Active Substance: Omalizumab.
Overview
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This medicine contains an important and useful components, as it consists of
Omalizumabis available in the market in concentration
Omalizumab
Not intended for treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus. Patient at risk of parasitic infections. May increase risk of malignancy. Delayed onset of anaphylaxis, it usually occurs 2 hr after admin but may also occur up to 4 days to >1 yr after initiation of regular treatment. Avoid abrupt withdrawal of corticosteroid therapy. Renal and hepatic impairment. Childn. Pregnancy and lactation. Monitoring Parameters Monitor for signs and symptoms of anaphylaxis, infections. Lactation: Unknown if distributed into breast milk; use caution
Severe allergic asthma
Previous severe hypersensitivity reaction, acute bronchospasm, status asthmaticus.
>10% Injection site reactions (45%),Viral infections (23%),URI (20%),Sinusitis (16%),Headache (15%),Pharyngitis (11%) 1-10% Pain (7%),Arthralgia (8%),Fracture (2%),Fatigue (3%),Dermatitis (2%),Arm pain (4%),Leg pain (4%),Dizziness (3%),Earache (2%),Pruritus (2%),Nasopharyngitis (3%),Pyrexia (3%),Upper abdominal pain (3%),Pharyngitis streptococcal (3%),Otitis media (3%),Viral gastroenteritis (3%),Epistaxis (3%) <1% Alopecia,Edema,Anaphylaxis,Bronchitis,Urticaria Potentially Fatal: Anaphylactic reactions including bronchospasm, hypotension, syncope, dyspnoea and/or angioedema of the throat or tongue.
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Omalizumab is an IgG monoclonal antibody (recombinant DNA-derived) which inhibits IgE binding to the high-affinity IgE receptor on mast cells and basophils.
Cytochrome P-450 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 Omalizumab. There is no pharmacological reason to expect that commonly prescribed medications used in the treatment of asthma will interact with omalizumab. In clinical studies, Omalizumab was commonly used in conjunction with inhaled and oral corticosteroids, inhaled short- and long-acting beta-agonists, leukotriene modifiers, theophyllines and oral antihistamines. There was no indication that the safety of Omalizumab was altered with these other commonly used asthma medications. Limited data are available on the use of Xolair in combination with specific immunotherapy (hyposensitisation therapy). Omalizumab may indirectly reduce the efficacy of medicinal products for the treatment of helminthic or other parasitic infections. Incompatibilities: Omalizumab should not be mixed with any medication or diluents other than water for injections.
Information not available