Palivizumab
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Palivizumab?
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| Therapeutic monoclonal antibody | |
| Source | Humanized |
| Target | RSV |
| Identifiers | |
| CAS number | |
| ATC code | J06 |
| PubChem | ? |
| DrugBank | |
| Chemical data | |
| Formula | ? |
| Mol. mass | ? |
| Pharmacokinetic data | |
| Bioavailability | ? |
| Metabolism | ? |
| Half life | 18-20 days |
| Excretion | ? |
| Therapeutic considerations | |
| Pregnancy cat. |
C |
| Legal status | |
| Routes | 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. [1]
Palivizumab targets the fusion protein of RSV,[2] inhibiting its entry into the cell and thereby preventing infection.
[edit] Recommendations for Palivizumab use
The American Academy of Pediatrics has published recommendations for the use of palivizumab[3] 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
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- ≤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)
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- Chronic lung disease of prematurity
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- 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
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- Congenital heart disease
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- 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)
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Other conditions where prophylaxis might be considered but inadequate data is available:
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.
[edit] References
- ^ http://www.fda.gov/cder/foi/label/2007/103770_5096lbl.pdf
- ^ Levinson, Wilson. "Medical Microbiology and Immunology, 8th ed." Lange: 2004. p. 430.
- ^ American Academy of Pediatrics. "Red Book: 2006 Report of the Committee on Infectious Diseases, 27th ed." pp 562-565.
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