US Healthcare Professionals

For uncontrolled moderate to severe allergic asthma patients 6 years and older.

XOLAIR AUTOINJECTOR

About the XOLAIR autoinjector

Things to know
Watch video
Autoinjector parts
Storage
How to inject guide
Dosing

Things to know about the XOLAIR autoinjector

The XOLAIR autoinjector comes boxed.

DO NOT OPEN the 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 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 autoinjector should be stored in the refrigerator and removed approximately 30 to 45 minutes before your injection to allow it to come to room temperature. DO NOT HEAT.

Watch instructions on how to self-inject

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 instructions for caregivers on how to inject another person.

How to store your XOLAIR

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

Learn the parts of the XOLAIR autoinjector

The cap on the autoinjector is there to protect you and the autoinjector until you are ready to inject. Underneath the cap is the needle guard. This is what you hold against the skin when you’re ready to inject. Never clean or touch the needle guard.

If your dose includes 75 mg XOLAIR, the autoinjector will have a blue needle guard.
If your dose includes 150 mg XOLAIR, the autoinjector will have a purple needle guard.
If your dose includes 300 mg XOLAIR, the autoinjector will have a gray needle guard.

Step-by-step* injection guide to using the XOLAIR autoinjector

  • The XOLAIR autoinjector comes boxed
  • DO NOT OPEN the carton until you are ready to use this medicine
  • Do not use if the packaging is damaged or appears to be tampered with as it may not be safe for you to use. Call your doctor’s office for guidance. For additional information, call 1-866-4XOLAIR (1-866-496-5247)
  • The boxed XOLAIR autoinjector 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 XOLAIR autoinjector. 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)
  • Do not try to inject yourself in the upper arm
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 XOLAIR autoinjector 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 autoinjector.
  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 autoinjector 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 autoinjector can warm up on its own to room temperature. Leave the XOLAIR autoinjector in the carton to protect it from light
    • If the XOLAIR 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
    • Check the expiration date on the autoinjector
    • Do not use it if the expiration date has passed. If the expiration date has passed, safely throw away the XOLAIR autoinjector in a sharps disposal container and contact your healthcare provider
    • 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. Inspect the XOLAIR autoinjector closely
    • Check the autoinjector. The medicine in the autoinjector should be clear and colorless to pale brownish-yellow. Do not use the autoinjector if the medicine contains particles or is cloudy or brown
  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 fan or blow on the cleaned skin
    • Do not touch the injection site again before giving the injection
  1. Hold the XOLAIR 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 XOLAIR autoinjector. Throw away the cap in the regular household trash
    • Do not clean or touch the needle guard of the device
  2. Hold the XOLAIR autoinjector comfortably with the needle guard directly against the skin.
    • The XOLAIR autoinjector should be at a 90-degree angle against the skin
  • Press straight down and hold the XOLAIR autoinjector firmly against the skin. The first click indicates that the injection has started
  • Hold the XOLAIR autoinjector tightly in place. Do not change the angle of injection or remove the autoinjector until the injection is completed
  • Keep holding the autoinjector against the skin. The green indicator will move within the viewing window
  • Listen for the second click. This indicates that the injection is almost complete
  • Hold the XOLAIR autoinjector in position until the green indicator has stopped moving and completely fills the viewing window to make sure the injection is complete
  1. 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    
  2. If your prescribed dose requires more than 1 injection:
    • Throw away the used XOLAIR autoinjector as described in “Disposing of the autoinjector” below
    • Repeat the steps in “Preparing for the injection,” “Giving the injection,” and “Start the injection” for the next injection using a new autoinjector
    • 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 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 XOLAIR autoinjectors in your household trash
  • Do not recap the XOLAIR 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, 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 XOLAIR autoinjectors

For more information about safe sharps disposal, and for specific information about sharps disposal in the state 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 autoinjectors do I need for my dose?

Based on your prescription, you may need to prepare 1-3 XOLAIR autoinjectors. 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 autoinjector, or combination of autoinjectors, for your prescription. And remember: It’s important to inject the medicine from all of your prescribed autoinjectors immediately after one another.

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

One 75 mg autoinjector

One 150 mg autoinjector

One 75 mg autoinjector + One 150 mg autoinjector

One 300 mg autoinjector

One 75 mg autoinjector + One 300 mg autoinjector

One 150 mg autoinjector + One 300 mg autoinjector

One 75 mg autoinjector + One 150 mg autoinjector + One 300 mg autoinjector

Two 300 mg autoinjectors

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

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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

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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 moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens. It is not known if XOLAIR is safe and effective in people with asthma under 6 years of age.

XOLAIR is not used to treat sudden breathing problems.

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 (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 asthma, 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 other asthma medicine 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.
  • Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive XOLAIR. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by XOLAIR. Tell your healthcare provider right away if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs.
  • 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 adults and children 12 years of age and older with asthma: joint pain especially in your arms and legs, dizziness, feeling tired, itching, skin rash, bone fractures, and pain or discomfort of your ears.
  • In children 6 to less than 12 years of age with asthma: swelling of the inside of your nose, throat, or sinuses, headache, fever, throat infection, ear infection, abdominal pain, stomach infection, and nose bleeds.

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.