Palivizumab

drugbox
type = mab


source = Humanized
target = RSV
CAS_number = 188039-54-5
ATC_prefix = J06
ATC_suffix = BB16
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PubChem =
DrugBank = BTD00097
chemical_formula =
molecular_weight =
bioavailability =
protein_bound =
metabolism =
elimination_half-life = 18-20 days
excretion =
pregnancy_AU =
pregnancy_US =
pregnancy_category = C
legal_AU =
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legal_US =
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. [http://www.fda.gov/cder/foi/label/2007/103770_5096lbl.pdf]

Palivizumab targets the fusion protein of RSV, [Levinson, Wilson. "Medical Microbiology and Immunology, 8th ed." Lange: 2004. p. 430.] inhibiting its entry into the cell and thereby preventing infection.

Recommendations for Palivizumab use

The American Academy of Pediatrics has published recommendations for the use of palivizumab [American Academy of Pediatrics. "Red Book: 2006 Report of the Committee on Infectious Diseases, 27th ed." pp 562-565.] 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.

Reasons to consider Palivizumab prophylaxis include:

:Prematurity::*≤28 weeks gestation, for the first 12 months of life::*29-32 weeks gestation, for the first 6 months of life::*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)

:Chronic lung disease of prematurity::*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