Palivizumab: Difference between revisions

Revision as of 03:58, 8 January 2014

Palivizumab
SYNAGIS^® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Overview

Palivizumab (brand name Synagis) is a monoclonal antibody produced by recombinant DNA technology. It is used in the prevention ofRespiratory Syncytial Virus (RSV) infections. It is recommended for certain infants that are high-risk (because of prematurity or other medical problems), see below.

Palivizumab is a humanized monoclonal antibody (IgG) directed against an epitope in the A antigenic site of the F protein of the Respiratory Syncytial Virus (RSV). In two Phase III clinical trials in the pediatric population, Palivizumab reduced the risk of hospitalization due to RSV infection by 55% and 45%. Palivizumab is dosed once a month via intramuscular (IM) injection, to be administered throughout the duration of the RSV season.^[1]

Palivizumab targets the fusion protein of RSV,^[2]inhibiting its entry into the cell and thereby preventing infection.

US Brand Names

SYNAGIS^®

FDA Package Insert

Mechanism of Action

References

↑ http://www.fda.gov/cder/foi/label/2007/103770_5096lbl.pdf
↑ Levinson, Wilson. "Medical Microbiology and Immunology, 8th ed." Lange: 2004. p. 430.

[1] ttp://www.fda.gov/cder/foi/label/2007/103770_5096lbl.pdf

[2] Levinson, Wilson. "Medical Microbiology and Immunology, 8th ed." Lange: 2004. p. 430.

[1]

[2]

