Grazax

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Grazax

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Method of action: Allergens

Treatment option:

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Grazax

Quick Facts: Grazax Overview

Property Description
Active ingredient Standardized Phleum pratense (Timothy grass) pollen extract
Form Lyophilisate for sublingual use (fast-dissolving tablet)
Pharmacological class Allergen Immunotherapy (AIT)
Common purpose Long-term desensitization and symptom reduction for grass pollen allergy
Origin / Status Biological drug, natural origin, prescription-only

Defining Grazax: A Disease-Modifying Immunotherapy

Grazax is classified as a specialized biological drug belonging to the Allergen Immunotherapy (AIT) pharmacological class. This classification establishes the medicine as a disease-modifying treatment, distinguishing it from conventional drugs that only offer acute symptomatic relief. Grazax is a prescription-only medicine whose therapeutic goal is to alter the underlying allergic condition. The product is clinically recognized for providing sustained relief of allergic rhinitis symptoms even after the standard treatment course, which is a characteristic feature of a true disease-modifying effect.

Composition and Form: Standardized Sublingual Delivery

The single active component in Grazax is the standardized allergen extract of Phleum pratense, derived from Timothy grass pollen, confirming its natural origin. A key factor is its physical form: the extract is prepared as a fast-dissolving oral lyophilisate, a tablet administered via the sublingual route (under the tongue). This dosage form facilitates the introduction of the allergen extract directly to the oral immune cells, which is necessary for the immune system to initiate the tolerization process. The extract is precisely quantified using a proprietary unit, ensuring every dose provides a consistent and measurable amount of allergen.

Long-Term Goal: Establishing Immunological Tolerance

The overarching therapeutic aim of Grazax is the establishment of long-term immunological tolerance and desensitization to grass pollen. By consistently administering the standardized extract, the treatment works to reduce the body's acute sensitivity over an extended period. This focus on long-term desensitization is intended to decrease the overall severity of symptoms related to seasonal conditions like hay fever and allergic rhinitis, aiming to lessen reliance on other allergy medications in individuals 5 years and older.

Regulatory References

  1. NIH: Allergen Immunotherapy Efficacy

What side effects are possible with Grazax?

Possible side effects and safety information

The safety profile of Grazax (grass pollen allergen extract) is based on data from clinical trials and post-marketing surveillance, as documented by regulatory authorities (e.g., EMA, FDA).

Adverse Reactions by Frequency (Official Classification):

The most commonly expected reactions are local allergic reactions in the mouth and throat. These reactions are typically mild to moderate and generally subside spontaneously within one to seven days of starting therapy.

Frequency Examples of Documented Side Effects
Very Common (May affect more than 1 in 10) Oral pruritus (itching of the mouth), throat irritation, ear pruritus, mouth swelling.
Common (May affect up to 1 in 10) Lip swelling, eye pruritus, sneezing, cough, stomach pain, nausea, urticaria (hives), fatigue, tightness of throat, difficulty swallowing.
Uncommon (May affect up to 1 in 100) Anaphylactic reaction, systemic allergic reaction, palpitations, altered taste, tonsil enlargement, eosinophilic esophagitis.

Serious Adverse Reactions and Safety Restrictions:

Severe, life-threatening allergic reactions, including anaphylaxis, have been reported. For this reason, the first tablet must be taken under medical supervision for at least 30 minutes. Treatment is strictly contraindicated (should not be used) in patients with severe, unstable, or uncontrolled asthma, systemic diseases affecting the immune system (e.g., cancer), or severe inflammation/ulceration in the mouth. Patients with asthma should be aware that the condition is a risk factor for severe systemic reactions.

Population Safety Notes:

There is limited or no clinical experience regarding the use of Grazax in children under 5 years of age, adults over 65 years, or during pregnancy and lactation. Initiation of treatment is generally not recommended in these groups. If a patient with pre-existing asthma becomes pregnant during treatment, continuation requires an individual physician's evaluation.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents state that taking more Grazax than prescribed may lead to exaggerated allergic symptoms, specifically involving local symptoms from the mouth and throat. The principal overdose risk is the potential for a severe, life-threatening allergic reaction, such as anaphylaxis or severe laryngopharyngeal restriction (swelling in the throat).

