Grazax (Phleum Pratense (225))

Grazax is a prescription sublingual tablet that contains 225 µg of Phleum pratense (timothy grass) allergen extract. It is formulated for oral administration under the tongue and is used in the European market as an allergen immunotherapy product to treat grass‑pollen‑induced seasonal allergic rhinitis. The medication is intended for daily use over a pre‑seasonal period to build tolerance to grass pollen and reduce symptom severity and improve quality of life.

Grazax is indicated for patients with confirmed grass‑pollen allergy who experience seasonal symptoms.

- Seasonal allergic rhinitis caused by timothy grass pollen. - Allergic rhinoconjunctivitis triggered by grass pollen exposure. - Patients who have a positive skin‑prick test or specific IgE to Phleum pratense. - Individuals seeking disease‑modifying therapy rather than symptomatic relief alone. - Use as part of a pre‑seasonal treatment regimen to reduce the need for antihistamines. - Adults and adolescents (12 years and older) with mild to moderate grass‑pollen allergy.

The safety profile of Grazax includes both frequently observed and rare adverse events.

Common: - Mild oral itching, tingling, or irritation at the tablet site, usually resolving within minutes. - Transient sore throat, hoarseness, or a feeling of throat tightness that subsides without treatment. - Nasal irritation, sneezing, or runny nose occurring shortly after the dose. - Mild gastrointestinal discomfort such as nausea or abdominal fullness that is self‑limited.

Serious: - Anaphylactic reaction characterized by hives, widespread swelling, difficulty breathing, or a drop in blood pressure. - Angioedema involving swelling of the lips, tongue, or throat that may compromise airway. - Persistent wheezing, severe shortness of breath, or bronchospasm requiring emergency medical attention.

Before starting Grazax, patients and clinicians should consider several precautionary measures to ensure safe use.

- Confirm diagnosis of grass‑pollen allergy with appropriate testing (skin‑prick or specific IgE). - Avoid initiating therapy in individuals with uncontrolled asthma or a history of severe allergic reactions. - Do not use in patients with active oral infections, lesions, or poor oral hygiene. - Discontinue the tablet and seek medical help if signs of anaphylaxis appear after dosing. - Pregnant or breastfeeding women should discuss potential risks with a healthcare professional, as safety data are limited. - Concomitant use of beta‑blockers may mask symptoms of an allergic reaction. - Keep the medication out of reach of children; accidental ingestion can cause serious effects.

Grazax may interact with other medications or substances that influence immune response or allergic reactions.

Avoid: - Concurrent use of other allergen immunotherapy products (e.g., subcutaneous grass pollen extracts) without medical supervision. - Simultaneous administration of systemic corticosteroids at high doses that could suppress the intended immunologic effect.

Use with caution: - Beta‑blockers, which can interfere with the treatment of severe allergic reactions. - ACE inhibitors, as they may increase the risk of angioedema. - Antihistamines or leukotriene receptor antagonists, which can be continued but may mask mild local reactions.