Prescribing information
EU Basic succinct statement: Xolair® Please see Summary of Product Characteristics for full prescribing information. Prescribing Information (PI) may vary from country to country. Please adopt locally as per local PI
Important note: Before prescribing, consult full prescribing information. Presentation (allergic asthma): 75 mg omalizumab. Powder and solvent for solution for injection or solution for injection in pre-filled syringe. One vial of Xolair® 75 mg delivers 75 mg of omalizumab. Reconstituted Xolair® contains 125 mg/mL of omalizumab (75 mg in 0.6 mL). One pre-filled syringe of Xolair® 75 mg contains 75 mg of omalizumab (75 mg in 0.5 mL). Presentation (allergic asthma and chronic spontaneous urticaria): 150 mg omalizumab. Powder and solvent for solution for injection or solution for injection in pre-filled syringe. One vial of Xolair® 150 mg delivers 150 mg of omalizumab. Reconstituted Xolair® contains 125 mg/mL of omalizumab (150 mg in 1.2 mL). One pre-filled syringe of Xolair® 150 mg contains 150 mg of omalizumab (150 mg in 1.0 mL). Omalizumab is a humanized monoclonal antibody manufactured from a mammalian cell line Indication (allergic asthma): Xolair® is indicated in adults, adolescents and children (6 to <12 years of age). Xolair® treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma Adults and adolescents (12 years of age and older) Xolair® is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled β2-agonist. Children (6 to <12 years of age) Xolair® is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled β2-agonist. Indication (chronic spontaneous urticaria): Xolair® is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1-antihistamine treatment. Dosage (allergic asthma): 75-600 mg in one to four subcutaneous injections every two to four weeks according to body weight and baseline serum total IgE level. Dosage (chronic spontaneous urticaria): 300 mg subcutaneous every four weeks. Contraindications (allergic asthma and chronic spontaneous urticaria): Hypersensitivity to omalizumab or to any of the excipients. Warnings/Precautions (allergic asthma and chronic spontaneous urticaria): Not indicated for the treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus; no abrupt discontinuation of corticosteroids; caution in use with renal or hepatic impaired patients, patients with autoimmune diseases and immune complex-mediated conditions; patients with high risk of parasitic infections; occurrence of local or systemic allergic reactions, including anaphylaxis, a history of anaphylaxis unrelated to omalizumab may be a risk factor for anaphylaxis following Xolair® administration, serum sickness or Churg-Strauss syndrome and hypereosinophilic syndrome as well as allergic reactions in latex-sensitive individuals using the pre-filled syringe; pregnancy; breast-feeding Interactions (allergic asthma and chronic spontaneous urticaria): None known Adverse drug reactions: Serious adverse reactions (allergic asthma): Rare: Angioedema, anaphylactic reactions and other allergic conditions; Uncommon: allergic bronchospasm. Serious additional undesirable effects reported during post marketing observations are: Allergic granulomatous vasculitis (i.e. Churg-Straus syndrome), idiopathic severe thrombocytopenia, serum sickness (may include fever and lymphadenopathy). Non-serious adverse reactions (allergic asthma): Very common: Pyrexia (in children 6 to <12 years of age), headache (in children 6 to <12 years of age; common in adults and adolescents). Common: Injection site reactions such as pain, swelling, erythema and pruritus, abdominal pain upper (in children 6 to <12 years of age). Uncommon: Dizziness, somnolence, paresthesia, syncope, postural hypotension, flushing, pharyngitis, coughing, nausea, diarrhea, dyspeptic signs and symptoms, urticaria, rash, photosensitivity, weight increase, fatigue, swelling arms, influenza-like illness. Rare: Parasitic infections, laryngoedema, anti-therapeutic antibody development. Other additional undesirable effects reported during post marketing observations are: Alopecia, arthralgia, myalgia, joint swelling. Non-serious adverse reactions (chronic spontaneous urticaria): Common: sinusitis, headache, arthralgia, injection site reactions, upper respiratory tract infections. Packs and prices (allergic asthma and chronic spontaneous urticaria): Country specific. Legal classification (allergic asthma and chronic spontaneous urticaria): Country specific.
For full EU SmPC see http://www.ema.europa.eu
Date of preparation: October 2016