Europe — EMA
Grazax
Grazax is a prescription sublingual tablet containing 225 SQ‑U Phleum pratense extract for grass‑pollen allergic rhinitis; learn indications, side effects, and precautions.
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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 oral administration under the tongue and is approved in the European Union for the treatment of grass‑pollen‑induced seasonal allergic rhinitis and allergic rhinoconjunctivitis. It belongs to the class of allergen immunotherapy and is supplied as a tablet for use.
What is Phleum Pratense (225) used for?
Grazax is indicated for patients with grass‑pollen‑related seasonal allergic rhinitis and allergic rhinoconjunctivitis, typically when symptoms are not adequately controlled by standard pharmacotherapy.
- Pre‑seasonal treatment to reduce the severity of grass‑pollen allergy symptoms. - Adjunct therapy for patients who experience nasal congestion, sneezing, and itchy eyes during the grass pollen season. - Long‑term immunotherapy aimed at modifying the underlying allergic response. - Use in adults and adolescents with a confirmed diagnosis of grass pollen allergy. - May be considered for patients seeking an alternative to daily antihistamines during peak pollen periods.
What are the side effects of Phleum Pratense (225)?
The safety profile of Grazax includes both frequently observed and less common reactions; most side effects are mild and transient.
Common: - Mild oral itching or tingling at the site of tablet placement. - Transient sore throat or throat irritation. - Nasal itching or mild rhinorrhea. - Mild gastrointestinal discomfort such as nausea. - Mouth swelling or mild lip edema.
Serious: - Severe allergic reactions, including anaphylaxis, requiring immediate medical attention. - Persistent or worsening asthma symptoms in patients with underlying asthma. - Swelling of the face, lips, or tongue indicating a systemic reaction. - Persistent severe respiratory distress or bronchospasm.
What precautions apply to Phleum Pratense (225)?
Before initiating Grazax, clinicians should evaluate patient history and consider specific precautions to ensure safe administration.
- Confirm a diagnosis of grass pollen allergy through appropriate testing. - Avoid use in individuals with uncontrolled or severe asthma. - Do not administer to patients with a history of severe systemic allergic reactions to allergen immunotherapy. - Pregnancy and lactation status should be assessed, as safety data are limited. - Patients should be observed for at least 30 minutes after the first dose for potential reactions. - Discontinue treatment if serious adverse events occur and seek medical evaluation.
What does Phleum Pratense (225) interact with?
Grazax may interact with other medications or conditions that affect immune response or increase the risk of allergic reactions.
Avoid: - Concurrent use of beta‑blockers, which can diminish the effectiveness of emergency epinephrine treatment. - Other allergen immunotherapy products targeting the same allergen, to prevent overlapping exposure.
Use with caution: - Antihistamines or corticosteroids, as they may mask early signs of an allergic reaction. - ACE inhibitors, which have been associated with increased incidence of angio‑edema. - Biologic agents that modulate immune function, such as omalizumab. - Vaccinations, especially live vaccines, should be timed appropriately around immunotherapy.
Frequently asked questions
What is the active ingredient in Grazax and how does it work?+
Who is eligible to receive Grazax treatment?+
How is Grazax administered?+
When should treatment with Grazax be started?+
What are the most common side effects of Grazax?+
Can Grazax cause severe allergic reactions?+
Is Grazax safe to use during pregnancy?+
Should I stop other allergy medications while taking Grazax?+
What should I do if I miss a dose of Grazax?+
Are there any drug interactions to be aware of with Grazax?+
How long does it take to see improvement with Grazax?+
Can children use Grazax?+
Product details
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