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ADMINISTRATION

DISCOVER ADMINISTRATION OPTIONS WITH XOLAIR4

 

ADMINISTRATION

DISCOVER ADMINISTRATION OPTIONS WITH XOLAIR4

 

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Dosage Forms and Strengths
How to use
Considering self-injection
Helping patients prepare for injection day

Dosage Forms and Strengths4

Effective April 11, 2025, the XOLAIR 75-mg and 150-mg prefilled syringes will have an updated design, including:

  • Dose strength is indicated on the colored plunger rod
  • A needle cap that does not contain any latex
  • A smaller gauge needle

300-mg configurations may mean fewer injections for some patients.*

Prefilled Syringe (colored plunger rod) Prefilled Syringe (colored needle-shield)

XOLAIR PREFILLED SYRINGE

300 mg/2 mL

NDC code: 50242-227-01

150 mg/1 mL

NDC code: 50242-215-03

75 mg/0.5 mL

NDC code: 50242-214-03

XOLAIR PREFILLED SYRINGE

150 mg/1 mL

NDC code: 50242-215-01

75 mg/0.5 mL

NDC code: 50242-214-01

XOLAIR AUTOINJECTOR

300 mg/2 mL

NDC code: 50242-227-55

150 mg/1 mL

NDC code: 50242-215-55

75 mg/0.5 mL

NDC code: 50242-214-55

150-MG VIAL

of lyophilized powder for reconstitution

NDC code: 50242-040-62

Products not shown actual size.

See the full Prescribing Information for selection criteria of patients for self-administration of the 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.

 

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 the 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.

How to use4

Prefilled Syringes Autoinjector 150-mg Vial

Which device are you prescribing for your patients?

The XOLAIR prefilled syringe is available with either a colored plunger rod or colored needle-shield. See below for how to identify your patient's device and dosage strength before getting started, as some directions differ per device.

 

Parts of the prefilled syringe with colored plunger rod

The prefilled syringe (colored plunger rod) is available in 3 dosage strengths, as indicated by the color of the plunger rod on the device. This device has safety guard wings and a needle-shield, which are intended to protect against accidental needle-stick injuries.

The needle cap on the prefilled syringe (colored plunger rod) does not contain any latex.

  • If the dose is 75 mg, the prefilled syringe will have a blue plunger rod
  • If the dose is 150 mg, the prefilled syringe will have a purple plunger rod
  • If the dose is 300 mg, the prefilled syringe will have a gray plunger rod

Parts of the prefilled syringe with colored needle-shield

The prefilled syringe (colored needle-shield) is available in 2 dosage strengths, as indicated by the color of the needle-shield on the device. This device has a needle-shield, which is intended to protect against 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 cap on the prefilled syringe (colored needle-shield) does contain a type of natural rubber latex. Ask your patients if they have a latex allergy.

  • If the dose is 75 mg, the prefilled syringe will have a blue needle-shield
  • If the dose is 150 mg, the prefilled syringe will have a purple needle-shield

Prefilled syringe preparation

Watch this video for XOLAIR prefilled syringe instructions

Step-by-step injection guides

Please review the steps detailed in the FDA-approved Instructions for Use pertaining to each of the different prefilled syringe devices. Afterward, you may use the following summaries as a quick reference before injecting.

For detailed Instructions for Use on the 75 mg, 150 mg, and 300 mg prefilled syringe (colored plunger rod), please refer to pages 15-26.
 

75 mg, 150 mg, and 300 mg prefilled syringe (colored plunger rod)
  • Do not use if the carton is damaged or appears to be tampered with
  • Do not open the carton until you are ready to inject
  • Do not use if the prefilled syringe is damaged or appears to be tampered with
  • Do not take the needle cap off until you are ready to inject
  • Do not use if the prefilled syringe has been dropped on a hard surface or dropped after removing the needle cap
  • Do not try to take apart the prefilled syringe at any time
  1. Take the carton containing the prefilled syringe out of the refrigerator.
    • If you need more than 1 prefilled syringe to deliver your full dose (see Dosing Table), take all cartons out of the refrigerator at the same time (each carton contains 1 prefilled syringe). 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 (see Step 14) and contact your healthcare provider
  3. Allow the prefilled syringe to reach room temperature.
    • Set aside the carton on a clean, flat surface for at least 30 to 45 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
  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 it if the expiration date has passed

