ORALAIR

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

ORALAIR: instructions for use and reviews

1. Release form and composition
2. Pharmacological action
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. Drug interactions
12. Analogs
13. Terms and conditions of storage
14. Terms of dispensing from pharmacies
15. Reviews
16. Price in pharmacies

Latin name: Oraleyr

ATX code: V01AA02

Active ingredient: grass pollen allergens (Grass pollen allergens)

Manufacturer: Senexi SAS (Cenexi SAS) (France); Delpharm Lille S.a. S. (Delpharm Lille SaS) (France)

Description and photo update: 2019-17-10

Prices in pharmacies: from 3999 rubles.

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ORALAIR is a medical immunobiological preparation (MIBP), grass pollen allergen.

Release form and composition

The drug is produced in the form of sublingual tablets: biconvex, round, from beige to white, with possible inclusions from light to dark brown, engraved 100 on each side for a tablet with an activity of 100 IR *, with an activity of 300 IR - engraving 300 [3 pcs. (100 IR) in a small blister, 28 pcs. (300 IR) in a large blister, in a cardboard box a set including a small + large blister; 30 pcs. (300 IR) in a blister, in a cardboard box 1 or 3 blisters. Each pack also contains instructions for the use of ORALEYR].

* IR - Reactivity Index (biological standardization unit).

1 tablet contains:

active ingredients: allergen extract from a mixture of grass pollen (sweet spikelet, meadow bluegrass, hedgehog, timothy grass, perennial chaff in equal proportions) - 100 or 300 IR;
additional components: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide.

pharmachologic effect

When carrying out ASIT (allergen-specific immunotherapy), the exact mechanism of action of the allergen has not been fully clarified, but the following biological action of the drug ORALEYR is proven:

an increase in the concentration of immunoglobulins of the G4 subclass (IgG4), which act as blocking antibodies;
a long-term decrease in the plasma level of immunoglobulin E (IgE), which is responsible for immediate-type allergies;
decrease in the reactivity of cells involved in an allergic reaction;
increased interaction activity between T-lymphocytes (T-helpers - Th) Th1 and Th2, and even Th0, which positively alters the production of cytokines that regulate the concentration of IgE [reducing the production of interleukin 4 (IL-4) and increasing the production of interferon gamma].

ASIT also induces an immune response, which allows maintaining immunobiological memory for a long period. Higher efficiency of ASIT is demonstrated in cases when therapy is started at an earlier stage of the disease.

Indications for use

ORALAIR is recommended for ASIT, which is indicated for persons with type I allergic reaction [IgE (immunoglobulin E) mediated], manifested in the form of rhinitis or rhinoconjunctivitis (moderate / severe course), as well as those with hypersensitivity to meadow grass pollen (meadow grass, sweet spikelet, common hedgehog, perennial chaff, timothy grass), confirmed by positive results during skin testing and / or increased level of specific IgE

Immunotherapy with MIBP ORALAIR is prescribed for adults and children who have reached 5 years of age.

Contraindications

autoimmune diseases or severe immunodeficiencies;
severe and / or uncontrolled bronchial asthma, with a forced expiratory volume of less than 70%;
malignant neoplasms;
inflammatory lesions of the oral mucosa (ulceration, mycoses of the oral mucosa; erosive and ulcerative form of lichen planus);
hereditary intolerance to galactose, impaired absorption of glucose and galactose, Lapp lactase deficiency;
combination therapy with β-blockers;
hypersensitivity to any of the additional components of ORALEYR.

ORALEYR, instructions for use: method and dosage

ORALAIR is taken sublingually (placed under the tongue), on an empty stomach, 1 time per day. The tablet should be kept under the tongue until it is completely dissolved - for at least 1 minute.

ORALAIR should be prescribed and started by a physician with appropriate training and experience in the treatment of allergic diseases. When using MIBP in pediatric practice, the doctor must have relevant experience in treating children. The first tablet should be taken under the supervision of a physician in order to monitor the patient's condition for 30 minutes.

Treatment is carried out in 2 stages - initial therapy (includes the first 3 days of dose escalation) and supportive therapy.

Recommended treatment regimen and doses of ORALEYR at the initial stage (1st month of treatment):

small blister (100 IR tablets): the first day - 1 pc., the second day - 2 pcs;
large blister (300 IR tablets): from the third to the thirtieth day of the course - 1 pc daily.

