Xolair® (Omalizumab)

Xolair® (Omalizumab)

Description

Omalizumab 150mg Injection — Anti-IgE Monoclonal Antibody for Allergic Asthma and Chronic Spontaneous Urticaria

Additional Information

Xolair® (Omalizumab) — Targeted Anti-IgE Therapy for Allergic Conditions

A Sourcing Guide for Hospitals, Allergy Clinics, and Pharmacies

Xolair® (Omalizumab) is a humanised monoclonal antibody indicated, according to the manufacturer’s approved prescribing information, for the treatment of moderate to severe persistent allergic asthma inadequately controlled with inhaled corticosteroids, and for chronic spontaneous urticaria (chronic hives) inadequately controlled with antihistamines. As with all biologic therapies, the decision to prescribe Xolair, including patient selection based on IgE levels and body weight, rests entirely with the treating physician, in accordance with the approved label. This page provides sourcing and procurement information for hospitals, clinics, and pharmacies, not clinical or treatment guidance.

As both a trusted medicine distributor in Delhi and a licensed pharmaceutical distributor in Delhi, A.K. Pharma supplies genuine Xolair (Omalizumab) 150mg to hospitals, allergy and respiratory clinics, and pharmacies across India, with cold chain-compliant handling throughout procurement and delivery.


What is Xolair (Omalizumab)?

Xolair contains Omalizumab, a recombinant humanised monoclonal antibody that selectively binds to circulating immunoglobulin E (IgE), a key antibody involved in the allergic response cascade.

The Role of IgE in Allergic Disease:

In allergic asthma and chronic urticaria, IgE antibodies bind to high-affinity IgE receptors (FcεRI) found on the surface of mast cells and basophils. When an allergen — or in chronic spontaneous urticaria, an often unidentified trigger — cross-links IgE molecules bound to these receptors, it causes mast cells and basophils to degranulate, releasing histamine, leukotrienes, and other inflammatory mediators. This release drives the characteristic symptoms of allergic asthma (airway inflammation, bronchoconstriction, mucus production) and chronic urticaria (hives, itching, angioedema).

Omalizumab’s Mechanism: According to the manufacturer’s prescribing information, Omalizumab binds to free IgE in the bloodstream at the same site IgE would use to bind its receptor, preventing IgE from attaching to mast cells and basophils. Over time, this also leads to a downregulation of FcεRI receptors on these cells, further reducing the allergic cascade’s ability to be triggered. Unlike therapies that block the downstream inflammatory mediators individually, Omalizumab acts further upstream, reducing the initiating step of the allergic cascade itself.

Full prescribing information is available at the FDA label for Omalizumab.


Clinical Studies and Evidence

INNOVATE Trial (Omalizumab in Severe Persistent Allergic Asthma)
Published in Allergy (2005), the INNOVATE trial evaluated Omalizumab as add-on therapy in patients with severe persistent allergic asthma inadequately controlled despite high-dose inhaled corticosteroids and long-acting beta-agonists. Key findings included a significant reduction in clinically significant asthma exacerbations and emergency visits compared to placebo, establishing Omalizumab’s role as add-on therapy in difficult-to-control allergic asthma.

ASTERIA I and ASTERIA II Trials (Omalizumab in Chronic Spontaneous Urticaria)
Published in the Journal of Investigative Dermatology (2013) and New England Journal of Medicine (2013) respectively, these trials evaluated Omalizumab in patients with chronic spontaneous urticaria that remained symptomatic despite antihistamine therapy. Both trials demonstrated significant reductions in itch severity and hive counts compared to placebo, establishing the evidence base for Omalizumab’s approval in this indication.

GLACIAL Trial (Long-Term Safety in Chronic Urticaria)
Published in the Journal of Allergy and Clinical Immunology: In Practice (2017), the GLACIAL trial provided extended safety follow-up for Omalizumab use in chronic spontaneous urticaria, supporting its long-term tolerability profile in this population.