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

  • 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
  • Take the prefilled syringe out of the blister pack by holding the middle part of the prefilled syringe
  • Do not handle the prefilled syringe by holding the plunger or needle cap
  1. Inspect the prefilled syringe closely.
    • Check the prefilled syringe. The medicine inside should be clear and colorless to pale brownish-yellow. You may see air bubbles in the medicine, which is normal. Do not try to remove the air bubbles
    • Do not use the prefilled syringe if the medicine contains particles, or if the medicine looks cloudy or brown
    • Check the expiration date on the prefilled syringe. Do not use the prefilled syringe if the expiration date has passed
    • Do not use if the prefilled syringe appears to be damaged or tampered with
    • 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 (see Step 14) and contact your healthcare provider
  2. Choose where to inject.
    • If giving yourself the injection, the injection sites are the front of your thigh or stomach area (abdomen). If a caregiver is giving the injection, the injection sites are the outer area of the upper arm, the front of the thigh, or the stomach area (abdomen). Do not try to inject yourself in the upper arm
    • 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 uncovered, clean skin
    • If your prescribed dose requires more than 1 injection, make sure your injections are at least 1 inch apart from each other
  3. Clean the injection site.
    • Wipe the injection site with an alcohol swab in a circular motion and let air dry for 10 seconds
    • Do not fan or blow on the cleaned skin
    • Do not touch the injection site again before giving the injection
  1. Remove the cap.
    • Hold the prefilled syringe firmly with 1 hand and pull the needle cap straight off with your other hand. Do not twist the 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
    • Do not put the cap back on the prefilled syringe. Throw away the needle cap in regular household trash
    • You may see a drop of liquid at the end of the needle. This is normal
  2. Pinch cleaned skin.
    • Use your other hand and gently pinch the area of skin that was cleaned. Hold the pinched skin tightly until the injection is complete
    • Pinching the skin is important to make sure that you inject under the skin (into the fatty area) but not any deeper (into muscle)
  3. Insert the needle using a quick, dart-like motion.
    • While holding the prefilled syringe by the center, insert the needle all the way into the pinched skin at an angle of about 45 degrees
    • 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
    • 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
  1. Slowly inject all of the medicine.
    • Gently push the plunger all the way down until the plunger head is between the safety guard wings
    • You must press the plunger all the way down to make sure that the full dose of medicine is injected. If the plunger is not fully pressed, the needle-shield will not extend to cover the needle when it is removed
  2. Release the plunger.
    • 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 (see Step 14)
  3. Care for the injection site.
    • Do not rub the injection site
    • There may be a little bleeding or drop of liquid at the injection site. You can press a cotton ball or gauze over the injection site until the bleeding stops
    • In case of skin contact with the medicine, wash the area that touched the medicine with water
    • If needed, cover the injection site with a small bandage

If your prescribed dose requires more than 1 injection:

  • Throw away the used prefilled syringe as described in Step 14
  • Repeat Step 2 through Step 13 for the next injection using a new prefilled syringe
  • Make sure each injection is at least 1 inch apart from each other
  • Complete all the required injections for your prescribed dose, immediately one after another. Contact your healthcare provider if you have any questions
  1. Throw away (dispose of) the prefilled syringe.
    • Put your used 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 the 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

For detailed Instructions for Use on the 75 mg and 150 mg prefilled syringe (colored needle-shield), please refer to pages 1-14.

75 mg and 150 mg prefilled syringe (colored needle-shield)
  • The needle cap contains a type of natural rubber latex. Tell your healthcare provider if you have a latex allergy
  • 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
  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 (see step 14) 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
  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 (see step 14) and contact your healthcare provider.

