Grazax (Phleum Pratense (225))

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.