関: palivizumab

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出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2017/10/02 06:17:07」(JST)

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Palivizumab (brand name Synagis which is manufactured by MedImmune) 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 infants that are high-risk because of prematurity or other medical problems such as congenital heart disease.

Palivizumab is a humanized monoclonal antibody (IgG) directed against an epitope in the A antigenic site of the F protein of 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. Palivizumab was approved for medical use in 1998.^[3]

Medical use

Palivizumab is used to reduce the risk of respiratory syncytial virus in children at increased risk of severe disease.^[4] Since the beginning of the drug's, the American Academy of Pediatrics has updated its guidance for the use of palivizumab 4 times as additional data became available to provide a better understanding of infants and young children at greatest risk of hospitalization attributable to RSV infection. The updated recommendations in this policy statement reflect new information regarding the seasonality of RSV circulation, palivizumab pharmacokinetics, the changing incidence of bronchiolitis hospitalizations, the effect of gestational age and other risk factors on RSV hospitalization rates, the mortality of children hospitalized with RSV infection, the effect of prophylaxis on wheezing, and palivizumab-resistant RSV isolates. This policy statement updates and replaces the recommendations found in the 2012 Red Book. Pediatrics 2014;134:415–420^[5]

Infants younger than one year with bronchopulmonary dysplasia (i.e. who were born at <32 weeks gestation and required supplemental oxygen for the first 28 days after birth) and infants younger than two years with bronchopulmonary dysplasia who required medical therapy (e.g. supplemental oxygen, glucocorticoids, diuretics) within six months of the anticipated RSV season are recommended to use palivizumab as prophylaxis. Also, infants younger than one year who were born at <29 weeks (i.e. ≤28 weeks, 6 days) of gestation are recommended to use palivizumab.

Other potential target groups for palivizumab prophylaxis include:^[6]

Infants younger than one year of age with hemodynamically significant congenital heart disease.
Children younger than one year of age with neuromuscular disorders impairing the ability to clear secretions from the upper airways or pulmonary abnormalities.
Children younger than two years of age who are immunocompromised (e.g. those with severe combined immunodeficiency; those younger than two years of age who have undergone lung transplantation or hematopoietic stem cell transplantation) during the RSV season.
Children with Down syndrome who have additional risk factors for lower respiratory tract infections.
Alaska native and American Indian infants.

Decisions regarding palivizumab prophylaxis for children in these groups should be made on a case-by-case basis.

Side effects

Palivizumab use may cause side effects, which include, but are not limited to:^[7]

Sore throat
Runny nose
Redness or irritation at injection site
Vomiting
Diarrhea

Some more serious side effects include:

Severe skin rash
Itching
Hives (urticaria)
Difficulty breathing

Patients experiencing any of the serious symptoms are advised to consult a health care provider immediately.

References

^ http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/palimed102302LB.pdf
^ Levinson, Wilson. "Medical Microbiology and Immunology, 8th ed." Lange: 2004. p. 430.
^ Long, Sarah S.; Pickering, Larry K.; Prober, Charles G. (2012). Principles and Practice of Pediatric Infectious Disease. Elsevier Health Sciences. p. 1502. ISBN 1437727026.
^ Committee, Committee on Infectious Diseases and Bronchiolitis Guidelines (2014-07-01). "Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection". Pediatrics. 134: peds.2014–1665. ISSN 0031-4005. PMID 25070315. doi:10.1542/peds.2014-1665.
^ "Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection". PEDIATRICS. 134: 415–420. PMID 25070315. doi:10.1542/peds.2014-1665.
^ Newborn, Committee on Infectious Diseases and Committee on Fetus and (2003-12-01). "Revised Indications for the Use of Palivizumab and Respiratory Syncytial Virus Immune Globulin Intravenous for the Prevention of Respiratory Syncytial Virus Infections". Pediatrics. 112 (6): 1442–1446. ISSN 0031-4005. PMID 14654627. doi:10.1542/peds.112.6.1442.
^ "Palivizumab Injection: MedlinePlus Drug Information". www.nlm.nih.gov. Retrieved 2016-01-30.

UpToDate Contents

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1. RSウイルス感染症：予防 respiratory syncytial virus infection prevention
2. 幼児および小児における細気管支炎：治療、転帰および予防 bronchiolitis in infants and children treatment outcome and prevention
3. 三尖弁（TV）閉鎖症 tricuspid valve tv atresia
4. 純型肺動脈閉鎖症（PA/IVS） pulmonary atresia with intact ventricular septum pa ivs
5. 新生児集中治療室（NICU）を退出した幼児のケア care of the neonatal intensive care unit graduate

English Journal

Revised recommendations concerning palivizumab prophylaxis for respiratory syncytial virus (RSV).

