Xolair

Omalizumab

Add-on therapy to improve asthma control in severe persistent allergic asthma in adults & adolescents ≥12 yr who have +ve skin test or in vitro reactivity to a perennial aeroallergen, reduced lung function (FEV₁ <80%), frequent daytime symptoms or night-time awakenings, & multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled β₂-agonist. Add-on therapy to improve asthma control in severe persistent allergic asthma in childn 6 to <12 yr who have +ve skin test or in vitro reactivity to a perennial aeroallergen, frequent daytime symptoms or night-time awakenings, & multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled β₂-agonist. Add-on therapy w/ intranasal corticosteroids for treatment of severe chronic rhinosinusitis w/ nasal polyps (CRSwNP) in adults ≥18 yr for whom therapy w/ intranasal corticosteroids does not provide adequate disease control. Add-on therapy for treatment of chronic spontaneous urticaria (CSU) in adults & adolescents ≥12 yr w/ inadequate response to H₁-antihistamine treatment.

SC Allergic asthma & CRSwNP 75-600 mg in 1-4 inj. Determine appropriate dose & frequency by baseline IgE (measured before starting treatment) & body wt (kg). Max: 600 mg every 2 wk. CSU 300 mg every 4 wk.

Hypersensitivity.

Do not administer by IV or IM route. Not indicated for treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus; in patients w/ hyper-IgE syndrome or allergic bronchopulmonary aspergillosis; for prevention of anaphylactic reactions. Abrupt discontinuation of systemic or inhaled corticosteroids is not recommended after treatment initiation in allergic asthma or CRSwNP. Risk of type 1 local or systemic allergic reactions, including anaphylaxis & anaphylactic shock; delayed allergic type III reactions, including serum sickness & serum sickness-like reactions. Discontinue treatment in case of anaphylactic or other serious allergic reaction; Churg-Strauss syndrome & hypereosinophilic syndrome. Caution in patients w/ autoimmune diseases, immune complex-mediated conditions, or pre-existing renal or hepatic impairment; patients at high risk of helminth infection. Latex-sensitive individuals. Safety & efficacy have not been established in patients <6 yr (allergic asthma); patients <12 yr (CSU); patients <18 yr (CRSwNP).

Allergic asthma & CRSwNP: Pyrexia. Headache; upper abdominal pain; arthralgia; inj site reactions eg, swelling, erythema, pain, pruritus. CSU: Sinusitis, headache, arthralgia, inj site reaction, URTI.

May indirectly reduce efficacy of anthelmintics or antiparasitics.

Antiasthmatic & COPD Preparations

R03DX05 - omalizumab ; Belongs to the class of other systemic drugs used in the treatment of obstructive airway diseases.

P₁S₁S₃