Itulazax (Betula Verrucosa (108))

Itulazax is used in allergen immunotherapy to modify the immune response to birch pollen exposure.

• Allergic rhinitis caused by birch pollen: reduces nasal congestion, sneezing and itching, improving daily functioning.
• Allergic conjunctivitis due to birch pollen: diminishes eye redness, tearing and irritation.
• Mild to moderate allergic asthma triggered by birch pollen: lowers bronchial hyper‑responsiveness and decreases reliance on rescue inhalers.

• Itulazax delivers repeated sublingual exposure to Betula verrucosa allergen, promoting a shift from IgE‑mediated hypersensitivity toward IgG4‑dominant tolerance. This immunological re‑education reduces mast‑cell activation and downstream inflammatory mediators, thereby decreasing clinical allergy symptoms upon natural birch pollen exposure.

Adverse reactions may occur with sublingual allergen immunotherapy and should be monitored.

Common Side Effects

• Oral itching or tingling: mild discomfort in the mouth after administration.
• Throat irritation: transient soreness or scratchy sensation.
• Transient oral edema: slight swelling of the lips or tongue that resolves spontaneously.
• Nausea: occasional upset stomach following dosing.
• Headache: mild to moderate headache within hours of dosing.
• Dysgeusia: temporary alteration in taste perception.

Serious or Rare Side Effects

• Anaphylaxis: rapid onset of systemic allergic reaction requiring emergency care.
• Severe oral swelling: pronounced edema that may compromise airway.
• Respiratory distress: wheezing or shortness of breath indicating systemic involvement.
• Systemic allergic reaction: generalized urticaria, hypotension or angioedema beyond the oral cavity.

Before initiating therapy, clinicians should evaluate patient history and monitor for reactions.

• Assess allergy severity: confirm birch pollen sensitisation with skin or serum testing.
• Monitor for systemic reactions: observe patients for at least 30 minutes after the first dose.
• Avoid use in uncontrolled asthma: ensure asthma is well‑controlled before starting.
• Contraindicated in known hypersensitivity to Betula verrucosa extract or any excipients.
• Use under medical supervision: dosing adjustments require professional oversight.
• Store at ambient temperature: keep in the original container, protect from moisture and direct heat.

Allergen immunotherapy may interact with other medications that affect immune or allergic responses.

Major Interactions (Avoid)

• Beta‑blockers: can mask signs of anaphylaxis and complicate emergency treatment.
• ACE inhibitors: increase risk of angioedema when combined with sublingual allergen exposure.
• Immunosuppressants: may diminish the therapeutic effect of immunotherapy.

Moderate Interactions (Monitor Closely)

• Antihistamines: may reduce local tolerability but generally do not affect efficacy.
• Systemic corticosteroids: could alter immune modulation and require dose adjustment.
• Concurrent allergen immunotherapies: additive exposure may raise risk of systemic reactions.