You Can Take ORALAIR® At Home

ORALAIR is an allergy immunotherapy treatment you can take at home. Your first dose of ORALAIR is taken in the allergy specialist’s office, where you will be observed for possible side effects. If you have no serious reactions to your first dose of ORALAIR, you will be able to take your grass allergy treatment daily at home, starting about 4 months before the grass allergy season begins and continuing throughout the season. It is important to continue taking ORALAIR before the grass allergy season starts even though you may not yet be experiencing symptoms.

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.

Please see additional Important Safety Information below and full Prescribing Information, including Boxed Warning and Medication Guide.

Follow these instructions when you take ORALAIR.

How to take ORALAIR

Step 1: Remove the ORALAIR tablet from the blister pack right before you take it.

Remove the ORALAIR tablet from the blister pack right before you take it.

Step 2: Place the ORALAIR tablet under your tongue right away. Keep the tablet there for at least 1 minute, then swallow.

Place the ORALAIR tablet under your tongue right away. Keep the tablet there for at least 1 minute, then swallow.

Step 3: Take the ORALAIR tablet without food or drink. Do not eat or drink anything for 5 minutes after you take ORALAIR.

Take the ORALAIR tablet without food or drink. Do not eat or drink anything for 5 minutes after you take ORALAIR.

 Step 4: Be sure to wash your hands after handling the ORALAIR tablet

Be sure to wash your hands after handling the ORALAIR tablet.

ORALAIR Dosing

Once ORALAIR is started in the allergy specialist’s office about 4 months before the grass allergy season begins, adult patients 18 to 65 years old will take one ORALAIR 300-IR tablet daily until the end of the grass allergy season. Children and adolescents 10 to 17 years old will take one ORALAIR 100-IR tablet in their allergy specialist’s office on the first day of treatment about 4 months before the grass allergy season begins; after that, they will take two ORALAIR 100-IR tablets on their second day of treatment, and then one ORALAIR 300-IR tablet on the third day and every day moving forward, until the end of the grass allergy season. ORALAIR should always be given to children under adult supervision.

At-home dosing for ORALAIR

Adults
18-65 years of age

Throughout the rest of treatment as prescribed
1 ORALAIR 300-IR tablet each day

Adults 18 to 65 years of age take one ORALAIR 300-IR tablet each day
throughout the rest of treatment as prescribed. Children and adolescents 10 to
17 years of age take two ORALAIR 100-IR tablets on day 2, and one ORALAIR
300-IR tablet on day 3 and throughout the rest of treatment as prescribed,
under adult supervision.

Children & Adolecents
10-17 years of age

Day 2
2 ORALAIR 100-IR tablets

Adults 18 to 65 years of age take one ORALAIR 300-IR tablet each day
throughout the rest of treatment as prescribed. Children and adolescents 10 to
17 years of age take two ORALAIR 100-IR tablets on day 2, and one ORALAIR
300-IR tablet on day 3 and throughout the rest of treatment as prescribed,
under adult supervision.

Day3 and throughout the rest of treatment as prescribed
1 ORALAIR 300-IR tablet each day

Adults 18 to 65 years of age take one ORALAIR 300-IR tablet each day
throughout the rest of treatment as prescribed. Children and adolescents 10 to
17 years of age take two ORALAIR 100-IR tablets on day 2, and one ORALAIR
300-IR tablet on day 3 and throughout the rest of treatment as prescribed,
under adult supervision.

(Under adult supervision)

Your allergy specialist will tell you when to stop taking ORALAIR.

If you forget to take ORALAIR, do not take a double dose. Take the next dose at your normal scheduled time the next day. If you don’t take ORALAIR for more than 1 day, contact your allergy specialist before restarting.

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.

Please see additional Important Safety Information below and full Prescribing Information, including Boxed Warning and Medication Guide.

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Pay $25 per prescription or save up to $1,500 annually*

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Remembering to Take ORALAIR

If you aren't experiencing allergy symptoms, remembering to take ORALAIR every day can be difficult. Here are some helpful tips:

Take ORALAIR at the same time you do another daily activity that you never forget, like getting dressed in the morning or feeding a pet

Set a reminder alarm on your cell phone or computer, or put a sticky note where you will always see it, like on your bathroom mirror or refrigerator

Keep your ORALAIR tablets in the same place where you can easily get to them

Use the ORALAIR Treatment Tracker to record your allergy medicines and grass allergy symptoms every day

Important Safety Information

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.

Do not take ORALAIR if you or your child:

  • Has severe, unstable, or uncontrolled asthma;
  • Had a severe allergic reaction in the past that included trouble breathing, dizziness or fainting, or rapid or weak heartbeat;
  • Has ever had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before;
  • Has ever been diagnosed with eosinophilic esophagitis; or
  • Is allergic to any of the inactive ingredients contained in ORALAIR.

Stop taking ORALAIR and contact your doctor if you or your child has any mouth surgery procedures (such as tooth removal), develops any mouth infections, ulcers or cuts in the mouth or throat, or has heartburn, difficulty swallowing, pain with swallowing, or chest pain that does not go away or worsens.

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.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Talk to your doctor before using ORALAIR while pregnant or breastfeeding.

Please see full Prescribing Information, including Boxed Warning and Medication Guide, for additional important safety information.

Important Safety Information

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.

Do not take ORALAIR if you or your child:

  • Has severe, unstable, or uncontrolled asthma;
  • Had a severe allergic reaction in the past that included trouble breathing, dizziness or fainting, or rapid or weak heartbeat;
  • Has ever had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before;
  • Has ever been diagnosed with eosinophilic esophagitis; or
  • Is allergic to any of the inactive ingredients contained in ORALAIR.

Stop taking ORALAIR and contact your doctor if you or your child has any mouth surgery procedures (such as tooth removal), develops any mouth infections, ulcers or cuts in the mouth or throat, or has heartburn, difficulty swallowing, pain with swallowing, or chest pain that does not go away or worsens.

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.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Talk to your doctor before using ORALAIR while pregnant or breastfeeding.

Please see full Prescribing Information, including Boxed Warning and Medication Guide, for additional important safety information.