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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.

Recommendations for use

Palivizumab was licensed in June 1998 by the Food and Drug Administration for the reduction of serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) in children at increased risk of severe disease. Since that time, 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^[3]

Infants younger than one year with bronchopulmonary dysplasia (ie, 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 (BPD) who required medical therapy (e.g., supplemental oxygen, glucocorticoids, diuretics) within six months of the anticipated RSV season.

•Infants younger than one year who were born at <29 weeks’ (ie, ≤28 weeks, 6 days) of gestation. Other potential target groups for palivizumab prophylaxis may include:

  Infants younger than one year of age with hemodynamically significant congenital heart disease 
  Children younger than one year of age with neuromuscular disorders that impairs the ability to clear secretions from the upper airways or pulmonary abnormalities 
  Children younger than two years of age who will be profoundly 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 RSV lower respiratory tract infection 
  Alaska native and American Indian infants

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

References

^ http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/palimed102302LB.pdf
^ Levinson, Wilson. "Medical Microbiology and Immunology, 8th ed." Lange: 2004. p. 430.
^ "Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection". doi:10.1542/peds.2014-1665.

Brady, Michael T., et al. "Updated guidance for Palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection." Pediatrics 134.2 (2014): e620-e638.

UpToDate Contents

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English Journal

Experimental animal model to analyze the immunobiological responses following vaccination with formalin-inactivated respiratory syncytial virus (FI-RSV).

Sawada A1, Nakayama T1.
Microbiology and immunology.Microbiol Immunol.2016 Feb 10. doi: 10.1111/1348-0421.12365. [Epub ahead of print]
Formalin-inactivated respiratory syncytial virus (FI-RSV) vaccine was developed in 1960s. However, the vaccine did not prevent the infection in RSV-naïve recipients, and the paradoxical effect of increasing severity of the RSV illness was noted following natural infection. This was a major obstacle
PMID 26865035

A Randomized, Blinded, Controlled, Dose-Ranging Study of a Respiratory Syncytial Virus Recombinant Fusion (F) Nanoparticle Vaccine in Healthy Women of Childbearing Age.

Glenn GM1, Fries LF1, Thomas DN1, Smith G1, Kpamegan E1, Lu H1, Flyer D1, Jani D1, Hickman SP1, Piedra PA2.
The Journal of infectious diseases.J Infect Dis.2016 Feb 1;213(3):411-22. doi: 10.1093/infdis/jiv406. Epub 2015 Aug 10.
BACKGROUND: Respiratory syncytial virus (RSV) is a leading cause of infant morbidity and mortality. A recombinant RSV fusion protein nanoparticle vaccine (RSV F vaccine) candidate for maternal immunization was tested for safety and immunogenicity in women of childbearing age.METHODS: Three hundred t
PMID 26259809

Erratum: Effect of Prophylactic Palivizumab on Admission Due to Respiratory Syncytial Virus Infection in Former Very Low Birth Weight Infants with Bronchopulmonary Dysplasia.

[No authors listed]
Journal of Korean medical science.J Korean Med Sci.2016 Feb;31(2):329. Epub 2016 Jan 25.
[This corrects the article on p. 924 in vol. 30, PMID: 26130956.].
PMID 26839492

Japanese Journal

抗RSウイルス薬 (特集抗ウイルス薬) -- (抗ウイルス薬の特性と適応・使い分け)

鈴村宏
日本臨床 70(4), 574-578, 2012-04-00
NAID 40019238352

乳幼児の気管支喘息における early intervention

吉原重美
日本小児アレルギー学会誌 = The Japanese journal of pediatric allergy and clinical immunology 26(1), 168-175, 2012-03-20
NAID 10030557489

神奈川県県央北相地区における Late preterm 児の出生状況と Palivizumab 投与に関する検討

伊坂雅行,横関祐一郎,野渡正彦,石井正浩
日本周産期・新生児医学会雑誌 = Journal of Japan Society of Perinatal and Neonatal Medicine 47(4), 878-881, 2011-12-20
NAID 10030287771

Related Pictures

★リンクテーブル★

リンク元	「mab」「パリビズマブ」「Synagis」

「mab」

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
Pharmacokinetic data
Biological half-life	18-20 days
Identifiers
CAS Registry Number	188039-54-5
ATC code	J06BB16
DrugBank	DB00110
UNII	DQ448MW7KS
ChEMBL	CHEMBL1201586
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