Overdose Risk & Manifestation Emergency Actions Required
Documented Manifestations Seek immediate medical attention
Allergic symptoms, including local irritation in the mouth and throat. The primary risk is a severe, life-threatening allergic reaction, such as anaphylaxis or severe laryngopharyngeal restriction (swelling in the throat). If you experience severe symptoms (e.g., difficulty breathing, change in voice, rapid swelling, or hypotension), you must immediately contact a doctor or a hospital. Treatment must be discontinued immediately in case of serious reactions.

Management of a severe systemic reaction involves symptomatic and supportive treatment, including the administration of adrenaline (epinephrine). Patients prescribed the US-equivalent tablet are directed to use auto-injectable epinephrine and subsequently seek immediate medical care. Special consideration is given to patients with underlying cardiac disease or those taking beta-blockers, as these conditions can complicate the management of a severe allergic reaction, according to regulatory labeling.

Therapeutic Uses of Grazax

What Grazax Treats: Main Uses and Benefits

Grazax is classified as a disease-modifying treatment used for confirmed grass pollen-induced allergic rhinoconjunctivitis, commonly known as hay fever, in adults and children aged 5 years and older. The indication specifically covers patients with clinically relevant symptoms diagnosed by a positive test to grass pollen.


The therapy is generally applied across domains involving heightened physiological activity to the allergen. It is relevant in conditions involving recurrent or episodic manifestations that include symptoms such as pronounced sneezing, nasal obstruction, runny nose, itchy eyes, and watering eyes. It is relevant when supportive symptom management is appropriate, particularly for patients whose symptoms have not responded well to conventional symptomatic therapies.

As a disease-modifying approach, Grazax contributes to easing the overall symptom burden, which helps maintain a sense of stability when symptoms are more noticeable. It assists with maintaining functional stability and may assist in easing the symptomatic load to potentially reduce reliance on other rescue medications during the grass season.


Quick Fact: Relief for Seasonal Allergies
Therapeutic Scope Supports long-term management of grass pollen-induced allergic rhinoconjunctivitis (hay fever).
Symptom Focus Addresses the combined nasal and ocular symptom cluster.
Patient Benefit Contributes to improved comfort and potentially reduces the need for symptomatic medications.
Clinical Context Relevant when conventional symptomatic therapies provide inadequate control of symptoms.

Eligibility and Restrictions for Use

Eligibility Scope

Category Description (Official Regulatory Status)
Populations Allowed Adults and children 5 years of age and older who have confirmed grass pollen allergy [FDA Prescribing Information].
Use Not Recommended Children under 5 years and older adults over 65 years due to insufficient clinical data [EMA SmPC].
Contraindicated Populations Patients with severe, unstable, or uncontrolled asthma [FDA Prescribing Information]. Patients with FEV1 less than 70% (adults) or less than 80% (children) of the predicted value [EMA SmPC]. Patients with malignant or systemic diseases affecting the immune system (e.g., autoimmune diseases) [EMA SmPC].

Condition-Specific Limitations

Official regulatory documents define specific limitations on use related to certain conditions:

  • Oral Wounds: Treatment must be temporarily interrupted for seven days following oral surgery, dental extraction, or tooth loss to allow the oral cavity to heal [EMA SmPC].
  • Pregnancy/Lactation: Treatment must not be initiated during pregnancy or while breastfeeding, although continuation during pregnancy may be considered after medical evaluation [EMA SmPC].
  • Organ Impairment: Clinical data are not available for use in patients with severe hepatic or severe renal impairment [EMA SmPC].

These rules define the required clinical baseline and patient profile for which the medicine is officially documented as permissible or prohibited.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The regulatory profile for the active ingredient, Standardized Phleum pratense (Timothy grass) pollen extract, confirms that no clinical studies investigating drug interactions have been conducted in humans. Consequently, the documented interaction profile primarily addresses administration constraints and critical safety management considerations for this allergen immunotherapy (AIT) product.