    • 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. Do not touch the needle-shield wings
    • Do not handle the prefilled syringe by holding the plunger or needle cap
  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 (see step 14) and contact your healthcare provider
    • Do not use if the packaging or prefilled syringe appears damaged, tampered with, or has been dropped
  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
  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
  1. 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
  2. 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)
  3. 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.
    • 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
  1. 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
  2. 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 (see step 14)
  3. 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 as described in step 14
  • Repeat step 2 through step 13 for the next injection using a new prefilled syringe
  • Choose a different injection site for each new injection at least 1 inch from other injection sites
  • Complete all the required injections for the prescribed dose, immediately one after another. Contact your healthcare provider if you have any questions
  1. 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 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

XOLAIR shipping and storage

Injection (prefilled syringe)

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.

How to store XOLAIR4

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

XOLAIR self-injection with autoinjector or prefilled syringe is FDA approved for appropriate patients as determined by a healthcare provider

Parts of the autoinjector

The prefilled 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 autoinjector, as this may damage it. They should also make sure to hold the autoinjector by the middle and not by the cap.

The autoinjector is not made with natural rubber latex.

The autoinjector comes in 3 dosage strengths:

  • If the dose is 75 mg, the autoinjector will have a blue needle guard
  • If the dose is 150 mg, the autoinjector will have a purple needle guard
  • If the dose is 300 mg, the autoinjector will have a gray needle guard

 

XOLAIR Autoinjector

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.

Step-by-step injection guide

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.

For detailed Instructions for Use on the 75 mg, 150 mg, and 300 mg autoinjector, please refer to pages 27-38.
 

  • Do not use if the carton is damaged or appears to be tampered with
  • Do not open the carton until you are ready to inject
  • Do not use if the autoinjector has been damaged or appears to be tampered with
  • Do not take the cap off the autoinjector until you are ready to inject
  • Do not use if the autoinjector has been dropped on a hard surface or dropped after removing the needle cap
  • Do not take apart the autoinjector at any time
  • Do not clean or touch the needle guard
  1. Take the carton containing the autoinjector out of the refrigerator.
    • If you need more than 1 autoinjector to deliver your prescribed dose, take all cartons out of the refrigerator at the same time (each carton contains 1 autoinjector). The following steps must be followed for each autoinjector
  2. Check the expiration date on the back of the XOLAIR carton.
    • Do not use if the expiration date has passed
    • If the expiration date has passed, safely throw away the autoinjector in a sharps disposal container (see Step 15) and contact your healthcare provider
  3. Allow the autoinjector to reach room temperature.
    • Set aside the carton on a clean, flat surface for at least 30 to 45 minutes so the autoinjector can warm up on its own to room temperature. Leave the autoinjector in the carton to protect it from light
    • If the autoinjector does not reach room temperature, this could cause the injection to feel uncomfortable
    • Do not speed up the warming process using any heat sources such as warm water or a microwave
  4. Open the carton.
    • Wash your hands with soap and water
    • Take the autoinjector out of the carton as shown
    • Do not turn the carton upside down to take out the autoinjector, as this may damage the autoinjector
    • Do not hold the autoinjector by the cap. Make sure you hold the autoinjector by the middle
    • Do not remove the cap until you are ready to inject
  5. Check the autoinjector before use.
    • Look through the viewing window of the autoinjector. The medicine in the autoinjector viewing window should be clear and colorless to pale brownish-yellow. You may see air bubbles in the medicine, which is normal
    • Do not use the autoinjector if the medicine contains particles, or if the medicine looks cloudy or brown
    • Check the expiration date on the autoinjector. Do not use the autoinjector if the expiration date has passed
    • Do not use the autoinjector if it appears to be damaged or tampered with
    • If the medicine does not look as described or if the expiration date has passed, safely throw away the autoinjector in a sharps disposal container (see Step 15) and contact your healthcare provider
  6. Choose where to inject.
    • If giving yourself the injection, the injection sites are the front of your thigh or stomach area (abdomen). If a caregiver is giving the injection, the injection sites are the outer area of the upper arm, the front of the thigh or stomach area (abdomen). Do not try to inject yourself in the upper arm
    • 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 uncovered, clean skin
    • If your prescribed dose requires more than 1 injection, make sure your injections are at least 1 inch apart from each other
  7. Clean the injection site.
    • Wipe the injection site with an alcohol swab in a circular motion and let it air dry for 10 seconds
    • Do not fan or blow on the cleaned skin
    • Do not touch the injection site again before giving the injection
  1. Remove the cap.
    • Hold the autoinjector firmly with 1 hand and pull the cap straight off with your other hand. Do not twist the cap
    • Do not put the cap back on the autoinjector. Throw away the cap in regular household trash
    • Do not clean or touch the needle guard of the device
  2. Position the autoinjector.
    • Hold the autoinjector comfortably with the needle guard directly against the skin
    • The autoinjector should be at a 90-degree angle against the skin
  3. Start the injection.
    • Press straight down and hold the autoinjector firmly against the skin. The 1st click indicates that the injection has started
    • Hold the autoinjector tightly in place. Do not change the angle of injection or remove the autoinjector until the injection is completed
  4. Monitor injection using green indicator.
    • Keep holding the autoinjector against the skin. The green indicator will move within the viewing window
  5. Complete injection.
    • Listen for the 2nd click. This indicates that the injection is almost complete
    • Hold the autoinjector in position until the green indicator has stopped moving and completely fills the viewing window to make sure the injection is complete
  6. Remove from skin and check the green indicator.
    • After the green indicator has stopped moving and has completely filled the viewing window, lift the autoinjector straight up from the skin. The needle guard will automatically extend and lock over the needle
    • If the green indicator has not completely filled the viewing window, contact your healthcare provider or pharmacist
  7. Care for the injection site.
    • Do not rub the injection site
    • There may be a little bleeding or a drop of liquid at the injection site. You can press a cotton ball or gauze pad over the injection site until any bleeding stops
    • In case of skin contact with the medicine, wash the area that touched the medicine with water
    • If needed, cover the injection site with a small bandage

