Palivizumab

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
Db00110
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.

Pharmacology
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Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
Contraindications & Blackbox Warnings
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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.

TargetActionsOrganism
AFusion glycoprotein F0Not AvailableHuman respiratory syncytial virus B (strain 18537)
ULow affinity immunoglobulin gamma Fc region receptor III-BNot AvailableHumans
UComplement C1r subcomponentNot AvailableHumans
UComplement C1q subcomponent subunit ANot AvailableHumans
UComplement C1q subcomponent subunit BNot AvailableHumans
UComplement C1q subcomponent subunit CNot AvailableHumans
ULow affinity immunoglobulin gamma Fc region receptor III-ANot AvailableHumans
UHigh affinity immunoglobulin gamma Fc receptor INot AvailableHumans
ULow affinity immunoglobulin gamma Fc region receptor II-bNot AvailableHumans
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
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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.
DrugInteraction
AbciximabThe risk or severity of adverse effects can be increased when Abciximab is combined with Palivizumab.
AdalimumabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Palivizumab.
Adenovirus type 7 vaccine liveThe therapeutic efficacy of Adenovirus type 7 vaccine live can be decreased when used in combination with Palivizumab.
AducanumabThe risk or severity of adverse effects can be increased when Palivizumab is combined with Aducanumab.
AlemtuzumabThe risk or severity of adverse effects can be increased when Alemtuzumab is combined with Palivizumab.
AlirocumabThe risk or severity of adverse effects can be increased when Palivizumab is combined with Alirocumab.
AmivantamabThe risk or severity of adverse effects can be increased when Palivizumab is combined with Amivantamab.
AnsuvimabThe risk or severity of adverse effects can be increased when Palivizumab is combined with Ansuvimab.
Anthrax immune globulin humanThe risk or severity of adverse effects can be increased when Palivizumab is combined with Anthrax immune globulin human.
Anthrax vaccineThe therapeutic efficacy of Anthrax vaccine can be decreased when used in combination with Palivizumab.
Interactions
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Food Interactions
No interactions found.

Products

Products
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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
SynagisPowder, for solution50 mg / vialIntramuscularAbbvie2002-09-262018-01-31Canada flag
SynagisInjection, solution100 mg/mLIntramuscularAstra Zeneca Ab2016-09-08Not applicableEU flag
SynagisInjection, powder, for solution50 mgIntramuscularAstra Zeneca Ab2016-09-08Not applicableEU flag
SynagisInjection, solution50 mg/0.5mLIntramuscularMedImmune, LLC1999-12-09Not applicableUS flag
SynagisSolution50 mg / 0.5 mLIntramuscularAbbvie2016-11-03Not applicableCanada flag
SynagisInjection, solution50 mg/0.5mLIntramuscularAstra Zeneca Ab2016-09-08Not applicableEU flag
SynagisInjection, solution50 mg/0.5mLIntramuscularSWEDISH ORPHAN BIOVITRUM AB (PUBL)1999-12-09Not applicableUS flag
SynagisPowder, for solution100 mg / vialIntramuscularAbbvie2002-09-262018-01-31Canada flag
SynagisInjection, solution100 mg/1mLIntramuscularMedImmune, LLC1998-06-19Not applicableUS flag
SynagisSolution100 mg / mLIntramuscularAbbvie2016-11-03Not applicableCanada flag

Categories

ATC Codes
J06BB16 — Palivizumab
Drug Categories
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
PubChem Substance
46506637
RxNav
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
PhaseStatusPurposeConditionsCount
4CompletedTreatmentChronic Lung Diseases1
3CompletedPreventionInfections, Respiratory Syncytial Virus2
3CompletedSupportive CareMalignancies1
3CompletedTreatmentRespiratory Syncytial Virus (RSV)1
3CompletedTreatmentRespiratory Syncytial Virus, Bronchiolitis1
3Not Yet RecruitingPreventionInfections, Respiratory Syncytial Virus1
2CompletedPreventionChronic Lung Disease and <= 24 Months of Age or / Infections, Respiratory Syncytial Virus / Premature With Gestational Age <=35 Weeks and <=6 Months of Age1
2CompletedPreventionCongenital Heart Disease (CHD)1
2CompletedTreatmentUnhealthy Children With a History of Prematurity1
2, 3Active Not RecruitingPreventionInfections, Respiratory Syncytial Virus1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
  • Abbott Laboratories Ltd.
  • Medimmune Inc.
Dosage Forms
FormRouteStrength
Injection, powder, for solutionIntramuscular
Injection, powder, for solutionIntramuscular50 mg
Injection, solutionIntramuscular100 mg/mL
Injection, solutionIntramuscular100 mg/1mL
Injection, solutionIntramuscular50 mg/0.5mL
Injection, solutionIntramuscular; Parenteral
Powder, for solutionIntramuscular100 mg / vial
Powder, for solutionIntramuscular50 mg / vial
SolutionIntramuscular100 mg / mL
SolutionIntramuscular50 mg / 0.5 mL
Injection, solutionIntramuscular
SolutionIntramuscular
SolutionIntramuscular50 mg
Injection, powder, lyophilized, for solutionIntramuscular50 mg
SolutionIntramuscular100 mg
Injection, powder, for solutionIntramuscular100 mg
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)Region
CA2197684No2000-10-312015-08-09Canada flag

Properties

State
Liquid
Experimental Properties
PropertyValueSource
melting point (°C)61 °C (FAB fragment), 71 °C (whole mAb)Vermeer, A.W.P. & Norde, W., Biophys. J. 78:394-404 (2000)

Targets

Drugtargets
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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
  1. 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]
  2. 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]
  3. 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
  1. 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
  1. 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
  1. 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
  1. 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
  1. 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
  1. 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
  1. 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
  1. 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 on June 13, 2005 13:24 / Updated on July 24, 2021 14:57