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 (Phleum pratense) pollen.
• Allergic rhinoconjunctivitis triggered by grass pollen exposure.
• Patients with confirmed IgE sensitisation to grass pollen.
• Use as part of a comprehensive allergy management plan, including avoidance measures.
• May be considered for individuals who prefer sublingual immunotherapy over injection.

Side effects reported with sublingual grass‑pollen immunotherapy are generally mild and transient, but rare serious reactions can occur.

Common

• Oral itching or mild irritation at the site of tablet placement.
• Throat discomfort or mild soreness.
• Ear or nasal itching.
• Mild gastrointestinal upset such as nausea.
• Transient headache.

Serious

• Anaphylaxis or severe systemic allergic reaction.
• Angioedema involving the face, lips, or tongue.
• Severe bronchospasm or respiratory distress.
• Persistent urticaria (hives) lasting more than 24 hours.
• Cardiovascular symptoms such as hypotension or syncope.

Before starting Grazax, certain precautions should be reviewed to ensure safe use.

• Confirm diagnosis of grass‑pollen allergy with appropriate testing.
• Do not initiate therapy in individuals with uncontrolled asthma or recent severe asthma exacerbations.
• Avoid use in patients with a history of severe systemic allergic reactions to grass pollen or other allergens.
• Counsel patients to remain seated for at least 30 minutes after each dose and to have emergency medication available.
• Pregnancy and lactation status should be discussed with a healthcare professional.
• Regular follow‑up is recommended to monitor tolerance and symptom control.

Grazax may interact with other medications or substances that affect the immune system or allergic response.

Avoid

• Concurrent use of other allergen immunotherapy products (e.g., subcutaneous grass‑pollen extracts).
• Systemic corticosteroids or immunosuppressive agents that could alter the intended immune response.
• Beta‑blockers in patients at risk of anaphylaxis, as they may interfere with emergency treatment.

Use with caution

• Antihistamines or mast‑cell stabilisers, which may mask early signs of an allergic reaction.
• ACE inhibitors or angiotensin receptor blockers, given the rare risk of angioedema.
• Non‑steroidal anti‑inflammatory drugs (NSAIDs) in patients with known NSAID‑exacerbated respiratory disease.
• Live vaccines, as immunotherapy may theoretically affect vaccine response.