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__NOTOC__
{{DrugProjectFormSinglePage
{{Palivizumab}}
|authorTag=
{{CMG}}; {{AE}} {{SS}}


==Overview==
{{VP}}
'''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 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.
|genericName=


==Category==
Palivizumab


Antiviral
|aOrAn=
==US Brand Names==
SYNAGIS<sup>®</sup>
==FDA Package Insert==


'''  [[Palivizumab description|Description]]'''
a
'''| [[Palivizumab clinical pharmacology|Clinical Pharmacology]]'''
'''| [[Palivizumab microbiology|Microbiology]]'''
'''| [[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]]'''


==Mechanism of Action==
|drugClass=
Palivizumab acts by binding the [[respiratory syncytial virus|RSV]] envelope fusion protein ([[respiratory syncytial virus|RSV]] F) on the surface of the virus and blocking a critical step in the membrane fusion process. Palivizumab also prevents cell-to-cell fusion of [[respiratory syncytial virus|RSV]]-infected cells.


==References==
monoclonal antibody
{{Reflist|2}}


[[Category:Antiviral]]
|indication=
[[Category:Wikinfect]]
 
prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease
 
|hasBlackBoxWarning=
 
 
 
|adverseReactions=
 
fever and rash
 
<!--Black Box Warning-->
 
|blackBoxWarningTitle=
Title
 
|blackBoxWarningBody=
<i><span style="color:#FF0000;">ConditionName: </span></i>
 
* Content
 
<!--Adult Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Adult)-->
 
|fdaLIADAdult=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
 
|offLabelAdultGuideSupport=
 
=====Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
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<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
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=====Condition1=====
 
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=====Condition2=====
 
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|offLabelPedGuideSupport=
 
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=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
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|offLabelPedNoGuideSupport=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
 
|contraindications=
 
* Condition1
 
<!--Warnings-->
 
|warnings=
 
* Description
 
====Precautions====
 
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|clinicalTrials=
 
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=====Body as a Whole=====
 
 
 
 
=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--Postmarketing Experience-->
 
|postmarketing=
 
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
=====Metabolic and Nutritional=====
 
 
 
=====Musculoskeletal=====
 
 
 
=====Neurologic=====
 
 
 
=====Respiratory=====
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
=====Special Senses=====
 
 
 
=====Urogenital=====
 
 
 
=====Miscellaneous=====
 
 
 
<!--Drug Interactions-->
 
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* Drug
:* Description
 
<!--Use in Specific Populations-->
 
|useInPregnancyFDA=
* '''Pregnancy Category'''
 
|useInPregnancyAUS=
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
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|useInPed=
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|useInGeri=
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|useInRace=
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|useInRenalImpair=
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|useInImmunocomp=
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<!--Administration and Monitoring-->
 
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* Oral
 
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|monitoring=
 
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* Description
 
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<!--Overdosage-->
 
|overdose=
 
===Acute Overdose===
 
====Signs and Symptoms====
 
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===Chronic Overdose===
 
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<!--Pharmacology-->
 
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<!--Pharmacodynamics-->
 
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<!--Pharmacokinetics-->
 
|PK=
 
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<!--Nonclinical Toxicology-->
 
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<!--Clinical Studies-->
 
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<!--How Supplied-->
 
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<!--Patient Counseling Information-->
 
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<!--Precautions with Alcohol-->
 
|alcohol=
 
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
<!--Brand Names-->
 
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* ®<ref>{{Cite web | title =  | url =  }}</ref>
 
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{{LabelImage
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<!--Category-->
 
[[Category:Drug]]

Revision as of 15:12, 14 August 2014

Palivizumab
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

Disclaimer

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Overview

Palivizumab is a monoclonal antibody that is FDA approved for the {{{indicationType}}} of prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease. Common adverse reactions include fever and rash.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Palivizumab in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Palivizumab in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Palivizumab in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Palivizumab in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Palivizumab in pediatric patients.

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Palivizumab in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Palivizumab in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Palivizumab in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Palivizumab during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Palivizumab with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Palivizumab with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Palivizumab with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Palivizumab with respect to specific gender populations.

Race

There is no FDA guidance on the use of Palivizumab with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Palivizumab in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Palivizumab in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Palivizumab in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Palivizumab in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Palivizumab in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Palivizumab in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Palivizumab in the drug label.

Pharmacology

There is limited information regarding Palivizumab Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Palivizumab in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Palivizumab in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Palivizumab in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Palivizumab in the drug label.

How Supplied

Storage

There is limited information regarding Palivizumab Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Palivizumab |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Palivizumab |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Palivizumab in the drug label.

Precautions with Alcohol

  • Alcohol-Palivizumab interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)


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Retrieved from "https://www.wikidoc.org/index.php?title=Palivizumab&oldid=1008878"