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 a allergen extract (sublingual immunotherapy) presented as a sublingual formulation for sublingual use. It is indicated for the treatment of allergic rhinitis and seasonal allergic rhinoconjunctivitis caused by birch (Betula) pollen in patients with confirmed sensitivity.

GNH India supplies Itulazax as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company ensures quality compliance with EU standards and provides reliable global distribution.

Manufacturer / TM Owner

Alk-Abello A/S

1
Pack/s
This product is added to your enquiry list

Request a Quote

Please fill out the form below and our team will get back to you shortly with pricing and further information.

A minimum order value applies. Our team will confirm the exact amount or quantity after reviewing your requirements.

Indications & Clinical Uses

Itulazax is employed in allergy immunotherapy to modify the immune response to birch pollen.

  • Allergic rhinitis caused by birch pollen: reduces nasal congestion, sneezing, itching and watery discharge.
  • Seasonal allergic rhinoconjunctivitis due to Betula verrucosa: improves ocular symptoms and overall quality of life.
  • Birch pollen‑induced allergic conjunctivitis: lessens eye redness, itching and tearing.

How It Works

  • Betula verrucosa extract administered sublingually repeatedly exposes the immune system to birch pollen allergens, promoting a shift from IgE‑mediated hypersensitivity toward a regulatory T‑cell phenotype. This induces immune tolerance, decreasing mast‑cell activation and inflammatory mediator release upon natural pollen exposure.

Side Effects

Sublingual exposure to Betula verrucosa extract may be associated with local and systemic reactions.

Common Side Effects

  • Oral itching or mild irritation.
  • Throat discomfort or mild swelling.
  • Transient taste disturbance.
  • Mild headache.
  • Minor gastrointestinal upset.
  • Localized erythema at the administration site.

Serious or Rare Side Effects

  • Anaphylaxis or severe systemic allergic reaction.
  • Angioedema involving the face or airway.
  • Bronchospasm or severe respiratory distress.
  • Eosinophilic esophagitis.
  • Severe urticaria.

Precautions & Warnings

Before prescribing Itulazax, clinicians should consider several precautionary measures.

  • Confirm diagnosis: verify birch pollen sensitivity through skin testing or specific IgE.
  • Monitor initial doses: observe patients for at least 30 minutes after the first administration.
  • Asthma status: avoid use in patients with uncontrolled or severe asthma.
  • Concomitant allergen therapy: do not combine with other allergen immunotherapies without specialist guidance.
  • Store at ambient temperature: keep in the original pack, protect from moisture and direct sunlight.

Avoid Interactions

Itulazax may interact with certain medications; awareness of major and moderate interactions helps ensure safe use.

Major Interactions (Avoid)

  • Beta‑blockers: may mask symptoms of anaphylaxis.
  • ACE inhibitors: increase risk of angioedema.
  • Concurrent sublingual immunotherapy with different allergens: heightened systemic reaction risk.

Moderate Interactions (Monitor Closely)

  • Antihistamines: may reduce local side‑effects but do not eliminate systemic risk.
  • Systemic corticosteroids: could blunt the immunologic response.
  • Immunosuppressants: may diminish treatment efficacy.

Frequently Asked Questions

Itulazax is a sublingual allergen extract containing Betula verrucosa that is prescribed to treat allergic rhinitis and seasonal allergic rhinoconjunctivitis caused by birch pollen. By delivering controlled doses of the birch allergen under the tongue, it aims to reduce nasal and ocular symptoms and improve overall tolerance to natural pollen exposure.

Betula verrucosa extract in Itulazax works by repeatedly presenting the birch pollen allergen to the immune system via the sublingual route. This exposure promotes the development of regulatory T‑cells and shifts the immune response away from IgE‑driven allergy toward a more tolerant phenotype, thereby decreasing mast‑cell activation and symptom severity during pollen season.

The dosing regimen for Itulazax is individualized and set by the prescribing physician based on the patient’s age, severity of allergy, and response to treatment. The prescriber determines the starting concentration, escalation schedule, and maintenance dose, which are adjusted during follow‑up visits to achieve optimal clinical benefit.

Safety data for Itulazax in pregnancy and lactation are limited. It should only be used when the potential benefit to the mother outweighs any possible risk to the fetus or infant. Healthcare providers are advised to discuss the lack of definitive safety information with pregnant or nursing patients before initiating therapy.

To order 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 any cold‑chain requirements) and the necessary import documentation.

Itulazax offers a sublingual route, which can be more convenient and avoids injections required for subcutaneous immunotherapy (SCIT). Sublingual administration allows patients to self‑dose at home after the initial supervised dose, while still achieving comparable long‑term tolerance. However, individual response varies, and the choice between sublingual and injectable forms depends on patient preference, adherence, and clinical considerations.

Itulazax should be stored at ambient temperature, preferably below 25 °C, in its original sealed container. Protect the product from moisture, direct sunlight and extreme temperature fluctuations. Do not refrigerate or freeze unless the manufacturer’s packaging specifically indicates a cold‑chain requirement.

Itulazax is administered sublingually. The patient places the prescribed dose under the tongue, holds it for the time indicated by the prescriber (typically 1–2 minutes), and then swallows. No water or food should be taken for at least 15 minutes after dosing to ensure optimal absorption.

The most serious risks include systemic allergic reactions such as anaphylaxis, angioedema, and severe bronchospasm. These events, although rare, require immediate medical attention. Patients should be educated to recognize early signs of a severe reaction and to seek emergency care promptly if symptoms develop.

Itulazax is contraindicated in individuals with a history of severe anaphylactic reaction to birch pollen, uncontrolled asthma, or other severe uncontrolled allergic diseases. Patients currently receiving other allergen immunotherapies without specialist guidance should also avoid using Itulazax until a thorough risk assessment is performed.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

Disclaimer

At GNH India, we aim to provide information that is expert-reviewed, accurate, and reliable. However, all content on this platform is intended for general informational purposes only and does not constitute professional medical advice, diagnosis, or treatment. While efforts are made to maintain accuracy and currency, the information may contain errors, omissions, or may not reflect the latest developments. Always consult a qualified healthcare professional regarding any medical concerns.

All product names, brand names, trademarks and registered trademarks displayed on this website are the property of their respective owners. This website and its operator are not affiliated with, endorsed by, or authorized by any such trade mark owners unless expressly stated. Any reference to product names or trademarks is made solely for descriptive and informational purposes. No commercial relationship, sponsorship, approval, or association with any trademark owner should be inferred. Information provided herein does not constitute promotion, advertising, or an offer for sale of any medicinal product and is intended solely for general informational purposes.

All trademarks and brand names displayed on this website are used strictly in accordance with the provisions of the Trade Marks Act, 1999, specifically Sections 30 and 30(1) governing fair use. Trademark ownership has been accurately attributed under the "Manufacturer/ TM Owner" section in compliance with statutory requirements.

Ordering Process

Simple, Secure, and Seamless

Learn how our streamlined ordering process guarantees fast, compliant, and reliable access to essential medicines worldwide.

Quote request form

01

Submit Quote Request Form

Tell us what medications you need by filling out our simple form and uploading a valid document.

Price estimate review

02

We Review & Send Estimate

Our licensed pharmacists will verify your details and provide you with a detailed cost estimate.

Secure payment

03

Confirm & Make Payment

Discuss any queries, approve the estimate, and complete your payment.

Worldwide delivery

04

Get Delivered

Your medicines, safely packed and delivered to your door or nearest airport — hassle-free.

Quality You Can Trust

Our internationally recognized certifications underscore our commitment to safety, quality, and excellence.