Grazax - instructions for use, dose, side effects, contraindications

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Dosage form: & nbsplyophilizate tablet

Composition:

1 tablet-lyophilizate contains:

Active substance: frozen drops of pollen allergen extract Timofeevka meadow (Phleum pratense) 75 000 SQ-T*.

Excipients: gelatin (fish high molecular weight) - 1.50 mg, gelatin (fish standard molecular weight) - 13.50 mg, mannitol - 12.70 mg, sodium hydroxide - q.s. to pH 7.5.

*SQ-T dose unit for Grazax®.

Description:

Round lyophilized tablets from white to almost white, with a circular engraving on one side.

Pharmacotherapeutic group:MIBP is an allergen

ATX: & nbsp

Allergens of grass pollen

Pharmacodynamics:

Immunobiological properties

Allergen specific immunotherapy (ASIT) consists in the repeated administration of allergens to persons with allergies and is directed to the activation of immunomodulatory mechanisms that ensure a steady decrease in the severity of allergy symptoms, a reduction in the need for medications for symptomatic allergy therapy and an improvement in the quality of life during the subsequent exposure to a natural allergen.

The pharmacodynamic effect is due to the effect of the drug on the immune system and is manifested in the modulation of the immune response to the allergen that the patient receives.A complete and accurate mechanism of action of the allergen of specific immunotherapy has not been fully studied and described. It is shown that treatment with Grazax® causes a systemic immune response with the formation of competing antibodies to the allergens of Timofeyevka grass, which is manifested in an increase in the titer of specific IgG₄ during therapy for 3 years. Increased titre of specific IgG₄ remains for 2 years after the completion of the course of treatment with Grazax®. The clinical significance of these immunobiological parameters is not currently established.

Pharmacokinetics:

Most of the allergens of Grazax® are polypeptides and proteins, which are expected to break down into amino acids and small polypeptides in the lumen of the gastrointestinal tract and in tissues. It is assumed that the allergens of Grazax® are practically not absorbed into the vascular system. Therefore, pharmacokinetic studies in animals or clinical studies on the pharmacokinetic profile and metabolism of Grazax® have not been carried out.

Indications:

Therapy of allergic rhinitis and conjunctivitis in adults and children (5 years and older), modifying the course of the disease,caused by sensitization to pollen grasses with cross-sensitization to pollen Timofeevka meadow (Phleum pratense), diagnosed by the results of a positive skin prik-test and / or identified by a specific IgE, and manifested clinically significant symptoms.

Contraindications:

- Hypersensitivity to any of the excipients;

- oncological diseases or systemic diseases affecting the immune system, for example, autoimmune diseases, diseases caused by the formation of immune complexes or immunodeficiency diseases;

- inflammatory diseases of the oral mucosa with severe lesions, such as red lichen planus with ulceration or severe mycosis of the oral mucosa:

- uncontrolled or severe bronchial asthma (volume of forced exhalation in the first second (FEV₁) in adults - less than 70% of the proper value after adequate pharmacotherapy, FEV₁ in children - less than 80% of the proper value after adequate pharmacotherapy);

- beta-blocker therapy, including topical dosage forms;

- age up to 5 years (not enough data on efficiency and safety).

Carefully:

Food allergy to fish; bronchial asthma; previous systemic reactions to subcutaneous immunotherapy with allergens of herbs (see section "Special instructions").

Pregnancy and lactation:

Pregnancy

Data on the clinical experience of Grazax® during pregnancy are not available. Studies in animals have not revealed any increase in risk to the fetus. Do not start Grazax® during pregnancy. If the pregnancy occurred during the period of therapy, the treatment can be continued after assessing the general condition of the patient (including lung function), taking into account the response to the previous administration of Grazax®. Patients with bronchial asthma in the anamnesis are recommended to carefully monitor the doctor during pregnancy.

Breastfeeding period

Clinical data on the use of Grazax® during breast-feeding are not available. No effect of the drug on the infant is expected.

Fertility

Clinical evidence of the effect of Grazax® on fertility is not available.

Dosing and Administration:

Grazaks® drug therapy should be started only under the supervision of a physician with experience in the treatment of allergic diseases and the possibility to arrest the allergic reaction. In applying the drug Grazaks® pediatric physician must have relevant experience in the treatment of allergic diseases in children.

It is recommended to take the first tablet of the drug under the supervision of a doctor to monitor the patient's condition for 20-30 minutes.

The tablet should be taken immediately after opening the blister. Tablet to be removed from the blister with dry fingers, placed under the tongue and leave it up to complete dissolution. Do not swallow saliva for one minute after taking the drug. Do not eat or drink for the next 5 minutes (see the illustrations below).

Adults and children (5 years and older)

The recommended daily dose for adults and children (5 years and above) - one tablet of the drug Grazaks® 75,000 SQ-T per day.

Age to 5 years

The clinical experience of immunotherapy with Grazax® in children under 5 years is limited.

