Omalizumab - @ - Monoclonal Antibodies- Leukotriene Formation Inhibitors
Drug Name:
Omalizumab - @ - Monoclonal Antibodies- Leukotriene Formation Inhibitors
List Of Brands:
 
Indication Type Description:
    
    
           
            Indication:
        
        
            
	Asthma
	 
	                    Patent Expiry Date of drugs (Ref - IDMA Publication)    
	 
	Chemical       Category                      Manufacturer/        US Patent
	Ingredient-                                           Marketer                   Expiration Date  
	 
	Omalizumab    Respiratory               Roche/Genetech       03-02-2014
        
     
    
    
           
            Adverse Reaction:
        
        
            
	CNS-     dizziness 3%    fatigue 3%
	Dermatogic -  Dermatitis  2% Pruritus 2%
	Musculoskeletal -     arm pain 2%    arthalgia  7%     fracture  2%      leg pain  3%
	Miscellaneous-     earache  2%     pain  6%
        
     
    
    
           
            Contra-Indications:
        
        
            
	Severe hypersensitivity to  omalizumab
	
	Special Precautions- 
	Hypersensitivity -  anaphylaxis has been reported to occur after administration of omalizumab.
	Some of the reactions have been life threatening
	Malignancy- malignant neoplasms were observed in omalizumab treated patients in clinical 
	stuudies of asthma and allergic disorders.
	The impact of longer usage of omalizimab or use in patients at higher risks for malignancy
	(eg, current smokers, elderly patients) is not known
	Acute asthma  exacerbation - do not use fot treatment of acute bronchspasm or status
	asthmaticus
	Corticosteroid reduction-  do not abruptly discontinue systemic or inhaled corticosteroids upon
	initiation of omalizumab therapy.
	Perform decreases in corticosteroids under the direct supervision of a physician , however,
	 decreases may need to be performed gradually
	Eosinophillic conditions- in rare case, patients with asthma on omalizumab therapy may present
	serious systemic eosinophilla. These events have not always been  associated with the reduction
	of oral corticosteroids therapy. Be alert to eosinophilia, vasculitic rash, worsening of pumonary
	symptoms.
	Parasite ( helminth infection )  - monitor patients for point of geohelminth infection for such infection
	while on omalizumab therapy. Insufficient data avialable to determine the length monitoring required
	Pregnancy- use omalizumab during pregnancy only  if required
	Lactation- excercise caution when administering omalizumab to a breast feeding woman
	Children- safety and efficacy in children younger than 12 years of age have not been established
	Lab test abnormalities- serum total IgE levels increase following administration of omalizumab
	because of formation of omalizumab IgE complexes noiticed. Elevated elevated IgE levels  may
	persist up to 1 year after discontinuation of omalizumab
	Monitoring- closely monitor patients for anaphylaxis for an appriopiate time after administration 
	Closely monitor patients at high risk of geohelminth infection while they are on omalizumab
	therapy
	
	 
        
     
    
    
           
            Dosages/ Overdosage  Etc:
        
        
            
	Indication-
	Asthma
	Dosage-
	Adults and adlosnts 12 years of age-
	Usual dosage - 150 to 375mg is administered simultaneously every 2 or 4 weeks.
	Because the injection is viscous it may take 10 seconds to administer.
        
     
    
    
           
            Patient Information:
        
        
            
	1. Advice patients of the risk of life threatening anaphylaxis with omalizumab therapy
	2. Inform patients that there have reports of anaphylaxis up to 4 days after administration of
	   omalizumab.
	3. Omalizumab should be administered in a health care setting by a physician
	4. Closely observe patients following administration.
	5. Inform patients to report signs and symptoms of anaphylaxis
	6. Tell patients receiving omalizumab not to decrease the dose or stop taking any other
	     asthma medications unlerss otherwise instructed by the Doctor
	7. Tell patients that they may see immediate improvement in their asthma after begining
	    omalizumab therapy   
        
     
    
    
           
            Pregnancy and lactation:
        
        
            
	Pregnancy-
	Use omalizumab during pregnancy only  if required
	Lactation-
	Excercise caution when administering omalizumab to a breast feeding woman
	Children-
	Safety and efficacy in children younger than 12 years of age have not been established