Bollani L1, Baraldi E2, Chirico G3, Dotta A4, Lanari M5, Del Vecchio A6, Manzoni P7, Boldrini A8, Paolillo P9, Di Fabio S10, Orfeo L11, Stronati M12, Romagnoli C13,14; Italian Society of Neonatology.
Italian journal of pediatrics.Ital J Pediatr.2015 Dec 15;41(1):97. doi: 10.1186/s13052-015-0203-x.
Respiratory Syncytial Virus infections are one of the leading causes of severe respiratory diseases that require hospitalization and, in some cases, intensive care. Once resolved, there may be respiratory sequelae of varying severity. The lack of effective treatments for bronchiolitis and the lack o
PMID 26670908

GS-5806 Inhibits a Broad Range of Respiratory Syncytial Virus Clinical Isolates by Blocking the Virus-Cell Fusion Process.

Perron M1, Stray K2, Kinkade A2, Theodore D2, Lee G2, Eisenberg E2, Sangi M2, Gilbert BE3, Jordan R2, Piedra PA3, Toms GL4, Mackman R2, Cihlar T2.
Antimicrobial agents and chemotherapy.Antimicrob Agents Chemother.2015 Dec 14. pii: AAC.01497-15. [Epub ahead of print]
Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infections in infants and young children. In addition, RSV causes significant morbidity and mortality in hospitalized elderly and immunocompromised patients. Currently, only palivizumab, a monoclonal antibody against the
PMID 26666922

Effectiveness of palivizumab in children with childhood interstitial lung disease: The French experience.

Drummond D1,2, Thumerelle C3, Reix P4,5, Fayon M6,7, Epaud R8,9,10, Clement A11, Mahloul M12,13, Habouria D12,13, Delacourt C1,2,14, Hadchouel A1,2,14.
Pediatric pulmonology.Pediatr Pulmonol.2015 Dec 4. doi: 10.1002/ppul.23354. [Epub ahead of print]
INTRODUCTION: There is a lack of evidence concerning the effectiveness of immunoprophylaxis with palivizumab in children with childhood interstitial lung disease (chILD). In this retrospective study, we evaluated the effectiveness of palivizumab for decreasing the rate of RSV-related hospitalization
PMID 26636747

Japanese Journal

Development and use of palivizumab (Synagis) : a passive immunoprophylactic agent for RSV

POLLACK Paul,GROOTHUIS Jessie R.
Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy 8(3), 201-206, 2002-09-01
NAID 50000646293

Prevention of respiratory syncytial virus infections in high-risk infants by monoclonal antibody (palivizumab)

GROOTHUIS Jessie R.,NISHIDA Hiroshi
Pediatrics international : official journal of the Japan Pediatric Society 44(3), 235-241, 2002-06-01
NAID 10009529534

Related Pictures

synagis - Best Professional | Synagis Print Ad synagis Palivizumab Injection Synagis® SYNAGIS POSTER synagis Synagis Rsv Virus In Adults Treatment Synagis 100 mg

★リンクテーブル★

リンク元	「パリビズマブ」「palivizumab」

「パリビズマブ」

Palivizumab
Monoclonal antibody
Type	Whole antibody
Source	Humanized (from mouse)
Target	RSV protein F
Clinical data
Trade names	Synagis
AHFS/Drugs.com	Monograph
MedlinePlus	a698034
Pregnancy; category	C;
Routes of; administration	intramuscular injection
ATC code	J06BB16 (WHO);
Pharmacokinetic data
Biological half-life	18-20 days
Identifiers
CAS Number	188039-54-5 ;
DrugBank	DB00110 ;
ChemSpider	none;
UNII	DQ448MW7KS;
ChEMBL	CHEMBL1201586 ;
Chemical and physical data
Formula	C6470H10056N1700O2008S50
Molar mass	145,388.51 g·mol−1
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　　[★]

英: palivizumab
商: シナジス Synagis
関: RSウイルス

添付文書

http://www.info.pmda.go.jp/go/pack/6250404E1021_1_14/6250404E1021_1_14?view=body

「palivizumab」

　　[★] パリビズマブ Synagis

[1] ttp://www.accessdata.fda.gov/drugsatfda_docs/label/2002/palimed102302LB.pdf

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

[3] Long, Sarah S.; Pickering, Larry K.; Prober, Charles G. (2012). Principles and Practice of Pediatric Infectious Disease. Elsevier Health Sciences. p. 1502. ISBN 1437727026.

[4] Committee, Committee on Infectious Diseases and Bronchiolitis Guidelines (2014-07-01). "Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection". Pediatrics. 134: peds.2014–1665. ISSN 0031-4005. PMID 25070315. doi:10.1542/peds.2014-1665.

[5] "Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection". PEDIATRICS. 134: 415–420. PMID 25070315. doi:10.1542/peds.2014-1665.

[6] Newborn, Committee on Infectious Diseases and Committee on Fetus and (2003-12-01). "Revised Indications for the Use of Palivizumab and Respiratory Syncytial Virus Immune Globulin Intravenous for the Prevention of Respiratory Syncytial Virus Infections". Pediatrics. 112 (6): 1442–1446. ISSN 0031-4005. PMID 14654627. doi:10.1542/peds.112.6.1442.

[7] "Palivizumab Injection: MedlinePlus Drug Information". www.nlm.nih.gov. Retrieved 2016-01-30.

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