If your prescribed dose requires more than 1 injection:

  • Throw away the used autoinjector as described in Step 15
  • Repeat Step 2 through Step 14 for the next injection using a new autoinjector
  • Make sure each injection is at least 1 inch apart from each other
  • Complete all the required injections for your prescribed dose, immediately one after another. Contact your healthcare provider if you have any questions
  1. Throw away (dispose of) autoinjector.
    • Put your used autoinjectors in an FDA-cleared sharps disposal container right away after use
    • The XOLAIR Autoinjector is a single-dose autoinjector and should not be used again
    • Do not throw away (dispose of) the autoinjectors in your household trash
    • Do not recap the autoinjector

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 autoinjectors. 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

How to store XOLAIR

The 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 XOLAIR Autoinjector has been damaged or appears to be tampered with
  Do not use if the XOLAIR 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 the 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 XOLAIR Autoinjector has been damaged or appears to be tampered with
Do not use if the XOLAIR 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 the XOLAIR Autoinjector is left at temperatures above 77 °F (25 °C) and discard in a sharps disposal container

XOLAIR self-injection with autoinjector or prefilled syringe is FDA approved for appropriate patients as determined by a healthcare provider

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

Supplies needed to reconstitute the vial and administer XOLAIR
 

Products not shown actual size.

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

Step-by-step injection guide

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.
 

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 Sterile Water for Injection (SWFI) USP.

Step 3:

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

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.

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.

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.

Graphic showing continued injection of XOLAIR

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

After reconstitution, the XOLAIR solution is somewhat viscous and will appear clear or slightly opalescent. It is acceptable if there are a few small bubbles or foam around the edge of the vial; there should be no visible gel-like particles in the reconstituted solution. Do not use if foreign particles are present.

Stability after reconstitution

The solution should be used for subcutaneous administration within 8 hours following reconstitution when refrigerated in the vial at 2°C to 8°C (36°F to 46°F) or within 4 hours of reconstitution when stored at room temperature. Reconstituted XOLAIR vials should be protected from direct sunlight.

XOLAIR is for single use only and contains no preservatives.

Note: Each XOLAIR vial delivers 150 mg of XOLAIR per 1.2 mL upon reconstitution with 1.4 mL of sterile water for injection, USP.

XOLAIR shipping and storage

  • 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.

