Grazax (Phleum Pratense (225))

Grazax is indicated for individuals with grass pollen‑induced allergic rhinitis, including seasonal hay fever, who require a disease‑modifying approach rather than symptomatic relief alone.

• Pre‑seasonal or early‑season initiation to build tolerance before peak pollen exposure.
• Adjunct to standard antihistamine or intranasal corticosteroid therapy during the grass pollen season.
• Use in patients aged 5 years and older, as approved by EU regulatory authorities.
• Management of intermittent or persistent allergic rhinitis triggered primarily by timothy grass and related grasses.
• Consideration for patients who prefer a non‑injectable immunotherapy option.

The safety profile of Grazax reflects the typical reactions seen with sublingual allergen immunotherapy; most are mild and transient, while rare events may require medical attention. Patients are advised to remain seated for at least 30 minutes after each dose and to have rescue medication available.

Common

• Mild oral itching or tingling at the site of tablet placement.
• Transient sore throat or mild dysphagia.
• Nasal congestion or mild rhinorrhea.
• Mild gastrointestinal discomfort such as nausea.
• Mild ear fullness or pressure.
• Transient skin redness or hives limited to the oral cavity.

Serious

• Anaphylaxis or severe systemic allergic reaction requiring emergency care.
• Severe bronchospasm or asthma exacerbation.
• Severe urticaria or angioedema involving the face, lips, or tongue.
• Persistent hypotension or syncope.

Grazax should be used with attention to specific precautions to minimize risk and ensure optimal benefit during grass pollen season.

• Confirm diagnosis of grass pollen allergy with appropriate testing before starting therapy.
• Ensure asthma is well‑controlled; do not begin during an active exacerbation.
• Avoid use in persons with a history of severe systemic reactions to grass pollen extracts.
• Discuss pregnancy, lactation, and limited safety data with a healthcare professional.
• If signs of anaphylaxis appear, discontinue and seek immediate medical attention.

Grazax may interact with certain medications or conditions; awareness of these interactions helps maintain safety during immunotherapy.

Avoid

• Concurrent use of beta‑blockers, which can blunt the response to epinephrine in case of anaphylaxis.
• Concurrent administration of other sublingual or injectable allergen immunotherapies targeting the same allergen.

Use with caution

• Antihistamines may reduce local oral symptoms but do not interfere with the immunologic effect.
• Corticosteroids, especially systemic, should be reviewed as they may alter immune response.
• ACE inhibitors or angiotensin receptor blockers, due to potential for increased angioedema risk.
• Patients with uncontrolled asthma should be monitored closely when starting therapy.