Xolair

Omalizumab (Omalizumab) instructions

Common name: Omalizumab
Trade name: Xule
Full names: Omalizumab, omalizumab for injection, Xule, Omalizumab

Indications:
Suitable For the treatment of patients diagnosed with IgE (immunoglobulin E)-mediated asthma
This product is suitable for adults and adolescents (12 years and above) patients with moderate to severe persistent allergic asthma who cannot effectively control symptoms after treatment with inhaled glucocorticoids and long-acting inhaled β2-adrenoceptor agonists.

Usage and Dosage:
Determine the appropriate dosage and frequency of this product based on baseline IgE (IU/mL, measured before the start of treatment) and body weight (kg). Before starting administration, a commercially available serum total IgE assay product should be used to detect the patient's IgE level to determine the dosage.
Based on the above measurement results, each dose is 75 - 600 mg, divided into 1 - 4 injections as needed.
Patients with IgE levels below 76 IU/ml have no obvious benefit. For adults and adolescents with IgE levels less than 76 IU/ml, prescribers should confirm that sensitization to perennial allergens is confirmed by in vitro assay (RAST) results before initiating treatment.
Patients whose baseline IgE levels or body weight (kg) are outside the range of the dosing table should not be treated with this product.
The maximum recommended dosage of this product is 600 mg, administered once every 2 weeks.

Adverse reactions:
Injection site pain, swelling, erythema, itching, headache, fever, upper abdominal pain

Contraindications:
It is prohibited for those who have allergic reactions to the active ingredients of this product or any other excipients.

Note:
This product is not suitable for the treatment of acute asthma exacerbation, acute bronchospasm or status asthmaticus.
This product has not been studied in patients with hyperimmune globulin E syndrome, allergic bronchopulmonary aspergillosis, or for the prevention of allergic reactions (including those caused by food allergy, atopic dermatitis, or allergic rhinitis). Therefore, this product is not suitable for treating the above diseases.
This product has not been studied in patients with autoimmune diseases, immune complex-mediated diseases, or patients with existing kidney or liver damage. This product should be used with caution in this patient population.
It is recommended not to abruptly discontinue systemic or inhaled corticosteroid therapy after starting treatment with this product. Glucocorticoid dosage should be reduced under the direct supervision of a physician, and the dose may be gradually reduced.
Only subcutaneous injection can be used, intravenous injection or intramuscular injection is not allowed.
Type I local or systemic allergic reactions (including anaphylaxis and anaphylactic shock) may occur during treatment with this product, and the above reactions may also occur after long-term treatment. Most reactions occur within 2 hours of the first and subsequent injections of this product, but some reactions occur after 2 hours and even 24 hours after injection. Therefore, after treatment with this product, patients should always have first-aid medicine to treat allergic reactions. Patients should be informed of the possibility of such reactions and should seek immediate medical attention if an allergic reaction occurs.
Serum sickness and serum sickness-like reactions (delayed type III hypersensitivity) have occurred in patients treated with humanized monoclonal antibodies, including omalizumab. Possible pathophysiological mechanisms include the formation and deposition of immune complexes due to the development of antibodies against omalizumab. Typical onset is 1 to 5 days after the first dose, or after subsequent injections, or after long-term treatment. Symptoms of serum sickness include arthritis/arthralgia, rash (urticaria or other type of rash), fever, and lymphadenopathy. Antihistamines and corticosteroids are available to prevent and treat the disease, and patients should be advised to report any suspicious symptoms.
Patients with severe asthma rarely develop systemic eosinophilia syndrome or allergic eosinophilic granulomatous vasculitis (Churg-Strauss syndrome), and systemic glucocorticoids are commonly used to treat the above symptoms.
In rare cases, systemic eosinophilia and vasculitis are present or developed in patients treated with antiasthmatic drugs, including omalizumab. These events are often associated with dose reductions of oral corticosteroids.
IgE may be involved in the immune response to some helminth infections. Results from a placebo-controlled trial in hypersensitivity patients with chronic high-risk helminth infections showed no changes in the duration, severity, and treatment response of infection, but a slight increase in the rate of infection. None of the clinical programs are designed to test for this disease, and the incidence of helminthiasis is less than 1/1000. However, patients at high risk for helminth infection should use the medication with caution, especially when traveling to areas where helminth infection is prevalent. If the patient does not respond to recommended antihelmintic treatment, discontinuation of this product should be considered.
This product has no or negligible effect on the ability to drive and operate machinery.

Storage:
Refrigerate at 2-8℃.

Do not freeze.
This product must be stored out of the reach of children.

Mechanism of action:
Omalizumab binds to IgE, thereby preventing IgE from binding to FCεRI (high-affinity IgE receptor) on basophils and mast cells, reducing free IgE levels that can lead to allergic cascade reactions. When this product is used to treat allergic subjects, it causes a significant down-regulation of FcεRI receptors on basophils.

Safety and Efficacy:
Study 011 was conducted in patients with moderate to severe asthma and had no restrictions on FEV1 at screening. Unlike Studies 008 and 009, treatment with long-acting beta2 agonists was allowed. Patients received at least 1000 µg/day of fluticasone propionate, and a subgroup of patients also received oral corticosteroids. Patients receiving other concomitant medications were excluded, and patients were not allowed to receive additional asthma control medications during the study. Patients who were current smokers were excluded.
The studies all include a lead-in period to achieve stable conversion to commonly used ICS (fluticasone propionate), and are then randomized to receive this product or placebo. Patients were stratified according to use of ICS alone or both ICS and oral steroids. Patients received this product for 16 weeks, and the glucocorticoid dose remained unchanged unless an acute exacerbation required an increase in glucocorticoid dose. The patient then entered a 16-week ICS tapering period, during which attempts were made to gradually reduce the dose of ICS or oral steroids.
At the end of treatment, the percentage reduction in inhaled corticosteroid dose was significantly greater in omalizumab-treated patients than in placebo patients (median 60% vs. 50%, p=0.003).