Brand Names:

• Oralair

Dosage Forms:

• Tablet

Warnings:

Use of Sweet Vernal/Orchard/Rye/Timothy/Kentucky Blue Grass mixed pollen allergen extract may lead to life-threatening allergic reactions including anaphylaxis and severe laryngopharyngeal edema. Do not use in patients with severe asthma that is unstable or uncontrolled. Monitor patients for at least 30 minutes after administration of the initial dose. Prescribe auto-injectable epinephrine and instruct on its use, including when to seek immediate medical care. Sweet Vernal/Orchard/Rye/Timothy/Kentucky Blue Grass mixed pollen allergen extract may not be appropriate for patients whose medical conditions decrease their ability to survive a serious allergic reaction or for patients who are unresponsive to epinephrine or inhaled bronchodilators, eg, when receiving beta-blocker therapy .

Classifications:

Therapeutic—

Immunological Agent

Uses of This Medicine:

Oralair® is used as an immunotherapy to treat symptoms of grass pollen allergic rhinitis with or without conjunctivitis (eg, sneezing, itchy, runny or stuffy nose, itchy and watery eyes). This is confirmed by a positive skin test that is caused by the five grass species (sweet vernal, orchard, perennial rye, timothy, and Kentucky blue grass). This medicine is a mixed allergen extract.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Oralair® in children 5 years of age and older. However, safety and efficacy have not been established in children younger than 5 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Oralair® in the elderly. However, safety and efficacy have not been established in elderly patients older than 65 years of age.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, or lactose monohydrate or
• Asthma, severe, unstable, or uncontrolled or
• Eosinophilic esophagitis (swelling of the esophagus), history of or
• Severe reaction to sublingual allergen immunotherapy, history of or
• Systemic allergic reaction, history of—Should not be used in patients with these conditions.

• Angina (severe chest pain), unstable or
• Arrhythmia (heart rhythm problem) or
• Breathing or lung problems (eg, COPD) or
• Heart attack, recent or
• Hypertension (high blood pressure), uncontrolled—It is not known if this medicine will work in patients with these conditions.

• Dental extraction or
• Mouth ulcers or thrush or
• Oral surgery—These conditions should be allowed to healed first before taking this medicine.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

Start using Oralair® 4 months before the expected onset of each grass pollen season, and continue using this medicine daily throughout the pollen season.

Your doctor will give you the first dose of Oralair® in a medical facility. This is to monitor you or your child for at least 30 minutes for any signs or symptoms of a severe allergic reaction. If you can tolerate the first dose of Oralair®, then you may take the next doses at home.

To use:

• Wash your hands before and after using the tablet.
• Remove the tablet from the blister pack if you are ready to use it.
• Place the tablet immediately under the tongue where it will dissolve for at least 1 minute before swallowing.
• Do not eat or drink anything for 5 minutes after using the tablet.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For sublingual dosage form (tablets):
  • For grass pollen rhinitis:
    • Adults 18 to 65 years of age—One tablet [300 IR (index of reactivity)] once a day.
    • Children 5 to 17 years of age—One tablet (100 IR) on Day 1. Then, two tablets of 100 IR taken on Day 2. Your doctor will increase your dose to 300 IR once a day on Day 3 onwards.
    • Children younger than 5 years of age—Use is not recommended.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. The most serious signs of this reaction include: very fast or irregular breathing, gasping for breath, or fainting. Other signs may include: changes in facial skin color, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

Your doctor may recommend that you have an emergency injection for allergic reactions (eg, epinephrine) available during the time of the year that you take this medication. If this is the case, make sure that you know how to use it properly for yourself or your child in case of a serious allergic reaction.

If you or your child have trouble breathing or if your asthma becomes difficult to control, call your doctor immediately.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Congestion

cough

difficulty with breathing

fever

itching ears, mouth, and tongue

noisy breathing

sore throat

swelling of the mouth

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tightness in the chest

Less common

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

runny nose or sneezing

swelling of the lips or tongue

unusual tiredness or weakness

Incidence not known

Blurred vision

chest pain or discomfort

cold hands and feet

confusion

diarrhea

difficulty swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast, irregular, pounding, or racing heartbeat or pulse

general feeling of discomfort or illness

heartburn

joint pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

lightheadedness

loss of appetite

loss of consciousness

mouth or throat blisters

muscle aches and pains

nausea

neck tenderness or swelling

pain or burning in the throat

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the face, neck, arms, and occasionally, upper chest

shivering

sores, ulcers, or white spots on the lips or tongue or inside the mouth

sweating

trouble sleeping

vomiting

weight decreased

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Belching

burning feeling in the chest or stomach

stomach discomfort, upset, or pain

Incidence not known

Anxiety

continuing ringing or buzzing or other unexplained noise in the ears

dry eyes

dry mouth

hearing loss

increased watering of the mouth

lack or loss of strength

sleepiness or unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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