From the 2nd month, the next stage of treatment begins - a course of maintenance therapy, during which it is recommended to take 1 tablet of 300 IR per day until the end of the dusting season.

ASIT should be carried out for 3-5 years by the above-described two-stage courses, starting 4 months before the expected start of the flowering season and continuing until its end.

In the course of a long-term study, it was found that after ASIT for 3 consecutive years according to the recommended scheme, the effect of therapy persists in the next season, without treatment.

When, against the background of treatment, it is not possible to achieve improvement during the first flowering season, further therapy is inappropriate.

If, during the treatment, a pass in admission was made less than 7 days, you can continue therapy without changes. With a pass exceeding 7 days, it is necessary to start taking the pills under the supervision of a doctor.

Side effects

During treatment with ORALAIR, there is a risk of both local and general side effects.

Side effects at the site of use, such as irritation in the throat, itching in the mouth, are usually observed at the beginning of the course, are transient and subside with time. With the development of such reactions, symptomatic treatment is allowed (including antihistamines).

It is required to immediately discontinue MIBP therapy in the event of significantly pronounced adverse effects in the throat or systemic allergic reactions (rapid development of reactions on the mucous membranes and / or skin, shortness of breath, persistent abdominal pain, lowering blood pressure and / or related symptoms). Treatment can be resumed only after consulting a specialist.

Common side reactions from systems and organs that can develop when taking ORALAIR tablets:

respiratory system, organs of the chest and mediastinum: very often - irritation in the throat; often - allergic rhinitis (sneezing, runny nose, nasal congestion, discomfort in the nose), nasal congestion, dry throat, cough, discomfort / pain in the oropharynx, swelling of the pharynx, dyspnoea, dysphonia, blisters in the oropharynx, asthma; infrequently - a feeling of tightness / numbness in the throat, wheezing, laryngeal edema;
nervous system: very often - headache; infrequently - drowsiness, change in taste, dizziness; rarely - anxiety;
mental disorders: infrequently - depression;
immune system: infrequently - oral allergic syndrome, hypersensitivity;
blood and lymphatic system: infrequently - enlarged lymph nodes;
infectious lesions: often - rhinitis, nasopharyngitis; infrequently - otitis media, oral herpes;
organ of vision: often - lacrimation, itching in the eyes, conjunctivitis; infrequently - eye redness, keratoconjunctivitis dry (dry eye syndrome), eye swelling;
organ of hearing and labyrinthine disorders: often - itching in the auditory canal; infrequently - discomfort in the ear area;
vessels: rarely - redness of the skin due to increased blood flow to the capillaries;
gastrointestinal tract: very often - itching in the mouth; often - dry mouth, discomfort in the mouth, oral hypoesthesia, itching of the tongue / lips, burning mouth syndrome, stomatitis, swelling of the lips / tongue, swelling of the oral cavity, oral paresthesia, swallowing disorders, dyspepsia, abdominal pain, nausea, diarrhea, vomiting; infrequently - an increase in the salivary glands, increased salivation, pain in the oral cavity, glossitis, cheilitis, gingivitis, pain when swallowing, ulcerative stomatitis, swelling of the soft palate; disorders in the oral cavity and disorders in the tongue area (clinical signs of an allergic reaction in the oral cavity or in the tongue area caused by the local release of histamine); belching, pain in the esophagus, gastritis, gastroesophageal reflux;
trauma, intoxication and complications of manipulation: rarely - a tendency to mechanical damage to the skin;
skin and subcutaneous tissues: often - itching, urticaria, atopic dermatitis; infrequently - rash, acne, Quincke's edema; rarely - facial edema;
laboratory and instrumental data: rarely - an increase in the number of eosinophils;
general disorders and disorders at the injection site: often - discomfort in the chest area; flu-like syndrome, asthenia.

In clinical studies in adult patients, a decrease in the number of adverse reactions during treatment in the 2nd and 3rd seasons of flowering was found when compared with the 1st season.

In patients under 18 years of age, the following undesirable effects may be observed more often than in adults: very often - nasopharyngitis, cough, oral edema; often - discomfort in the ear, oral allergic syndrome, glossitis, cheilitis, a feeling of tightness in the throat. Also, in the treatment of children and adolescents, the following violations were recorded: often - tonsillitis, bronchitis; infrequently - chest pain; frequency unknown (post-registration experience of use) - systemic allergic reaction, exacerbation of asthma, eosinophilic esophagitis.

