Europe — EMA
Grazax
Learn about Grazax sublingual tablet (225 S.U. Phleum pratense) for grass pollen allergy, its uses, side effects, precautions, and drug interactions.
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What is Phleum Pratense (225)?
GRAZAX is a sublingual tablet containing 225 S.U. of Phleum pratense (timothy grass) allergen extract, marketed for the treatment of grass pollen allergy. It is an immunotherapy product approved in the EU. The tablet is placed under the tongue daily to induce immune tolerance to grass pollen, helping reduce symptoms of seasonal allergic rhinitis in patients with confirmed grass‑pollen sensitivity through a structured dosing schedule.
What is Phleum Pratense (225) used for?
Grazax is indicated for the management of grass‑pollen–related allergic conditions.
- Seasonal allergic rhinitis (hay fever) caused by grass pollen. - Allergic conjunctivitis triggered by grass pollen exposure. - Prevention of symptom recurrence during the grass pollen season. - Use as part of a comprehensive allergy management plan in patients with confirmed grass‑pollen sensitivity.
What are the side effects of Phleum Pratense (225)?
Side effects reported with sublingual grass pollen immunotherapy vary in frequency and severity.
Common: - Mild itching or irritation of the mouth or throat. - Transient oral swelling or tingling sensation. - Mild gastrointestinal discomfort such as nausea. - Localized ear or nasal itching.
Serious: - Persistent or severe oral swelling that interferes with breathing. - Anaphylactic reaction requiring emergency medical attention. - Severe asthma exacerbation triggered by the tablet.
What precautions apply to Phleum Pratense (225)?
Before starting Grazax, certain precautions should be considered to ensure safe use.
- Confirmed diagnosis of grass‑pollen allergy by skin test or specific IgE. - Not recommended for patients with uncontrolled asthma or severe respiratory disease. - Use under medical supervision, especially during the first dose. - Avoid if you have a history of severe allergic reactions to any component of the tablet. - Discuss use during pregnancy or breastfeeding with a healthcare professional. - Keep the tablet out of reach of children.
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 without medical guidance. - Systemic corticosteroids at high doses during the treatment period.
Use with caution: - Beta‑agonist inhalers for asthma; monitor symptoms closely. - Antihistamines may mask early signs of an allergic reaction. - ACE inhibitors or NSAIDs if they have a known propensity to cause angio‑edema.
Frequently asked questions
What is the active ingredient in Grazax and how strong is it?+
How should Grazax be administered for optimal effect?+
Can Grazax be used by children with grass pollen allergy?+
What are the most common side effects experienced with Grazax?+
When should a patient seek emergency care while taking Grazax?+
Is Grazax safe to use during pregnancy or while breastfeeding?+
Can I take antihistamines together with Grazax?+
Should I stop Grazax if I develop a cold or flu?+
How long does a typical course of Grazax treatment last?+
What monitoring is required while on Grazax therapy?+
Product details
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