Documented Interaction Categories

Interaction Type Regulatory Status / Official Constraint
Pharmacokinetic / Metabolic None documented. Official labeling states that no human drug interaction studies were performed for the active substance.
Timing-Based Restriction Food or beverage must be avoided for 5 minutes following the sublingual administration of the tablet.
Pharmacodynamic Co-administration with symptomatic anti-allergic agents (e.g., antihistamines, corticosteroids) may increase the patient’s tolerance level to the immunotherapy.

Indirect Interaction: Emergency Epinephrine

The most significant interaction concerns drugs that modify the body's response to epinephrine (adrenaline), which is required for the emergency treatment of severe systemic allergic reactions, a known risk of AIT.

  • Contraindication: Co-administration with Beta-blockers is contraindicated in some official labels due to the potential for reduced effectiveness of emergency epinephrine.
  • Caution: The adverse effects of epinephrine may be potentiated by co-administration with substances such as Tricyclic Antidepressants and Monoamine Oxidase Inhibitors (MAOIs), a factor noted in regulatory prescribing information.

Mechanism of Action

The action of Grazax is defined by a systematic process of immunological reprogramming aimed at establishing long-term tolerance to the grass pollen allergen.


Cellular Reprogramming: Targeting Dendritic Cells

This mechanism begins with the standardized grass pollen extract being internalized by Antigen-Presenting Cells (APCs), primarily Dendritic Cells (DCs), in the sublingual environment. This consistent exposure signals the DCs to mature into a regulatory phenotype, redirecting the initial immune response pathway. This step modifies the nature of the antigen presentation signal within the immune system.


Pathway Deviation: Inducing Treg and Suppressing Th2

The reprogrammed DCs activate specialized Regulatory T-cells (, Tregs), which are essential regulatory cells that actively suppress the pro-allergic T-helper type 2 (, Th2) pathway. This deviation is biochemically mediated by Treg-secreted immunosuppressive cytokines, chiefly Interleukin-10 (IL-10) and Transforming Growth Factor-beta (TGF-beta), contributing to the suppression of the allergic signaling cascade at the cellular level.


Humoral Switch: Generating IgG4 Blocking Antibodies

The Treg-derived signals drive an antibody isotype switch in B-cells, resulting in a downarrow decrease in IgE antibody synthesis and a measurable uparrow increase in the non-inflammatory IgG4 blocking antibodies. These IgG4 molecules circulate and competitively bind the grass allergen, preventing it from cross-linking IgE on mast cells. This mechanical action inhibits the immediate molecular event of mediator release and results in a systemic state of reduced immunological responsiveness to the allergen.

Dosage and Administration Information

Administration and Dosing Principles

The use of Grazax is defined by a standardized, once-daily regimen involving a single tablet of 75,000 SQ-T, administered via the sublingual route (under the tongue). This is a fixed dose with no required titration.

The protocol mandates a long-term commitment, requiring daily administration for a full course of three consecutive years to achieve sustained usage. Treatment must be initiated well in advance of the expected grass pollen season, typically at least 12 to 16 weeks prior to the season's start, and is continued throughout the season.


Procedural and Time Constraints

Procedural Constraint Instruction
Initial Administration The first tablet must be taken under medical supervision in a clinical setting, followed by an observation period of 20 to 30 minutes.
Oral Intake The tablet must be kept under the tongue until dissolved, with swallowing avoided for approximately one minute. Food or beverages must not be consumed for five minutes after administration.
Handling The oral lyophilisate must be removed from the blister and handled using dry fingers to prevent premature dissolution.
Missed Dose Rule If a daily dose is missed, it should be taken later that day; a double dose must not be taken to compensate.

Use in Specific Populations

The medicine is approved for use in individuals aged 5 years and older. Clinical experience is limited in patients aged 65 years and older. The required use of the sublingual route and the fixed daily dose establish the defined framework for treatment.

Recent Clinical Evidence

Recent Clinical Evidence

Clinical research has extensively evaluated the sublingual immunotherapy tablet, Grazax (Grass pollen allergen extract standardized), as a treatment for grass pollen-induced rhinoconjunctivitis. The primary research focus is on its long-term impact on symptom management and medication use, specifically in children and adults with seasonal allergic rhinitis.