Overdose

No cases of overdose with the immunobiological preparation ORALEYR were registered. If the recommended dose is exceeded, the threat of side effects, including severe local and systemic reactions, is aggravated. In case of the development of such serious phenomena as voice change, difficulty swallowing, Quincke's edema, a feeling of tightness in the neck, shortness of breath, you should urgently seek medical help.

In the event of the possible occurrence of the above reactions caused by an overdose of ORALEYR, symptomatic therapy is required.

special instructions

If it is necessary to carry out surgical operations in the oral cavity, including tooth extraction, it is required to temporarily stop taking ORALAIR until it is completely cured (for a period of at least 7 days).

Episodes of the development of eosinophilic esophagitis caused by sublingual immunotherapy have been recorded. If persistent or severe symptoms from the upper alimentary canal appear during the use of ORALAIR tablets, such as swallowing problems or painful sensations in the chest, the use of the drug should be discontinued and a doctor should be consulted. In this case, therapy can be resumed only on the recommendation of a specialist.

Influence on the ability to drive vehicles and complex mechanisms

ORALAIR has no negative impact on the ability to drive vehicles and control complex mechanisms.

Application during pregnancy and lactation

There are no data on the use of ORALAIR by pregnant women. According to the results of preclinical studies conducted on animals, no direct or indirect effects on reproductive function were found.

Oraleir should not be prescribed to pregnant women. But if pregnancy occurred against the background of therapy, it is allowed to continue the latter only under close medical supervision.

There is no data on the excretion of the active substance in breast milk, however, ASIT is not recommended during breastfeeding. Since the systemic effect of ORALEYR on a nursing woman is insignificant, during lactation its use is possible after assessing the ratio of the expected benefit and potential risk.

Pediatric use

In children under the age of 5 years, the effectiveness and safety of ASIT have not been established.

For children over 5 years of age and adolescents, MIBP doses are recommended, as for adults.

Drug interactions

funds for symptomatic therapy of allergies (steroids, antihistamines): there is no drug interaction with these drugs, which is confirmed by the results of clinical studies;
other allergens used for immunotherapy: there is no information about the possible risk of combination treatment with these drugs;
monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants: extreme caution is required when combined with these drugs, since if epinephrine is prescribed to relieve possible severe allergic reactions, the risk of life-threatening side effects is aggravated;
vaccines: there is no clinical experience of the simultaneous use of ORALAIR and vaccination, as a result of this, the latter can be carried out without interrupting drug therapy only after agreement with the doctor.

Analogs

Analogues of ORALAIR are RAGVISAX, Grazax, Lais Grass, Fostal "Tree pollen allergen", Mixed allergen from meadow grass pollen for diagnosis and treatment, Allergen from wormwood pollen for diagnosis and treatment, Dandelion pollen allergen for diagnosis and treatment, H -AL therapeutic "Autumn pollen mixture".

Terms and conditions of storage

Store at a temperature not exceeding 25 ° C, out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about ORALAIR

According to the majority of reviews, ORALAIR is an effective drug used to treat grass pollen allergy. Many patients note that positive dynamics is observed at 1–2 years of admission, and the therapeutic effect is achieved at 3–4 years. Some consider the drug to be the only effective treatment for pollinosis. To be treated with these MIBP, however, it is recommended only under the strict supervision of an allergist.

Almost all of the disadvantages of the drug include its high cost, the need for long-term therapy and the presence of a large number of adverse reactions. In some cases, they indicate a lack of result after the treatment with ORALEYR.

Price for ORALAIR in pharmacies

The price for ORALAIR, sublingual tablets, can be: a set of two blisters 3 pcs. (100 IR) + 28 pcs. (300 IR) - 3950 rubles; packing 30 pcs. (300 IR) - 4350 rubles; packing 90 pcs. (300 IR) - 9100 rubles.

ORALAIR: prices in online pharmacies

Drug name

Price

Pharmacy

Oraleir 100 IR + 300Ir sublingual tablets Initial course 31 pcs.

3999 RUB

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Oraleir 300 IR sublingual tablets Supporting course 30 pcs.

3999 RUB

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Oraleir tab. sublingual 100ir # 3 + 300ir # 28

4439 RUB

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Oraleir 300 IR sublingual tablets Supporting course 90 pcs.

RUB 9581

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Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!