Available Strength

Xolair is available as:

PresentationStrengthAdministration
Xolair 150mg Injection150mg per vial/pre-filled syringeSubcutaneous injection

Dosing frequency and number of vials per administration vary by indication and are calculated by the prescribing physician based on body weight and baseline IgE levels (for allergic asthma) or administered as a fixed dose (for chronic urticaria), per the approved prescribing information.


Indications — What Xolair is Used For

Moderate to Severe Persistent Allergic Asthma:

  • Adults and adolescents (per approved age criteria) with allergic asthma inadequately controlled with inhaled corticosteroids
  • Patient selection is based on skin test or in vitro reactivity to a perennial aeroallergen, combined with symptoms inadequately controlled by inhaled corticosteroids

Chronic Spontaneous Urticaria:

  • Adults and adolescents with chronic hives that persist despite antihistamine treatment
  • Used as add-on therapy when antihistamines alone do not adequately control symptoms

For detailed indication information refer to MedlinePlus Omalizumab.


Key Benefits of Xolair

Targets the Allergic Cascade Upstream
By binding free IgE before it can attach to mast cells and basophils, Omalizumab addresses the allergic response earlier in the pathway than therapies that only manage downstream symptoms such as bronchospasm or itching.

Established Option for Difficult-to-Control Allergic Asthma
For patients whose allergic asthma remains inadequately controlled on standard inhaled therapy, Omalizumab provides an additional treatment pathway supported by clinical trial evidence for reducing exacerbations.

Addresses Antihistamine-Refractory Chronic Urticaria
Chronic spontaneous urticaria that does not respond to antihistamines can be significantly disruptive to quality of life; Omalizumab provides an evidence-based option for these patients per its approved indication.

Convenient Dosing Interval
Depending on indication and physician-determined dosing, Xolair is typically administered every 2 to 4 weeks, less frequent than daily oral or inhaled therapies.


Dosage and Administration — General Reference

Dosing of Xolair is individualised by the prescribing physician according to the approved label, based on:

  • For allergic asthma: body weight and pre-treatment serum total IgE level, using the manufacturer’s dosing table to determine dose and frequency
  • For chronic spontaneous urticaria: a standard fixed dose administered every 4 weeks, per the approved label

General Administration Notes (per manufacturer information):

  • Administered as a subcutaneous injection by a healthcare professional
  • Patients should be observed for a period after administration, given the recognised risk of anaphylaxis with biologic therapies
  • Do not administer intravenously or intramuscularly

Full dosing guidelines are available in the manufacturer’s official prescribing information and should always be followed exactly as directed by the treating physician.


Who Should Use Xolair

Xolair is prescribed by allergists, pulmonologists, and dermatologists for:

  • Patients with moderate to severe persistent allergic asthma not adequately controlled on inhaled corticosteroid therapy
  • Patients with chronic spontaneous urticaria not adequately controlled with antihistamines

Xolair is prescribed by specialists managing allergic and immunological conditions. A.K. Pharma supplies Xolair to hospitals, allergy clinics, respiratory clinics, and pharmacies across Delhi and India.


Possible Side Effects

Common side effects reported in clinical trials include injection site reactions, headache, and upper respiratory tract infections.

Serious side effects include:

Anaphylaxis: A Boxed Warning in the US prescribing information notes that anaphylaxis has been reported following Xolair administration, in some cases after the first dose but also after later doses. Patients should be monitored appropriately following administration, per the treating physician’s protocol.

Malignancy: Clinical trial data has been monitored for a potential association between Omalizumab and malignancy; ongoing monitoring is part of routine pharmacovigilance for this class of biologic.

Cardiovascular and Cerebrovascular Events: Some post-marketing surveillance has evaluated potential cardiovascular risk signals in Omalizumab-treated populations, and this remains part of ongoing safety monitoring per regulatory guidance.

Full side effect information is available at FDA Omalizumab Safety Information.


