Europe — EMA
Grazax
Grazax sublingual tablet (225 µg Phleum pratense) for grass pollen allergy in the EU – uses, side effects, precautions and interactions.
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What is Phleum Pratense (225)?
Grazax is a sublingual tablet that contains 225 µg of the grass pollen allergen Phleum pratense. It is marketed in the European Union as an allergen immunotherapy product designed to modify the immune response to grass pollen exposure. The tablet is taken orally under the tongue and is intended for use in individuals with confirmed grass pollen allergy, following medical evaluation.
What is Phleum Pratense (225) used for?
Grazax is indicated for the treatment of allergic rhinitis caused by grass pollen. Clinical use focuses on long‑term reduction of symptoms and medication need.
- Reduces seasonal nasal congestion, sneezing, and itchy eyes associated with grass pollen. - Decreases reliance on antihistamines and nasal corticosteroids during grass season. - Suitable for adults and children with a confirmed grass pollen allergy. - Administered daily throughout the grass pollen season to maintain tolerance. - May be considered as part of a broader allergy management plan.
What are the side effects of Phleum Pratense (225)?
Side effects of Grazax vary in frequency and severity. Most users experience mild, transient reactions, while rare serious events require medical attention.
Common: - Oral itching or mild throat irritation. - Ear or nasal itching. - Mild gastrointestinal discomfort. - Transient swelling of the lips or tongue. - Localized rash at the site of tablet placement.
Serious: - Anaphylaxis or severe systemic allergic reaction. - Persistent swelling of the throat that interferes with breathing. - Severe urticaria (hives) covering large body areas. - Acute bronchospasm or wheezing. - Rapid onset of cardiovascular symptoms such as hypotension.
What precautions apply to Phleum Pratense (225)?
Before starting Grazax, certain precautions should be considered to ensure safe use.
- Confirm diagnosis of grass pollen allergy through skin testing or specific IgE measurement. - Avoid use in individuals with uncontrolled asthma or recent asthma exacerbations. - Do not initiate therapy in patients who have experienced anaphylaxis to grass pollen extracts. - Monitor for local oral reactions during the first weeks of treatment. - Discuss any history of cardiovascular disease with a healthcare professional. - Pregnant or breastfeeding individuals should consult a physician before use.
What does Phleum Pratense (225) interact with?
Grazax may interact with other medications or substances that affect the immune system or allergic response.
Avoid: - Concurrent use of other sublingual or subcutaneous grass pollen immunotherapy products. - Administration of systemic antihistamines or corticosteroids immediately before the tablet, as they may mask early reactions.
Use with caution: - Beta‑blockers, which can interfere with treatment of anaphylaxis. - ACE inhibitors, due to potential for increased angioedema risk. - Immunosuppressive agents that may alter the intended immune response. - Herbal supplements that have known allergenic potential.
Frequently asked questions
What is the active ingredient in Grazax and how does it work?+
Who is eligible to use Grazax for grass pollen allergy?+
How should Grazax be taken for optimal effect?+
Can Grazax be used together with antihistamines?+
What are the most common side effects of Grazax?+
When should a patient seek medical help while using Grazax?+
Is Grazax safe for people with asthma?+
Should pregnant or breastfeeding women use Grazax?+
What medications should be avoided while on Grazax?+
How long does treatment with Grazax typically last?+
Can Grazax cause interactions with beta‑blockers?+
What should be done if a dose of Grazax is missed?+
Product details
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