Europe — EMA
Grazax
Learn about Grazax sublingual tablet, its uses for grass‑pollen allergic rhinitis, side effects, precautions, and FAQs.
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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. It is formulated for allergen immunotherapy and is administered by placing the tablet under the tongue. The product is approved in the European Union for the treatment of grass‑pollen‑induced seasonal allergic rhinitis and related symptoms. Patients typically start therapy before the grass pollen season and continue daily throughout the exposure period, under medical supervision.
What is Phleum Pratense (225) used for?
Grazax is indicated for the management of grass‑pollen‑related allergic conditions, providing a disease‑modifying approach that can reduce the need for rescue medications.
- Seasonal allergic rhinitis caused by Timothy grass pollen. - Allergic rhinoconjunctivitis triggered by grass pollen exposure. - Prevention of symptom escalation during the grass pollen season. - Adjunct to standard pharmacotherapy for patients seeking disease‑modifying treatment. - Use in individuals aged 5 years and older as approved in the EU. - Long‑term therapy to achieve sustained clinical benefit after a typical three‑year treatment course.
What are the side effects of Phleum Pratense (225)?
Side effects observed with Grazax are typically mild and localized to the oral cavity, though occasional systemic reactions have been reported. Most patients experience only transient discomfort that resolves without intervention.
Common: - Local oral itching or tingling. - Mild throat irritation. - Transient mouth swelling. - Gastrointestinal discomfort (e.g., nausea). - Hoarseness or voice change. - Mild dizziness.
Serious: - Systemic allergic reaction such as anaphylaxis. - Severe throat swelling that compromises airway.
What precautions apply to Phleum Pratense (225)?
Before initiating Grazax, healthcare providers should evaluate patient history and consider specific safety considerations to minimize risk.
- Contraindicated in individuals with severe uncontrolled asthma. - Not recommended for patients with a history of anaphylaxis to grass pollen or related allergens. - Initiate therapy under medical supervision, with observation for at least 30 minutes after the first dose. - Avoid use in pregnant or breastfeeding women unless the benefit outweighs potential risk. - Caution in patients taking beta‑blockers, as they may mask anaphylaxis symptoms. - Ensure proper storage below 30 °C and keep out of reach of children.
What does Phleum Pratense (225) interact with?
Grazax may interact with certain medications or conditions, requiring avoidance or careful monitoring.
Avoid: - Concurrent use of other allergen immunotherapy products targeting grass pollen. - Administration with epinephrine auto‑injectors for prophylactic purposes.
Use with caution: - Beta‑blockers, because they can interfere with treatment of severe allergic reactions. - ACE inhibitors, which may increase the risk of angioedema. - Antihistamines, as they may mask early signs of systemic reactions. - Immunosuppressive agents, which could alter the immunologic response to the tablet.
Frequently asked questions
What is the active ingredient in Grazax and how much does each tablet contain?+
For which condition is Grazax primarily prescribed?+
How should Grazax be taken to ensure proper absorption?+
When is the optimal time to start Grazax therapy before the pollen season?+
Can children use Grazax, and if so, from what age?+
What are the most common mild side effects experienced with Grazax?+
What serious adverse reactions require immediate medical attention while using Grazax?+
Are there any medications that should be avoided while taking Grazax?+
How do beta‑blockers affect the safety profile of Grazax?+
Is it safe to continue Grazax during pregnancy or while breastfeeding?+
What storage conditions are recommended for Grazax tablets?+
How long is a typical course of treatment with Grazax?+
Product details
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