Grazax (Phleum Pratense (225))

Grazax is a prescription sublingual tablet that contains 225 µg of Phleum pratense (Timothy grass) extract. It is formulated for oral administration under the tongue and is approved in the European Union for allergen immunotherapy. The tablet is designed to gradually desensitize individuals with grass‑pollen‑induced allergic rhinitis by exposing the immune system to a controlled amount of the allergen. over a treatment course that typically spans several months.

Grazax is indicated for the management of seasonal allergic rhinitis caused by grass pollen, particularly Timothy grass, and for allergic rhinoconjunctivitis that occurs during the grass pollen season.

- Treatment of grass‑pollen‑induced allergic rhinitis in patients aged 5 years and older. - Prevention of seasonal symptoms such as sneezing, nasal congestion, and itchy eyes. - Use as a disease‑modifying therapy to reduce the need for symptomatic antihistamines or nasal corticosteroids. - Administration before the start of the grass pollen season to establish tolerance. - Option for patients who prefer a sublingual route over injection‑based immunotherapy.

The safety profile of Grazax reflects the immune response to sublingual allergen exposure; most reactions are mild and localized, while rare systemic events may occur.

Common: - Itching or mild irritation of the mouth and throat. - Transient oral swelling or tingling sensation. - Mild gastrointestinal discomfort such as nausea. - Localized ear or sinus congestion.

Serious: - Anaphylaxis or severe systemic allergic reaction. - Persistent wheezing or bronchospasm. - Severe swelling of the lips, tongue, or face. - Rapid onset of hives covering large skin areas.

Before prescribing Grazax, clinicians should evaluate patient history and consider specific warnings to ensure safe use.

- Not recommended for individuals with uncontrolled asthma or severe chronic obstructive pulmonary disease. - Contraindicated in patients with a known hypersensitivity to Timothy grass pollen or any tablet excipients. - Initiate treatment under medical supervision, especially the first dose, to monitor for adverse reactions. - Advise patients to avoid eating or drinking for at least 10 minutes after tablet placement. - Caution in pregnant or breastfeeding women; safety data are limited. - Regular follow‑up is advised to assess tolerance development and adjust therapy as needed.

Grazax may interact with other medications or conditions that affect immune function or increase the risk of allergic reactions.

Avoid: - Concurrent use of systemic corticosteroids or immunosuppressive agents that could blunt the immunotherapy response. - Other allergen immunotherapy products targeting grass pollen, to prevent overlapping exposure.

Use with caution: - Beta‑agonist inhalers for asthma; monitor respiratory status during treatment. - Antihistamines or leukotriene receptor antagonists; they do not interfere but symptom control may mask early reactions. - ACE inhibitors, which can increase the incidence of angio‑edema. - Live vaccines; schedule immunotherapy at least two weeks apart.