Description
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.
This product is available in the following dosage forms:
- Tablet
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
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.
- For grass pollen rhinitis:
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
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
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.
DRG-20095256
