Grazax

Grazax is a prescription sublingual tablet containing 225 AU of Phleum pratense (timothy grass) extract. It is formulated for the sublingual administration of a standardized grass pollen allergen to help manage grass pollen‑induced allergic rhinoconjunctivitis (hay fever) in the European market. The product is intended for use under medical supervision and is part of allergen immunotherapy aimed at inducing immune tolerance through repeated dosing during the pollen season.

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.