Considering self-injection4

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:

Safety icon

The patient has no history of anaphylaxis

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

Medical necessity icon

The patient has initiated XOLAIR in-office

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

Dosing icon

The patient or caregiver has the required skills

  • Recognize symptoms of anaphylaxis
  • Treat anaphylaxis appropriately
  • Perform subcutaneous injections with the autoinjector or prefilled syringe with proper technique according to the prescribed dosing regimen and Instructions for Use

Instruct patients or caregivers to follow the directions provided in the “Instructions for Use” for preparation and administration of the autoinjector or prefilled syringe

  • Adolescents 12 years of age and older: The autoinjector or prefilled syringe may be self-administered under adult supervision
  • Pediatric patients 1 to 11 years of age: The prefilled syringe should be administered by a caregiver

XOLAIR self-injection is available for appropriate patients in all approved indications. The autoinjector (all doses) is not intended for use in pediatric patients under 12 years of age.

Helping patients prepare for injection day

Learn about the injection

Remind patients to read the Medication Guide and Instructions for Use before every injection.

Discussing the injection process

Patients should know where the injection will be applied so they can wear clothes that offer easy access to the injection site.

What if they have a fear of needles?

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.

Models are for illustrative purposes. Individual results may vary.

Monitor for any reactions4

  • If you decide that the patient or a caregiver may be able to give the autoinjector or prefilled syringe injections on their own, they should receive training on the right way to prepare and inject XOLAIR. They should not try to inject the autoinjector or prefilled syringe until you show them the right way to give XOLAIR injections. They should use XOLAIR exactly as it’s prescribed
  • For adolescents 12 years of age and older, the autoinjector or prefilled syringe may be self-administered under adult supervision
  • The autoinjector is not intended for use in pediatric patients under 12 years of age
  • For pediatric patients 1 to 11 years of age, the prefilled syringe should be administered by a caregiver
  • Patients or caregivers who are administering XOLAIR should have adequate at-home support
  • To help your patients prepare and inject XOLAIR, review the Instructions for Use with them
NEXT: Printable Resources >

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      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.

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      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.

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      Boyce JA, Assa’ad Amal, Burks AW, et al; NIAID-Sponsored Expert Panel. Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel. J Allergy Clin Immunol. 2010;126(suppl 6):S1-S58.

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      Oettgen HC. Mast cells in food allergy: inducing immediate reactions and shaping long-term immunity. J Allergy Clin Immunol. 2023;151(1):21-25.

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      Anvari S, Miller J, Yeh CY, Davis CM. IgE-mediated food allergy. Clinic Rev Allergy Immunol. 2019;57(2):244​-260.

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      Zablotsky B, Black LI, Akinbami LJ. Diagnosed allergic conditions in children aged 0–17 years: United States, 2021. NCHS Data Brief. 2023;(459):1-8.

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      Mahdavinia M, Fox SR, Smith BM, et al. Racial differences in food allergy phenotype and health care utilization among US children. J Allergy Clin Immunol Pract. 2017;5(2):352​-357.e1.

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      Sicherer SH, Sampson HA. Food allergy: a review and update on epidemiology, pathogenesis, diagnosis, prevention, and management. J Allergy Clin Immunol. 2018;141(1):41-58.

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      Lieberman JA, Chehade M. Use of omalizumab in the treatment of food allergy and anaphylaxis. Curr Allergy Asthma Rep. 2013;13(1):78-84.

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      El Ansari YS, Kanagaratham C, Oettgen HC. Mast cells as regulators of adaptive immune responses in food allergy. Yale J Biol Med. 2020;93(5):711​-718.

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      Ruiter B, Shreffler WG. The role of dendritic cells in food allergy. J Allergy Clin Immunol. 2012;129(4):921​-928.

    • Gupta S, Warren C, Seetasith A, Schuldt R, Gupta R, Casale TB. Mental health concerns of patients and their caregivers in the food allergy research & education (FARE) patient registry add to the burden of food allergy. Poster presented at: American Academy of Allergy, Asthma & Immunology (AAAAI) 2023 Annual Scientific Meeting; February 24-27, 2023; San Antonio, TX.

