GNH USA

Europe — EMA

Grazax

Learn about Grazax sublingual tablet (225 µg Phleum pratense) for grass‑pollen allergic rhinitis, its uses, side effects, precautions, and interactions.

Phleum Pratense (225)

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What is Phleum Pratense (225)?

Grazax is a sublingual tablet containing 225 µg of Phleum pratense (Timothy grass) extract. It is an allergen immunotherapy product approved in the European Union for prescription use. The tablet is designed for sublingual administration to help manage grass‑pollen‑induced allergic rhinitis by gradually inducing immune tolerance. The therapy is administered daily throughout the grass pollen season and is intended to modify the underlying allergic response rather than provide immediate symptom relief.

What is Phleum Pratense (225) used for?

Grazax is indicated for patients with confirmed grass‑pollen‑induced allergic rhinitis who seek a disease‑modifying approach. Clinical use focuses on seasonal allergy management through sublingual immunotherapy and may reduce reliance on symptomatic medications.

- Initiates a gradual desensitization to Timothy grass pollen. - Intended for use before and during the grass pollen season. - Prescribed for adults and adolescents with moderate to severe symptoms. - Used as part of a comprehensive allergy management plan. - May complement, but not replace, rescue antihistamines or nasal corticosteroids.

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

Side effects of Grazax reflect the local immune response to sublingual exposure and are generally mild to moderate. They are categorized as common or serious based on frequency and severity.

Common: - Mild oral itching or tingling at the tablet site. - Transient throat irritation or mild hoarseness. - Small increase in nasal congestion or sneezing shortly after dosing.

Serious: - Persistent wheezing or shortness of breath. - Severe oral swelling that interferes with breathing or swallowing. - Anaphylactic reactions requiring emergency medical attention.

What precautions apply to Phleum Pratense (225)?

Precautions for Grazax aim to identify patients who may be at higher risk for adverse reactions and to ensure safe administration of the sublingual tablet before initiating therapy.

- Not recommended for individuals with uncontrolled asthma or recent severe asthma exacerbations. - Contraindicated in patients with a history of severe allergic reactions to grass pollen extracts. - Should be avoided in those with active oral infections or lesions. - Use with caution during pregnancy; safety data are limited. - Discontinue the tablet if serious systemic symptoms develop and seek medical care promptly. - Avoid concurrent use of other sublingual immunotherapy products. - Ensure the tablet remains under the tongue until fully dissolved; do not swallow immediately.

What does Phleum Pratense (225) interact with?

Grazax may interact with other medications or substances that affect the immune system or increase the risk of allergic reactions. Interactions are grouped by those to avoid and those requiring caution.

Avoid: - Concurrent use of other allergen immunotherapy tablets or injections targeting grass pollen. - Simultaneous administration of systemic corticosteroids at high doses that may suppress the intended immune response. - Use with investigational immunomodulatory agents lacking safety data.

Use with caution: - Beta‑agonist inhalers for asthma; monitor respiratory status during treatment. - Antihistamines or nasal steroids; they may mask early signs of an allergic reaction.

Frequently asked questions

What is the active ingredient in Grazax and how much does each tablet contain?+
Each Grazax tablet contains 225 µg of Phleum pratense (Timothy grass) extract, which is the standardized allergen used for immunotherapy.
How does Grazax work to reduce allergic rhinitis symptoms?+
Grazax induces immune tolerance by repeated sublingual exposure to grass pollen allergen, shifting the immune response from a Th2‑dominant (allergic) profile toward a Th1 profile, increasing allergen‑specific IgG4 and reducing IgE‑mediated mast cell activation.
Who is a suitable candidate for Grazax therapy?+
Grazax is prescribed for patients with confirmed grass‑pollen‑induced allergic rhinitis who require a disease‑modifying approach, typically adults and adolescents with moderate to severe seasonal symptoms.
When should Grazax treatment be started relative to the grass pollen season?+
Treatment is generally initiated before the start of the grass pollen season and continued throughout the season to maintain desensitization.
What are the most common side effects experienced with Grazax?+
Common side effects include mild oral itching or tingling, transient throat irritation or hoarseness, and a temporary increase in nasal congestion or sneezing after the tablet is taken.
What serious adverse reactions require immediate medical attention?+
Serious reactions such as persistent wheezing, severe oral swelling that interferes with breathing or swallowing, or signs of anaphylaxis should be treated as emergencies.
Are there any conditions that contraindicate the use of Grazax?+
Grazax should not be used in individuals with uncontrolled asthma, a history of severe allergic reactions to grass pollen extracts, or active oral infections.
Can Grazax be used safely during pregnancy?+
Safety data for use during pregnancy are limited; therefore, Grazax should be used with caution and only if the potential benefit justifies the potential risk.
Should I stop other allergy medications while taking Grazax?+
Grazax can be used alongside rescue antihistamines or nasal corticosteroids, but it does not replace them. Patients should discuss any medication changes with their healthcare provider.
What drug interactions should I be aware of when taking Grazax?+
Avoid using other allergen immunotherapy products or high‑dose systemic corticosteroids concurrently. Use beta‑agonist inhalers and antihistamines with caution, as they may mask early signs of an allergic reaction.
How should the Grazax tablet be administered?+
Place the tablet under the tongue, allow it to dissolve completely without swallowing, and avoid eating or drinking for a few minutes after administration.
What should I do if I experience a severe reaction after taking Grazax?+
Discontinue the tablet immediately, seek emergency medical care, and inform the healthcare professional about the reaction and the use of Grazax.
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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