Europe — EMA
Grazax
Learn about Grazax sublingual tablet (225 µg Phleum pratense) for grass‑pollen allergic rhinitis, its uses, side effects, precautions, and FAQs.
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What is Phleum Pratense (225)?
Grazax is a prescription sublingual tablet that contains 225 µg of the grass pollen allergen Phleum pratense. It is formulated for oral administration under the tongue and is marketed in the European Union for allergen immunotherapy. The product is designed to help patients develop tolerance to grass pollen and reduce symptoms of seasonal allergic rhinitis. It is taken daily before and during the grass pollen season under medical supervision.
What is Phleum Pratense (225) used for?
Grazax is indicated for patients with grass‑pollen induced seasonal allergic rhinitis who require immunotherapy to modify their allergic response.
- Reduces nasal congestion, sneezing, and itchy eyes caused by grass pollen exposure. - Improves quality of life by decreasing reliance on symptomatic antihistamines or nasal corticosteroids. - Can be used in adults and adolescents with confirmed grass‑pollen allergy, as determined by skin‑prick testing or specific IgE. - May be considered when allergen avoidance alone is insufficient to control symptoms. - Supports long‑term disease modification when administered according to the recommended treatment schedule.
What are the side effects of Phleum Pratense (225)?
Side effects of Grazax vary in frequency and severity; most are mild and transient, while rare reactions may require medical attention.
Common: - Mild oral itching or tingling at the site of tablet placement. - Transient throat irritation or mild sore throat. - Brief nasal itching or sneezing shortly after dosing. - Minor gastrointestinal discomfort such as nausea. - Ear fullness or mild ear pressure. - Temporary hoarseness or voice change.
Serious: - Persistent or worsening oral swelling that interferes with breathing. - Anaphylactic reaction characterized by hives, difficulty breathing, or low blood pressure.
What precautions apply to Phleum Pratense (225)?
Before starting Grazax, patients and healthcare providers should consider several precautions to ensure safe and effective use.
- Perform a confirmed diagnosis of grass‑pollen allergy using skin‑prick testing or specific IgE measurement. - Initiate therapy under medical supervision, especially the first dose, to monitor for adverse reactions. - Avoid use in individuals with uncontrolled asthma or a history of severe allergic reactions to grass pollen. - Do not administer if the patient has an active oral infection, ulcer, or severe dental disease. - Counsel patients to keep the tablet under the tongue until it dissolves completely; swallowing may reduce efficacy. - Pregnant or breastfeeding women should discuss potential risks with their clinician, as safety data are limited. - Discontinue the tablet and seek medical help if persistent oral swelling or systemic symptoms develop.
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.
Avoid: - Concurrent use of systemic corticosteroids or immunosuppressive agents without physician guidance. - Other allergen immunotherapy products targeting grass pollen administered simultaneously.
Use with caution: - Antihistamines or leukotriene receptor antagonists, as they may mask early signs of an allergic reaction. - Beta‑blockers, which can interfere with the treatment of severe allergic reactions. - ACE inhibitors, due to the potential for enhanced angioedema risk. - Live vaccines, because immunotherapy may alter immune response.
Frequently asked questions
What is the active ingredient in Grazax and how much does each tablet contain?+
How does Grazax work to reduce allergy symptoms?+
Who is eligible to receive Grazax treatment?+
Can pregnant or breastfeeding women use Grazax?+
What are the most common side effects experienced with Grazax?+
What signs indicate a serious allergic reaction to Grazax?+
Do I need to take Grazax every day throughout the pollen season?+
Are there any medications that should be avoided while using Grazax?+
How should I administer the Grazax tablet?+
What monitoring is required when starting Grazax?+
Can Grazax be used together with antihistamines?+
Is Grazax available over the counter in the EU?+
Product details
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