Europe — EMA
Grazax
Learn about Grazax sublingual tablet (225 µg Phleum pratense) for grass‑pollen allergic rhinitis, its uses, side effects, precautions, and interactions.
Request sourcing
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?+
How does Grazax work to reduce allergic rhinitis symptoms?+
Who is a suitable candidate for Grazax therapy?+
When should Grazax treatment be started relative to the grass pollen season?+
What are the most common side effects experienced with Grazax?+
What serious adverse reactions require immediate medical attention?+
Are there any conditions that contraindicate the use of Grazax?+
Can Grazax be used safely during pregnancy?+
Should I stop other allergy medications while taking Grazax?+
What drug interactions should I be aware of when taking Grazax?+
How should the Grazax tablet be administered?+
What should I do if I experience a severe reaction after taking Grazax?+
Product details
Related products

A
Liquid Extract From Viscum Album Subsp. Abietis Var Abies Alba (1:20), Extraction Solvents: Water Fo

A
Liquid Extract From Viscum Album Subsp. Abietis Var Abies Alba (1:20), Extraction Solvents: Water Fo

A
Liquid Extract From Viscum Album Subsp. Abietis Var Abies Alba (1:20), Extraction Solvents: Water Fo

A
Liquid Extract From Viscum Album Subsp. Abietis Var Abies Alba (1:20), Extraction Solvents: Water Fo