Grazax (Phleum Pratense (225))

Grazax is indicated for patients with seasonal allergic rhinitis or rhinoconjunctivitis triggered by grass pollen. It is used as a disease‑modifying therapy that aims to reduce symptom severity over time.

• Initiates treatment before the onset of the grass pollen season to build tolerance.
• Administered as a daily sublingual tablet under the tongue.
• Continued throughout the pollen exposure period, typically for three consecutive years.
• Suitable for adults and adolescents with confirmed grass pollen allergy.
• May be combined with symptomatic rescue medications as needed.

Grazax may cause local and systemic reactions related to sublingual allergen exposure. Most adverse events are mild and transient, while rare serious events require medical attention.

Common

• Oral itching or mild irritation of the mouth and throat.
• Mild ear or nasal congestion occurring shortly after dosing.
• Transient throat swelling that resolves without intervention.
• Gastrointestinal discomfort such as nausea or abdominal fullness.
• Itchy or watery eyes occurring within minutes of tablet placement.
• Mild skin redness or rash localized to the face or neck.

Serious

• Persistent or worsening throat swelling that interferes with breathing.
• Anaphylactic reactions characterized by hives, wheezing, or drop in blood pressure.

Grazax should be used with caution in specific patient groups and clinical situations. The following precautions are recommended to ensure safe administration.

• Confirmed diagnosis of grass pollen allergy through skin testing or specific IgE before initiating therapy.
• Initiate treatment under the supervision of a qualified healthcare professional experienced in allergen immunotherapy.
• Patients with uncontrolled asthma or severe respiratory disease should defer treatment until stability is achieved.
• Avoid use in individuals with a history of severe systemic reactions to allergen immunotherapy.
• Pregnant or breastfeeding women should discuss risks with their physician, as safety data are limited.
• Discontinue the tablet and seek medical advice if persistent throat swelling or respiratory symptoms develop.

Grazax may interact with other medications or therapies that affect the immune system or increase the risk of allergic reactions. Consider the following guidance.

Avoid

• Concurrent use of other allergen immunotherapy products targeting grass pollen, as this may amplify immune responses.
• Systemic corticosteroids at high doses, which can suppress the intended immunologic effect of the tablet.

Use with caution

• Antihistamines or leukotriene receptor antagonists, which may mask early signs of an allergic reaction.
• Beta‑agonist inhalers for asthma, ensuring that asthma remains well‑controlled during treatment.
• Immunosuppressive agents such as methotrexate or biologics, which could alter the development of tolerance.