Identification
- Summary
Palivizumab is a monoclonal anti respiratory syncytial virus F protein antibody used to prevent serious sequelae caused by respiratory syncytial virus infection in pediatric patients.
- Brand Names
- Synagis
- Generic Name
- Palivizumab
- DrugBank Accession Number
- DB00110
- Background
Humanized monoclonal antibody (IgG1k) produced by recombinant DNA technology, directed to an 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 was derived from the constant domains of human IgG1 and the variable framework regions of the VH genes Cor (1) and Cess (2). The human lightchain sequence was 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 (mouse) 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)
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Monoclonal antibody (mAb) - Protein Structure
- Protein Chemical Formula
- Not Available
- Protein Average Weight
- Not Available
- Sequences
>VH region MEDI-493 QVTLRESGPALVKPTQTLTLTCTFSGFSLSTSGMSVGWIRQPPGKALEWLADIWWDDKKD YNPSLKSRLTISKDTSKNQVVLKVTNMDPADTATYYCARSMITNWYFDVWGAGTTVTVSS
>VH Region QVTLRESGPALVKPTQTLTLTCTFSGFSLSTSGMSVGWIRQPPGKALEWLADIWWDDKKD YNPSLKSRLTISKDTSKNQVVLKVTNMDPADTATYYCARSMITNWYFDVWGAGTTVTVSS
Download FASTA Format- Synonyms
- Palivizumab
- External IDs
- MEDI 493
Pharmacology
- Indication
For prophylaxis of respiratory diseases casued by respiratory syncytial virus.
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- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- Pharmacodynamics
Synagis 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 action
Palivizumab binds to the fusion glycoprotein of RSV. This prevents its binding and uptake by host cellular receptors.
Target Actions Organism AFusion glycoprotein F0 Not Available Human respiratory syncytial virus B (strain 18537) ULow affinity immunoglobulin gamma Fc region receptor III-B Not Available Humans UComplement C1r subcomponent Not Available Humans UComplement C1q subcomponent subunit A Not Available Humans UComplement C1q subcomponent subunit B Not Available Humans UComplement C1q subcomponent subunit C Not Available Humans ULow affinity immunoglobulin gamma Fc region receptor III-A Not Available Humans UHigh affinity immunoglobulin gamma Fc receptor I Not Available Humans ULow affinity immunoglobulin gamma Fc region receptor II-b Not Available Humans - Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
Most likely removed by opsonization via the reticuloendothelial system.
- Route of elimination
Not Available
- Half-life
18-20 days (in adults)
- Clearance
Not Available
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
Not Available
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Palivizumab. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Palivizumab. Adenovirus type 7 vaccine live The therapeutic efficacy of Adenovirus type 7 vaccine live can be decreased when used in combination with Palivizumab. Aducanumab The risk or severity of adverse effects can be increased when Palivizumab is combined with Aducanumab. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Palivizumab. Alirocumab The risk or severity of adverse effects can be increased when Palivizumab is combined with Alirocumab. Amivantamab The risk or severity of adverse effects can be increased when Palivizumab is combined with Amivantamab. Anifrolumab The risk or severity of adverse effects can be increased when Palivizumab is combined with Anifrolumab. Ansuvimab The risk or severity of adverse effects can be increased when Palivizumab is combined with Ansuvimab. Anthrax immune globulin human The risk or severity of adverse effects can be increased when Palivizumab is combined with Anthrax immune globulin human. 