Elderly patients over 65 years of age

The clinical experience of carrying out immunotherapy with Grazax® in elderly patients over 65 years is limited.

For pre-seasonal-seasonal allergy therapy, taking the drug 1 tablet a day must begin at least 4 months before the expected start of flowering of the herb and continue until the end of its flowering. In case the treatment is started 2-3 months before the flowering season, one can also expect a certain clinical effect of the drug.

For the year-round disease-modifying therapy, it is recommended to take the drug 1 tablet per day for three years continuously.

Do not take more than one tablet a day. If you miss the drug, you need to return to the usual reception schedule the next day. If the admission pass is more than 7 days in a row, consult your doctor.

If, during the treatment with Grazax®, begun at least 4 months before the expected onset of flowering of the herb, there is no significant reduction in the severity of symptoms during the first flowering season, then subsequent treatment with the drug is inappropriate.

Side effects:

The most frequently reported adverse reactions to Grazax® are local allergic reactions in the mucous membrane of the oral cavity, mostly of mild to moderate severity. In most patients, these reactions occurred at the beginning of therapy, lasting from several minutes to several hours after each administration of Grazax® and, as a rule, stopped spontaneously within 1-7 days.

The following are side effects identified in the clinical trials of Grazax® in adults and children with seasonal rhinoconjunctivitis associated with flowering grasses, including patients with mild to moderate bronchial asthma, also associated with grass blooming.

According to the WHO classification, all reactions are presented according to organ systems and development frequency: very frequent (≥1 / 10), frequent (from ≥1 / 100 to <1/10), infrequent (from ≥1 / 1000 to <1/100 ), rare (≥1 / 10000 to <1/1000), very rare (<1/10000).

System of organs	Frequency development of	Adverse Reactions
Infectious and parasitic diseases	highly frequent	nasopharyngitis
	frequent	pharyngitis, rhinitis, upper respiratory tract infections
	infrequent	laryngitis
Violations of the blood and lymphatic system	infrequent	lymphadenopathy
Immune system disorders	infrequent	anaphylactic reaction
Disturbances from the nervous system	frequent	headache, paresthesia
Disturbances from the nervous system	infrequent	dizziness, perversion of taste
Disturbances on the part of the organ of sight	frequent	itchy eyes, conjunctivitis
Disturbances on the part of the organ of sight	infrequent	hyperemia of the conjunctiva, inflammation of the conjunctiva, increased lachrymation, swelling in the eye area, edema of the eyelids
Heart Disease	infrequent	heart palpitations
Hearing disorders and labyrinthine disorders	frequent	itching in the ears
Hearing disorders and labyrinthine disorders	infrequent	discomfort in the ear, earache
Disturbances from the respiratory system, chest and mediastinal organs	highly frequent	sore throat
	frequent	sneezing, bronchial asthma symptoms, cough, dryness in the throat, dyspnea, nasal discomfort, nasal congestion, oropharyngeal pain, pharyngeal edema, rhinorrhea, allergic rhinitis
	infrequent	dysphonia, a feeling of tightness in the throat, erythema of the pharynx, hyperesthesia of the pharynx, hypertrophy of the tonsils, wheezing, the formation of vesicles / vesicles on the mucous membrane of the oropharynx
	rare	bronchospasm
Infringements from digestive systems	highly frequent	itching in the mouth
	frequent	edema in the oral cavity, swelling of the lips, discomfort in the oral cavity, oral paresthesia, stomatitis, tongue edema, dysphagia, abdominal pain, diarrhea, dyspepsia, nausea, vomiting
	infrequent	erythema of the oral mucosa, discomfort in the oropharynx, edema of the palate, dry mouth, bubbles on the lips, cheilitis, mouth pain, oral disease, swallowing pain, enlargement of the salivary glands, hypersecretion of the salivary glands, swelling of the gums, aphthous stomatitis, oral ulcers, vesicles / vesicles in the tongue, language diseases, glossitis, glossodynia, gastritis, gastroesophageal reflux, abdominal discomfort, loss of appetite
	rare	eosinophilic esophagitis
Disturbances from the skin and subcutaneous tissues	frequent	itching, urticaria, eczema, rash
Disturbances from the skin and subcutaneous tissues	infrequent	angioedema, swelling of the face, erythema, hyperemia of the skin
Systemic disorders and disorders at the site of administration	frequent	weakness, discomfort in the chest, fever
	infrequent	pain in the chest, a feeling of heat, malaise, foreign body sensation

When there are pronounced adverse reactions during the treatment period, it is necessary to consider the possibility of using antiallergic drugs.

During the post-marketing use of the drug, cases of serious anaphylactic reactions, including anaphylactic shock, were noted. Therefore, at the beginning of treatment, an important precaution is careful monitoring of the doctor. In some cases, severe anaphylactic reactions have been observed with subsequent therapy after taking the first pill (see the section on "Dosage and administration" and "Interaction with other drugs").

