Asthma: Omalizumab is used for adults and children aged 6 years and above who have moderate to severe persistent asthma, show a positive skin test or in vitro sensitivity to a year-round aeroallergen, and whose symptoms are not properly controlled with inhaled corticosteroids.

Nasal Polyps: Omalizumab is used as an additional maintenance treatment for nasal polyps in adults aged 18 years and older who do not respond adequately to nasal corticosteroids.

Chronic Spontaneous Urticaria (CSU): Omalizumab is indicated for adults and adolescents aged 12 years and older with chronic spontaneous urticaria who continue to experience symptoms despite treatment with H1 antihistamines.

Asthma and Nasal Polyps: Omalizumab blocks the attachment of IgE to the high-affinity IgE receptor (FcεRI) found on mast cells, basophils, and dendritic cells, leading to a reduction of these receptors on the cell surface. In patients with allergic asthma, omalizumab helps reduce IgE-related inflammation by lowering blood and tissue eosinophils and decreasing inflammatory substances such as IL-4, IL-5, and IL-13.

Chronic Spontaneous Urticaria (CSU): Omalizumab binds with IgE and lowers the amount of free IgE in the blood. As a result, IgE receptors (FcεRI) on cells decrease. However, the exact way this improves CSU symptoms is not fully understood.

For subcutaneous (SC) administration only. Divide doses of more than 150 mg among more than one injection site to limit injections to not more than 150 mg per site.

Asthma: omalizumab 75 to 375 mg SC every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts.

Nasal Polyps: omalizumab 75 to 600 mg SC every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts.

Chronic Spontaneous Urticaria: omalizumab 150 or 300 mg SC every 4 weeks. Dosing in CSU is not dependent on serum IgE level or body weight.

Omalizumab is contraindicated in patients who have severe hypersensitivity to omalizumab or to any of its components.

Asthma: In clinical studies involving adults and adolescents aged 12 years and older, the most common adverse reactions (≥1%) were joint pain, general body pain, leg pain, fatigue, dizziness, fractures, arm pain, itching, dermatitis, and ear pain. In pediatric patients aged 6 to less than 12 years, the most common adverse reactions included nasopharyngitis, headache, fever, upper abdominal pain, streptococcal pharyngitis, otitis media, viral gastroenteritis, insect bites, and nosebleeds.

Nasal Polyps: In adult patients, the most common adverse reactions (≥3%) were headache, injection site reactions, joint pain, upper abdominal pain, and dizziness.

Chronic Spontaneous Urticaria: The most common adverse reactions (≥2%) included nausea, nasopharyngitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection, joint pain, headache, and cough.

Poorly or moderately controlled asthma during pregnancy may carry certain risks. There is no clear information about the presence of omalizumab in human breast milk or its effect on milk production. However, omalizumab is a human monoclonal antibody (IgG1 kappa), and small amounts of immunoglobulin (IgG) are normally present in human milk.

• Anaphylaxis: Omalizumab treatment should be started in a healthcare setting where proper management of anaphylaxis is available, as it may be life-threatening. Patients should be observed for an appropriate period after administration.
• Malignancy: Cases of malignancy have been reported in clinical studies.
• Acute Asthma Symptoms: Omalizumab should not be used for treating acute bronchospasm or status asthmaticus.
• Corticosteroid Reduction: Corticosteroids should not be stopped suddenly after starting omalizumab therapy.
• Eosinophilic Conditions: Monitor for eosinophilia, vasculitic rash, worsening lung symptoms, heart complications, and/or nerve-related problems, especially when reducing oral corticosteroids.
• Fever, Arthralgia, and Rash: Omalizumab should be discontinued if symptoms similar to serum sickness develop.

Antihistamines, anti-allergic agents, and hypo-sensitisation therapy.

Omalizumab prefilled syringe should be transported and stored in a refrigerator at 2°C to 8°C in its original carton. Keep it protected from direct sunlight. The syringe may be removed from and returned to the refrigerator if necessary, but the total time outside the refrigerator should not exceed 2 days. Do not use if exposed to temperatures above 25°C. Do not freeze. Do not use if the syringe has been frozen.