Itulazax (Betula Verrucosa (108))

Itulazax is used in allergy immunotherapy to address hypersensitivity reactions triggered by birch pollen.

• Birch pollen allergy: reduces the severity and frequency of nasal, ocular and respiratory symptoms by inducing specific immunological tolerance to the birch allergen.
• Allergic rhinitis: alleviates nasal congestion, sneezing, itching and rhinorrhea associated with birch pollen exposure through sustained desensitization.
• Allergic conjunctivitis: diminishes eye redness, tearing, itching and swelling caused by birch pollen allergens by modulating the immune response.

• Itulazax contains standardized Betula verrucosa extract that presents multiple birch pollen allergens to the immune system via the sublingual mucosa. Repeated exposure promotes a shift from a Th2‑dominant response toward regulatory T‑cell activity and IgG4 production, thereby reducing IgE‑mediated mast cell activation and establishing long‑term immunological tolerance to birch pollen. The process also involves cytokine modulation and decreased eosinophil recruitment, contributing to sustained clinical benefit.

The safety profile of Itulazax reflects the typical reactions observed with sublingual allergen immunotherapy.

Common Side Effects

• Oral itching: mild irritation of the mouth or throat after administration.
• Throat irritation: transient soreness or tickling sensation.
• Mild nasal congestion: temporary blockage or runny nose.
• Ear pruritus: occasional itching in the ears.
• Gastrointestinal upset: mild nausea or abdominal discomfort.

Serious or Rare Side Effects

• Anaphylaxis: severe, potentially life‑threatening allergic reaction requiring immediate medical attention.
• Angioedema: rapid swelling of lips, tongue or facial tissues.
• Respiratory distress: wheezing or difficulty breathing not typical of mild reactions.
• Severe urticaria: widespread hives persisting beyond 24 hours.
• Systemic allergic reaction: generalized symptoms such as widespread rash, fever or malaise.

When prescribing Itulazax, clinicians should consider several precautionary measures to ensure safe use.

• Patient selection: confirm diagnosis of birch pollen allergy and assess severity before initiating therapy.
• Prior immunotherapy: evaluate any recent allergen immunotherapy or systemic steroid use.
• Concomitant medications: review antihistamines or beta‑blockers that may mask or exacerbate reactions.
• Monitoring: observe patients for at least 30 minutes after the first dose for adverse responses.
• Pregnancy and lactation: use only if potential benefit justifies potential risk, as safety data are limited.
• Store at ambient temperature: keep below 25 °C in the original container, protect from moisture and direct sunlight.

Itulazax may interact with other agents that influence immune response or allergic reactions.

Major Interactions (Avoid)

• Beta‑blockers: may impede treatment of severe allergic reactions such as anaphylaxis.
• ACE inhibitors: can increase risk of angioedema when combined with allergen immunotherapy.

Moderate Interactions (Monitor Closely)

• Antihistamines: may reduce perceived efficacy of sublingual therapy; timing adjustments may be needed.
• Systemic corticosteroids: can suppress immune response and affect tolerance development.
• Immunosuppressants: may diminish the immunomodulatory effect of the extract.