Xolair^®

omalizumab

Indications & Important Safety Information

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.
• 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.

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 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:

• 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.
• 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 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.