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Patients & Caregivers

ADMINISTRATION

THE CHOICE IS YOURS: YOU CAN OFFER MORE OPTIONS TO YOUR APPROPRIATE PATIENTS WITH XOLAIR

XOLAIR self-injection with prefilled syringe (PFS) is FDA 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.

Instruct patients or caregivers to follow the directions provided in the “Instructions for Use” for preparation and administration of XOLAIR PFS

  • Adolescents 12 years of age and older: XOLAIR PFS may be self-administered under adult supervision
  • Pediatric patients 6 to 11 years of age: XOLAIR PFS should be administered by a caregiver

XOLAIR self-injection is available for appropriate patients in all approved indications.

What you need to know about XOLAIR formulation options

Quick links

Prefilled syringe for self-injection or in-office use
Vial for in-office use


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 to read the XOLAIR Medication Guide and Instructions for Use before starting treatment and before each subsequent treatment

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 considered4:
 

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 considered4:
 

Circular icon of a plus sign outline
NO HISTORY OF ANAPHYLAXIS

Patient should have no prior history of anaphylaxis, including to XOLAIR or other agents, such as foods, drugs, biologics, etc

Circular icon of a healthcare professional wearing a stethoscope
INITIATED XOLAIR
IN-OFFICE

Patient has received at least 3 doses of XOLAIR under healthcare provider guidance and has displayed no hypersensitivity reactions

Circular icon of a hand holding an injection syringe
HAVE THE REQUIRED SKILLS. PATIENT OR CAREGIVER IS ABLE TO:
  • Recognize symptoms of anaphylaxis
  • Treat anaphylaxis appropriately
  • Perform subcutaneous injections with XOLAIR PFS with proper technique according to the prescribed dosing regimen and Instructions for Use

Prefilled syringe preparation

Watch this video for XOLAIR prefilled syringe instructions

There are 2 options in XOLAIR formulation, vial or prefilled syringe

Option 1: Use a prefilled syringe


No reconstitution required

Drawing of a XOLAIR omalizumab prefilled syringe showing a view before and after use with the various syringe parts labeled

Important Information

  • The needle cap contains a type of natural rubber latex. Tell your healthcare provider if you have a latex allergy.
  • Inject XOLAIR within 4 hours after taking it out of the refrigerator.
  • Do not open the sealed carton until you are ready to inject XOLAIR.
  • Do not take the needle cap off until you are ready to inject XOLAIR.
  • Do not try to take the prefilled syringe apart at any time.
  • Do not reuse the same prefilled syringe.
  • Do not leave the prefilled syringe unattended.
XOLAIR prefilled syringe 75mg and 150mg

How should I store XOLAIR?4

  • Keep your unused prefilled syringes in the original carton and store the carton in a refrigerator between 36˚F to 46˚F (2˚C to 8˚C). Do not remove the prefilled syringe from its original carton during storage.
  • Before giving an injection, the carton can be removed from and placed back in the refrigerator if needed. The total combined time out of the refrigerator may not exceed 2 days. If the prefilled syringe is exposed to temperatures above 77°F (22°C), do not use it and throw away in a sharps disposal container.
  • Keep your XOLAIR prefilled syringes out of direct sunlight.
  • Do not freeze. Do not use if the prefilled syringe has been frozen.

Keep the XOLAIR prefilled syringe, sharps disposal container and all medicines out of the reach of children.

Icon of a XOLAIR dosage box indicating where the expiration date is located

1. Take the carton containing the prefilled syringe out of the refrigerator

  • If your dose requires you to give more than 1 injection, take all cartons out of the refrigerator at the same time. The following steps must be followed for each prefilled syringe

2. Check the expiration date on the XOLAIR carton

  • Do not use if the expiration date has passed.

If the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container and contact your healthcare provider

3. Place the carton on a clean, flat surface

  • Set aside the carton for at least 15 to 30 minutes so the prefilled syringe can warm up on its own to room temperature. Leave the prefilled syringe in the carton to protect it from light.
  • If the prefilled syringe does not reach room temperature, this could cause the injection to feel uncomfortable and make it hard to push the plunger.
  • Do not speed up the warming process using any heat sources such as warm water or a microwave.
Icon of a hand removing a XOLAIR blister pack out of the box

4. Open the carton

  • Wash your hands with soap and water
  • Take the blister pack out of the carton
  • Check the expiration date on the blister pack
  • Do not use if the expiration date has passed

If the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container and contact your healthcare provider.

