US Healthcare Professionals

For people 1 year of age and older at risk of food allergic reactions after accidental exposure.

XOLAIR PREFILLED SYRINGE

About the XOLAIR prefilled syringe

Things to know
Watch video
Prefilled syringe parts
Storage
How to inject guide
Dosing

Things to know about the XOLAIR prefilled syringe

The XOLAIR prefilled syringe comes boxed.

DO NOT OPEN the sealed outer carton until you are ready to use this medicine.

DO NOT USE XOLAIR for the emergency treatment of any allergic reactions, including anaphylaxis, hives, or sudden breathing problems.

DO NOT USE this medicine if the seal on the outer carton or the seal of the blister pack is broken, as it may not be safe to use.

DO NOT USE if the packaging is damaged or appears to be tampered with, as it may not be safe to use. Call your doctor’s office for guidance. For additional information, call 1-866-4XOLAIR (1-866-496-5247).

The boxed syringes should be stored in the refrigerator. Remove before your injection and allow to come to room temperature for:

  • Approximately 15 to 30 minutes for the 75 mg or 150 mg syringes 
  • Approximately 30 to 45 minutes for the 300 mg syringe

DO NOT HEAT.

Watch instructions on how to self-inject

XOLAIR Prefilled Syringe

Watch this supplemental step-by-step video guide on how to properly prepare, inject, store, and dispose of the XOLAIR prefilled syringe. This video also includes instructions for caregivers on how to inject another person.

How to store your XOLAIR

Your XOLAIR prefilled syringe will be shipped to you from the pharmacy under refrigerated conditions. It is important to store it as directed below.

Prefilled Syringe (75 mg and 150 mg) Prefilled Syringe (300 mg)

Learn the parts of the XOLAIR 75 mg and 150 mg prefilled syringe

The XOLAIR prefilled syringe has a needle-shield. This is intended to protect against accidental needle-stick injuries.

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 XOLAIR prefilled syringe contains a type of natural rubber latex. Tell your healthcare provider if you have a latex allergy.

If your dose includes 75 mg XOLAIR, the prefilled syringe will have a blue needle-shield.
If your dose includes 150 mg XOLAIR, the prefilled syringe will have a purple needle-shield.

Step-by-step* injection guide to using the XOLAIR 75 mg and 150 mg prefilled syringe

  • The XOLAIR prefilled syringe comes boxed and individually sealed in a plastic wrapper
  • DO NOT OPEN the sealed outer carton until you are ready to use this medicine
  • DO NOT USE if packaging is damaged or appears to be tampered with as it may not be safe to use. Call your doctor’s office for guidance. For additional information, call 1-866-4XOLAIR (1-866-496-5247)
  • The boxed syringe should be stored in the refrigerator. Always make sure XOLAIR is kept at the correct temperature (between 36 °F and 46 °F)

An injection site is the place on the body where you are going to use the prefilled syringe. There are several possible sites that you can use. Choose the one that is most comfortable for you.

  • Do not inject through clothing. The injection site should be exposed, clean skin
  • Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin
  • If your prescribed dose requires more than 1 injection, choose a different site for each new injection. They should be at least 1 inch from other injection sites

If you are giving yourself the injection, you can inject into any of these sites:

  • Front of thighs
  • Middle of thighs
  • Stomach area (abdomen). Do not inject within the 2-inch area directly around your belly button (navel)
Giving the injection to your child or to another adult

If you are giving the injection to your child (or another adult), you can use:

  • Any of the sites shown on the “front” image
  • Outer area of the upper arms (Do not use this area if you are giving the injection to yourself)
  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 XOLAIR 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 XOLAIR 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 XOLAIR 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 XOLAIR prefilled syringe in a sharps disposal container 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. When holding the prefilled syringe, make sure you always hold the prefilled syringe as shown. Do not touch the needle-shield wings
    • Do not handle the prefilled syringe by holding the plunger or needle cap
  5. Inspect the XOLAIR 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
  6. Choose an 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
  1. Hold the XOLAIR 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 the 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.
    • 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. Use a quick, dart-like motion to insert the needle all the way into the pinched skin at a 45- to 90-degree angle.
    • 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
  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
  4. If your prescribed dose requires more than 1 injection:
    • Throw away the used prefilled syringe as described in "Disposing of the prefilled syringe" below
    • Repeat the steps in "Preparing for the injection," "Giving the injection," and "Inserting the needle" 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 your prescribed dose, immediately one after another. Contact your healthcare provider if you have any questions

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 XOLAIR 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, leak-resistant plastic
  • Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
  • Upright and stable during use
  • Properly labeled: Hazardous waste inside the container

You should reach out to your pharmacy for a sharps disposal container. All pharmacies have different processes.

