Grazax (Phleum Pratense (225))

Grazax is indicated for patients with confirmed grass‑pollen‑induced allergic rhinitis who seek a disease‑modifying approach. Clinical use focuses on seasonal allergy management through sublingual immunotherapy and may reduce reliance on symptomatic medications.

• Initiates a gradual desensitization to Timothy grass pollen.
• Intended for use before and during the grass pollen season.
• Prescribed for adults and adolescents with moderate to severe symptoms.
• Used as part of a comprehensive allergy management plan.
• May complement, but not replace, rescue antihistamines or nasal corticosteroids.

Side effects of Grazax reflect the local immune response to sublingual exposure and are generally mild to moderate. They are categorized as common or serious based on frequency and severity.

Common

• Mild oral itching or tingling at the tablet site.
• Transient throat irritation or mild hoarseness.
• Small increase in nasal congestion or sneezing shortly after dosing.

Serious

• Persistent wheezing or shortness of breath.
• Severe oral swelling that interferes with breathing or swallowing.
• Anaphylactic reactions requiring emergency medical attention.

Precautions for Grazax aim to identify patients who may be at higher risk for adverse reactions and to ensure safe administration of the sublingual tablet before initiating therapy.

• Not recommended for individuals with uncontrolled asthma or recent severe asthma exacerbations.
• Contraindicated in patients with a history of severe allergic reactions to grass pollen extracts.
• Should be avoided in those with active oral infections or lesions.
• Use with caution during pregnancy; safety data are limited.
• Discontinue the tablet if serious systemic symptoms develop and seek medical care promptly.
• Avoid concurrent use of other sublingual immunotherapy products.
• Ensure the tablet remains under the tongue until fully dissolved; do not swallow immediately.

Grazax may interact with other medications or substances that affect the immune system or increase the risk of allergic reactions. Interactions are grouped by those to avoid and those requiring caution.

Avoid

• Concurrent use of other allergen immunotherapy tablets or injections targeting grass pollen.
• Simultaneous administration of systemic corticosteroids at high doses that may suppress the intended immune response.
• Use with investigational immunomodulatory agents lacking safety data.

Use with caution

• Beta‑agonist inhalers for asthma; monitor respiratory status during treatment.
• Antihistamines or nasal steroids; they may mask early signs of an allergic reaction.