Efficacy and Symptom Reduction

Studies, including large-scale randomized controlled trials (RCTs), have explored the relationship between consistent use of the sublingual tablet and the reduction of allergic symptoms during the grass pollen season. Efficacy is often measured using a combined Rhinoconjunctivitis Total Symptom Score (RTSS) and a Medication Score (RMS).

Research has shown that patients receiving the tablet may experience lower combined RTSS and RMS scores compared to those receiving a placebo, indicating a potential association with improved seasonal tolerance. These benefits were observed to persist for up to two to three years after the conclusion of the treatment course in some follow-up studies.


Tolerability and Safety Profile

The safety profile of the treatment has been documented across multiple clinical trials. The most commonly reported adverse events are local, mild, and generally occur early in the treatment phase, specifically:

  • Oral Pruritus (Itching): Often reported upon initiation of therapy.
  • Throat Irritation: A transient sensation noted after the tablet dissolves.
  • Mild Lip/Mouth Swelling: Typically localized and self-limiting.

Systemic allergic reactions are infrequent but have been noted in research and should be managed as per standard medical protocol. The long-term safety data collected over several years of observation indicate a favorable risk-benefit profile in the specific populations studied.

Frequently Asked Questions (FAQ)

Common questions about Grazax (FAQ)


Q: How long does it take for Grazax to start working noticeably?

A: Studies and official information indicate that the full clinical effect in the first grass pollen season is anticipated when treatment is initiated at least 4 months (or 12 weeks, depending on the regulatory region) prior to the expected start of the season, and is administered daily throughout that season. Some evidence suggests that initiating treatment 2–3 months before the season may still provide some efficacy.


Q: When is the best time of year to start taking Grazax?

A: Regulatory instructions state that treatment should begin well in advance of the expected grass pollen season. Specifically, it should be initiated at least 12 to 16 weeks (or 4 months) before the season’s onset, and administration is continued throughout that season. This pre-seasonal start allows the immune system time to build tolerance before exposure to high pollen counts.


Q: Can I take pain relievers like paracetamol or ibuprofen while on Grazax?

A: The official product information notes that no specific clinical studies investigating drug interactions have been conducted with Grazax. Therefore, no explicit guidance is available regarding the co-administration of common over-the-counter pain relievers, such as paracetamol or ibuprofen.


Q: Can I take other allergy medications like nasal sprays or eye drops with Grazax?

A: Official labeling indicates that co-administration with symptomatic anti-allergic agents is permissible. This includes medications like antihistamines, corticosteroids, nasal sprays, and eye drops. Co-administration may increase the patient’s tolerance level to the immunotherapy, particularly during the initial phase of treatment.


Q: Can I take Grazax if I am planning to become pregnant?

A: Official regulatory documents state that treatment with Grazax must not be initiated during established pregnancy. While continuation during pregnancy may be considered after medical evaluation, the regulatory label does not specifically address the commencement of treatment during the pre-conception or planning phase.


Q: Is it okay to swallow saliva right after the Grazax tablet has dissolved?

A: The administration instructions specify that the tablet must be kept under the tongue until it dissolves completely. Swallowing must be avoided for at least one minute after placing the tablet under the tongue to ensure proper absorption. Additionally, food or beverage consumption must be avoided for the five minutes following administration.


Q: Does eating or drinking right before or after taking Grazax affect how it works?

A: Food or beverage consumption must be avoided for the five minutes following the administration of the tablet to allow for proper absorption by the immune cells in the mouth. The regulatory information does not state any specific constraints on consuming food or drink immediately before taking the dose.


Q: Does research show a long-term benefit after stopping Grazax treatment?

A: The medicine is administered daily for three consecutive years. Clinical studies have shown that the effectiveness of the treatment can be sustained for a period of at least one grass pollen season after the conclusion of the 3-year treatment course, suggesting a prolonged benefit.


Q: How is Grazax different from regular allergy tablets like antihistamines?

A: Grazax is classified as an Allergen Immunotherapy (AIT) product, which is a disease-modifying treatment that seeks to build long-term tolerance to the allergen. In contrast, regular allergy tablets like antihistamines are conventional medicines that typically offer immediate, acute relief of symptoms without altering the underlying allergic response.


