Grazax

Grazax is a prescription sublingual tablet that contains 225 units of Phleum pratense (timothy grass) allergen extract. It is formulated for sublingual administration and is classified as an allergen immunotherapy product. Grazax is marketed in the European Union for the treatment of seasonal allergic rhinitis caused by grass pollen. The tablet is designed to be placed under the tongue and absorbed daily through the oral mucosa.

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

- Initiation of treatment prior to the start of the grass pollen season. - Use in adults and children aged 5 years and older, as determined by a physician. - Management of nasal congestion, sneezing, itching and watery eyes caused by grass pollen exposure. - Adjunct to allergen avoidance strategies such as staying indoors during high pollen counts. - Long‑term therapy aimed at modifying the underlying immune response to grass pollen. - Can be combined with symptomatic antihistamines if needed, under medical supervision.

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

Common: - Mild itching or tingling in the mouth or throat. - Transient oral swelling or irritation. - Nasal congestion or runny nose shortly after dosing. - Gastrointestinal discomfort such as nausea. - Cough or mild throat irritation lasting less than an hour. - Sneezing episodes within 30 minutes after tablet placement. - Mild headache that resolves without medication.

Serious: - Anaphylaxis or severe systemic allergic reaction. - Persistent swelling of the lips, tongue or airway requiring medical attention. - Severe bronchospasm or wheezing that does not improve with usual rescue inhaler. - Persistent gastrointestinal bleeding or severe abdominal pain.

Before starting Grazax, patients should be evaluated for specific safety considerations and informed about measures to reduce risk.

- Confirm diagnosis of grass‑pollen allergy with appropriate testing. - Avoid use in individuals with uncontrolled asthma or severe chronic obstructive pulmonary disease. - Do not administer to patients with a history of anaphylaxis to any allergen immunotherapy. - Ensure the first dose is taken under medical supervision in a setting equipped for emergency treatment. - Pregnant or breastfeeding women should discuss potential risks with their healthcare provider. - Patients with oral or facial angio‑edema unrelated to allergy should be evaluated before treatment. - Concomitant use of beta‑blockers may mask symptoms of anaphylaxis; discuss alternatives with a physician.

Grazax may interact with other medications or substances that affect the immune system or allergic response.

Avoid: - Concurrent use of other allergen immunotherapy products targeting grass pollen. - Administration of systemic corticosteroids at high doses during the initial treatment phase. - Use of investigational drugs that modulate IgE or IgG4 pathways without physician oversight.

Use with caution: - Antihistamines or leukotriene receptor antagonists, which may mask early signs of an allergic reaction. - Beta‑blockers, as they can interfere with the treatment of severe allergic reactions. - ACE inhibitors, which have been associated with increased incidence of angio‑edema.