Europe — EMA
Grazax
Learn about Grazax sublingual tablet, its uses for grass‑pollen allergic rhinitis, dosing, side effects, precautions and drug interactions.
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What is Phleum Pratense (225)?
Grazax is a prescription sublingual tablet that contains 225 µg of Phleum pratense (timothy grass) allergen extract. The tablet is designed for oral administration under the tongue and is used in the European market for allergen immunotherapy. By delivering a standardized dose of grass pollen allergen, Grazax aims to modify the immune response in patients with grass‑pollen‑induced allergic rhinitis and may reduce symptoms over the pollen season.
What is Phleum Pratense (225) used for?
Grazax is indicated for the treatment of seasonal allergic rhinitis and allergic rhinoconjunctivitis that are triggered by grass pollen exposure. The tablet is prescribed as part of a disease‑modifying immunotherapy regimen, typically initiated before the start of the grass pollen season and continued throughout the exposure period.
- Patients with confirmed grass‑pollen allergy based on clinical history and diagnostic testing. - Adults and adolescents for whom sublingual immunotherapy is appropriate. - Use as a pre‑seasonal or continuous therapy to reduce symptom severity. - Adjunct to standard pharmacotherapy such as antihistamines when needed. - May be considered for patients seeking a non‑injectable immunotherapy option.
What are the side effects of Phleum Pratense (225)?
The safety profile of Grazax reflects the local and systemic reactions that can occur with sublingual allergen exposure. Most patients experience mild, transient effects, while rare serious events have been reported.
Common: - Mild oral itching or tingling at the site of tablet placement. - Transient throat irritation or mild sore throat. - Nasal congestion or runny nose shortly after dosing. - Mild gastrointestinal discomfort such as nausea.
Serious: - Anaphylaxis or severe systemic allergic reaction requiring emergency care. - Severe bronchospasm or asthma exacerbation. - Persistent swelling of the lips, tongue, or face. - Urticaria or widespread hives.
What precautions apply to Phleum Pratense (225)?
Before prescribing Grazax, clinicians should evaluate patient history and consider specific precautions to ensure safe use.
- Contraindicated in individuals with a history of severe systemic reactions to grass pollen immunotherapy. - Not recommended for patients with uncontrolled asthma or recent asthma exacerbations. - Use with caution in pregnant or breastfeeding women, as safety data are limited. - Avoid administration in patients taking beta‑blockers, which may interfere with treatment of anaphylaxis. - Patients should discontinue the tablet if they experience any signs of anaphylaxis and seek immediate medical attention. - Regular follow‑up is advised to monitor response and adjust therapy as needed.
What does Phleum Pratense (225) interact with?
Grazax may interact with certain medications or conditions that affect immune response or increase the risk of allergic reactions.
Avoid: - Concurrent use of other allergen immunotherapy products (injectable or sublingual). - Beta‑blockers, which can diminish the effectiveness of emergency treatment for severe reactions. - ACE inhibitors in patients prone to angio‑edema.
Use with caution: - Antihistamines or leukotriene receptor antagonists, which may mask early symptoms of a reaction. - Systemic corticosteroids, as they may alter immune response to the tablet. - Immunosuppressive agents, which could affect the development of tolerance.
Frequently asked questions
What is the active ingredient in Grazax and how much does each tablet contain?+
For which conditions is Grazax prescribed?+
How is Grazax administered?+
When should treatment with Grazax be started?+
Can children use Grazax?+
What are the most common side effects of Grazax?+
What serious reactions require immediate medical attention while using Grazax?+
Is Grazax safe to use during pregnancy?+
Should I stop taking other allergy medications while on Grazax?+
What medications should be avoided while taking Grazax?+
How does Grazax work to reduce allergy symptoms?+
What monitoring is required while on Grazax therapy?+
Product details
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