Manufacturer
NOVARTIS PHARMA STEIN AG
Contents
Omalizumab
Indication
Adults & adolescents (≥12 yr): Moderate to severe persistent allergic asthma whose symptoms are inadequately controlled w/ inhaled corticosteroids. Add-on therapy of chronic spontaneous urticaria (CSU) w/ inadequate response to H1-antihistamine treatment. Childn 6-<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 nighttime awakenings & who have had multiple documented severe asthma exacerbation despite daily high-dose inhaled corticosteroids + long-acting inhaled β2-agonist.
Instruction
For subcutaneous administration only. Do not administer by the intravenous or intramuscular route.
Drug interaction
Cytochrome P450 enzymes, efflux pumps and protein binding mechanisms are not involved in the clearance of omalizumab; thus, there is little potential for drug-drug interactions. No formal drug or vaccine interaction studies have been performed with Xolair.There is no pharmacological reason to expect that commonly prescribed medications used in the treatment of asthma or CSU will interact with omalizumab. Allergic Asthma: In clinical studies Xolair was commonly used in conjunction with inhaled and oral corticosteroids, inhaled short-acting and long-acting beta2-agonists, leukotriene modifiers, theophyllines and oral antihistamines. There was no indication that the safety of Xolair was altered with these other commonly used asthma medications. Limited data are available on the use of Xolair in combination with specific immunotherapy (hypo-sensitization therapy). Chronic Spontaneous Urticaria (CSU): In clinical studies in CSU Xolair was used in conjunction with antihistamines (anti-H1, anti-H2) and leukotriene receptor antagonists (LTRAs). There was no evidence that the safety of omalizumab was altered when used with these medicinal products relative to its known safety profile in allergic asthma. In addition, a population pharmacokinetic analysis showed no relevant effect of H2 antihistamines and LTRAs on omalizumab pharmacokinetics (see PHARMACOLOGY under Actions).
Malaysia
