Europe — EMA
Grazax
Grazax is a prescription sublingual tablet containing Phleum pratense allergen extract for grass‑pollen allergic rhinitis prophylaxis in the EU.
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What is Phleum Pratense (225)?
Grazax is a prescription sublingual tablet that contains a standardized Phleum pratense (timothy grass) allergen extract, typically supplied as 225 µg of the active component per tablet. The product is formulated for oral administration under the tongue and is marketed in the European Union for the prophylaxis of seasonal allergic rhinitis caused by grass pollen. It is intended to be taken daily throughout the grass pollen season to build tolerance.
What is Phleum Pratense (225) used for?
Grazax is indicated for the prevention of symptoms associated with grass‑pollen induced allergic rhinitis and rhinoconjunctivitis.
- Seasonal allergic rhinitis caused by timothy grass (Phleum pratense) pollen. - Allergic rhinoconjunctivitis triggered by grass pollen exposure. - Patients with confirmed IgE sensitisation to grass pollen. - Use as part of a comprehensive allergy management plan, including avoidance measures. - May be considered for individuals who prefer sublingual immunotherapy over injection.
What are the side effects of Phleum Pratense (225)?
Side effects reported with sublingual grass‑pollen immunotherapy are generally mild and transient, but rare serious reactions can occur.
Common: - Oral itching or mild irritation at the site of tablet placement. - Throat discomfort or mild soreness. - Ear or nasal itching. - Mild gastrointestinal upset such as nausea. - Transient headache.
Serious: - Anaphylaxis or severe systemic allergic reaction. - Angioedema involving the face, lips, or tongue. - Severe bronchospasm or respiratory distress. - Persistent urticaria (hives) lasting more than 24 hours. - Cardiovascular symptoms such as hypotension or syncope.
What precautions apply to Phleum Pratense (225)?
Before starting Grazax, certain precautions should be reviewed to ensure safe use.
- Confirm diagnosis of grass‑pollen allergy with appropriate testing. - Do not initiate therapy in individuals with uncontrolled asthma or recent severe asthma exacerbations. - Avoid use in patients with a history of severe systemic allergic reactions to grass pollen or other allergens. - Counsel patients to remain seated for at least 30 minutes after each dose and to have emergency medication available. - Pregnancy and lactation status should be discussed with a healthcare professional. - Regular follow‑up is recommended to monitor tolerance and symptom control.
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 allergen immunotherapy products (e.g., subcutaneous grass‑pollen extracts). - Systemic corticosteroids or immunosuppressive agents that could alter the intended immune response. - Beta‑blockers in patients at risk of anaphylaxis, as they may interfere with emergency treatment.
Use with caution: - Antihistamines or mast‑cell stabilisers, which may mask early signs of an allergic reaction. - ACE inhibitors or angiotensin receptor blockers, given the rare risk of angioedema. - Non‑steroidal anti‑inflammatory drugs (NSAIDs) in patients with known NSAID‑exacerbated respiratory disease. - Live vaccines, as immunotherapy may theoretically affect vaccine response.
Frequently asked questions
What is the active ingredient in Grazax and how does it work?+
Who is a suitable candidate for Grazax therapy?+
How is Grazax administered and what is the recommended schedule?+
What are the most common side effects experienced with Grazax?+
Can Grazax cause severe allergic reactions?+
Are there any contraindications for using Grazax?+
How should Grazax be stored before use?+
Can Grazax be taken together with antihistamines?+
What should a patient do if they experience oral itching after taking Grazax?+
Is Grazax safe to use during pregnancy or breastfeeding?+
How long does it typically take to see a reduction in allergy symptoms with Grazax?+
What monitoring is required while on Grazax therapy?+
Product details
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