When severe systemic reactions occur, angioedema, difficulty swallowing, difficulty breathing, voice changes, arterial hypotension, or sensation of a foreign body in the throat should immediately consult a doctor. In such cases it is necessary to stop taking the medication completely or for the time recommended by the doctor.

Children

In general, the profile of adverse reactions in children and adolescents with Grazax® is similar to that in adults. Frivolous systemic allergic reactions, inflammation of the conjunctiva, erythema of the pharynx, bubbles on the lips,an increase in the salivary glands, erythema, ear pain and chest pain were observed in children with a higher frequency (often) compared to the table above. In general, the severity of the reactions was assessed from mild to moderate.

Overdose:

In clinical studies, patients with pollen allergies received the drug in doses up to 1 000 000 SQ-T.

When taking the drug at a dose higher than the recommended dose, the risk of side effects may increase, including the risk of systemic or severe local reactions. If severe reactions occur such as angioedema, difficulty swallowing, difficulty breathing, changing the voice or feeling foreign body in the throat, you should immediately consult a doctor. Symptomatic therapy is used to treat these reactions.

When developing these reactions, treatment should be discontinued completely or follow the recommendations of the doctor.

Interaction:

Simultaneous use with symptomatic antiallergic drugs (eg, antihistamines, corticosteroids and / or mast cell membrane stabilizers) can improve the tolerability of immunotherapy by the patient.

Data on the possible risks with simultaneous use of Grazax® and other allergens used for immunotherapy are not available.

Special instructions:

When surgical interventions in the oral cavity, including the removal of teeth, therapy with Grazax® should be stopped for 7 days before the healing of the oral mucosa.

In patients with bronchial asthma and concomitant acute upper respiratory infection, treatment with Grazax® should be temporarily suspended until infection is resolved.

The patient, when treated with Grazax®, is exposed to an allergen that causes allergy symptoms, therefore, during the period of therapy, one should expect mainly local allergic reactions of mild to moderate severity. If there are significant local side reactions, you should consider the possibility of using antiallergic drugs (eg, antihistamines).

In the course of post-marketing use of the drug, cases of serious anaphylactic reactions were noted, therefore, at the beginning of treatment, careful medical supervision is an important precaution.In some cases, severe anaphylactic reactions were observed with subsequent therapy after taking the first tablet.

The first signs of development of systemic reactions may be hyperemia, intense itching of the palms and feet, as well as other areas of the body, as in urticaria. There may also be a feeling of heat, general discomfort and agitation or anxiety. If severe systemic reactions occur, angioedema, difficulty swallowing, difficulty breathing, changes in voice, arterial hypotension, or sensation of a foreign body in the throat should immediately consult a doctor. When developing these reactions, treatment should be discontinued completely or follow the recommendations of the doctor. If patients with concomitant bronchial asthma develop symptoms that indicate a worsening of the course of the disease, therapy with Grazax® should be stopped and immediately contacted by a doctor to decide whether to continue taking the drug.

The risk of developing a severe reaction with Grazax® in patients with previous systemic reactions to subcutaneous immunotherapy with grass allergens may be higher.It is necessary to carefully weigh the benefit and risk of using Grazax® before starting therapy and to provide measures to stop the allergic reaction.

Serious anaphylactic reactions can be stopped with adrenaline. The effect of epinephrine can be enhanced in patients receiving tricyclic antidepressants and / or monoamine oxidase inhibitors, with a possible fatal outcome, which must be taken into consideration before the initiation of specific immunotherapy.

During the post-marketing application of Grazax®, individual cases of eosinophilic esophagitis were noted. In patients with severe or chronic gastroesophageal symptoms, such as dysphagia or dyspepsia, consideration should be given to discontinuing Grazax® therapy.

The clinical experience of simultaneous vaccination and treatment with Grazax® is not available. Vaccination is possible without suspension of therapy with Grazax® after a medical assessment of the patient's general condition.

Grazax® contains gelatin, derived from fish.The available data do not indicate an increased risk of allergic reactions in patients with severe allergy to fish in the anamnesis. Nevertheless, caution should be exercised at the beginning of treatment with Grazax® in such patients.

Effect on the ability to drive transp. cf. and fur:

Grazax® does not affect or has a significant effect on the ability to drive vehicles and mechanisms.

Form release / dosage:

Liofilizate tablets, 75,000 SQ-T.

Packaging:

For 10 tablets in an aluminum blister. For 3 blisters together with instructions for use in a pack of cardboard.

Storage conditions:

Store and transport at a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

4 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-004127

Date of registration:08.02.2017

Expiration Date:08.02.2022

The owner of the registration certificate:ALK-Abello A / SALK-Abello A / S Denmark

Manufacturer: & nbsp

CATALENT UK SWINDON ZYDIS, Ltd. United Kingdom

Representation: & nbspABBOTT LABORATORIES LLC ABBOTT LABORATORIES LLC Russia

Information update date: & nbsp15.03.2017

Illustrated instructions

Instructions

Grazax® (Grazax®)