Details for: ORALAIR
Company: STALLERGENES CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02381885 | ORALAIR | GRASS POLLEN ALLERGEN EXTRACT | 100 UNIT | TABLET | SUBLINGUAL |
| 02381893 | ORALAIR | GRASS POLLEN ALLERGEN EXTRACT | 300 UNIT | TABLET | SUBLINGUAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
ORALAIR is used for the treatment of patients with a history of allergy to a specific grass pollen. Grass pollen allergy is characterised by rhinitis (sneezing, runny or itchy nose, nasal congestion) with or without conjunctivitis (itchy and watery eyes).
Before the treatment, your allergy will be confirmed by a physician with adequate training and experience in allergic diseases, who will perform appropriate skin and/or blood tests.
There is no experience with ORALAIR in children younger than 5 years and in patients over 50 years of age.
What it does
ORALAIR reduces symptoms associated with exposure to specific grass allergens. It contains an allergen extract that helps to make you less sensitive to the grass pollens you are allergic to.
When it should not be used
Do not use ORALAIR if:
- you are allergic (hypersensitive) to any of the other ingredients of ORALAIR (see What the nonmedicinal ingredients are);
- you are taking beta-blockers and ACE inhibitors (medicines prescribed for heart conditions and cardiovascular diseases, for example high blood pressure);
- you suffer from severe and/or unstable asthma;
- your immune system is very weakened or if you suffer from a disease that attacks your own immune system;
- you suffer from a malignant disease (for example cancer);
- you have any inflammation in your mouth
What the medicinal ingredient is
Grass pollen allergen extract from: Cocksfoot (Dactylis glomerata L.), Sweet vernal grass (Anthoxanthum odoratum L.), Rye grass (Lolium perenne L.), Meadow grass (Poa pratensis L.) and Timothy (Phleum pratense L.).
What the non-medicinal ingredients are
Colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose.
What dosage form it comes in
ORALAIR sublingual tablets are available in two strengths, each containing either 100 IR or 300 IR of grass pollen allergen extract. The IR (index of reactivity) expresses the potency (strength) of the tablets.
ORALAIR (100 IR and 300 IR) is supplied in blister cards, divided into blister units that contain individual tablets. The tablets of 100 IR are white to beige, engraved “100” on both surfaces. The tablets of 300 IR are white to beige, engraved “300” on both surfaces.
ORALAIR is supplied in blisters of 3 sublingual tablets of 100 IR and blisters of 30 sublingual tablets of 300 IR (cartons with 30 or 90 tablets).
Warnings and precautions
Serious Warnings and Precautions
- ORALAIR is intended for use only by physicians with adequate training and experienced in the treatment of allergic diseases. With prescription for children, the doctor should also have the relevant experience.
- The first tablet of ORALAIR must be taken at the 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.
- The administration of ORALAIR to children must be supervised by an adult for at least 30 minutes after each dose.
- Because ORALAIR contains grass pollen extracts, you may therefore expect mild to moderate local allergic reactions (such as swelling of the mouth or a discomfort feeling in the mouth) during treatment. Your physician will explain to you the type of reactions you may experience and what to do about it.
- 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.
BEFORE you use ORALAIR talk to your physician or pharmacist if:
- You have intolerance to some sugars or severe allergies to milk as ORALAIR contains lactose.
- You have to undergo surgery in the mouth or if you are having a tooth pulled. You should stop the treatment with ORALAIR for 7 days to allow your oral cavity to heal. Thereafter, restart the treatment with the previous dosage. If you stopped the treatment for more than 7 days, please ask your physician how you should restart the treatment.
- You have any history of eosinophilic esophagitis, symptoms of which can include: severe or persistent upper abdominal pain, swallowing difficulties or chest pain.
- You are pregnant or planning to become pregnant. At present there is no experience for the use of ORALAIR during pregnancy. Therefore, you should not start an immunotherapy if you are pregnant. If you become pregnant, speak to your physician about whether it is appropriate for you to continue the treatment.
- You are breast feeding. There is no experience for the use of ORALAIR during breast-feeding as well. No effects on infants who are breast-fed during the treatment are anticipated. However, you should not start an immunotherapy if you are breast-feeding. If you wish to breastfeed while on treatment, speak to your physician about whether it is appropriate for you to continue the treatment.
No effect on the capacity to drive or operate machinery has been observed with ORALAIR.
Interactions with this medication
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Your doctor will tell you if it is safe to take other medicines while you are using ORALAIR.
Proper use of this medication
Always take ORALAIR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
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, in an empty mouth.
The administration of ORALAIR to children must be supervised by an adult for at least 30 minutes after each dose.
Usual Dose
Adults and children above the age of 5
The therapy is done as follows:
- the dose is increased over the first 3 days of treatment from 100 IR to 300 IR;
- the treatment is then continued with an ORALAIR dose of 300 IR per day.
When you begin the treatment with ORALAIR, use the small blister which contains 3 tablets of 100 IR during the first 2 days of treatment:
Starting on Day 3 and onwards, take 1 tablet of 300 IR once a day until the end of the treatment duration.
Method of administration
Keep the tablet (or the 2 tablets on day 2) under your tongue until complete dissolution. Swallow the tablet after about 1 minute.
Duration of treatment
Start your ORALAIR treatment on the day determined by your physician. The treatment starts about 4 months before the first expected appearance of the pollen and continues until the end of the pollen season.
General information about the safe and effective use of ORALAIR
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
It is recommended to wash your hands after taking ORALAIR to prevent inadvertent spreading.
If necessary, your physician may at the same time prescribe medications to treat the possible allergic reactions.
