XOLAIR-treated and 2829 non-XOLAIR-treated patients ≥12 years of age with moderate to severe persistent asthma and a positive skin test reaction to a perennial aeroallergen to evaluate the long term safety of XOLAIR, including the risk of malignancy. Similar percentages of patients in both cohorts were current (5%) or former smokers (29%). Patients had a mean age of 45 years and were followed for a mean of 3.7 years. More XOLAIR-treated patients were diagnosed with severe asthma (50%) compared to the non-XOLAIR-treated patients (23%). A higher incidence rate (per 1000 patient-years) of overall cardiovascular and cerebrovascular serious adverse events (SAEs) was observed in XOLAIR-treated patients (13.4) compared to non-XOLAIR-treated patients (8.1). Increases in rates were observed for transient ischemic attack (0.7 vs 0.1), myocardial infarction (2.1 vs 0.8), pulmonary hypertension (0.5 vs 0), pulmonary embolism/venous thrombosis (3.2 vs 1.5), and unstable angina (2.2 vs 1.4), while the rates observed for ischemic stroke and cardiovascular death were similar among both study cohorts. The results suggest a potential increased risk of serious cardiovascular and cerebrovascular events in patients treated with XOLAIR, however the observational study design, the inclusion of patients previously exposed to XOLAIR (88% for a mean of 8 months), baseline imbalances in cardiovascular risk factors between the treatment groups, an inability to adjust for unmeasured risk factors, and the high study discontinuation rate (44%) limit the ability to quantify the magnitude of the risk.
Pregnancy: Data with XOLAIR use in pregnant women are insufficient to inform on drug associated risk.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682 .
Please see full Prescribing Information, including Boxed WARNING and Medication Guide, for additional Important Safety Information.
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