Europe — EMA
Grazax
Learn about Grazax sublingual tablet, its uses for grass pollen allergy, dosage, 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. It is used for allergen immunotherapy and is placed properly under the tongue to help people with seasonal allergic rhinitis caused by grass pollen. Marketed in the European Union, Grazax is intended for daily, regularly use during the grass pollen season under the guidance of a qualified healthcare professional.
What is Phleum Pratense (225) used for?
Grazax is indicated for the treatment of seasonal allergic rhinitis that is triggered by grass pollen, particularly timothy grass.
- Reduces symptoms such as sneezing, nasal congestion, and itchy eyes during the grass pollen season. - Provides a disease‑modifying approach by gradually inducing immune tolerance to the grass allergen. - Can be used as a monotherapy for patients who have not responded adequately to antihistamines or nasal corticosteroids. - May be prescribed for adults and adolescents with confirmed grass‑pollen allergy, as determined by skin‑prick testing or specific IgE testing. - Intended for daily administration throughout the grass pollen season, typically starting before the onset of pollen exposure.
What are the side effects of Phleum Pratense (225)?
Side effects of Grazax may occur, ranging from mild local reactions to rare systemic events.
Common: - Mild itching or tingling in the mouth shortly after the tablet is placed under the tongue. - Transient sore throat or mild irritation of the oral mucosa. - Temporary increase in nasal congestion or sneezing during the first weeks of therapy. - Minor gastrointestinal discomfort such as nausea or abdominal fullness. - Mild headache or fatigue that usually resolves without intervention.
Serious: - Anaphylaxis or severe systemic allergic reaction requiring immediate medical attention. - Persistent or worsening asthma symptoms, including wheezing or shortness of breath.
What precautions apply to Phleum Pratense (225)?
Before starting Grazax, certain precautions and warnings should be considered to ensure safe use.
- Do not use if you have a known severe allergy to timothy grass or any tablet component. - Avoid starting therapy if you have uncontrolled asthma or a recent asthma exacerbation. - Tell your healthcare provider about any history of anaphylaxis, especially to allergens or medicines. - Use caution during pregnancy or breastfeeding; safety has not been fully established. - Stop the tablet and seek medical help if you develop swelling, hives, or breathing difficulty. - Store at room temperature, protected from moisture, and keep out of reach of children.
What does Phleum Pratense (225) interact with?
Grazax may interact with certain medications or conditions; consider the following guidance.
Avoid: - Concurrent use of beta‑blockers, which can mask symptoms of anaphylaxis and complicate emergency treatment. - Simultaneous administration of other allergen immunotherapy products targeting grass pollen.
Use with caution: - Antihistamines or nasal corticosteroids, as they may affect the perception of local side effects. - Asthma medications, especially leukotriene modifiers, requiring close monitoring of respiratory status. - Immunosuppressive drugs, which could alter the immune response to the sublingual tablet. - Vaccinations, particularly live vaccines, should be scheduled at least two weeks before or after starting Grazax.
Frequently asked questions
What is the active ingredient in Grazax and how much does each tablet contain?+
How does Grazax work to reduce grass pollen allergy symptoms?+
Who is eligible to receive Grazax treatment?+
When should treatment with Grazax be started each year?+
Can Grazax be taken together with antihistamines?+
What are the most common side effects reported with Grazax?+
What signs indicate a serious allergic reaction to Grazax?+
Is Grazax safe to use during pregnancy or while breastfeeding?+
Should I stop Grazax if I develop asthma symptoms while on therapy?+
How should Grazax be stored to maintain its effectiveness?+
Are there any medications that should be avoided while taking Grazax?+
What monitoring is required during Grazax therapy?+
Product details
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