Product image of Itulazax (Betula Verrucosa (108)) supplied by GNH India

Itulazax

Active Ingredient:
Betula Verrucosa (108)
Origin:
EU

Itulazax (Betula Verrucosa (108))

Betula Verrucosa, the active ingredient in Itulazax, is an allergen extract presented as a sublingual preparation for sublingual use. It is employed in allergy immunotherapy to induce tolerance to birch pollen allergens in patients with seasonal allergic conditions.

GNH India supplies Itulazax as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to EU quality standards and provides regulatory‑approved batches for global distribution.

Manufacturer / TM Owner

Alk-Abello A/S

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Indications & Clinical Uses

Itulazax is used in allergy immunotherapy targeting birch pollen–related allergic diseases.

  • Birch pollen allergic rhinitis: reduces nasal congestion, sneezing and itching.
  • Birch pollen allergic conjunctivitis: alleviates eye redness, tearing and itching.
  • Birch pollen‑induced asthma: helps lower bronchial hyper‑responsiveness and medication need.

How It Works

  • Itulazax delivers repeated sublingual exposure to Betula Verrucosa proteins, prompting a shift from IgE‑mediated hypersensitivity toward IgG4 production and regulatory T‑cell activation. This immune modulation promotes long‑term tolerance to birch pollen allergens, decreasing clinical reactivity during exposure seasons.

Side Effects

Sublingual administration of Itulazax may be associated with a range of adverse reactions.

Common Side Effects

  • Oral itching or tingling: mild discomfort on the tongue or palate.
  • Throat irritation: transient soreness or scratchy sensation.
  • Mild gastrointestinal upset: occasional nausea or abdominal discomfort.
  • Local swelling: slight enlargement of the lips or mouth.

Serious or Rare Side Effects

  • Anaphylaxis: rapid onset of systemic allergic reaction requiring emergency care.
  • Angioedema: swelling of face, lips, or airway that can compromise breathing.
  • Severe respiratory distress: wheezing or bronchospasm not relieved by usual rescue medication.

Precautions & Warnings

Before prescribing Itulazax, clinicians should evaluate patient suitability and monitor for reactions.

  • Confirm diagnosis: verify birch pollen sensitization with skin testing or specific IgE.
  • Initiate under supervision: first dose administered in a medical setting.
  • Observe post‑dose: monitor patient for at least 30 minutes after initial administration.
  • Avoid in uncontrolled asthma: severe airway disease may increase risk of systemic reactions.
  • Contraindicated in severe immunodeficiency: patients with compromised immune systems should not receive.
  • Store at room temperature: keep in the original pack, protect from moisture and light.

Avoid Interactions

Potential drug interactions should be reviewed before starting therapy.

Major Interactions (Avoid)

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

Moderate Interactions (Monitor Closely)

  • Antihistamines: may reduce the immunogenic response and affect efficacy.
  • Systemic corticosteroids: can interfere with the intended immune tolerance development.
  • Concurrent allergen extracts: simultaneous use may raise cumulative allergen load and heighten reaction risk.

Frequently Asked Questions

Itulazax is a sublingual allergen extract containing Betula Verrucosa, used in allergy immunotherapy to treat patients with birch pollen‑related allergic rhinitis, conjunctivitis, and asthma. By gradually exposing the immune system to the birch pollen allergen, it aims to reduce symptom severity during the birch pollen season.

Betula Verrucosa provides the specific birch pollen proteins that, when administered repeatedly under the tongue, shift the immune response from an IgE‑driven allergy toward a protective IgG4 and regulatory T‑cell profile. This re‑education of the immune system promotes long‑term tolerance and diminishes allergic reactions upon natural exposure.

The dosing regimen for Itulazax is individualized by the prescribing clinician based on the patient’s sensitivity, age, and treatment goals. The prescriber determines the starting concentration, escalation schedule, and maintenance dose, ensuring safe and effective immunotherapy tailored to each patient.

Safety data for Itulazax in pregnancy and lactation are limited. Because the product is a biologic allergen extract, clinicians generally recommend weighing potential benefits against unknown risks. Pregnant or breastfeeding individuals should discuss use with their healthcare provider before starting therapy.

To request Itulazax, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain if needed), and import documentation.

Itulazax is a sublingual formulation, offering the convenience of at‑home administration after the initial supervised dose, unlike subcutaneous injections that require clinic visits. Its allergen extract is standardized to Betula Verrucosa, providing a comparable efficacy profile to other birch pollen extracts while reducing injection‑related discomfort.

Itulazax should be stored at room temperature, preferably below 25 °C, in its original packaging. Protect the product from moisture, direct sunlight, and extreme temperature fluctuations. Do not refrigerate or freeze unless specifically instructed by the manufacturer.

Itulazax is taken sublingually. The patient places the prescribed dose under the tongue and holds it there for the time specified by the prescriber, usually a few minutes, before swallowing. The first dose is administered in a medical setting to monitor for any immediate reactions.

The most serious risks include systemic allergic reactions such as anaphylaxis, severe angioedema, and respiratory distress. These events are rare but require immediate medical attention. Patients should be educated on recognizing early signs and have emergency medication, such as epinephrine, readily available if prescribed.

Itulazax is contraindicated in individuals with a history of severe systemic reactions to birch pollen extracts, uncontrolled asthma, severe immunodeficiency, or those receiving beta‑blockers or ACE inhibitors without close medical supervision. Pregnant or breastfeeding women should only use it after a thorough risk‑benefit discussion with their clinician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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