Itulazax (Betula Verrucosa (108))

Itulazax is employed in allergy immunotherapy targeting birch pollen–related respiratory conditions.

• Birch pollen allergic rhinitis: reduces nasal congestion, sneezing and itching by inducing immune tolerance to the birch allergen.
• Seasonal allergic rhinoconjunctivitis: improves both ocular and nasal symptoms during birch pollen season through immunomodulation.
• Birch‑related allergic rhinitis: provides long‑term reduction in medication use and symptom severity by shifting the immune response toward a regulatory profile.

• Itulazax delivers Betula verrucosa allergen sublingually, where repeated exposure promotes immune tolerance. The allergen interacts with oral mucosal dendritic cells, leading to a shift from a Th2‑dominated IgE response toward regulatory T‑cell activity and increased IgG4 production, thereby reducing hypersensitivity to birch pollen.

Adverse reactions to Itulazax are generally related to local exposure and systemic immune activation.

Common Side Effects

• Oral itching or tingling: mild discomfort on the tongue or palate.
• Throat irritation: transient soreness after administration.
• Mild swelling of the lips or mouth: resolves without intervention.
• Transient cough: brief irritation of the airway.
• Gastrointestinal upset: occasional nausea or mild stomach discomfort.
• Localized rash at the site of administration.

Serious or Rare Side Effects

• Anaphylaxis: rapid onset of severe allergic reaction requiring emergency care.
• Severe oral or facial edema: pronounced swelling that may affect breathing.
• Systemic allergic reaction: widespread urticaria, wheezing or hypotension.
• Asthma exacerbation: worsening of pre‑existing asthma symptoms.
• Angioedema: deep tissue swelling, particularly of the lips, tongue or throat.

When prescribing Itulazax, clinicians should consider several safety measures.

• Medical supervision: administration should be performed under the guidance of an allergist or qualified healthcare professional.
• Contraindications: avoid use in patients with severe uncontrolled asthma or a history of anaphylaxis to birch pollen.
• Pregnancy: safety has not been established; use only if the potential benefit justifies the potential risk.
• Concurrent immunotherapy: do not combine with other allergen extracts without specialist advice.
• Monitoring: observe patients for at least 30 minutes after the initial dose for any adverse reaction.
• Store at ambient temperature: keep in the original container, protect from moisture and direct sunlight.

Itulazax may interact with certain medications that affect allergic response pathways.

Major Interactions (Avoid)

• Beta‑blockers: can mask symptoms of anaphylaxis and complicate emergency treatment.
• ACE inhibitors: increase the risk of angioedema when combined with allergen exposure.
• Immunosuppressants: may reduce the efficacy of the immunotherapy.

Moderate Interactions (Monitor Closely)

• Antihistamines: may blunt the assessment of early local reactions during dose escalation.
• Corticosteroids: could interfere with the development of immune tolerance if used concurrently.