Grazax (Phleum Pratense (225))

Grazax is indicated for the treatment of grass pollen‑induced allergic rhinoconjunctivitis (hay fever) and for the prevention of seasonal allergic rhinitis symptoms in patients with a confirmed sensitivity to timothy grass.

• Initiation of therapy before the start of the grass pollen season.
• Use in adults and children aged 5 years and older with a positive skin‑test or specific IgE to Phleum pratense.
• Administration as a single daily sublingual tablet taken on an empty stomach.
• Continuation throughout the entire pollen season to maintain clinical benefit.
• Adjunct to standard symptomatic medications when those are insufficient.

The safety profile of Grazax reflects the typical reactions seen with sublingual allergen immunotherapy.

Common

• Oral itching or mild irritation of the mouth and throat.
• Transient ear or nasal itching.
• Mild gastrointestinal discomfort such as nausea.
• Localized swelling of the lips or tongue that resolves within minutes.
• Hoarseness or voice changes lasting less than an hour.
• Mild skin redness at the site of tablet dissolution.

Serious

• Anaphylaxis or severe systemic allergic reaction requiring emergency treatment.
• Persistent wheezing or bronchospasm indicative of asthma exacerbation.
• Angioedema affecting the face or airway.
• Severe hypotension or syncope.

Before prescribing Grazax, clinicians should evaluate several precautionary factors to ensure safe use.

• Not recommended for patients with uncontrolled asthma or a history of severe asthma attacks.
• Contraindicated in individuals who have experienced anaphylaxis to grass pollen or any component of the tablet.
• Use with caution in pregnant or breastfeeding women, as safety data are limited.
• Avoid in patients taking beta‑blockers, which may interfere with emergency treatment of anaphylaxis.
• Monitor for systemic reactions during the first weeks of therapy.
• Ensure the tablet is placed under the tongue and not swallowed immediately.
• Discontinue if persistent oral swelling or respiratory symptoms develop.

Grazax may interact with other medications that affect allergic responses or emergency treatment of reactions.

Avoid

• Beta‑blockers, because they can reduce the effectiveness of epinephrine in anaphylaxis.
• ACE inhibitors, which may increase the risk of angioedema when combined with allergen exposure.
• Immunosuppressive agents that could alter the intended immune‑modulating effect of the tablet.
• Systemic corticosteroids, which may suppress the desired immunologic response to the allergen.

Use with caution

• Antihistamines or leukotriene receptor antagonists, which may mask early signs of a systemic reaction.
• Seasonal intranasal corticosteroids, as combined therapy may increase local irritation.
• Other sublingual immunotherapy products, to avoid overlapping allergen exposure.