Grazax (Phleum Pratense (225))

Grazax is indicated for the treatment of grass‑pollen–induced allergic conditions in patients with confirmed sensitivity.

• Seasonal allergic rhinitis (hay fever) caused by timothy grass pollen.
• Allergic conjunctivitis associated with grass pollen exposure.
• Adjunct therapy for patients seeking disease‑modifying treatment rather than symptomatic relief alone.
• Use in individuals aged 5 years and older, as prescribed by a physician.
• May be considered for patients who have not achieved adequate control with antihistamines or nasal corticosteroids.

Side effects reported with sublingual grass‑pollen immunotherapy are generally mild and related to local exposure, but rare systemic reactions can occur.

Common

• Itching or mild irritation of the mouth and throat.
• Swelling of the tongue or lips.
• Transient gastrointestinal discomfort such as nausea.
• Mild headache or fatigue.

Serious

• Anaphylaxis or severe systemic allergic reaction.
• Respiratory distress, including wheezing or bronchospasm.
• Rapid onset of hives or angioedema beyond the oral cavity.

Before prescribing Grazax, clinicians should evaluate patient history and consider specific safety considerations.

• Confirm diagnosis of grass‑pollen allergy with appropriate testing.
• Avoid use in patients with uncontrolled asthma or severe chronic respiratory disease.
• Do not initiate therapy in individuals with a history of severe systemic allergic reactions to allergen extracts.
• Monitor patients for at least 30 minutes after the first dose to detect possible systemic reactions.
• Counsel patients to keep the tablet under the tongue until it dissolves completely; do not swallow immediately.
• Discontinue treatment if persistent oral swelling or systemic symptoms develop.
• Use with caution in pregnant or breastfeeding women; safety data are limited.

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

Avoid

• Concurrent use of other allergen immunotherapy products (subcutaneous or sublingual) without medical supervision.
• Beta‑blockers, which can interfere with the treatment of severe allergic reactions.
• ACE inhibitors in patients with a history of angioedema.

Use with caution

• Antihistamines or nasal corticosteroids, which may mask early signs of systemic reactions.
• Immunosuppressive agents that could alter the intended immune‑modulating effect.
• Live vaccines, as immune response may be affected during active immunotherapy.