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- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Synagis Injection, solution 50 mg/0.5mL Intramuscular Astra Zeneca Ab 2016-09-08 Not applicable EU 
Synagis Powder, for solution 100 mg / vial Intramuscular Abbvie 2002-09-26 2018-01-31 Canada 
Synagis Solution 100 mg / mL Intramuscular Astra Zeneca 2016-11-03 Not applicable Canada Synagis Injection, solution 50 mg/0.5mL Intramuscular MedImmune, LLC 1999-12-09 Not applicable US 
Synagis Injection, powder, for solution 100 mg Intramuscular Astra Zeneca Ab 2016-09-08 Not applicable EU Synagis Powder, for solution 50 mg / vial Intramuscular Abbvie 2002-09-26 2018-01-31 Canada Synagis Injection, solution 50 mg/0.5mL Intramuscular SWEDISH ORPHAN BIOVITRUM AB (PUBL) 1999-12-09 Not applicable US Synagis Injection, solution 100 mg/1mL Intramuscular MedImmune, LLC 1998-06-19 Not applicable US Synagis Injection, solution 100 mg/mL Intramuscular Astra Zeneca Ab 2016-09-08 Not applicable EU Synagis Injection, powder, for solution 50 mg Intramuscular Astra Zeneca Ab 2016-09-08 Not applicable EU
Categories
- ATC Codes
- J06BD01 — Palivizumab
- Drug Categories
- Amino Acids, Peptides, and Proteins
- Anti-Infective Agents
- Antibodies
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Antiinfectives for Systemic Use
- Antiviral Agents
- Antiviral monoclonal antibodies
- 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
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- DQ448MW7KS
- CAS number
- 188039-54-5
References
- General References
- Not Available
- External Links
- PubChem Substance
- 46506637
- 194279
- ChEMBL
- CHEMBL1201586
- Therapeutic Targets Database
- DAP000386
- PharmGKB
- PA164748781
- RxList
- RxList Drug Page
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Palivizumab
- FDA label
- Download (36.1 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Treatment Lung Disorder 1 3 Completed Prevention Infections, Respiratory Syncytial Virus 2 3 Completed Supportive Care Cancer 1 3 Completed Treatment Respiratory Syncytial Virus (RSV) 1 3 Completed Treatment Respiratory Syncytial Virus, Bronchiolitis 1 3 Recruiting Prevention Infections, Respiratory Syncytial Virus 1 2 Completed Prevention Chronic Lung Disease and <= 24 Months of Age or / Infections, Respiratory Syncytial Virus / Premature With Gestational Age <=35 Weeks and <=6 Months of Age 1 2 Completed Prevention Congenital Heart Disease (CHD) 1 2 Completed Treatment Unhealthy Children With a History of Prematurity 1 2, 3 Active Not Recruiting Prevention Infections, Respiratory Syncytial Virus 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Abbott Laboratories Ltd.
- Medimmune Inc.
- Dosage Forms
Form Route Strength Injection, powder, for solution Intramuscular 50 MG Injection, solution Intramuscular 100 mg/1mL Injection, solution Intramuscular 50 mg/0.5mL Injection, solution Intramuscular; Parenteral 100 MG/ML Powder, for solution Intramuscular 100 mg / vial Powder, for solution Intramuscular 50 mg / vial Solution Intramuscular 100 mg / mL Solution Intramuscular 50 mg / 0.5 mL Injection, solution Intramuscular Injection, solution Intramuscular 100 ml Solution Intramuscular 100 mg/ml Injection, solution Intramuscular 50 mg/ml Solution Intramuscular 50 mg Injection, solution Intramuscular 100 mg/ml Injection, powder, for solution Intramuscular 100 mg/mL Injection, powder, lyophilized, for solution Intramuscular 50 mg Solution Intramuscular 100 mg Injection, powder, for solution Intramuscular 100 mg - Prices
- Not Available
- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region CA2197684 No 2000-10-31 2015-08-09 Canada
Properties
- State
- Liquid
- Experimental Properties
Property Value Source melting point (°C) 61 °C (FAB fragment), 71 °C (whole mAb) Vermeer, A.W.P. & Norde, W., Biophys. J. 78:394-404 (2000)
Targets
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- Kind
- Protein
- Organism
- Human respiratory syncytial virus B (strain 18537)
- Pharmacological action
- Yes
- General Function
- Not Available
- Specific Function
- During virus entry, induces fusion of viral and cellular membranes leading to delivery of the nucleocapsid into the cytoplasm. The fusogenic activity is inactive untill entry into host cell endosom...
