1 What is Oralair?

Brand: Oralair

Generic: Sweet Vernal/Orchard/Perennial Rye/Timothy/Kentucky Blue Grass Mixed Pollen Allergen Extract

OralairВ® is a mixed allergen extract used for immunotherapy in treating the symptoms of grass pollen allergic rhinitis with or without conjunctivitis.

This is confirmed by a positive skin test that is caused by the five grass species. This drug requires a prescription.

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2 What to Know Before Using

If you are about to start using Oralair, speak with your doctor about what you need to know. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. Studies in children 10 to 17 years of age have not demonstrated any pediatric-specific problems that would limit the utility of OralairВ®.

However, safety and efficacy have not been established in children younger than 10 years of age. Studies in the elderly have not demonstrated geriatric-specific problems that would limit the utility of OralairВ®.

However, safety and efficacy have not been established in elderly patients older than 65 years of age. Indications of harm to the fetus have not been reported in animal studies and risks to the fetus have not been demonstrated in studies of pregnant women.

Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about potential risks and benefits of taking this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other prescription or nonprescription drugs. Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as:

  • Allergy to mannitol
  • Microcrystalline cellulose
  • Croscarmellose sodium
  • Colloidal anhydrous silica
  • Magnesium stearate
  • Or lactose monohydrate
  • Asthma
  • Eosinophilic esophagitis
  • Severe reaction to sublingual allergen immunotherapy
  • Systemic allergic reaction
  • Angina
  • Arrhythmia
  • Breathing or lung problems
  • Heart attack
  • Hypertension
  • Dental extraction
  • Mouth ulcers or thrush
  • Or oral surgery

3 Proper Usage

To use Oralair properly, you must follow all instructions given by your doctor. It is recommended to start taking OralairВ® 4 months before the expected onset of each grass pollen season, and continue taking this drug daily throughout the pollen season.

It is recommended to take the first dose of OralairВ® in a clinic or hospital for proper monitoring of at least 30 minutes for any signs or symptoms of a severe allergic reaction. You may take the succeeding doses at home if you can tolerate the first dose of OralairВ®.

Your hands must be washed before and after taking the tablet. The tablet must be removed from the blister pack if you are ready to take it. The tablet must be placed immediately under the tongue where it will dissolve for about 1 minute before swallowing. Avoid eating or drinking anything for 5 minutes after taking the tablet.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug. 

Adults 18 to 65 years of age with grass pollen rhinitis are advised to take one tablet once a day. Children 10 to 17 years of age must take one tablet on Day 1. Then, two tablets of 100 IR taken on Day 2. Your healthcare professional will increase your dose to 300 IR once a day on Day 3 onwards. Use in children younger than 10 years of age is not recommended.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Oralair, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug.

Seek immediate medical attention if you have symptoms of anaphylaxis such as:

  • Very fast or irregular breathing
  • gasping for breath
  • wheezing
  • fainting
  • changes in color of the skin of the face
  • very fast but irregular heartbeat or pulse
  • hive-like swellings on the skin
  • puffiness or swellings of the eyelids or around the eyes

You will be advised to have an emergency injection for allergic reactions available during the time of year you take this drug. Call your healthcare professional immediately if you have trouble breathing or if your asthma becomes difficult to control.

Consult with your healthcare professional before taking any other prescription or nonprescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Oralair. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • Congestion
  • Cough
  • Difficulty with breathing
  • Fever
  • Itching ears, mouth, and tongue
  • Noisy breathing
  • Sore throat
  • Swelling of the mouth
  • Swollen glands
  • Tightness in the chest
  • Body aches or pain
  • Chills
  • Headache
  • Hives or welts, itching, or skin rash
  • Loss of voice
  • Numbness or tingling feeling around the mouth
  • Redness of the skin
  • A runny nose or sneezing
  • Swelling of the lips or tongue
  • Unusual tiredness or weakness
  • Difficulty swallowing
  • Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • Fast, irregular, pounding or racing heartbeat or pulse
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue redness of the face, neck, arms, and occasionally, upper chest
  • Sweating, swollen, painful, or tender lymph glands in the neck, armpit, or groin

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

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