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Th1089 details
Primary information
ID10481
Therapeutic IDTh1089
Protein NamePalivizumab
Sequence>Th1089_Palivizumab QVTLRESGPALVKPTQTLTLTCTFSGFSLSTSGMSVGWIRQPPGKALEWLADIWWDDKKDYNPSLKSRLTISKDTSKNQVVLKVTNMDPADTATYYCARSMITNWYFDVWGAGTTVTVSS
Molecular WeightNA
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting point61 (FAB fr
Half-life18-20 days (in adults)
DescriptionHumanized, recombinant, monoclonal antibody (IgG1k) directed agaisnt the epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Synagis is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence is derived from the constant domains of human IgG1 and the variable framework regions of the VH genes Cor (1) and Cess (2). The human light chain sequence is derived from the constant domain of Ck and the variable framework regions of the VL gene K104 withJk-4. Palivizumab is expressed from a stable murine myeloma cell line (NS0). Palivizumab is composed of to heavy chains (50.6 kDa each) and two light chains (27.6 kDa each), contains 1-2% carbohydrate by weight and has a molecular weight of 147.7 kDa ± 1 kDa (MALDI-TOF).
Indication/DiseaseFor prophylaxis of respiratory diseases casued by respiratory syncytial virus.
PharmacodynamicsSynagis exhibits neutralizing and fusion-inhibitory activity against Respiratory syncytial virus (RSV). These activities inhibit RSV replication or spread. Synagis is given to prevent the development of lower respiratory tract disease in pediatric patients.
Mechanism of ActionPalivizumab binds to the fusion glycoprotein of RSV. This prevents its binding and uptake by host cellular receptors.
ToxicityNA
MetabolismMost likely removed by opsonization via the reticuloendothelial system.
AbsorptionNA
NA
ClearanceNA
CategoriesAmino Acids, Peptides, and Proteins,Anti-Infective Agents,Antibodies,Antibodies, Monoclonal,Antibodies, Monoclonal, Humanized,Antiinfectives for Systemic Use,Antiviral Agents,Blood Proteins,Fusion Protein Inhibitors,Globulins,Immune Sera and Immunoglobulins,Immunoglobulins,Immunoproteins,Proteins,Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody,Serum Globulins,Specific Immunoglobulins
Patents NumberCA2197684
Date of Issue31-Oct-2000
Date of Expiry9-Aug-2015
Drug InteractionNA
TargetFusion glycoprotein F0,Low affinity immunoglobulin gamma Fc region receptor III-B,Complement C1r subcomponent,Complement C1q subcomponent subunit A,Complement C1q subcomponent subunit B,Complement C1q subcomponent subunit C,Low affinity immunoglobulin gamma Fc region receptor III-A,High affinity immunoglobulin gamma Fc receptor I,Low affinity immunoglobulin gamma Fc region receptor II-b
Brand NameSynagis
CompanyMedImmune
Brand DescriptionMedImmune
Prescribed ForPalivizumab inhibits the actions of respiratory syncytial virus (RSV) and helps to prevent the disease
Chemical NameNA
Formulation100 mg single-dose vial of Synagis liquid solution contains 100 mg of palivizumab and also contains chloride (0.5 mg), glycine (0.1 mg), and histidine (3.9 mg), in a volume of 1 mL.
Physical Appearance Sterile, preservative-free liquid solution
Route of AdministrationIntramuscular
Recommended Dosagerecommended dose of Synagis is 15 mg per kg of body weight given monthly by intramuscular injection. The first dose of Synagis should be administered prior to commencement of the RSV season and the remaining doses should be administered monthly throughout the RSV season. Children who develop an RSV infection should continue to receive monthly doses throughout the RSV season. In the northern hemisphere, the RSV season typically commences in November and lasts through April, but it may begin earlier or persist later in certain communities.
Contraindicationindicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.The following points should be considered when prescribing Synagis: Safety and efficacy were established in children with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (less than or equal to 35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD).
Side Effectshigh fever, ear pain or drainage, tugging at the ear; warmth or swelling of the ear; crying or fussiness, especially while lying down; change in sleeping patterns; poor feeding or loss of appetite; easy bruising or bleeding; or trouble breathing.
Useful Link 1Link
Useful Link 2NA
RemarksNA