Icon of a XOLAIR blister pack with peel tab denoted
  • Peel off the blister pack cover fully. Be careful when taking out the prefilled syringe.
  • Do not flip the blister pack upside down to take out the prefilled syringe. This may damage the prefilled syringe.
  • Take the prefilled syringe out of the blister pack by holding the middle part of the prefilled syringe. When holding the prefilled syringe, make sure you always hold the prefilled syringe as shown. Do not touch the needle-shield wings (see “Prefilled Syringe Parts”).
  • Do not handle the prefilled syringe by holding the plunger or needle cap.
Icon showing hand removing XOLAIR prefilled syringe out of the blister pack

5. Inspect the prefilled syringe closely

  • Check the prefilled syringe. The medicine in the prefilled syringe should be clear and colorless to pale brownish-yellow. Do not use the prefilled syringe if the medicine is cloudy, discolored, or contains particles.
  • Check the expiration date on the prefilled syringe. Do not use the prefilled syringe if the expiration date has passed.
  • If the medicine does not look as described or if the expiration date has passed, safely throw away the prefilled syringe in a sharps disposal container and contact your healthcare provider.
  • Do not use if the packaging or prefilled syringe appears damaged, tampered with, or has been dropped.
Icon showing xolair injection sites on upper arms and thighs

6. Choose an injection site

  • If you are giving yourself the injection, you can inject into the front and middle of the thighs and the stomach area (abdomen). The outer area of the upper arms may also be used if the injection is being given by a caregiver. Do not try to inject into the upper arm area by yourself.
  • Do not inject within the 2-inch area directly around your belly button (navel)
  • Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin.
  • Do not inject through clothing. The injection site should be exposed, clean skin.
  • If your prescribed dose requires more than 1 injection, choose a different injection site for each new injection, at least 1 inch from other injection sites.
Icon of hand with alcohol wipe cleaning XOLAIR injection site

7. Wipe the injection site with an alcohol swab in a circular motion and let it air dry for 10 seconds.

  • Do not touch the injection site again before giving the injection.
  • Do not fan or blow on the cleaned skin.
Icon showing how to remove the needle cap from a XOLAIR prefilled syringe

8. Hold the prefilled syringe firmly by the center with 1 hand and pull the needle cap straight off with your other hand.

  • Do not twist the needle cap.
  • Do not hold, push or pull the plunger while you remove the needle cap.
  • Do not touch the needle or let it touch any surfaces after removing the needle cap.
  • Throw away the needle cap in regular household trash. Do not recap the needle.
  • There may be 1 or more small air bubbles in the prefilled syringe. This is normal, and you should not try to remove the air bubbles.
  • You may also see a drop of liquid at the end of the needle. This is also normal and will not affect the dose. 

9. Use your other hand and gently pinch the area of skin that was cleaned. Hold the pinched skin tight.

  • Pinching the skin is important to make sure that you inject under the skin (into the fatty area) but not any deeper (into muscle).
Icon showing how to administer XOLAIR injection using two hands

10. Continue holding the prefilled syringe by the center and use a quick, dart-like motion to insert the needle all the way into the pinched skin at an angle between 45 degrees to 90 degrees as shown.

  • It is important to use the correct angle to make sure the medicine is delivered under the skin (into the fatty area), or the injection could be uncomfortable and the medicine may not work.
  • Do not touch the plunger while inserting the needle into the skin.
  • Do not insert the needle through clothing.
  • Hold the prefilled syringe tightly in place and do not change the angle of injection or insert the needle again after the needle is inserted.
  • You should not move and should avoid sudden movements when giving the injection.
Icon showing the XOLAIR syringe in a hand with the plunger fully pressed

11. Slowly inject all of the medicine by gently pushing the plunger all the way down until the needle-shield wings are pushed apart.

  • You must press the plunger all the way down to make sure that the full dose of medicine gets injected. If the plunger is not fully pressed, the needle-shield will not extend to cover the needle when it is removed.
Icon showing the XOLAIR syringe in a hand with the plunger released after administering the injection

12. Release the plunger and allow the needle to be covered by the needle-shield.

  • If the needle is not covered by the needle-shield, carefully remove the prefilled syringe from the skin and throw away the prefilled syringe in a sharps disposal container.

13. There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site.

  • Do not rub the injection site.
  • If needed, cover the injection site with a small bandage.
  • In case of skin contact with the medicine, wash the area that touched the medicine with water.

