Oralair

Oralair is a prescription medication used to treat symptoms of moderate to severe seasonal grass pollen allergic rhinitis with or without conjunctivitis in patients 5 to 50 years of age.

Oralair is considered allergy immunotherapy. These work by decreasing your body’s reaction to an allergen.

This medication comes in a sublingual tablet form and is taken once a day in the morning on an empty stomach.

Common side effects of Oralair include oral pruritus, throat irritation, ear pruritus, and mild to moderate local allergic reactions.

Oralair is a prescription medication used to treat symptoms of moderate to severe seasonal grass pollen allergic rhinitis with or without conjunctivitis in patients 5 to 50 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Oralair. See the “Oralair Precautions” section.

Common side effects of Oralair include the following:

• Oral pruritus
• Throat irritation
• Ear pruritus
• Mild to moderate local allergic reactions (i.e. oral swelling or discomfort)

This is not a complete list of Oralair side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Oralair including the following:

• Allergic reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of allergic reactions.
  • sensation of swelling in the throat
  • difficulty swallowing 
  • breathing or voice changes
• hypersensitivity
• diarrhea
• angioneurotic edema

Do not take Oralair if you:

• are allergic to Oralair or to any of its ingredients
• have extreme sensitivity to the specific allergen determined from previous anaphylaxis following exposure.
• are on beta-blockers or on ACE inhibitors
• have severe and/or unstable asthma
• have severe immune deficiency or auto-immune disease
• have an autoimmune disease
• have malignant diseases (e.g. cancer)
• have oral inflammations

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Oralair, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Oralair, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Oralair or to any of its ingredients
• have severe immune deficiency or an auto-immune disease

• are being treated with beta-blockers or ACE inhibitors
• have oral inflammations
• have cancer
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

The manufacturer has not determined the category for Oralair.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Oralair crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Oralair.

Take Oralair exactly as prescribed.

Oralair comes in a sublingual tablet form and is taken once a day, in the morning.

Take Oralair on an empty stomach.

Patients should wash their hands before and after taking the tablets to prevent contamination.

The tablet must be placed under the tongue and held there until it is completely dissolved (for at least 1 minute) and the dose is swallowed.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Oralair at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

In adults and children (above the age of 5), the dose will gradually be increased for 3 days. (The dose may need to be increased slower than 3 days if undesirable side effects occur)

• Day 1: 100 IR (Index of Reactivity)
• Day 2: 200 IR (Index of Reactivity) Take 2 tablets of 100 IR simultaneously, with both tablets held under the tongue.
• Day 3: 300 IR (Index of Reactivity) Take 1 tablet of 300 IR.

The recommended dose for Oralair (grass pollen extract) for the treatment of symptoms of moderate to severe seasonal grass pollen allergic rhinitis is 300 IR (Index of Reactivity) per day until the end of the pollen season.

If you take too much Oralair, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• It is recommended that the first tablet of Oralair is taken under medical supervision and that the patient is monitored for 30 minutes.
• Treatment should be initiated about 4 months before the expected onset of the pollen season and must be maintained throughout the pollen season.
• Store at room temperature (15°C to 30°C).
• Store in the original package in order to protect from moisture. The tablet should remain in the sealed blister until use.
• Keep out of reach of children.