Q: Does Grazax cure my grass allergy or just treat the symptoms?

A: Grazax is defined as a disease-modifying treatment that aims to increase immunological tolerance to grass pollen over a long period. The goal is to reduce the severity of allergic symptoms. It is not indicated for the immediate or acute relief of allergic symptoms.


Q: Does alcohol interact with Grazax?

A: The official product labeling for Grazax does not contain specific information regarding any interactions between the medicine and alcohol. As no human drug interaction studies were performed for the active substance, no specific guidance on this topic is provided.


Q: Is it common to have a flare-up of allergy symptoms at the start of treatment?

A: Local allergic reactions in the mouth and throat are common, typically mild to moderate, and tend to occur early in therapy (within the first 1 to 7 days). These usually go away on their own. Official information focuses on these local side effects rather than a temporary worsening or flare-up of the main allergy symptoms.


Q: Does Grazax make you feel tired or drowsy?

A: Fatigue is listed as a common side effect of Grazax in clinical trials, meaning it may affect up to 1 in 10 people. The specific side effect of drowsiness, or somnolence, is not explicitly listed in the official product information.


Q: Can Grazax affect my sense of taste?

A: Yes, altered taste is listed as an uncommon side effect of Grazax. This means that, based on clinical trials, it may affect up to 1 in 100 people taking the medicine.


Q: Can people with certain food allergies still take Grazax?

A: Official documents note that Grazax contains fish-derived gelatin as an inactive ingredient. Available data has not indicated an increased risk of allergic reactions in patients with a severe fish allergy, but this component is noted in the official prescribing information.


Q: Does the dose of Grazax ever change over the course of treatment?

A: No. The entire recommended course of treatment for adults and children (5 years or older) involves a fixed, once-daily dose. The dose does not change over the course of the three-year period of administration.


Q: Does Grazax work for all types of grass allergies?

A: The active ingredient in Grazax is a standardized extract of Timothy grass (Phleum pratense) pollen. The medicine is indicated for confirmed grass pollen allergies that are linked to Timothy grass or cross-reactive grass pollens.


Q: How quickly does the mouth irritation from Grazax usually go away?

A: The most commonly reported local allergic reactions, such as itching in the mouth (oral pruritus) and irritation, are typically mild to moderate. According to regulatory data, these reactions generally subside spontaneously within 1 to 7 days of starting the therapy.


Q: Are there any foods or drinks to avoid while taking Grazax?

A: The regulatory information only mandates that food or beverage consumption must be avoided for the five minutes following the administration of the tablet. It does not list any specific types of foods or drinks that must be avoided entirely during the course of treatment.


Q: Can Grazax interact with blood pressure medications?

A: Of primary concern is the interaction with Beta-blockers, a type of blood pressure medication. Official labeling advises caution because Beta-blockers may reduce the effectiveness of emergency epinephrine (adrenaline), which is required for treating a severe systemic allergic reaction—a known risk of immunotherapy.


Q: How do I know if the Grazax treatment is actually working for me?

A: Official prescribing information states that if no relevant improvement of symptoms is observed during the first pollen season, there is no indication for continuing the treatment beyond that point.


Q: How effective is Grazax based on clinical trials?

A: Efficacy was established based on clinical trials where patients on the active treatment experienced a reduction in the combined Rhinoconjunctivitis Total Symptom Score (RTSS) and Medication Score (RMS) compared to those receiving a placebo.

How should Grazax be stored and disposed of?

Official Storage and Disposal Requirements

Official regulatory labeling dictates specific conditions for storing and disposing of Grazax sublingual lyophilisate. This medicine does not require any special storage conditions concerning temperature or environment, making it stable at normal room conditions. It must be kept strictly out of the sight and reach of children at all times.

Requirement Area Labeled Condition
Temperature No special conditions required.
Packaging Store in the original carton and do not use after the expiry date.
Handling Use immediately after opening the blister and handle with dry hands.
Disposal Do not dispose of via household waste or wastewater.

Disposal instructions require the product to be taken to a pharmacist or local collection point for pharmaceutical waste. This measure ensures proper handling of unused or expired medicine to help protect the environment.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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