    • If your prescribed dose requires more than 1 injection:

  • Throw away the used prefilled syringe.
  • Follow the previous steps
  • Choose a different injection site for each new injection at least 1 inch from other injection sites.
  • Complete all the required injections for your prescribed dose, immediately one after another. Contact your healthcare provider if you have any questions.
Icon showing a hand disposing a used XOLAIR syringe in a sharps container

14. Throw away (dispose of) your used XOLAIR prefilled syringes in an FDA-cleared sharps disposal container right away after use.

  • The XOLAIR prefilled syringe is a single-dose prefilled syringe and should not be used again.
  • Do not throw away prefilled syringes in your household trash.
  • Do not recap the needle.

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used prefilled syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal

 

  • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
  • Do not recycle your used sharps disposal container.

Option 2: Reconstitute from a vial (only in a healthcare provider's office)

 

SUPPLIES NEEDED TO RECONSTITUTE THE VIAL AND ADMINISTER XOLAIR

Graphic containing labeled images of the supplies needed to reconstitute the XOLAIR vials for administering

Products not shown to scale.

Once the correct dose has been determined and the necessary supplies have been assembled, you are ready to begin.

First, determine the number of vials you will need to reconstitute.
Each vial contains 150 mg of XOLAIR.

Graphic depicting the steps to open the XOLAIR vial for use

STEP 1:
Remove the plastic cap from the XOLAIR vial.

Graphic depicting the steps to open the diluent vial for use

STEP 2:
Remove the plastic cap from the diluent vial containing SWFI, USP.

Graphic depicting the steps to sanitize the XOLAIR vial and diluent vial for use

STEP 3:
Using an alcohol swab, wipe the rubber stopper of the XOLAIR vial and the diluent vial.

Graphic depicting the steps to reconstitute the XOLAIR dose

STEP 1:
Draw 1.4 mL of SWFI, USP, into a 3-mL syringe equipped with a 1-inch, 18-gauge needle.

Graphic depicting the steps to reconstitute the XOLAIR dose

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.

Graphic depicting the steps to reconstitute the XOLAIR dose

STEP 3:
Keeping the XOLAIR vial upright, gently swirl the vial for approximately 1 minute to evenly wet the powder. Do not shake.

Graphic depicting the steps to reconstitute the XOLAIR dose

STEP 4:
Gently swirl the vial 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.

Graphic showing the steps to prepare the reconstituted XOLAIR dose

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.

Graphic showing the steps to prepare the reconstituted XOLAIR dose

STEP 2:
Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.

Graphic showing the steps to prepare the reconstituted XOLAIR dose

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.

Graphic showing the steps to administer a subcutaneous dose 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

Graphic showing the steps to administer a subcutaneous dose of XOLAIR

STEP 2:
Prepare the injection site by swabbing it with alcohol

Graphic showing the steps to administer a subcutaneous dose of XOLAIR

STEP 3:
Administer XOLAIR following your facility’s standard guidelines for subcutaneous injections

Graphic showing the steps to administer a subcutaneous dose of XOLAIR

STEP 4:
Because the solution is somewhat viscous, the injection may take 5 to 10 seconds to administer

XOLAIR is viscous liquid. Due to the fluid’s thickness or resistance to flow, there may be added pressure when injecting

Graphic showing the steps to administer a subcutaneous dose of XOLAIR

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

For Injection (Vial)

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

For Injection (Vial)

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.

XOLAIR shipping and storage

Injection (Prefilled Syringe)

  • XOLAIR prefilled syringe should be shipped and stored under refrigerated conditions 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 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.

For Injection (Vial)

  • XOLAIR vial should be shipped at a controlled ambient temperature (≤30°C [≤86°F]) and stored under refrigerated conditions (2°C to 8°C [36°F to 46°F])
  • DO NOT use XOLAIR beyond the expiration date stamped on the carton. To learn more, read the administration instructions

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.

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    • Casale TB, Chipps BE, Rosén K, et al. Response to omalizumab using patient enrichment criteria from trials of novel biologics in asthma. Allergy. 2018;73(2):490-497.

      Casale TB, Chipps BE, Rosén K, et al. Response to omalizumab using patient enrichment criteria from trials of novel biologics in asthma. Allergy. 2018;73(2):490-497.

    • Arbes SJ Jr, Gergen PJ, Vaughn B, Zeldin DC. Asthma cases attributable to atopy: results from the Third National Health and Nutrition Examination Survey. J Allergy Clin Immunol. 2007;120(5):1139-1145.

