Itulazax (Betula Verrucosa (108))

Itulazax is used in allergen immunotherapy targeting birch pollen–induced respiratory allergy.

• Allergic rhinitis due to birch pollen: reduces nasal congestion, sneezing and itching.
• Allergic conjunctivitis due to birch pollen: alleviates ocular redness, tearing and itching.
• Seasonal birch pollen allergy: improves overall tolerance and may decrease the need for rescue antihistamines.

• Itulazax delivers standardized Betula verrucosa allergen extracts sublingually, exposing the oral mucosal immune system to controlled amounts of birch pollen proteins. Repeated exposure promotes a shift from IgE‑mediated hypersensitivity toward IgG4 production and induces regulatory T‑cell responses, thereby establishing immune tolerance and reducing allergic inflammation upon natural pollen exposure. The sublingual route bypasses gastrointestinal degradation and facilitates direct interaction with dendritic cells in the oral cavity, enhancing antigen presentation and long‑term immunomodulation.

Sublingual administration of Itulazax may be associated with local and systemic adverse reactions.

Common Side Effects

• Mild oral itching or tingling: transient sensation on the tongue or palate.
• Transient throat irritation: mild discomfort that resolves without treatment.
• Nasal congestion: temporary increase in nasal blockage.
• Mild headache: occasional tension‑type headache.

Serious or Rare Side Effects

• Anaphylaxis: severe systemic allergic reaction requiring immediate medical attention.
• Angioedema: swelling of lips, tongue or airway that may compromise breathing.
• Severe asthma exacerbation: sudden worsening of bronchospasm in asthmatic patients.

Prior to prescribing Itulazax, clinicians should consider several safety and handling precautions.

• Allergy testing: confirm sensitisation to Betula verrucosa before initiation.
• Medical history: assess for uncontrolled asthma or severe cardiovascular disease.
• Concurrent immunotherapy: avoid simultaneous use of other allergen extracts without specialist guidance.
• Pregnancy and lactation: use only if potential benefit justifies potential risk, as data are limited.
• Monitoring: observe patients for at least 30 minutes after the first dose for systemic reactions.
• Store at ambient temperature: keep below 25 °C, in original container, protected from moisture and direct sunlight.

Itulazax may interact with medications that influence immune response or increase the risk of allergic reactions.

Major Interactions (Avoid)

• Beta‑blockers: may mask symptoms of anaphylaxis and complicate emergency treatment.
• ACE inhibitors: can potentiate angioedema risk when combined with allergen exposure.

Moderate Interactions (Monitor Closely)

• Antihistamines: may reduce perceived efficacy of sublingual immunotherapy; timing adjustments may be needed.
• Corticosteroids: systemic steroids can alter immune modulation; monitor clinical response.
• Other allergen extracts: concurrent use may increase cumulative allergen load; coordinate with allergist.