GNH USA

Europe — EMA

Grazax

Grazax sublingual tablet (225 µg Phleum pratense) is a prescription allergy immunotherapy for grass pollen‑induced allergic rhinitis and rhinoconjunctivitis.

Phleum Pratense (225)

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What is Phleum Pratense (225)?

Grazax is a prescription sublingual tablet that contains 225 µg of Phleum pratense (timothy grass) allergen. It is formulated for sublingual administration and is approved in the European Union for allergen immunotherapy. The tablet is designed to be placed under the tongue, where it delivers a standardized dose of grass pollen extract to help the immune system develop tolerance to seasonal grass pollen exposure through regular use.

What is Phleum Pratense (225) used for?

Grazax is indicated for the management of grass pollen‑induced allergic conditions in adults and children, and it is prescribed as part of a structured immunotherapy regimen.

- Grass pollen‑induced allergic rhinitis (hay fever) in patients with a confirmed sensitivity. - Allergic rhinoconjunctivitis caused by grass pollen, when symptoms are seasonal. - Prevention of seasonal allergy symptoms during the grass pollen season. - Adjunct to standard pharmacotherapy for patients seeking disease‑modifying treatment. - Long‑term immunotherapy to reduce the need for rescue antihistamines. - Suitable for patients who have experienced inadequate control with conventional symptomatic medications.

What are the side effects of Phleum Pratense (225)?

The safety profile of Grazax reflects the typical reactions associated with sublingual allergen immunotherapy.

Common: - Mild itching or tingling sensation under the tongue that usually resolves within minutes. - Transient oral discomfort, including throat irritation or mild soreness, occurring shortly after placement of the tablet. - Nasal itching, sneezing, or watery eyes that may appear within the first hour of dosing and are typically brief.

Serious: - Anaphylaxis or a severe systemic allergic reaction characterized by rapid onset of symptoms such as difficulty breathing, drop in blood pressure, or widespread hives. - Persistent wheezing, bronchospasm, or tightening of the chest that does not improve with usual rescue inhalers. - Angioedema involving the lips, tongue, or airway, which can compromise breathing and requires immediate medical attention.

What precautions apply to Phleum Pratense (225)?

Before starting Grazax, patients and clinicians should consider several precautionary measures to ensure safe administration.

- Confirmed diagnosis of grass pollen allergy through skin testing or specific IgE measurement is required. - Initiate therapy under medical supervision, especially the first dose, to monitor for acute reactions. - Patients with uncontrolled asthma or a history of severe allergic reactions should be evaluated before use. - Avoid administration on the same day as other allergen immunotherapies to reduce cumulative risk. - Do not swallow the tablet; allow it to dissolve completely under the tongue. - Pregnant or breastfeeding individuals should discuss potential risks with their healthcare provider.

What does Phleum Pratense (225) interact with?

Grazax may interact with certain medications or conditions; awareness of these interactions helps minimize adverse outcomes.

Avoid: - Concomitant use of other sublingual or subcutaneous allergen immunotherapies, which can increase the risk of systemic allergic reactions. - Administration of beta‑blockers in patients with severe asthma, as they may blunt the response to emergency treatment of anaphylaxis.

Use with caution: - Antihistamines or leukotriene receptor antagonists, which may mask early signs of an allergic reaction and should be reviewed by a clinician. - Systemic corticosteroids, especially at high doses, because they can alter immune response to the immunotherapy. - ACE inhibitors, which have been associated with increased incidence of angioedema in susceptible individuals.

Frequently asked questions

What is the active ingredient in Grazax and how much does each tablet contain?+
Each Grazax tablet contains 225 µg of the Phleum pratense (timothy grass) allergen, which is the standardized active ingredient used for immunotherapy.
How is Grazax administered and what is the recommended route?+
Grazax is taken as a sublingual tablet. The tablet is placed under the tongue and allowed to dissolve completely without swallowing.
For which patients is Grazax indicated?+
Grazax is indicated for adults and children with a confirmed sensitivity to grass pollen who experience allergic rhinitis or rhinoconjunctivitis during the grass pollen season.
How does sublingual immunotherapy with Grazax work to reduce allergy symptoms?+
The tablet delivers grass pollen allergen to the oral mucosa, promoting a shift from a Th2‑dominant response to a Th1‑dominant response and increasing IgG4 production, which together help the immune system tolerate the allergen.
How long does it typically take to see a clinical benefit from Grazax?+
Clinical improvement is usually observed after several months of regular dosing, although individual response times can vary.
Can Grazax be used in combination with antihistamines?+
Antihistamines may be taken alongside Grazax, but they can mask early signs of an allergic reaction; clinicians should review the combination for each patient.
What are the most common side effects experienced with Grazax?+
Common side effects include mild itching or tingling under the tongue, transient oral discomfort or throat irritation, and brief nasal itching or sneezing after dosing.
What serious adverse reactions require immediate medical attention while using Grazax?+
Signs of anaphylaxis, persistent wheezing or bronchospasm, and angioedema affecting the lips, tongue, or airway should be treated as emergencies.
Are there any specific conditions that contraindicate the use of Grazax?+
Grazax should be avoided in patients with uncontrolled asthma, a history of severe systemic allergic reactions, or when other allergen immunotherapies are being used on the same day.
How should the first dose of Grazax be taken to ensure safety?+
The first dose should be administered under medical supervision, typically in a clinical setting, so that any acute reaction can be observed and managed promptly.
Is Grazax safe to use during pregnancy or while breastfeeding?+
The safety of Grazax during pregnancy or lactation has not been established; patients should discuss potential risks with their healthcare provider before starting therapy.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Phleum Pratense (225)
Route
Sublingual Use
Manufacturer
Alk-Abello A/S
Origin
EU

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