      Arbes SJ Jr, Gergen PJ, Vaughn B, Zeldin DC. Asthma cases attributable to atopy: results from the Third National Health and Nutrition Examination Survey. J Allergy Clin Immunol. 2007;120(5):1139-1145.

    • Lanier B, Bridges T, Kulus M, Taylor AF, Berhane I, Vidaurre CF. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol. 2009;124(6):1210-1216.

      Lanier B, Bridges T, Kulus M, Taylor AF, Berhane I, Vidaurre CF. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol. 2009;124(6):1210-1216.

    • Milgrom H, Fowler-Taylor A, Vidaurre CF, Jayawardene S. Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma. Curr Med Res Opin. 2011;27(1):163-169.

      Milgrom H, Fowler-Taylor A, Vidaurre CF, Jayawardene S. Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma. Curr Med Res Opin. 2011;27(1):163-169.

    • Namazy JA, Blais L, Andrews EB, et al. Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort. J Allergy Clin Immunol. 2020;145(2):528-536.e1.

      Namazy JA, Blais L, Andrews EB, et al. Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort. J Allergy Clin Immunol. 2020;145(2):528-536.e1.

    • Gevaert P, Omachi TA, Corren J, et al. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials [published correction appears in J Allergy Clin Immunol. 2021;147(1):416]. J Allergy Clin Immunol. 2020;146(3):595-605. doi:10.1016/j.jaci.2020.05.032

      Gevaert P, Omachi TA, Corren J, et al. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials [published correction appears in J Allergy Clin Immunol. 2021;147(1):416]. J Allergy Clin Immunol. 2020;146(3):595-605. doi:10.1016/j.jaci.2020.05.032

    • Bachert C, Zhang L, Gevaert P. Current and future treatment options for adult chronic rhinosinusitis: focus on nasal polyposis. J Allergy Clin Immunol. 2015;136(6):1431-1440. doi:10.1016/j.jaci.2015.10.010

      Bachert C, Zhang L, Gevaert P. Current and future treatment options for adult chronic rhinosinusitis: focus on nasal polyposis. J Allergy Clin Immunol. 2015;136(6):1431-1440. doi:10.1016/j.jaci.2015.10.010

    • Hopkins C, Slack R, Lund V, Brown P, Copley L, Browne J. Long-term outcomes from the English national comparative audit of surgery for nasal polyposis and chronic rhinosinusitis. Laryngoscope. 2009;119(12):2459-2465. doi:10.1002/lary.20653

      Hopkins C, Slack R, Lund V, Brown P, Copley L, Browne J. Long-term outcomes from the English national comparative audit of surgery for nasal polyposis and chronic rhinosinusitis. Laryngoscope. 2009;119(12):2459-2465. doi:10.1002/lary.20653

    • DeConde AS, Mace JC, Levy JM, Rudmik L, Alt JA, Smith TL. Prevalence of polyp recurrence after endoscopic sinus surgery for chronic rhinosinusitis with nasal polyposis. Laryngoscope. 2017;127(3):550-555. doi:10.1002/lary.26391

      DeConde AS, Mace JC, Levy JM, Rudmik L, Alt JA, Smith TL. Prevalence of polyp recurrence after endoscopic sinus surgery for chronic rhinosinusitis with nasal polyposis. Laryngoscope. 2017;127(3):550-555. doi:10.1002/lary.26391

    • 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.

    IMPORTANT SAFETY INFORMATION

    INDICATIONS

    XOLAIR®     (omalizumab) is indicated for:

    • Adults and pediatric patients 6 years of age and older 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.

      Limitations of Use: XOLAIR is not indicated for the relief of acute bronchospasm, status asthmaticus, or for treatment of other allergic conditions.

    • Add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

    • Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment.

      Limitations of Use: XOLAIR is not indicated for treatment of other forms of urticaria.

    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.


    CONTRAINDICATIONS

    XOLAIR is contraindicated in patients with a severe hypersensitivity reaction to XOLAIR or to any ingredient of XOLAIR.

    WARNINGS AND PRECAUTIONS

    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 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 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 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. In CSU patients, the use of XOLAIR in combination with corticosteroids has not been evaluated.

    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.

