Concise Prescribing Info
Add-on therapy w/ intranasal corticosteroids (INC) for adults ≥18 yr w/ chronic rhinosinusitis w/ nasal polyps (CRSwNP) for whom therapy w/ INC does not provide adequate disease control. Adults & adolescents ≥12 yr: Moderate to severe persistent allergic asthma whose symptoms are inadequately controlled w/ inhaled corticosteroids. Add-on therapy for chronic spontaneous urticaria (CSU) w/ inadequate response to H1-antihistamine treatment. Childn 6 to <12 yr: Add-on therapy to improve asthma control w/ severe persistent allergic asthma who have +ve skin test or in vitro reactivity to perennial aeroallergen & frequent daytime symptoms or night-time awakenings & who have had multiple documented severe asthma exacerbation despite daily high-dose inhaled corticosteroids + long-acting inhaled β2-agonist.
Dosage/Direction for Use
SC Allergic asthma & CRSwNP 75-600 mg in 1-4 inj every 2-4 wk based on body wt & IgE level. CSU 150-300 mg every 4 wk.
Special Precautions
Not to be inj IV or IM. Not indicated for acute asthma exacerbations, acute bronchospasm or status asthmaticus. Autoimmune diseases & immune complex-mediated conditions; high risk of parasitic infections; occurrence of local or systemic allergic reactions including anaphylaxis or serum sickness. Avoid abrupt discontinuation of corticosteroids. Renal or hepatic impairment. Pregnancy & lactation. Childn <18 yr w/ CRSwNP; <12 yr w/ CSU. Not recommended in childn <6 yr w/ allergic asthma.
Adverse Reactions
Pyrexia. Headache, dizziness; upper abdominal pain; inj site reactions eg, pain, erythema, pruritus, swelling; arthralgia; nasopharyngitis, sinusitis, viral upper resp tract infections, UTI, sinus headache; myalgia, pain in extremity, musculoskeletal pain.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03DX05 - omalizumab ; Belongs to the class of other systemic drugs used in the treatment of obstructive airway diseases.
Xolair powd for inj 150 mg
(6 mL + 2 mL solvent (amp)) 1's
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