What to do when your sharps container is full:

  • 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 website at: http://www.fda.gov/safesharpsdisposal.

IMPORTANT: 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.

Learn the parts of the XOLAIR 300 mg prefilled syringe

The XOLAIR prefilled syringe has a needle-shield. This is intended to protect against accidental needle-stick injuries.

If your dose includes 300 mg XOLAIR, the prefilled syringe will have a gray plunger rod.

Step-by-step* injection guide to using the XOLAIR 300 mg prefilled syringe

  • The XOLAIR prefilled syringe comes boxed and individually sealed in a plastic wrapper
  • DO NOT OPEN the outer carton until you are ready to use this medicine
  • DO NOT USE if packaging is damaged or appears to be tampered with as it may not be safe to use. Call your doctor’s office for guidance. For additional information, call 1-866-4XOLAIR (1-866-496-5247)
  • The boxed syringe should be stored in the refrigerator. Always make sure XOLAIR is kept at the correct temperature (between 36 °F and 46 °F)

An injection site is the place on the body where you are going to use the prefilled syringe. There are several possible sites that you can use. Choose the one that is most comfortable for you.

  • Do not inject through clothing. The injection site should be exposed, clean skin
  • Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin
  • If your prescribed dose requires more than 1 injection, choose a different site for each new injection. They should be at least 1 inch from other injection sites

If you are giving yourself the injection, you can inject into any of these sites:

  • Front of thighs
  • Stomach area (abdomen). Do not inject within the 2-inch area directly around your belly button (navel)
Giving the injection to your child or to another adult

If you are giving the injection to your child (or another adult), you can use:

  • Any of the sites shown on the “front” image
  • Outer area of the upper arms (Do not use this area if you are giving the injection to yourself)
  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 XOLAIR 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 30 to 45 minutes so the XOLAIR 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 XOLAIR 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 XOLAIR prefilled syringe in a sharps disposal container 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
  5. Inspect the XOLAIR 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 contains particles or looks cloudy or brown
    • 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 to be damaged or tampered with
  6. Choose an 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
  1. Hold the XOLAIR prefilled syringe firmly by the center 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 needle cap back on the prefilled syringe. Throw away the needle cap in regular household trash
    • You may see air bubbles in the medicine, which is normal. Do 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.
    • 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. Use a quick, dart-like motion to insert the needle all the way into the pinched skin at a 45-degree angle.
    • 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 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 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    
  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
  4. If your prescribed dose requires more than 1 injection:
    • Throw away the used prefilled syringe as described in "Disposing of the syringe" below
    • Repeat the steps in "Preparing for the injection," "Giving the injection," and "Inserting the needle" 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 your prescribed dose, immediately one after another. Contact your healthcare provider if you have any questions

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 XOLAIR 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, leak-resistant plastic
  • Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
  • Upright and stable during use
  • Properly labeled: Hazardous waste inside the container

You should reach out to your pharmacy for a sharps disposal container. All pharmacies have different processes.

What to do when your sharps container is full

  • 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 website at: http://www.fda.gov/safesharpsdisposal.

IMPORTANT: 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.

*Please review the steps detailed in the FDA-approved Instructions for Use. Afterward, you may use the above summary as a quick reference before injecting.

Self-injection patient brochure

Download the Brochure

How many syringes do I need for my dose?

Based on your prescription, you may need to prepare 1-3 XOLAIR prefilled syringes. Depending on your weight and IgE level, you will inject XOLAIR every 2 or 4 weeks. There are 3 strengths of XOLAIR.

