Palivizumab

Palivizumab Brand Name– Synagis

What is Palivizumab

Palivizumab is the first monoclonal antibody approved to provide passive immunity for an infectious disease.

Palivizumab is used to prevent infection in high-risk pediatric patients due to respiratory syncytial virus (RSV), the most common cause of pneumonia and bronchiolitis in infancy and early childhood.

Palivizumab is produced by recombinant DNA technology and is a composite of human (95%) and murine (5%) antibody sequences.

Palivizumab is an IgG₁ kappa immunoglobulin that contains a human framework region, which surrounds the murine regions responsible for binding to RSV.

This type of humanized monoclonal antibody tends to have little immunogenicity.

Palivizumab was shown to provide a 55% reduction in RSV hospitalizations in high-risk pediatric patients. A lower incidence of RSV-related ICU admissions was also seen in palivizumab treated children.

In October 2002, data from a large (n = 1287 children), multinational Phase III clinical study indicated that palivizumab was safe and effective in preventing RSV-related hospitalizations in young children with congenital heart disease, as evidenced by 45% fewer hospitalizations due to RSV (p = 0.003), significantly fewer RSV-related hospital days (p = 0.003), and fewer days of increased oxygen usage (p = 0.014) in the treated group than in the placebo group.

Despite the beneficial effect in certain high risk groups, additional data have shown that this benefit does not extend to as many patient populations as previously thought.

Based on available data, the American Academy of Pediatrics (AAP) recommends limiting palivizumab administration in the U.S. to certain preterm infants, infants with certain chronic illnesses, and some Alaska Native and American Indian infants.

Palivizumab is not recommended for the prevention of healthcare-associated RSV disease, and it is not recommended for the treatment of RSV.

Palivizumab received FDA approval in June 1998.

Indications

• respiratory syncytial virus (RSV) infection prophylaxis

Side Effects

1. anaphylactic shock
2. anaphylactoid reactions
3. angioedema
4. antibody formation
5. arrhythmia exacerbation
6. cough
7. cyanosis
8. diarrhea
9. dyspnea
10. elevated hepatic enzymes
11. erythema
12. fever
13. infection
14. injection site reaction
15. pruritus
16. rash
17. rhinitis
18. thrombocytopenia
19. urticaria
20. vomiting
21. wheezing

Monitoring Parameters

• laboratory monitoring not necessary

Contraindications

• acute bronchospasm
• breast-feeding
• coagulopathy
• human anti-human antibody (HAHA)
• hypotension
• murine protein hypersensitivity
• pregnancy
• surgery
• thrombocytopenia

Interactions

There are no drug interactions associated with Palivizumab products.