Itulazax (Betula Verrucosa (108))

• Itulazax is used in allergy immunotherapy to address birch pollen–induced allergic rhinitis.
• Allergic rhinitis caused by Betula verrucosa (birch pollen): reduces nasal congestion, sneezing, and ocular itching by inducing tolerance to the birch allergen.
• Seasonal allergic conjunctivitis caused by birch pollen: alleviates eye irritation and tearing.
• Cross‑reactive pollen allergies (e.g., alder, hazel): may provide partial symptom relief.

• Itulazax delivers standardized Betula verrucosa allergen extracts sublingually, allowing the immune system to encounter the antigen repeatedly in low doses. This exposure promotes the generation of regulatory T cells and IgG4 antibodies, shifting the immune response away from IgE‑mediated hypersensitivity and fostering long‑term immunological tolerance to birch pollen.

Side effects are generally mild and related to local exposure of the oral mucosa.

Common Side Effects

• Oral itching or tingling
• Mild throat irritation
• Transient tongue swelling
• Slight increase in nasal discharge
• Temporary hoarseness
• Mild headache

Serious or Rare Side Effects

• Anaphylaxis or severe systemic allergic reaction
• Laryngeal edema causing breathing difficulty
• Severe bronchospasm
• Persistent urticaria or angioedema
• Hypotension requiring medical intervention
• Rare cases of eosinophilic esophagitis

• Patients should be evaluated for suitability before initiating therapy.
• Assess patient history: confirm documented birch pollen sensitivity and rule out uncontrolled asthma.
• Monitor for immediate reactions: observe for at least 30 minutes after the first dose.
• Avoid use in severe uncontrolled asthma: risk of bronchospasm may be heightened.
• Do not administer if previous severe systemic reaction to birch allergen occurred.
• Store at room temperature: keep in the original pack, protect from moisture and direct sunlight.

Potential drug interactions should be reviewed prior to prescribing.

Major Interactions (Avoid)

• Concurrent use of ACE inhibitors may increase risk of angioedema.
• Simultaneous administration of other allergen immunotherapies can amplify systemic allergic responses.

Moderate Interactions (Monitor Closely)

• Beta‑blockers may mask symptoms of anaphylaxis and should be used with caution.
• Antihistamines may reduce the efficacy of sublingual immunotherapy if taken immediately before dosing.
• Immunosuppressive agents could diminish the intended immunological tolerance effect.