Asthma and Nasal Polyps: Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and dendritic cells, resulting in FcεRI down-regulation on these cells. In allergic asthmatics, treatment with omalizumab inhibits IgE-mediated inflammation, as evidenced by reduced blood and tissue eosinophils and reduced inflammatory mediators, including IL-4, IL-5, and IL-13.

Chronic Spontaneous Urticaria (CSU): Omalizumab binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. The mechanism by which these effects of omalizumab result in an improvement of CSU symptoms is unknown.

Asthma: Omalizumab is indicated for adults and pediatric patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

Nasal Polyps: Omalizumab is indicated for add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

Chronic Spontaneous Urticaria (CSU): Omalizumab is indicated for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.

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 with severe hypersensitivity reaction to Omalizumab or any ingredient of Omalizumab.

Asthma: The most common adverse reactions (≥1% of patients) in clinical studies with adult and adolescent patients ≥12 years of age were arthralgia, pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In clinical studies with pediatric patients 6 to <12 years of age, the most common adverse reactions were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, and epistaxis.

Nasal Polyps: The most common adverse reactions (≥3% of patients) in clinical studies with adult patients included the following: headache, injection site reaction, arthralgia, upper abdominal pain, and dizziness.

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

• Anaphylaxis: Initiate omalizumab therapy in a healthcare setting prepared to manage anaphylaxis which can be life-threatening and observe patients for an appropriate period of time after administration.
• Malignancy: Malignancies have been observed in clinical studies.
• Acute Asthma Symptoms: Do not use for the treatment of acute bronchospasm or status asthmaticus.
• Corticosteroid Reduction: Do not abruptly discontinue corticosteroids upon initiation of omalizumab therapy.
• Eosinophilic Conditions: Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids.
• Fever, Arthralgia, and Rash: Stop omalizumab if patients develop signs and symptoms similar to serum sickness.

Pregnancy & Lactation

There are risks associated with poorly or moderately controlled asthma in pregnancy. There is no information regarding the presence of omalizumab in human milk or the effects on milk production. However, omalizumab is a human monoclonal antibody (IgG1 kappa), and immunoglobulin (IgG) is present in human milk in small amounts.