Overdose
If you take more ORALAIR than you should, you may experience allergic symptoms including local symptoms from mouth and throat. If you experience severe symptoms, immediately contact your physician.
Missed Dose
If you miss one dose of ORALAIR, skip the missed dose and continue with the next scheduled dose. Do not take a double dose to make up for forgotten dose.
If you stop taking ORALAIR
If you stop taking ORALAIR, you may not have an effect of the treatment.
If you interrupt the treatment with ORALAIR during the continuation phase for less than one week, you can take up treatment where you left off. If you stopped the treatment for more than 7 days, please ask your physician how you should restart the treatment.
Side effects and what to do about them
Like all medicines, ORALAIR can cause side effects, although not everybody gets them.
During treatment with ORALAIR, you will be exposed to substances that may cause local allergic reactions and/or allergic reactions that could affect your whole body. You may therefore expect mild to moderate local allergic reactions (such as swelling of the mouth or a discomfort feeling in the mouth) during this time. About half or fifty percent (50%) of those reactions occur during the first three days of treatment. The reactions are temporary and will go down.
Significant side effects or symptoms you should look out for, and measures to be taken if you are affected:
Uncommonly, stronger allergic reactions can occur, with a feeling of swelling in the throat, difficulty swallowing or breathing and voice changes.
In these cases please contact your physician immediately. The treatment has to be stopped immediately until your physician advises otherwise.
During treatment, if you have severe or persistent upper abdominal pain, swallowing difficulties or chest pain, please contact your doctor who may reconsider your treatment.
Other possible side effects
The following side effects were reported by adults who were treated with ORALAIR in a clinical study:
Very common (seen in at least 1 in 10 patients):
Itching in the mouth and/or eyes and/or ears, irritation of the throat, runny nose, blocked nose, sneezing, cough.
Common (seen in at least 1 in 100 patients, but in less than 1 in 10 patients):
Headache, general feeling of tingling or numbness, watery eyes, swelling and/or irritation inside the nose, shortness of breath, swelling in the mouth and/or throat and/or lips, dry throat, inflammation and/or burning of the tongue and/or mouth, swollen tongue, blisters in the mouth, mouth tingling, numbness and/or pain, dry mouth, facial swelling, itching, nettle-rash, tiredness, foreign body sensation in the mouth, stomach pain, feeling sick, indigestion, diarrhoea, throat swelling and/or tightness, pain in the throat and voice box area, gullet pain, difficulty in swallowing, acid stomach, chest discomfort, anxiety, mouth and/or tooth pain, altered voice, vomiting, nausea.
Uncommon (seen in at least 1 in 1,000 patients, but in less than 1 in 100 patients):
Abnormal sense of taste, itching and/or swelling of the eyelids, dizziness, irritation of the voice box, dry nose, diarrhoea, inflammation of the mouth, overproduction of saliva, belching, tongue blistering, problems with the tongue, lip blister, local swelling, swelling of the ankles, feet or fingers, allergic reaction, fatigue, thirst, noises in the ear, dry eyes.
The following side effects were reported by children and adolescents who were treated with ORALAIR in a clinical study:
Very common (seen in at least 1 in 10 patients):
Itching in the mouth, collection of fluid in the mouth tissue, cough.
Common (seen in at least 1 in 100 patients, but in less than 1 in 10 patients):
Itchy eyes, itching in the ears, irritation of the throat, blocked nose, asthma, sneezing, uncomfortable feeling in the nose, shortness of breath, irritation of the voice box, throat tightness, swollen lips, swollen tongue, formation of blisters in the mouth, inflammation of the mouth, vomiting, dry and/or cracked lips, inflammation of the tongue and/or lips, uncomfortable feeling in the mouth, allergic inflammation of the skin, itching, chest discomfort, headache, runny nose, voice alteration, stomach pain, painful swallowing, inflammation of the nose, throat and/or tonsils, bronchitis, influenza, shortness of breath, rash, watery eyes, abdominal pain, diarrhoea, nausea, dizziness, nose bleeding.
Uncommon (seen in at least 1 in 1,000 patients, but in less than 1 in 100 patients):
A feeling that the ear is blocked, uncomfortable feeling in the ear, swelling of the voice box and the throat, feeling sick, indigestion, difficult swallowing, reduced sensitivity in the mouth, pain in the mouth, swelling of the tongue and/or mouth, inflammation of the skin, growing pains, weakness, chest pain, allergic reaction.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Call your physician immediately and stop taking drug |
|---|---|---|---|
| Uncommon | |||
| Stronger allergic reactions with a feeling of swelling in the throat, difficulty swallowing or breathing or voice changes. | ✔ | ||
| Common | |||
| Swelling and/or irritation inside the nose, swelling in the mouth and/or throat, blocked and/or runny nose, facial swelling, itching. | ✔ | ||
| Shortness of breath. | ✔ | ||
| Dry throat, sneezing, inflammation and/or burning of the tongue, swollen tongue, blisters in the mouth, mouth tingling. | ✔ | ||
| Rare | |||
| Severe allergic reactions and asthma | Seek emergency medical care immediately | ||
This is not a complete list of side effects. For any unexpected effects while taking ORALAIR, contact your physician or pharmacist.
How to store
Keep out of the reach and sight of children.
Store at room temperature (15°C to 30°C). Store in the original package in order to protect from moisture. The tablet should remain in the sealed blister until use.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about ORALAIR:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://webprod5.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp).
This full document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Stallergenes Canada Inc. at
ca.medicalinformation@stallergenes.com
This leaflet was prepared by Stallergenes Canada Inc.
Last revised: September 2016