Grazax (Phleum Pratense (225))

Grazax is indicated for the management of symptoms caused by grass pollen exposure in patients with allergic rhinitis.

• Grass pollen‑induced seasonal allergic rhinitis (hay fever).
• Allergic rhinoconjunctivitis caused by timothy grass.
• Patients who have a confirmed IgE‑mediated sensitivity to grass pollen.
• Use as part of a pre‑seasonal immunotherapy regimen to reduce symptom severity.
• Adults and adolescents (typically ≥12 years) with appropriate medical evaluation.
• Individuals seeking an alternative to subcutaneous allergy shots.

The most frequently reported adverse events with sublingual grass pollen immunotherapy are mild and transient.

Common

• Oral itching or mild irritation at the site where the tablet dissolves, typically lasting a few minutes.
• Mild throat irritation or tickle sensation that may be felt for a short period after dosing.
• Transient ear or nasal itching that resolves without intervention.
• Mild headache occurring within a few hours of the first dose.

Serious

• Anaphylactic reaction, characterized by widespread hives, swelling, and difficulty breathing, requiring immediate emergency care.
• Persistent swelling of the lips, tongue, or throat that interferes with breathing or swallowing and needs urgent medical attention.

Before starting Grazax, certain precautions should be considered to ensure safe use and to identify patients who may be at higher risk of adverse reactions.

• Confirmed IgE‑mediated grass pollen allergy through skin testing or specific IgE measurement.
• Avoid use in patients with uncontrolled asthma or a history of severe asthma exacerbations.
• Do not administer to individuals with active oral infections, severe dental disease, or mucosal lesions.
• Pregnancy and breastfeeding status should be discussed with a healthcare provider, as safety data are limited.
• Patients should be observed for at least 30 minutes after the first dose for possible systemic reactions.
• Use only under the supervision of a qualified allergist or immunologist.

Grazax may interact with other medications or substances that affect the immune system or increase the risk of allergic reactions.

Avoid

• Concurrent use of beta‑blockers, which can mask symptoms of anaphylaxis and complicate emergency treatment.
• Simultaneous administration of other allergen immunotherapy products targeting different allergens.

Use with caution

• Antihistamines or mast cell stabilizers, which may alter the perception of local side effects.
• Systemic corticosteroids, especially if used at high doses, as they may affect the immunologic response.
• ACE inhibitors, due to rare reports of increased angioedema risk.