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-{{drugbox-mab |
+__NOTOC__
-| image             =
+{{Palivizumab}}
-| source            = Humanized
+{{CMG}}; {{AE}} {{SS}}
-| target            = RSV
-| CAS_number = 188039-54-5
-| ATC_prefix = J06
-| ATC_suffix = BB16
-| ATC_supplemental =
-| PubChem =
-| DrugBank = BTD00097
-| chemical_formula =
-| molecular_weight =
-| bioavailability =
-| protein_bound =
-| metabolism =
-| elimination_half-life = 18-20 days
-| excretion =
-| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
-| pregnancy_US = <!-- A / B / C / D / X -->
-| pregnancy_category = C
-| legal_AU = <!-- Unscheduled / S2 / S4 / S8 -->
-| legal_UK = <!-- GSL / P / POM / CD -->
-| legal_US = <!-- OTC / Rx-only -->
-| legal_status =
-| routes_of_administration = IM
-}}
-'''Palivizumab''' (brand name '''Synagis''') is a [[monoclonal antibody]] produced by recombinant DNA technology. It is used in the prevention of [[Respiratory Syncytial Virus]] (RSV) infections. It is recommended for certain infants that are high-risk (because of prematurity or other medical problems), see below.
-Palivizumab is a humanized monoclonal antibody (IgG) directed against an epitope in the A antigenic site of the F protein of the Respiratory Syncytial Virus (RSV).  In two Phase III clinical trials in the pediatric population, Palivizumab reduced the risk of hospitalization due to RSV infection by 55% and 45%.  Palivizumab is dosed once a month via intramuscular (IM) injection, to be administered throughout the duration of the RSV season. <ref>http://www.fda.gov/cder/foi/label/2007/103770_5096lbl.pdf </ref>
+==Overview==
+'''Palivizumab''' (brand name '''Synagis''') is a [[monoclonal antibody]] produced by recombinant DNA technology. It is used in the prevention of[[Respiratory Syncytial Virus]] (RSV) infections. It is recommended for certain infants that are high-risk (because of prematurity or other medical problems), see below.
-Palivizumab targets the fusion protein of RSV,<ref>Levinson, Wilson.  "Medical Microbiology and Immunology, 8th ed."  Lange: 2004. p. 430.</ref> inhibiting its entry into the cell and thereby preventing infection.
+Palivizumab is a humanized monoclonal antibody (IgG) directed against an epitope in the A antigenic site of the F protein of the Respiratory Syncytial Virus (RSV).  In two Phase III clinical trials in the pediatric population, Palivizumab reduced the risk of hospitalization due to RSV infection by 55% and 45%.  Palivizumab is dosed once a month via intramuscular (IM) injection, to be administered throughout the duration of the RSV season.<ref>http://www.fda.gov/cder/foi/label/2007/103770_5096lbl.pdf </ref>
-== Recommendations for Palivizumab use ==
+Palivizumab targets the fusion protein of RSV,<ref>Levinson, Wilson.  "Medical Microbiology and Immunology, 8th ed."  Lange: 2004. p. 430.</ref>inhibiting its entry into the cell and thereby preventing infection.
-The [[American Academy of Pediatrics]] has published recommendations for the use of palivizumab<ref>American Academy of Pediatrics.  "Red Book:  2006 Report of the Committee on Infectious Diseases, 27th ed." pp 562-565.</ref>  Palivizumab is used only for prevention, not for treatment, and once initiated for a given RSV season (i.e. winter), it should be continued for the full duration of that season.
+==Category==
-Reasons to consider Palivizumab prophylaxis include:
+Antiviral
+==US Brand Names==
+SYNAGIS<sup>®</sup>
+==FDA Package Insert==
-:'''[[Premature birth |Prematurity]]'''
+'''  [[Palivizumab description|Description]]'''
-::*≤28 weeks gestation, for the first 12 months of life
+'''| [[Palivizumab clinical pharmacology|Clinical Pharmacology]]'''
-::*29-32 weeks gestation, for the first 6 months of life
+'''| [[Palivizumab microbiology|Microbiology]]'''
-::*32-35 weeks gestation, for the first 6 months of life, only if there are at least two risk factors (child care attendance, school-aged siblings, exposure to environmental air pollutants, congenital airway abnormalities, severe neuromuscular disease)
+'''| [[Palivizumab indications and usage|Indications and Usage]]'''
+'''| [[Palivizumab contraindications|Contraindications]]'''
+'''| [[Palivizumab warnings and precautions|Warnings and Precautions]]'''
+'''| [[Palivizumab adverse reactions|Adverse Reactions]]'''
+'''| [[Palivizumab drug interactions|Drug Interactions]]'''
+'''| [[Palivizumab overdosage|Overdosage]]'''
+'''| [[Palivizumab clinical studies|Clinical Studies]]'''
+'''| [[Palivizumab dosage and administration|Dosage and Administration]]'''
+'''| [[Palivizumab how supplied|How Supplied]]'''
+'''| [[Palivizumab labels and packages|Labels and Packages]]'''
-:'''[[Bronchopulmonary dysplasia|Chronic lung disease of prematurity]]'''
+==Mechanism of Action==
-::*Chronic lung disease still requiring oxygen/medication, for the first and second RSV seasons
-::*Chronic lung disease that required oxygen/medication within the 6 months preceding RSV season, for the first RSV season
-:'''[[Congenital heart disease]]'''
-::*Cyanotic heart disease, for the first 24 months of life
-::*Moderate to severe pulmonary hypertension, for the first 24 months of life
-::*Congestive heart failure requiring medication, for the first 24 months of life
-::*Children who have undergone open heart surgery during RSV season, for one additional dose after [[cardiopulmonary bypass]] (only if they still meet one of the other criteria)
-Other conditions where prophylaxis might be considered but inadequate data is available:
-:*[[Immunocompromise]]
-:*[[Cystic fibrosis]]
-Of note, a course of Palivizumab is quite expensive, and the above recommendations were written based on estimates of its overal cost-effectiveness for preventing severe RSV disease.  However, the issues of cost vs benefit remain an area of ongoing research and discussion.
 ==References==
+{{Reflist|2}}
-<references/>
+[[Category:Antiviral]]
+[[Category:Wikinfect]]
-{{treatment-stub}}
-{{monoclonal-antibody-stub}}
-{{Humanizedmonoclonals}}
-[[Category:Monoclonal antibodies]]
-[[de:Palivizumab]]
-{{WikiDoc Help Menu}}
-{{WikiDoc Sources}}