- Gene Name
- F
- Uniprot ID
- P13843
- Uniprot Name
- Fusion glycoprotein F0
- Molecular Weight
- 63687.815 Da
References
- Huang K, Incognito L, Cheng X, Ulbrandt ND, Wu H: Respiratory syncytial virus-neutralizing monoclonal antibodies motavizumab and palivizumab inhibit fusion. J Virol. 2010 Aug;84(16):8132-40. doi: 10.1128/JVI.02699-09. Epub 2010 Jun 2. [Article]
- Wu H, Pfarr DS, Losonsky GA, Kiener PA: Immunoprophylaxis of RSV infection: advancing from RSV-IGIV to palivizumab and motavizumab. Curr Top Microbiol Immunol. 2008;317:103-23. [Article]
- Robinson KA, Odelola OA, Saldanha I, McKoy N: Palivizumab for prophylaxis against respiratory syncytial virus infection in children with cystic fibrosis. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD007743. doi: 10.1002/14651858.CD007743.pub2. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Not Available
- Specific Function
- Receptor for the Fc region of immunoglobulins gamma. Low affinity receptor. Binds complexed or aggregated IgG and also monomeric IgG. Contrary to III-A, is not capable to mediate antibody-dependent...
- Gene Name
- FCGR3B
- Uniprot ID
- O75015
- Uniprot Name
- Low affinity immunoglobulin gamma Fc region receptor III-B
- Molecular Weight
- 26215.64 Da
References
- Hiatt A, Bohorova N, Bohorov O, Goodman C, Kim D, Pauly MH, Velasco J, Whaley KJ, Piedra PA, Gilbert BE, Zeitlin L: Glycan variants of a respiratory syncytial virus antibody with enhanced effector function and in vivo efficacy. Proc Natl Acad Sci U S A. 2014 Apr 22;111(16):5992-7. doi: 10.1073/pnas.1402458111. Epub 2014 Apr 7. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Serine-type peptidase activity
- Specific Function
- C1r B chain is a serine protease that combines with C1q and C1s to form C1, the first component of the classical pathway of the complement system.
- Gene Name
- C1R
- Uniprot ID
- P00736
- Uniprot Name
- Complement C1r subcomponent
- Molecular Weight
- 80118.04 Da
References
- Hiatt A, Bohorova N, Bohorov O, Goodman C, Kim D, Pauly MH, Velasco J, Whaley KJ, Piedra PA, Gilbert BE, Zeitlin L: Glycan variants of a respiratory syncytial virus antibody with enhanced effector function and in vivo efficacy. Proc Natl Acad Sci U S A. 2014 Apr 22;111(16):5992-7. doi: 10.1073/pnas.1402458111. Epub 2014 Apr 7. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Not Available
- Specific Function
- C1q associates with the proenzymes C1r and C1s to yield C1, the first component of the serum complement system. The collagen-like regions of C1q interact with the Ca(2+)-dependent C1r(2)C1s(2) proe...
- Gene Name
- C1QA
- Uniprot ID
- P02745
- Uniprot Name
- Complement C1q subcomponent subunit A
- Molecular Weight
- 26016.47 Da
References
- Hiatt A, Bohorova N, Bohorov O, Goodman C, Kim D, Pauly MH, Velasco J, Whaley KJ, Piedra PA, Gilbert BE, Zeitlin L: Glycan variants of a respiratory syncytial virus antibody with enhanced effector function and in vivo efficacy. Proc Natl Acad Sci U S A. 2014 Apr 22;111(16):5992-7. doi: 10.1073/pnas.1402458111. Epub 2014 Apr 7. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Not Available
- Specific Function
- C1q associates with the proenzymes C1r and C1s to yield C1, the first component of the serum complement system. The collagen-like regions of C1q interact with the Ca(2+)-dependent C1r(2)C1s(2) proe...
