ORALAIR^® Safety and Side Effects

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

ORALAIR can cause severe allergic reactions that may be life-threatening. Symptoms of allergic reactions to ORALAIR include:

• Trouble breathing
• Throat tightness or swelling
• Trouble swallowing or speaking
• Dizziness or fainting
• Rapid or weak heartbeat
• Severe stomach cramps or pain, vomiting, or diarrhea
• Severe flushing or itching of the skin

If any of these symptoms occur, stop taking ORALAIR and immediately seek medical care.

For home administration of ORALAIR, your doctor should prescribe auto-injectable epinephrine for you to keep at home for treating a severe reaction, should one occur. Your doctor will train and instruct you on the proper use of auto-injectable epinephrine.

Who should not take ORALAIR?

You or your child should not take ORALAIR if:

• You or your child has severe, unstable, or uncontrolled asthma
• You or your child had a severe allergic reaction in the past that included any of these symptoms:
• Trouble breathing
• Dizziness or fainting
• Rapid or weak heartbeat
• You or your child has ever had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before
• Your or your child has ever been diagnosed with eosinophilic esophagitis
• You or your child is allergic to any of the inactive ingredients contained in ORALAIR
• The inactive ingredients contained in ORALAIR are: mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, Magnesium stearate and lactose monohydrate

What should I tell my doctor before taking ORALAIR?

Your doctor may decide that ORALAIR is not the best course of therapy if:

• You or your child has asthma, depending on how severe it is
• You or your child suffers from lung disease such as chronic obstructive pulmonary disease (COPD)
• You or your child suffers from heart disease such as coronary artery disease, an irregular heart rhythm, or you have hypertension that is not well controlled
• You or your daughter is pregnant, plans to become pregnant during the time you will be taking ORALAIR, or is breast-feeding
• You or your child is unable or unwilling to administer auto-injectable epinephrine to treat a severe allergic reaction to ORALAIR
• You or your child is taking certain medicines that enhance the likelihood of a severe reaction, or interfere with the treatment of a severe reaction. These medicines include:
• Beta blockers and alpha-blockers (prescribed for high blood pressure)
• Cardiac glycosides (prescribed for heart failure or problems with heart rhythm)
• Diuretics (prescribed for heart conditions and high blood pressure)
• Ergot alkaloids (prescribed for migraine headache)
• Monoamine oxidase inhibitors or tricyclic antidepressants (prescribed for depression)
• Thyroid hormone (prescribed for low thyroid activity);

You should tell your doctor if you or your child is taking or has recently taken any other medicines, including medicines obtained without a prescription and herbal supplements. Keep a list of them and show it to your doctor and pharmacist each time you get a new supply of ORALAIR. Ask your doctor or pharmacist for advice before taking ORALAIR.

Are there any reasons to stop taking ORALAIR?

Stop ORALAIR and contact your doctor if you or your child:

• Has any type of a serious allergic reaction
• Develops throat tightness or swelling of the tongue or throat that causes trouble speaking, breathing or swallowing after taking ORALAIR
• Has trouble breathing or asthma or another breathing condition that gets worse
• Experiences dizziness or fainting
• Develops rapid or weak heartbeat
• Experiences severe stomach cramps or pain, vomiting, or diarrhea
• Develops severe flushing or itching of the skin
• Has heartburn, difficulty swallowing, pain with swallowing, or chest pain that does not go away or worsens
• Has any mouth surgery procedures (such as tooth removal), develops any mouth infections, ulcers or cuts in the mouth or throat

What are the possible side effects of ORALAIR?

In children and adults, the most commonly reported side effects were itching of the mouth, lips, tongue or throat. These side effects, by themselves, are not dangerous or life-threatening.

ORALAIR can cause severe allergic reactions that may be life-threatening. Symptoms of allergic reactions to ORALAIR include:

• Trouble breathing
• Throat tightness or swelling
• Trouble swallowing or speaking
• Dizziness or fainting
• Rapid or weak heartbeat
• Severe stomach cramps or pain, vomiting, or diarrhea
• Severe flushing or itching of the skin

For additional information on the possible side effects of ORALAIR, talk with your doctor or pharmacist. You may report side effects to the US Food and Drug Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see accompanying full Prescribing Information, including Boxed Warning, and Medication Guide.

Remember

If you have any symptoms of an allergic reaction to ORALAIR, call your allergy specialist right away. If you have any of these symptoms and you cannot reach your allergy specialist, call 911 for emergency medical attention.