Oralair

What is Oralair?

ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L), Orchard ( Dactylis glomerata L), Perennial Rye ( Lolium perenne L), Timothy ( Phleum pratense L), and Kentucky Blue Grass ( Poa pratensis L).

What are the uses of this medicine?

• 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 these grass pollens. 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 four months before the expected start of the grass pollen season and is continued throughout the grass pollen season.

Limitations of use:

• ORALAIR is NOT a medication that gives immediate relief of allergy symptoms.

How does this medicine work?

• The precise mechanisms of action of allergen immunotherapy are not known.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Severe, unstable or uncontrolled asthma
• History of any severe systemic allergic reaction
• History of any severe local reaction to sublingual allergen immunotherapy
• A history of eosinophilic esophagitis
• Hypersensitivity to any of the inactive ingredients (mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and lactose monohydrate) contained in this product.

What drug interactions can this medicine cause?

• No formal clinical drug interaction studies have been performed with ORALAIR.

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

• Initiate treatment 4 months before the expected onset of each grass pollen season and continue treatment throughout the season.

Recommended Dosage:

• For adults 18 through 65 years of age, the dose is 300 IR (index of reactivity) daily.
• For children and adolescents 5 through 17 years of age, the dose is increased over the first three days as shown below:

Age(years)	Dose
Day 1	Day 2 Day 3 and following
5-17	100 IR	2× 100 IR	300 IR
18-65	300 IR	300 IR	300 IR

Administration

• Take ORALAIR exactly as your doctor tells you.
• ORALAIR is a prescription medicine that is placed under the tongue.
• Remove the ORALAIR tablet from the blister just prior to dosing.
• Place the ORALAIR tablet immediately under the tongue until complete dissolution for at least 1 minute before swallowing.
• Do not take ORALAIR with food or beverage. Food and beverage should not be taken for the following 5 minutes.
• Wash hands after handling the tablet.
• Take the first tablet of ORALAIR in your doctor's office. After taking the first tablet, you or your child will be observed for at least 30 minutes for symptoms of a serious allergic reaction.
• The first dose for children will be one 100 IR tablet.
• The first dose for adults will be one 300 IR tablet.
• If you or your child tolerates the first dose of ORALAIR, you or your child will continue daily ORALAIR therapy at home.
• The first dose at home for children is two 100 IR tablets.
• The first dose at home for adults is one 300 IR tablet.
• After the first dose at home, the dose for children and adults is one 300 IR tablet each day.
• Children should be given each dose of ORALAIR by an adult who will watch for any symptoms of a serious allergic reaction.
• Take ORALAIR as prescribed by your doctor until the end of the treatment course. 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 one day, contact your health provider before restarting.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets, 100 IR and 300 IR

This medicine is available in fallowing brand namesː

• ORALAIR

What side effects can this medication cause?

The most common side effects of this medicine include:

• itching of the mouth, lips, tongue or throat

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

What special precautions should I follow?

• Inform patients of the signs and symptoms of severe allergic reactions and instruct them to seek immediate medical care and discontinue therapy should any of these occur.
• In case of oral inflammation or wounds, stop treatment with ORALAIR to allow complete healing of the oral cavity.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Available human data do not establish the presence or absence of ORALAIR-associated risks during pregnancy, labor and delivery.

Can this medicine be used in children?

• The safety and effectiveness of ORALAIR have not been established in children below 5 years of age.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• PHLEUM PRATENSE POLLEN
• ANTHOXANTHUM ODORATUM POLLEN
• DACTYLIS GLOMERATA POLLEN
• POA PRATENSIS POLLEN
• LOLIUM PERENNE POLLEN

Inactive ingredients:

• SILICON DIOXIDE
• LACTOSE MONOHYDRATE
• CROSCARMELLOSE SODIUM
• MAGNESIUM STEARATE

Who manufactures and distributes this medicine?

• Manufactured by:

Stallergenes SAS Antony, 92183, France

• Distributed by:

GREER Laboratories, Inc. Lenoir

What should I know about storage and disposal of this medication?

• Keep ORALAIR out of the reach of children.
• Throw away any unused ORALAIR after the expiration date which is stated on the carton and blister pack after "EXP."
• Store ORALAIR in a dry place at room temperature, 20°C to 25°C (68°F to 77°F), in the original package.

• Dailymed label info on Oralair
• FDA Oralair

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