Grazax (Phleum Pratense (225))

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.

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.

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.

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.