      Gupta S, Warren C, Seetasith A, Schuldt R, Gupta R, Casale TB. Mental health concerns of patients and their caregivers in the food allergy research & education (FARE) patient registry add to the burden of food allergy. Poster presented at: American Academy of Allergy, Asthma & Immunology (AAAAI) 2023 Annual Scientific Meeting; February 24-27, 2023; San Antonio, TX.

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      Vandenplas Y. Prevention and management of cow’s milk allergy in non-exclusively breastfed infants. Nutrients. 2017;9(7):731.

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      Don’t let hidden holiday allergies ruin your good cheer. American College of Allergy, Asthma & Immunology. Published April 11, 2019. Accessed February 12, 2024. https://acaai.org/news/dont-let-hidden-holiday-allergies-ruin-your-good-cheer/

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      Hill DJ, Heine RG, Hosking CS. The diagnostic value of skin prick testing in children with food allergy. Pediatr Allergy Immunol. 2004;15(5):435​-441.

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      Fierstein JL, Brown D, Gupta R, Bilaver L. Understanding food-related allergic reactions through a US national patient registry. J Allergy Clin Immunol Pract. 2021;9(1):206​-215.e1.

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      Permaul P, Stutius LM, Sheehan WJ, et al. Sesame allergy: role of specific IgE and skin-prick testing in predicting food challenge results. Allergy Asthma Proc. 2009;30(6):643​-648.

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      Soy. American College of Allergy, Asthma & Immunology. Updated April 9, 2019. Accessed July 22, 2024. https://acaai.org/allergies/allergic-conditions/food/soy/

    • Sokol K, Rasooly M, Dempsey C, et al. Prevalence and diagnosis of sesame allergy in children with IgE-mediated food allergy. Pediatr Allergy Immunol. 2020;31(2):214​-218.

      Sokol K, Rasooly M, Dempsey C, et al. Prevalence and diagnosis of sesame allergy in children with IgE-mediated food allergy. Pediatr Allergy Immunol. 2020;31(2):214​-218.

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      Verstege A, Mehl A, Rolinck-Werninghaus C, et al. The predictive value of the skin prick test weal size for the outcome of oral food challenges. Clin Exp Allergy. 2005;35(9):1220​-1226.

    • Giannetti A, Ruggi A, Ricci G, Giannì G, Caffarelli C. Natural history of hazelnut allergy and current approach to its diagnosis and treatment. Children (Basel). 2023;10(3):585.

      Giannetti A, Ruggi A, Ricci G, Giannì G, Caffarelli C. Natural history of hazelnut allergy and current approach to its diagnosis and treatment. Children (Basel). 2023;10(3):585.

    • Cortot CF, Sheehan WJ, Permaul P, et al. Role of specific IgE and skin-prick testing in predicting food challenge results to baked egg. Allergy Asthma Proc. 2012;33(3):275​-281.

      Cortot CF, Sheehan WJ, Permaul P, et al. Role of specific IgE and skin-prick testing in predicting food challenge results to baked egg. Allergy Asthma Proc. 2012;33(3):275​-281.

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      Koplin JJ, Perrett KP, Sampson HA. Diagnosing peanut allergy with fewer oral food challenges. J Allergy Clin Immunol Pract. 2019;7(2):375​-380.

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      Feng C, Kim JH. Beyond avoidance: the psychosocial impact of food allergies. Clin Rev Allergy Immunol. 2019;57(1):74-82.

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      Chokshi NY, Maskatia Z, Miller S, Guffey D, Minard CG, Davis CM. Risk factors in pediatric shrimp allergy. Allergy Asthma Proc. 2015;36(4):65-71.

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    IMPORTANT SAFETY INFORMATION

    INDICATION

    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 or status asthmaticus.

    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 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. 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 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.

    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.

    Injection Site Reactions: 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.

    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 for a different indication to evaluate the long term safety of XOLAIR, including the risk of malignancy. 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.

    INDICATION

    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 or status asthmaticus.


    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 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. 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 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.

    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.

    Injection Site Reactions: 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.

    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 for a different indication to evaluate the long term safety of XOLAIR, including the risk of malignancy. 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.