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 cat. | C |
| Legal status | ? |
| Routes | intramuscular injection |
| Pharmacokinetic data | |
| Half-life | 18-20 days |
| Identifiers | |
| CAS number | 188039-54-5  |
| ATC code | J06BB16 |
| DrugBank | BTD00097 |
| UNII | DQ448MW7KS |
| ChEMBL | CHEMBL1201586  |
| Chemical data | |
| Formula | ? |
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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.
[edit] Recommendations for use
The American Academy of Pediatrics (AAP) has published recommendations for the use of palivizumab[3] Updated AAP recommendations were published in 2009.[4] Palivizumab (brand name Synagis manufactured by MedImmune) is used only for prevention, not for treatment, and once initiated for a given RSV season (usually November–March), 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 and < 12 months of age at the start of RSV season
- 29-32 weeks gestation and < 6 months of age at the start of RSV season
- 32-35 weeks gestation and < 3 months of age at the start of RSV season, if there is a risk factor (child care attendance or sibling younger than 5 years old)
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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 overall cost-effectiveness for preventing severe RSV disease. However, the issues of cost versus benefit remain an area of ongoing research and discussion.
[edit] References
- ^ http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/palimed102302LB.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.
- ^ American Academy of Pediatrics. "Red Book: 2009 Report of the Committee on Infectious Diseases, 28th ed." pp 562-569.
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