Xolair (Omalizumab alfa) – Allergic diseases | HongKong DengYue Medicine

Xolair Application Scope

Xolair is indicated for:

• Moderate to Severe Persistent Allergic Asthma: For adults and children aged 6 years and older with a positive skin test or perennial aeroallergen reactivity whose symptoms are inadequately controlled with inhaled corticosteroids.

• Chronic Spontaneous Urticaria (CSU): For adults and adolescents aged 12 years and older with CSU who remain symptomatic despite H1 antihistamine treatment.

• Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): For adults aged 18 years and older with inadequate response to nasal corticosteroids.

  

Xolair Characteristics

• Ingredients: Omalizumab

• Properties:​ Binds circulating free IgE, lowers free IgE and down-regulates FcεRI receptors on mast cells/basophils, thereby reducing IgE-mediated allergic responses

• Packaging Specification:​ 75 mg/0.5 mL, 150 mg/mL, and 300 mg/2 mL solution in single-dose prefilled syringes

• Storage:​ Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton; protect from light; do not freeze

• Expiry Date: Use the expiry date printed on the carton and syringe/vial

• Executive Standard: ​Refer to the local approved prescribing information

• Approval Number: U.S. FDA BLA: BLA 103976 (Varies by country and region)

• Date of Revision: Product labeling is updated periodically

• Manufacturer: Genentech, Inc.

Guidelines for the Use of Xolair

• Dosage and Administration:

  • Recommended Dose:

    • Asthma: 75 mg to 375 mg SC every 2 or 4 weeks. Dose and frequency are determined by baseline serum total IgE (IU/mL) and body weight (kg) using dosing tables.

    • CRSwNP & IgE-mediated food allergy: 75 mg to 600 mg SC every 2 or 4 weeks, dosing determined by baseline IgE and body weight (see product dosing tables).

    • Chronic spontaneous urticaria (CSU): 150 mg or 300 mg SC every 4 weeks (dose in CSU is independent of IgE level and body weight).

  • Administration:

    • The injection should be administered by a healthcare professional in a setting equipped to manage anaphylaxis.

    • The initial dose should be observed for a period of time post-injection as per local guidelines.

    • It is not for intravenous use.

  • Missed Dose:​ If a scheduled dose is missed, administer as soon as possible and resume dosing schedule per prescribing information; refer to local label for specific guidance on intervals and dose adjustments.

• Adverse Reactions:

  • Common Adverse Reactions: Injection-site reactions (pain, redness, swelling), headache, upper respiratory infections, arthralgia, fever in some populations. Frequency varies by indication and population.

  • Serious Adverse Reactions:

    • Anaphylaxis: A boxed warning—anaphylaxis has occurred after administration (may occur after first dose or after long-term use). Monitor patients after injection and ensure immediate access to emergency care.

    • Malignancy: Malignancies were observed in clinical studies; causality not definitively established—see label for details.

    • Eosinophilic conditions / vasculitis: Rare cases of eosinophilia and vasculitic syndromes (e.g., eosinophilic granulomatosis with polyangiitis) have been reported; monitor clinical signs.

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• Contraindications:

  • Hypersensitivity to the active substance or any of the excipients.

  • Patients with a history of severe hypersensitivity reaction to Xolair.

• Precautions:

  • Anaphylaxis: The risk of anaphylaxis is a boxed warning. Patients should be observed post-injection and prescribed an epinephrine auto-injector.

  • Asthma-Related: Xolair is not for the treatment of acute bronchospasm or status asthmaticus.

  • CSU: Xolair should not be used for the treatment of other forms of urticaria (e.g., cold, pressure, cholinergic).

  • Pregnancy and Lactation: Use only if clearly needed. Consult a physician.

  • Laboratory Test: Serum total IgE levels increase during treatment and remain elevated for up to 1 year after discontinuation. These levels should not be used to monitor treatment response.

Xolair Interactions

• No formal drug-drug interaction studies have been performed.

• Live attenuated vaccines: The safety and efficacy of using live attenuated vaccines with Xolair have not been established.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.