Grazax (Phleum Pratense (225))

Grazax is a prescription sublingual tablet containing 225 µg of Phleum pratense (timothy grass) extract. It is formulated for oral administration under the tongue and is classified as an allergen immunotherapy product for the treatment of grass pollen‑induced allergic rhinitis and seasonal allergic rhinoconjunctivitis in the European market. The medication is intended for use before the grass pollen season and requires a prescription from a qualified healthcare professional.

Grazax is indicated for patients with documented sensitivity to grass pollen who experience allergic rhinitis or rhinoconjunctivitis symptoms.

- Initiation of allergen immunotherapy prior to the start of the grass pollen season. - Reduction of seasonal nasal congestion, sneezing, and itchy eyes associated with grass pollen exposure. - Long‑term disease‑modifying effect that may lessen the need for symptomatic medications. - Use in adults and children (typically from age 5) with confirmed grass pollen allergy. - Administration as a single daily sublingual tablet under medical supervision.

The safety profile of Grazax includes both frequently observed and less common reactions, most of which are mild and transient.

Common: - Oral itching or mild irritation of the mouth and throat. - Transient throat swelling that resolves without intervention. - Mild ear or nasal itching. - Slight increase in nasal discharge shortly after dosing. - Mild abdominal discomfort or nausea. - Transient headache or dizziness.

Serious: - Persistent or progressive swelling of the lips, tongue, or throat that may affect breathing. - Anaphylactic reaction characterized by hives, difficulty breathing, or cardiovascular symptoms. - Severe systemic allergic reaction requiring emergency medical care.

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

- Confirmed diagnosis of grass pollen allergy through skin testing or specific IgE measurement. - Avoid use in patients with uncontrolled asthma or severe chronic respiratory disease. - Assess for a history of severe allergic reactions, especially to sublingual or oral immunotherapy. - Do not administer to pregnant or breastfeeding individuals unless the benefit outweighs potential risk. - Ensure the tablet is placed under the tongue and not swallowed immediately to allow proper absorption. - Monitor patients during the first administration for signs of systemic allergic response.

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

Avoid: - Concurrent use of beta‑blockers, which can mask symptoms of anaphylaxis and complicate emergency treatment. - Simultaneous administration of other allergen immunotherapy products targeting the same or different allergens.

Use with caution: - Antihistamines or corticosteroids may reduce the perception of mild local reactions, potentially delaying recognition of a serious event. - Immunosuppressive agents (e.g., systemic steroids, biologics) could alter the efficacy of the immunotherapy. - Vaccinations, particularly live vaccines, should be spaced appropriately from Grazax dosing.