Precautions

  • Anaphylaxis risk — Boxed Warning; administration should occur under appropriate clinical observation
  • Not intended for acute bronchospasm or status asthmaticus — Xolair is not a rescue medication
  • Malignancy monitoring — as part of routine pharmacovigilance for this therapeutic class
  • Pregnancy — use per physician assessment of benefit versus risk, in accordance with the approved label
  • Should not be abruptly substituted for corticosteroid therapy without physician guidance
  • Refer to manufacturer prescribing information for complete management context

Storage and Handling

  • Store in a refrigerator (2°C to 8°C)
  • Do not freeze
  • Protect from direct light
  • Keep out of reach of children

As a responsible medicine distributor in Delhi, A.K. Pharma stores all biologic medicines including Xolair under manufacturer-recommended cold chain conditions ensuring product integrity for every supply.


Manufacturer Information

Xolair (Omalizumab) was developed by Genentech/Novartis and Roche, and received FDA approval in 2003 for allergic asthma, with subsequent approval for chronic spontaneous urticaria in 2014. A.K. Pharma supplies only genuine Xolair sourced from authorised distributors.


Related Allergy and Immunology Medicines Available at A.K. Pharma


Frequently Asked Questions

Q. What is Xolair used for?
Xolair (Omalizumab) is used to treat moderate to severe persistent allergic asthma inadequately controlled with inhaled corticosteroids, and chronic spontaneous urticaria inadequately controlled with antihistamines.

Q. What is the generic name of Xolair?
The generic name of Xolair is Omalizumab, a humanised monoclonal antibody that targets circulating IgE.

Q. How does Xolair work?
Xolair binds to free IgE in the bloodstream, preventing it from attaching to receptors on mast cells and basophils, which reduces the release of histamine and other inflammatory mediators responsible for allergic symptoms.

Q. Is Xolair a rescue medication for asthma attacks?
No. Xolair is not intended for the treatment of acute bronchospasm or status asthmaticus. It is a longer-term add-on therapy for chronic allergic asthma management, and patients should continue to use rescue inhalers as directed by their physician.

Q. Why is patient monitoring recommended after Xolair administration?
Anaphylaxis has been reported following Xolair administration in some patients, which is why the US prescribing information carries a Boxed Warning and clinical observation following injection is recommended.

Q. Is Xolair available in India?
Xolair can be supplied to hospitals, allergy clinics, and pharmacies across India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi and pharmaceutical distributor in Delhi — for availability and pricing.

Q. What is the price of Xolair in India?
Xolair price in India varies by pack size and order quantity. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.

Q. How to order Xolair from A.K. Pharma?
You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827 with your requirements and we will respond promptly.

Q. Does A.K. Pharma supply Xolair in bulk?
Yes. A.K. Pharma supplies Xolair in bulk to hospitals, allergy clinics, and pharmacies across Delhi and India.


Why Order Xolair from A.K. Pharma?

  • Licensed medicine distributor in Delhi and pharmaceutical distributor in Delhi with all required drug licenses
  • 100% genuine Xolair sourced from authorised distributors
  • Cold chain-compliant storage and delivery for biologic integrity
  • Available alongside related allergy and respiratory biologics — EpiPen, Nucala, Fasenra — simplifying procurement
  • Bulk supply available for hospitals and clinics
  • Prompt response to all quote requests
  • Serving allergists, pulmonologists, and dermatologists across Delhi NCR and India

Contact A.K. Pharma for Xolair Supply

📍 E-2/257A, 2nd Floor, Shastri Nagar, New Delhi 110052
📞 011 4172 6999
📱 WhatsApp: +91 9810034827
🌐 akpharma.in


Disclaimer: This page is intended for informational and sourcing/procurement purposes only and does not constitute medical or clinical advice. All treatment decisions, including drug selection and dosing, should be made by a qualified healthcare professional in accordance with the approved prescribing information. A.K. Pharma is a licensed medicine distributor and does not provide clinical guidance.

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