Omalizumab

XOLAIR is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids. Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment. IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance. Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment.

Asthma, Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy 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 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 chronic spontaneous urticaria (CSU) symptoms is unknown.

For subcutaneous (SC) administration only. See full prescribing information for administration instructions. Asthma: XOLAIR 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. Chronic Rhinosinusitis with Nasal Polyps: XOLAIR 75 to 600 mg SC every 2 or 4 weeks. IgE-Mediated Food Allergy: XOLAIR 75 mg to 600 mg SC every 2 or 4 weeks. See the dose determination chart. Chronic Spontaneous Urticaria: XOLAIR 150 or 300 mg SC every 4 weeks. Dosing in CSU is not dependent on serum IgE level or body weight.

XOLAIR is contraindicated in patients with severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR. Severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR

Boxed warning (anaphylaxis): Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Anaphylaxis: Initiate XOLAIR 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 XOLAIR therapy.

The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis Malignancies 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 (≥3% of patients) were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, and epistaxis. Chronic Rhinosinusitis with 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.

No formal drug interaction studies have been performed with XOLAIR. In patients with asthma, CRSwNP, and IgE-mediated food allergy the concomitant use of XOLAIR and allergen immunotherapy has not been evaluated. In patients with CSU, the use of XOLAIR in combination with immunosuppressive therapies has not been studied. No formal drug interaction studies have been performed.

Storage XOLAIR should be shipped at controlled ambient temperature (≤30°C [≤86°F]). Store XOLAIR under refrigerated conditions 2°C to 8°C (36°F to 46°F) in the original carton.