Sweet vernal/orchard/perennial rye/timothy/kentucky blue grass mixed pollen allergen extract (Sublingual route)
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 .
Uses of This Medicine:
Oralair® is a mixed allergen extract which is used as an immunotherapy to treat 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 (sweet vernal, orchard, perennial rye, timothy, and Kentucky blue grass mixed pollens 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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Oralair® in children 10 to 17 years of age. However, safety and efficacy have not been established in children younger than 10 years of age.
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.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
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.
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 (inflammation 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. Ask your doctor if you have any questions.
Start taking Oralair® 4 months before the expected onset of each grass pollen season, and continue taking this medicine daily throughout the pollen season.
It is recommended to take the first dose of Oralair® in a clinic or hospital. This is to monitor you or your child for at least 30 minutes of any signs or symptoms of a severe allergic reaction. If you can tolerate the first dose of Oralair®, then you may take the succeeding doses at home.
- Wash your hands before and after taking the tablet.
- Remove the tablet from the blister pack if you are ready to take it.
- Place the tablet immediately under the tongue where it will dissolve for about 1 minute before swallowing.
- Do not eat or drink anything for 5 minutes after taking the tablet.
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 10 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 10 years of age—Use is not recommended.
- For grass pollen rhinitis:
Call your doctor or pharmacist for instructions.
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 take it.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face, 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 available during the time of year 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:
- More common
- difficulty with breathing
- itching ears, mouth, and tongue
- noisy breathing
- sore throat
- swelling of the mouth
- swollen glands
- tightness in the chest
- Less common
- Body aches or pain
- 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
- 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
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- Less common
- Acid or sour stomach
- stomach discomfort, upset, or pain
- Less common or rare
- Burning feeling in the chest or stomach
- nausea or vomiting
- Incidence not known
- dry eyes
- dry mouth
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:
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:
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.
Last Updated: 9/4/2017