Allergies are caused by substances called allergens. Grasses produce tiny, light, dry pollen grains that are carried by the wind from one plant to another. These pollen grains release the allergens that cause grass allergies through contact with your airway. Your allergy symptoms are linked to the amount of grass pollen in the air, which is known as the pollen count. Peak season for grass pollen is typically late spring through early summer.
The symptoms of grass allergies can include:
- Runny, stuffy, or itchy nose
- Itchy and watery eyes
- Sneezing
Yes, there are different types of grass throughout the United States, and most people with grass allergies are sensitive to more than 1 type of grass. People allergic to grasses may be sensitive to a small number or a larger number of different grasses. Your body’s immune system may be able to tell these grasses apart and may react differently to each of them. Allergies to grasses are the most common form of seasonal allergy in the U.S.
ORALAIR is the first and only FDA-approved sublingual (under the tongue) allergy immunotherapy tablet that includes a 5 grass, mixed pollens allergen extract from sweet vernal grass, orchard grass, perennial ryegrass, Kentucky bluegrass, and timothy grass.
ORALAIR is a prescription medicine used for sublingual (under the tongue) immunotherapy prescribed to treat sneezing, runny or itchy nose, nasal congestion, or itchy and watery eyes due to allergy to any of the grass pollens contained in ORALAIR. ORALAIR may be prescribed for persons 5 to 65 years of age whose doctor has confirmed are allergic to any of the grass pollens contained in ORALAIR.
ORALAIR is taken for about 4 months before the expected start of the grass pollen season and is continued throughout the grass pollen season.
ORALAIR is NOT a medication that gives immediate relief of allergy symptoms.
ORALAIR may be the right treatment choice for people who have grass allergy symptoms confirmed to be due to 1 or more of the 5 grass pollens contained in ORALAIR.
Treatments for grass allergies include over-the-counter or prescription allergy medicines, such as antihistamines or nasal sprays, and allergy immunotherapy. Traditionally, allergy immunotherapy in the United States has been given as allergy shots, which requires that patients come into the allergy specialist’s office regularly in order to receive them. This can be an inconvenience, so they may decide against allergy shots for themselves or their children. Cost and fear of needles are also reasons why some people choose not to get allergy shots.
If you are looking for an easy, convenient allergy immunotherapy treatment for your grass allergies, then ORALAIR may be an option for you. The only way to know if ORALAIR is right for you is to talk with your allergy specialist.
ORALAIR may be prescribed for children 5 years and older whose allergy specialist has confirmed are allergic to any of the grass pollens contained in ORALAIR. Ask your child’s allergy specialist for more information.
ORALAIR is a prescription allergy immunotherapy treatment you can take at home. Taking ORALAIR may help reduce your grass allergy symptoms—such as itchy, watery eyes and runny nose—and how much other allergy medicine you take. 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
If any of these symptoms occur, stop taking ORALAIR and immediately seek medical care.
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 fda.gov/medwatch.
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.
ORALAIR is a grass allergy immunotherapy treatment that you start about 4 months before the grass allergy season begins, when you aren’t likely having any symptoms of your grass allergy. It is not a medication that gives immediate relief of allergy symptoms. You will continue to take ORALAIR daily throughout the grass allergy season, until your allergy specialist tells you to stop taking it. This is how ORALAIR was evaluated in medical studies, where people who took ORALAIR had improved symptoms and took less other allergy medicine than people who did not take ORALAIR.
You should not take ORALAIR with food or water. You should wait 5 minutes to eat or drink after the tablet dissolves.
No interactions were reported in ORALAIR medical studies during which participants were able to take antihistamines and corticosteroids. However, for more information, speak with your allergy specialist.
Your allergy specialist may decide that ORALAIR is not the best course of therapy if you are 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 allergy specialist if you are taking or have 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 allergy specialist or pharmacist for advice before taking ORALAIR.
No studies of ORALAIR have been done in pregnant women. Your doctor will prescribe ORALAIR during pregnancy or breastfeeding only if clearly needed. You should talk with your doctor if you are pregnant, plan to become pregnant, or plan to breastfeed while taking ORALAIR.
- If you do become pregnant or breastfeed during treatment with ORALAIR, you should talk with your doctor to determine if you can continue treatment
You or your child should not take ORALAIR if you or your child:
- Has severe, unstable, or uncontrolled asthma
- Had a severe allergic reaction in the past that included any of these symptoms:
- Trouble breathing
- Dizziness or fainting
- Rapid or weak heartbeat
- Has ever had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy
- Has ever been diagnosed with eosinophilic esophagitis
- Is allergic to any of the inactive ingredients contained in ORALAIR (mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, and lactose monohydrate)
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.
You will be given your first dose of ORALAIR at your allergy specialist’s office. You will stay at the office for 30 minutes so you can be watched for any possible side effects.
The most commonly reported side effects of ORALAIR in children and adults were itching of the mouth, lips, tongue, or throat. These side effects, by themselves, are not dangerous or life-threatening. Your allergy specialist will be able to help you tell the difference between severe allergic reactions and other side effects of treatment.
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 allergy specialist or pharmacist. You may report side effects to the US Food and Drug Administration (FDA) at 1-800-FDA-1088 or fda.gov/medwatch.
Remember, ORALAIR is not a medication that gives immediate relief of allergy symptoms; it is an allergy immunotherapy. Treatment with ORALAIR is started about 4 months before the allergy season begins and continued throughout the grass allergy season. In medical studies, many people had significant improvement in their grass allergy symptoms and used less of other allergy medicines during the first pollen season.
The most commonly reported side effects of ORALAIR in children and adults were itching of the mouth, lips, tongue, or throat. These side effects, by themselves, are not dangerous or life-threatening. Remember to take ORALAIR exactly as your doctor told you.
You take ORALAIR for about 4 months before the expected start of the grass allergy season and continue taking it throughout the grass allergy season. Talk with your allergy specialist about exactly when to stop taking ORALAIR. For more information on ORALAIR, see your allergy specialist.
Stop taking 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), or develops any mouth infections, ulcers, or cuts in the mouth or throat
Be sure to keep ORALAIR out of the reach of children. It should be stored in a dry place at room temperature, 20°C to 25°C (68°F to 77°F), in the original package.
Throw away any unused ORALAIR after the expiration date, which you can find listed on the carton and blister pack after “EXP.”
Yes, the ORALAIR co-pay assistance program may help you save money by reducing the cost of your ORALAIR co-pay to as little as $15 per prescription, for a maximum monthly savings of $100. Please note that the eligibility restrictions, terms, and conditions apply.
- Click here for more information about the ORALAIR co-pay assistance program, including eligibility restrictions, terms, and conditions
You can pick up your prescription of ORALAIR at a participating pharmacy, like you do with most of your other prescriptions. Or, you can have ORALAIR delivered right to your house. Talk to your allergy specialist when he or she prescribes ORALAIR about which option is right for you.
For more information about allergies, please talk with your allergy specialist. You can also get information from these professional allergy groups:
Talking With Your
Allergy Specialist
ORALAIR is a prescription allergy medicine. If you have additional questions about seasonal grass allergies and ORALAIR treatment, you should make an appointment to talk with your allergy specialist. Because ORALAIR is a treatment that you start about 4 months before the grass allergy season begins, you should make your appointment then. Ask your doctor when that is.
See our Allergy Specialist Discussion Guide for questions you may want to ask during the appointment
If your child doesn’t have an allergy specialist, visit these Web sites to find one near you:
