This product is taken sublingually.
Why is it prescribed?
Grass pollen allergen extract is indicated for the treatment of symptoms of moderate to severe seasonal grass pollen allergic rhinitis with or without eye symptoms in patients 5 to 50 years of age. Patients prescribed the extract should have a history of allergic rhinitis during at least two pollen seasons and an inadequate response to the usual pharmacotherapy, or have an allergy to grass pollen confirmed by allergy testing.
Oralair® is used for the treatment of patients with a history of allergy to a specific grass pollen. Grass pollen allergy is characterized by sneezing, runny or itchy nose, and nasal congestion with or without itchy, watery eyes.
Before the treatment, your allergy will be confirmed by a physician with adequate training and experience in allergic disease, who will perform appropriate tests.
Treatment with the extract should begin abut 4 months before the start of pollen season and should be continued throughout the season.
You must take the first tablet under medical supervision at your physician's office. Your physician will also ask you to stay on site for 30 minutes to monitor and discuss possible side effects to the treatment you may have.
It is recommended to take Oralair® in the morning, on an empty stomach.
When Oralair® is given to children, they must be supervised by an adult for 30 minutes after every dose.
Store at room temperature in the original package.
Treatment with Oralair® should begin 4 months before the start of pollen season and should be continued throughout the season.
It is recommended that the first dose of Oralair® is given under medical supervision and that the patient is monitored for 30 minutes afterwards.
Oralair® is given with increasing doses over 3 days until the maintenance dose is reached. The following dosing regimen is for patients 5 years of age and older:
- Day 1: Take one 100mg tablet once daily. The tablet must be placed under the tongue and allowed to dissolve.
- Day 2: Dissolve two 100mg tablets at once under the tongue once daily.
- Day 3: Dissolve one 300mg tablet under the tongue once daily.
Wash your hands thoroughly after handling Oralair®.
The immune system is the target of immunotherapy. The aim is to prevent or suppress allergic symptoms, such as allergic rhinitis, through repeated administration of the cause of the allergy. The effect of sublingual immunotherapy is thought to be mediated through local and systemic immunomodulatory mechanisms (immune deviation) including changes in allergen specific antibodies and regulatory T- cells leading to long-term tolerance development.
Along with its benefit, grass pollen allergen extract can cause some unwanted effects. Because patients are being treated with a known allergen in an attempt to desensitize them to it, it is possible that the patient will experience mild allergic reactions during treatment. Mild to moderate local reactions to the tablet may be experienced. Fifty percent of these reactions occur in the first three days of treatment when the dose is increasing.
Possible side effects of grass pollen allergen extract include:
- itching in the mouth
- itching in the ears
- itching in the eyes
- irritation of the throat
- runny nose
- blocked nose
If signs of a severe allergic reaction occur, contact your physician immediately. Signs of a severe reaction include:
- swelling of the throat
- difficulty swallowing or breathing
- voice changes
Treatment with grass pollen allergen extract should only be prescribed and initiated by physicians with adequate training and experience in the treatment of respiratory allergic diseases. In case of pediatric treatment, the physicians should have the corresponding training and experience in children.
- The first tablet must be taken at the physician's office under medical supervision and the patient must be monitored for at least 30 minutes.
- Extra precautions must be taken while treating children. Each time a dose is given, the child must be supervised by an adult for at least 30 minutes.
- Because this medication contains grass pollen extracts, you may expect mild to moderate local allergic reactions (such as swelling of the mouth or a discomfort feeling in the mouth) during treatment.
- If you experience, stronger allergic reactions with a feeling of swelling in the throat, difficulty swallowing or breathing and voice changes, contact your physician immediately. The treatment has to be stopped immediately until your physician advises otherwise.
- Oralair® contains lactose. Patients who are allergic to lactose should not use grass pollen allergen extract tablets.
Use in pregnancy and breastfeeding: Experience is limited. Consult your doctor or pharmacist before using.