Europe — EMA
Grazax
Learn about Grazax sublingual tablet, its uses for grass‑pollen allergy, side effects, precautions, and drug interactions.
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What is Phleum Pratense (225)?
Grazax is a prescription sublingual tablet containing 225 SQ‑U of Phleum pratense (timothy grass) allergen extract. It is formulated for allergen immunotherapy and is marketed in the European Union. The tablet is placed under the tongue, where it delivers a standardized dose of grass pollen protein to help the immune system develop tolerance. Grazax is used under medical supervision for grass‑pollen allergy treatment in adults and children.
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 pollen. - Grass pollen‑induced allergic rhinoconjunctivitis in patients with confirmed sensitivity. - Use as part of a pre‑seasonal immunotherapy regimen to reduce need for antihistamines. - Suitable for individuals aged 5 years and older when prescribed by a specialist. - May be considered when conventional pharmacotherapy does not provide adequate symptom control.
What are the side effects of Phleum Pratense (225)?
Side effects reported with Grazax are generally mild and related to the sublingual route of administration.
Common: - Itching or mild irritation of the mouth and throat. - Transient oral swelling or tingling sensation. - Mild gastrointestinal discomfort such as nausea. - Sneezing or nasal congestion shortly after dosing.
Serious: - Persistent oral swelling that interferes with breathing. - Severe allergic reaction (anaphylaxis) with hives, difficulty breathing, or throat tightness. - Systemic urticaria extending beyond the oral cavity. - Severe asthma exacerbation triggered by the tablet.
What precautions apply to Phleum Pratense (225)?
Grazax should be prescribed and monitored according to specific safety considerations to minimize risk.
- Confirmed diagnosis of grass‑pollen allergy by skin test or specific IgE before initiation. - Initiate treatment under medical supervision, with the first dose observed in a clinical setting. - Not recommended for patients with uncontrolled asthma or severe oral allergy syndrome. - Avoid use in individuals with a history of anaphylaxis to any allergen. - Pregnancy and breastfeeding status should be discussed with a healthcare provider. - Children under 5 years of age are not approved for this therapy. - Discontinue if severe oral swelling or systemic reaction occurs.
What does Phleum Pratense (225) interact with?
Grazax may interact with other medications or conditions that affect immune response or increase allergic risk.
Avoid: - Concurrent use of other allergen immunotherapy products targeting grass pollen. - Beta‑blockers in patients at risk of anaphylaxis, as they may blunt emergency treatment. - ACE inhibitors in patients with a history of angio‑edema.
Use with caution: - Antihistamines or leukotriene receptor antagonists may mask early signs of a reaction. - Systemic corticosteroids may reduce the efficacy of the immunotherapy. - Immunosuppressive agents, including biologics, may alter the immune response to the tablet.
Frequently asked questions
What is the active ingredient in Grazax?+
How is Grazax administered?+
For which condition is Grazax prescribed?+
Can children use Grazax?+
What should I expect during the first dose of Grazax?+
Is it safe to take Grazax while pregnant?+
What are common side effects of Grazax?+
What serious reactions require stopping Grazax?+
Can I use other allergy medications with Grazax?+
Does Grazax interact with beta‑blockers?+
How long does a typical Grazax treatment course last?+
What monitoring is required while taking Grazax?+
Product details
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