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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.

Palivizumab targets the fusion protein of RSV, inhibiting its entry into the cell and thereby preventing infection.

Recommendations for use

The American Academy of Pediatrics (AAP) has published recommendations for the use of palivizumab Updated AAP recommendations were published in 2009. 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

• ≤ 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)

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 overall cost-effectiveness for preventing severe RSV disease. However, the issues of cost versus benefit remain an area of ongoing research and discussion.

References

1. http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/palimed102302LB.pdf
2. Levinson, Wilson. "Medical Microbiology and Immunology, 8th ed." Lange: 2004. p. 430.
3. American Academy of Pediatrics. "Red Book: 2006 Report of the Committee on Infectious Diseases, 27th ed." pp 562-565.
4. American Academy of Pediatrics. "Red Book: 2009 Report of the Committee on Infectious Diseases, 28th ed." pp 562-569.

• Monoclonal antibodies
• AstraZeneca