- Gene Name
- C1QB
- Uniprot ID
- P02746
- Uniprot Name
- Complement C1q subcomponent subunit B
- Molecular Weight
- 26721.62 Da
References
- Hiatt A, Bohorova N, Bohorov O, Goodman C, Kim D, Pauly MH, Velasco J, Whaley KJ, Piedra PA, Gilbert BE, Zeitlin L: Glycan variants of a respiratory syncytial virus antibody with enhanced effector function and in vivo efficacy. Proc Natl Acad Sci U S A. 2014 Apr 22;111(16):5992-7. doi: 10.1073/pnas.1402458111. Epub 2014 Apr 7. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Not Available
- Specific Function
- C1q associates with the proenzymes C1r and C1s to yield C1, the first component of the serum complement system. The collagen-like regions of C1q interact with the Ca(2+)-dependent C1r(2)C1s(2) proe...
- Gene Name
- C1QC
- Uniprot ID
- P02747
- Uniprot Name
- Complement C1q subcomponent subunit C
- Molecular Weight
- 25773.56 Da
References
- Hiatt A, Bohorova N, Bohorov O, Goodman C, Kim D, Pauly MH, Velasco J, Whaley KJ, Piedra PA, Gilbert BE, Zeitlin L: Glycan variants of a respiratory syncytial virus antibody with enhanced effector function and in vivo efficacy. Proc Natl Acad Sci U S A. 2014 Apr 22;111(16):5992-7. doi: 10.1073/pnas.1402458111. Epub 2014 Apr 7. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Not Available
- Specific Function
- Receptor for the Fc region of IgG. Binds complexed or aggregated IgG and also monomeric IgG. Mediates antibody-dependent cellular cytotoxicity (ADCC) and other antibody-dependent responses, such as...
- Gene Name
- FCGR3A
- Uniprot ID
- P08637
- Uniprot Name
- Low affinity immunoglobulin gamma Fc region receptor III-A
- Molecular Weight
- 29088.895 Da
References
- Hiatt A, Bohorova N, Bohorov O, Goodman C, Kim D, Pauly MH, Velasco J, Whaley KJ, Piedra PA, Gilbert BE, Zeitlin L: Glycan variants of a respiratory syncytial virus antibody with enhanced effector function and in vivo efficacy. Proc Natl Acad Sci U S A. 2014 Apr 22;111(16):5992-7. doi: 10.1073/pnas.1402458111. Epub 2014 Apr 7. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Receptor signaling protein activity
- Specific Function
- High affinity receptor for the Fc region of immunoglobulins gamma. Functions in both innate and adaptive immune responses.
- Gene Name
- FCGR1A
- Uniprot ID
- P12314
- Uniprot Name
- High affinity immunoglobulin gamma Fc receptor I
- Molecular Weight
- 42631.525 Da
References
- Hiatt A, Bohorova N, Bohorov O, Goodman C, Kim D, Pauly MH, Velasco J, Whaley KJ, Piedra PA, Gilbert BE, Zeitlin L: Glycan variants of a respiratory syncytial virus antibody with enhanced effector function and in vivo efficacy. Proc Natl Acad Sci U S A. 2014 Apr 22;111(16):5992-7. doi: 10.1073/pnas.1402458111. Epub 2014 Apr 7. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Not Available
- Specific Function
- Receptor for the Fc region of complexed or aggregated immunoglobulins gamma. Low affinity receptor. Involved in a variety of effector and regulatory functions such as phagocytosis of immune complex...
- Gene Name
- FCGR2B
- Uniprot ID
- P31994
- Uniprot Name
- Low affinity immunoglobulin gamma Fc region receptor II-b
- Molecular Weight
- 34043.355 Da
References
- Hiatt A, Bohorova N, Bohorov O, Goodman C, Kim D, Pauly MH, Velasco J, Whaley KJ, Piedra PA, Gilbert BE, Zeitlin L: Glycan variants of a respiratory syncytial virus antibody with enhanced effector function and in vivo efficacy. Proc Natl Acad Sci U S A. 2014 Apr 22;111(16):5992-7. doi: 10.1073/pnas.1402458111. Epub 2014 Apr 7. [Article]
Drug created at June 13, 2005 13:24 / Updated at March 24, 2023 20:19