Make sure you have received the correct  prefilled syringe, or combination of prefilled syringes, for your prescription. And remember: It’s important to inject the medicine from all of your prescribed syringes, immediately after one another.

To see how many prefilled syringes you need, select your prescribed dose:

One 75 mg prefilled syringe

One 150 mg prefilled syringe

One 75 mg prefilled syringe + One 150 mg prefilled syringe

One 300 mg prefilled syringe

One 75 mg prefilled syringe + One 300 mg prefilled syringe

One 150 mg prefilled syringe + One 300 mg prefilled syringe

One 75 mg prefilled syringe + One 150 mg prefilled syringe + One 300 mg prefilled syringe

Two 300 mg prefilled syringes

Have questions about self-injection with XOLAIR? You’re not alone! You can:

Virtual Session icon on wave background illustration

Schedule a virtual 1:1 education session with a Clinical Education Manager* trained to provide information about XOLAIR and support programs available. Call 1-866-878-0493

Phone icon on wave background illustration

Call 1-866-4XOLAIR (1-866-496-5247) if you have any questions

*Clinical Education Managers are Genentech employees who educate about XOLAIR. They do not provide medical advice to patients. If patients have questions about their health or treatment, they are encouraged to contact their healthcare provider.

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IMPORTANT SAFETY INFORMATION & INDICATION

What is XOLAIR?

XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic. While taking XOLAIR you should continue to avoid all foods to which you are allergic. It is not known if XOLAIR is safe and effective in people with food allergy under 1 year of age.

XOLAIR should not be used for the emergency treatment of any allergic reactions, including anaphylaxis.

What is the most important information I should know about XOLAIR?

Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:

  • wheezing, shortness of breath, cough, chest tightness, or trouble breathing
  • low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”
  • flushing, itching, hives, or feeling warm
  • swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction.

Do not receive and use XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.

Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you:

  • have a latex allergy or any other allergies (such as seasonal allergies). The needle cap on the XOLAIR prefilled syringe contains a type of natural rubber latex.
  • have sudden breathing problems (bronchospasm)
  • have ever had a severe allergic reaction called anaphylaxis
  • have or have had a parasitic infection
  • have or have had cancer
  • are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive and use XOLAIR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I receive and use XOLAIR?

  • When starting treatment, XOLAIR should be given by your healthcare provider in a healthcare setting.
  • If your healthcare provider decides that you or a caregiver may be able to give your own XOLAIR prefilled syringe or autoinjector injections, you should receive training on the right way to prepare and inject XOLAIR.
  • Do not try to inject XOLAIR until you have been shown the right way to give XOLAIR prefilled syringe or autoinjector injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider.
  • The XOLAIR autoinjector (all doses) is intended for use only in adults and adolescents aged 12 years and older. For children 12 years of age and older, XOLAIR prefilled syringe or autoinjector may be self-injected under adult supervision. For children 1 to 11 years of age, XOLAIR prefilled syringe should be injected by a caregiver.
  • See the detailed Instructions for Use that comes with XOLAIR for information on the right way to prepare and inject XOLAIR.
  • XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks.
  • In people with food allergy, a blood test for a substance called IgE must be performed before starting XOLAIR to determine the appropriate dose and dosing frequency.
  • Do not decrease or stop taking any of your food allergy medicine or allergen immunotherapy, unless your healthcare providers tell you to.
  • You may not see improvement in your symptoms right away after XOLAIR treatment. If your symptoms do not improve or get worse, call your healthcare provider.
  • If you inject more XOLAIR than prescribed, call your healthcare provider right away.

What are the possible side effects of XOLAIR?

XOLAIR may cause serious side effects, including:

  • Cancer. Cases of cancer were observed in some people who received XOLAIR.
  • Fever, muscle aches, and rash. Some people get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider.
  • Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving XOLAIR. Your healthcare provider can test your stool to check if you have a parasite infection.
  • Heart and circulation problems. Some people who receive XOLAIR have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether these are caused by XOLAIR.

The most common side effects of XOLAIR in people with food allergy: injection site reactions and fever.

These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.

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 Medication Guide, for additional Important Safety Information and Instructions for Use.