XOLAIR (omalizumab) for self-injection

Self-injection with the XOLAIR prefilled syringe

When starting treatment XOLAIR should be given by your healthcare provider in a healthcare setting. After you've established your XOLAIR treatment in a doctor's office or infusion center, your doctor will determine if you or a caregiver may inject XOLAIR.

If your doctor decides that you or a caregiver may be able to give your own XOLAIR prefilled syringe injections, you should receive training on the right way to prepare and inject XOLAIR. Do not try to inject your XOLAIR prefilled syringe until you have been shown the right way to give XOLAIR injections by your doctor. For children 12 years of age and older, the XOLAIR prefilled syringe may be self-injected under adult supervision. For children 6 to 11 years of age, the XOLAIR prefilled syringe should be injected by a caregiver.

You can find helpful information here on this site. As always, your healthcare team is your best resource.

You can schedule a virtual session with certified personnel by calling 1-866-878-0493.

Watch this supplemental step-by-step video guide on how to properly prepare, inject, store, and dispose of the XOLAIR prefilled syringe(s).

XOLAIR Prefilled Syringe Self-Injection

Call your doctor if you have any questions.

DOWNLOAD THE PREFILLED SYRINGE INSTRUCTIONS FOR USE

How to Store 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.

How to store your XOLAIR (omalizumab)

Disposing of XOLAIR Syringes Safely

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

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

*Sharps Container—a heavy-duty, leak-proof container with a sealable lid that is designated by the FDA as a biomedical waste receptacle, generally used for discarding objects that can be used to puncture skin.

You should reach out to your pharmacy for a sharps disposal container. All pharmacies have different processes. If you do not have a sharps disposal container, you may use a household container that can stand upright, made of heavy-duty, leak-resistant plastic with a tight-fitting, puncture-resistant lid. Make sure to properly label the container as hazardous waste.

XOLAIR (omalizumab) patient self-injection booklet

DOWNLOAD SELF-INJECTION BOOKLET

Frequently Asked Questions

Now that you have the XOLAIR prefilled syringe, you have options. You are not limited to only using it at home. You can take it with you—as long as you follow the correct storage and self-injection procedure. You can even take a trip and take your XOLAIR with you when you travel. But, there are certain things to remember, whether you travel by car, train, bus, or by air. Make sure to keep XOLAIR at the right temperature: between 36°F and 46°F. Also, remember to talk to your doctor before traveling. If flying, you should check your airline’s carry-on policy regarding medications as you may need to supply a doctor’s letter.

Call your doctor to discuss when you should inject the next dose.

Do not use if 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 you can also call 1-866-4XOLAIR (1-866-496-5247).

Safely throw away the prefilled syringe in a sharps disposal container and contact your healthcare provider.

DO NOT USE the prefilled syringe if the medicine is cloudy, discolored or contains particles. The medicine in the prefilled syringe should be clear and colorless to pale brownish-yellow. You may see an air bubble, which is normal. 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.

Allow about 15 to 30 minutes so the prefilled syringe can warm up on its own to room temperature. (Leave the syringe in the box 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.

Temperature change may affect the medicine. The prefilled syringe should not be used after 48 hours at room temperature. If this happens, do not use the prefilled syringe, and call your doctor’s office.

Activating the prefilled syringe guard too early could cause that dose of XOLAIR to no longer work. The syringe guard will totally cover the needle. It is there to prevent accidental needle sticks after use. Once the guards are activated, even if the dose has not been administered, the prefilled syringe should be properly disposed of in a sharps container. If this happens, talk to your healthcare provider.

Dispose of used prefilled syringes immediately in a sharps disposal container.

Use XOLAIR exactly as prescribed by your healthcare provider. For children 12 years of age and older, XOLAIR prefilled syringe may be self-injected under adult supervision. For children 6 to 11 years of age, XOLAIR prefilled syringe should be injected by a caregiver.

XOLAIR should be stored in the refrigerator, between 36°F and 46°F. DO NOT FREEZE. (Do not use if the prefilled syringe has been frozen.)

Store it in the original packaging to protect it from light. Always keep your medicine out of sight and reach of children.

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.

Complete all the required injections for your prescribed dose, immediately one after another. Contact your healthcare provider if you have any questions.

Call your doctor’s office and ask for another training session. You can also:

Call 1-866-4XOLAIR (1-866-496-5247) if you have any questions
Watch our step-by-step video on self-injection

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.
nasal polyps in people 18 years of age and older when medicines to treat nasal polyps called nasal corticosteroids have not worked well enough. It is not known if XOLAIR is safe and effective in people with nasal polyps under 18 years of age.
chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if XOLAIR is safe and effective in people with CSU under 12 years of age.

XOLAIR is not used to treat other allergic conditions, other forms of hives, or 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 (such as food allergy or 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 injections, you should receive training on the right way to prepare and inject XOLAIR.
Do not try to inject your XOLAIR prefilled syringe until you have been shown the right way to give XOLAIR injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider. For children 12 years of age and older, XOLAIR prefilled syringe may be self-injected under adult supervision. For children 6 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 and nasal polyps, a blood test for a substance called IgE must be performed before starting XOLAIR to determine the appropriate dose and dosing frequency.
In people with chronic hives, a blood test is not necessary to determine the dose or dosing frequency.
Do not decrease or stop taking any of your other asthma, nasal polyps, or hive medicine unless your healthcare providers tell you to.
You may not see improvement in your symptoms right away after XOLAIR treatment. If your asthma 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; 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.
In adults with nasal polyps: headache, injection site reactions, joint pain, upper abdominal pain, and dizziness.
In people with chronic spontaneous urticaria: nausea, headaches, swelling of the inside of your nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.

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.