Grazax (Phleum Pratense (225))

Grazax is indicated for the prevention of symptoms associated with grass‑pollen induced allergic rhinitis and rhinoconjunctivitis.

• Seasonal allergic rhinitis caused by timothy grass pollen.
• Grass pollen‑induced allergic rhinoconjunctivitis in patients with confirmed sensitivity.
• Use as part of a pre‑seasonal immunotherapy regimen to reduce need for antihistamines.
• Suitable for individuals aged 5 years and older when prescribed by a specialist.
• May be considered when conventional pharmacotherapy does not provide adequate symptom control.

Side effects reported with Grazax are generally mild and related to the sublingual route of administration.

Common

• Itching or mild irritation of the mouth and throat.
• Transient oral swelling or tingling sensation.
• Mild gastrointestinal discomfort such as nausea.
• Sneezing or nasal congestion shortly after dosing.

Serious

• Persistent oral swelling that interferes with breathing.
• Severe allergic reaction (anaphylaxis) with hives, difficulty breathing, or throat tightness.
• Systemic urticaria extending beyond the oral cavity.
• Severe asthma exacerbation triggered by the tablet.

Grazax should be prescribed and monitored according to specific safety considerations to minimize risk.

• Confirmed diagnosis of grass‑pollen allergy by skin test or specific IgE before initiation.
• Initiate treatment under medical supervision, with the first dose observed in a clinical setting.
• Not recommended for patients with uncontrolled asthma or severe oral allergy syndrome.
• Avoid use in individuals with a history of anaphylaxis to any allergen.
• Pregnancy and breastfeeding status should be discussed with a healthcare provider.
• Children under 5 years of age are not approved for this therapy.
• Discontinue if severe oral swelling or systemic reaction occurs.

Grazax may interact with other medications or conditions that affect immune response or increase allergic risk.

Avoid

• Concurrent use of other allergen immunotherapy products targeting grass pollen.
• Beta‑blockers in patients at risk of anaphylaxis, as they may blunt emergency treatment.
• ACE inhibitors in patients with a history of angio‑edema.

Use with caution

• Antihistamines or leukotriene receptor antagonists may mask early signs of a reaction.
• Systemic corticosteroids may reduce the efficacy of the immunotherapy.
• Immunosuppressive agents, including biologics, may alter the immune response to the tablet.