Patient information: uses, side effects, how to take - Xolair

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

XOLAIR may cause serious side effects, including:

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.

What is XOLAIR?

XOLAIR 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.
chronic rhinosinusitis with nasal polyps (CRSwNP) in people 18 years of age and older when medicines to treat CRSwNP called nasal corticosteroids have not worked well enough. It is not known if XOLAIR is safe and effective in people with CRSwNP under 18 years of age.
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.
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 should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. XOLAIR should also not be used to treat other forms of hives, or sudden breathing problems.

Who should not receive and use XOLAIR?

Do not receive and use XOLAIR if you:

are allergic to omalizumab or any of the ingredients in XOLAIR. See the end of this Medication Guide for a complete list of ingredients in XOLAIR.

What should I tell my healthcare provider before receiving XOLAIR?

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

have any allergies (such as seasonal allergies).
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, CRSwNP and food allergy, 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, CRSwNP, hive medicine, 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:

See " What is the most important information I should know about XOLAIR? "
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
shortness of breath

chest pain
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 chronic rhinosinusitis 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.
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 FDA at 1-800-FDA-1088.

How should I store XOLAIR?

Store XOLAIR in the refrigerator between 36°F to 46°F (2°C to 8°C).
Keep your unused XOLAIR prefilled syringes or autoinjectors in the original carton until use to protect them from light.
XOLAIR prefilled syringe or autoinjector can be removed from and placed back in the refrigerator if needed. The total combined time out of refrigerator may not be more than 2 days. Do not use if XOLAIR prefilled syringe or autoinjector is left at temperatures above 77°F (25°C) and discard in a sharps disposal container.
Do not freeze. Do not use if XOLAIR prefilled syringes or autoinjectors have been frozen.
Keep XOLAIR out of direct sunlight.
Do not use XOLAIR past the expiration date.

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

General information about the safe and effective use of XOLAIR.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XOLAIR for a condition for which it was not prescribed. Do not give XOLAIR to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about XOLAIR that is written for health professionals.

For more information, go to www.xolair.com or call 1-866-4XOLAIR (1-866-496-5247).

What are the ingredients in XOLAIR?

Active ingredient: omalizumab

Inactive ingredients:

Prefilled syringe or Autoinjector: arginine hydrochloride, histidine, L-histidine hydrochloride monohydrate, and polysorbate 20

Vial: histidine, L-histidine hydrochloride monohydrate, polysorbate 20 and sucrose

Manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. U.S. License No.: 1048

Jointly marketed by:

Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990

Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936-1080

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 2/2024

Instructions for Use

Xolair^®(ZOHL-air)

(omalizumab)

injection, for subcutaneous use

Prefilled Syringe

Read this Instructions for Use before you start using Xolair prefilled syringe and each time you get a refill. Before you use Xolair prefilled syringe for the first time, make sure your healthcare provider shows you the right way to use it. Contact your healthcare provider if you have any questions.

Do not use Xolair for the emergency treatment of any allergic reactions, including anaphylaxis, hives, or sudden breathing problems.

Prefilled Syringe Parts

Supplies needed to give your injection

Xolair prefilled syringe .

The following supplies are not included in the carton:

Alcohol swab
Sterile cotton ball or gauze
Small bandage
Sharps disposal container (see Step 14)

Note: You may need more than 1 Xolair prefilled syringe for your prescribed dose. See the Dosing Table for more information. Each Xolair carton contains 1 prefilled syringe.

Choose the correct prefilled syringe or combination of prefilled syringes

Xolair prefilled syringes are available in 3 dose strengths (1 prefilled syringe in each carton). These instructions are to be used for all 3 dose strengths.

Your prescribed dose may require more than 1 injection. The Dosing Table below shows the combination of prefilled syringes needed to give your full dose. Check the label on the Xolair carton to make sure you have received the correct prefilled syringe or combination of prefilled syringes for your prescribed dose. If your dose requires more than 1 injection, complete all injections for your prescribed dose, immediately one after another. Contact your healthcare provider if you have any questions.

Dosing Table

Note: Your healthcare provider may prescribe a different combination of syringes for your complete dose.

How should I store Xolair?

Keep your unused prefilled syringes in the original carton and store the carton in a refrigerator between 36°F to 46°F (2°C to 8°C). Do not remove the prefilled syringe from its original carton during storage.
Before giving an injection, the carton can be removed from and placed back in the refrigerator if needed. The total combined time out of the refrigerator may not be more than 2 days. If the prefilled syringe is left at temperatures above 77°F (25°C), do not use it and throw away in a sharps disposal container.
Keep your prefilled syringes out of direct light.
Do not freeze. Do not use if the prefilled syringe has been frozen.

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

Important Information

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.

Preparing for the Injection

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, as shown.
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 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.

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 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.

7 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.

Giving the Injection

8 Remove the cap.

Hold the prefilled syringe firmly with 1 hand and pull the needle cap straight off with your other hand as shown. 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.

9 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).

10 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 as shown.
It is important to use the correct angle to make sure the medicine is delivered under the skin (into the fatty area), or the injection could be uncomfortable and the medicine may not work.
Do not touch the plunger while inserting the needle into the skin.
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.

11 Slowly inject all of the medicine.

Gently push the plunger all the way down until the plunger head is between the safety guard wings as shown.
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.

12 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 ).

13 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.

After the Injection

14 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.

Manufactured by:

Genentech, Inc., A Member of the Roche Group,

1 DNA Way, South San Francisco, CA 94080-4990

U.S. License No.: 1048

Jointly marketed by:

Genentech USA, Inc., A Member of the Roche Group,

1 DNA Way, South San Francisco, CA 94080-4990

Novartis Pharmaceuticals Corporation,

One Health Plaza, East Hanover, NJ 07936-1080

Xolair^®is a registered trademark of Novartis AG.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 8/2026