    ADVERSE REACTIONS

    Asthma: In patients ≥12 years of age, the most common adverse reactions (≥1% more frequent in XOLAIR treated patients) 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%). In pediatric patients 6 to <12 years of age, the most commonly observed adverse reactions (≥3% more frequent in XOLAIR treated pediatric patients) were: nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bite, and epistaxis.

    Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): The most common adverse reactions (≥3% incidence in XOLAIR-treated patients and more frequent than placebo) included: headache (8.1%), injection site reaction (5.2%), arthralgia (3.0%), upper abdominal pain (3.0%), and dizziness (3.0%).

    Chronic Spontaneous Urticaria (CSU): The most common adverse reactions (≥2% XOLAIR-treated patients and more frequent than in placebo) for XOLAIR 150 mg and 300 mg, respectively, included: headache (12%, 6%), nasopharyngitis (9%, 7%), arthralgia (3%, 3%), viral upper respiratory infection (2%, 1%), nausea (1%, 3%), sinusitis (1%, 5%), upper respiratory tract infection (1%, 3%), and cough (1%, 2%).

    Injection Site Reactions

    Asthma: In adults and adolescents with asthma, injection site reactions of any severity occurred at a rate of 45% in XOLAIR treated patients compared with 43% in placebo-treated patients. Severe injection site reactions occurred more frequently in XOLAIR‑treated patients compared with patients in the placebo group (12% vs 9%, respectively). The types of injection site reactions in asthma studies included: bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation.

    Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): 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.

    Chronic Spontaneous Urticaria (CSU): Injection site reactions of any severity occurred in more XOLAIR-treated patients (11 patients [2.7%] at 300 mg, 1 patient [0.6%] at 150 mg) compared with 2 placebo-treated patients (0.8%). The types of injection site reactions included: swelling, erythema, pain, bruising, itching, bleeding, and urticaria. None of the events resulted in study discontinuation or treatment interruption.

    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.

    INDICATIONS

    XOLAIR®     (omalizumab) is indicated for:

    • Adults and pediatric patients 6 years of age and older 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.

      Limitations of Use: XOLAIR is not indicated for the relief of acute bronchospasm, status asthmaticus, or for treatment of other allergic conditions.

    • Add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

    • Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment.

      Limitations of Use: XOLAIR is not indicated for treatment of other forms of urticaria.


    CONTRAINDICATIONS

    XOLAIR is contraindicated in patients with a severe hypersensitivity reaction to XOLAIR or to any ingredient of XOLAIR.

    WARNINGS AND PRECAUTIONS

    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 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 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 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. In CSU patients, the use of XOLAIR in combination with corticosteroids has not been evaluated.

    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.

    ADVERSE REACTIONS

    Asthma: In patients ≥12 years of age, the most common adverse reactions (≥1% more frequent in XOLAIR treated patients) 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%). In pediatric patients 6 to <12 years of age, the most commonly observed adverse reactions (≥3% more frequent in XOLAIR treated pediatric patients) were: nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bite, and epistaxis.

    Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): The most common adverse reactions (≥3% incidence in XOLAIR-treated patients and more frequent than placebo) included: headache (8.1%), injection site reaction (5.2%), arthralgia (3.0%), upper abdominal pain (3.0%), and dizziness (3.0%).

    Chronic Spontaneous Urticaria (CSU): The most common adverse reactions (≥2% XOLAIR-treated patients and more frequent than in placebo) for XOLAIR 150 mg and 300 mg, respectively, included: headache (12%, 6%), nasopharyngitis (9%, 7%), arthralgia (3%, 3%), viral upper respiratory infection (2%, 1%), nausea (1%, 3%), sinusitis (1%, 5%), upper respiratory tract infection (1%, 3%), and cough (1%, 2%).

    Injection Site Reactions

    Asthma: In adults and adolescents with asthma, injection site reactions of any severity occurred at a rate of 45% in XOLAIR treated patients compared with 43% in placebo-treated patients. Severe injection site reactions occurred more frequently in XOLAIR‑treated patients compared with patients in the placebo group (12% vs 9%, respectively). The types of injection site reactions in asthma studies included: bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation.

    Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): 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.

    Chronic Spontaneous Urticaria (CSU): Injection site reactions of any severity occurred in more XOLAIR-treated patients (11 patients [2.7%] at 300 mg, 1 patient [0.6%] at 150 mg) compared with 2 placebo-treated patients (0.8%). The types of injection site reactions included: swelling, erythema, pain, bruising, itching, bleeding, and urticaria. None of the events resulted in study discontinuation or treatment interruption.

    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.