NEODOSE

INDICATIONS

• AAP Recommendations: For prophylaxis during RSV season restricted to the populations detailed below .
• Preterm infants without chronic lung disease (CLD) of prematurity or congenital heart disease (CHD): May administer palivizumab in the first year of life if born before 29 weeks, 0 days gestation who are younger than 12 months at start of RSV season. NOT universally recommended if born at 29 weeks, 0 days gestation or later. Palivizumab was associated with a significantly reduced rate of hospitalization for RSV (3.1% vs 5%), but the rate of hospitalization for bronchiolitis without RSV diagnosis was increased (3.3% vs 1.9%, p=0.05) in infants 29 to 32 weeks’ gestation. No difference was observed for those infants 33 to 36 weeks’ gestation in a retrospective study (N=14,097) .
• Preterm infants with CLD of prematurity: May be considered in first year of life during RSV season in preterm infants who develop CLD of prematurity (ie, gestational age younger than 32 weeks, 0 days and require more than 21% oxygen for at least the first 28 days after birth). May be considered in the second year of life ONLY in patients with CLD of prematurity who still require medical therapy, such as chronic corticosteroids, diuretics, or supplemental oxygen, during the 6-month period before the second RSV season begins.
• Infants with hemodynamically significant heart disease: May be considered in the first year of life for infants with conditions such as acyanotic heart disease requiring medications for heart failure and anticipatory cardiac surgery as well as moderate to severe pulmonary hypertension. May also consider in children younger than 24 months who undergo cardiac transplantation during RSV season .
• Children with anatomic pulmonary abnormalities or neuromuscular disease: Consider prophylaxis during first year of life if condition impairs clearance of secretions from upper airway.
• Alaskan native populations: Due to cost associated with transportation from remote areas and burden of disease, prophylaxis may be justified.
• Navajo and White Mountain Apache infants: Data are insufficient but prophylaxis may be justified .
• Profoundly immunocompromised and younger than 24 months: Consider prophylaxis during RSV season.
• Children with Down syndrome: Data are insufficient to establish efficacy for RSV infection prophylaxis.
• Children with cystic fibrosis (CF): A single randomized controlled trial (n=186 infants; age range 0.4 to 24.4 months) did not detect any clinically meaningful differences between 5 monthly injections of palivizumab and placebo after 12 months of follow-up. There was some evidence in non-randomized studies to support a role for prophylactic palivizumab in reduction of hospitalizations due to respiratory syncytial virus in a systematic review of 10 studies in 3,891 children 2 years or younger with CF; however, there was substantial interstudy variation in regimens used, risk of bias was moderate to serious, and safety and tolerability could not be ascertained. Prophylaxis in children with CF is not recommendedunless the child qualifies for other reasons. Consider prophylaxis if chronic lung disease is clinically evident and/or nutritional compromise is present in the first year of life. Manifestation of severe lung disease or weight less than 10th percentile may justify use through the second year.
• Not Recommended: Infants and children with hemodynamically insignificant heart disease (eg, secundum atrial septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, and patent ductus arteriosus). Infants with lesions sufficiently revised with surgery, unless continued medication for congestive heart failure is required. Infants with mild cardiomyopathy who do not receive medical treatment for cardiomyopathy. Children in the second year of life who do not rely on medical support. For the prevention of healthcare-associated RSV disease.
• Alternative regimen (based on mathematical modeling): Administer the second dose 29 days after the first and then subsequent doses every 38 days (total of 4 or 5 doses); initiate palivizumab on a fixed start date based on longitudinal local RSV data from previous seasons. This alternative regimen provides protection for regions that experience early and/or prolonged RSV seasons. Palivizumab treatment in high-risk infants reduced the risk of RSV hospitalizations (relative risk (RR), 0.49 (95% CI, 0.37 to 0.64)) and the frequency of intensive care admissions (RR, 0.5 (95% CI, 0.3 to 0.81) by half compared with placebo in a meta-analysis (3 studies, n=2831). Economic evaluations from review of 34 additional studies ranged from highly costeffective to not cost-effective; all studies were sponsored by pharmaceutical companies.

FDA APPROVED INDICATION

Indicated for the prevention of serious lower respiratory tract disease due to respiratory syncytial virus (RSV) in pediatric patients with:

• a history of premature birth (≤35 weeks gestational age) and who are 6 months of age or younger at the start of RSV season.
• bronchopulmonary dysplasia that required medical treatment within the last 6 months and who are 24 months of age or younger at the start of RSV season.
• hemodynamically significant congenital heart disease and who are 24 months of age or younger at the start of RSV season.

Limitations of use: Not indicated for the treatment of RSV disease.

PRECAUTIONS

Anaphylaxis, anaphylactic shock, and other acute hypersensitivity reactions, some severe and/or fatal, have been reported on initial exposure or re-exposure to palivizumab; permanently discontinue if a severe hypersensitivity reaction occurs. Do not administer to patients who have had a previous significant hypersensitivity reaction to palivizumab

ADVERSE EFFECTS

In clinical trials, fever and rash occurred slightly more frequently in palivizumab recipients (27% and 12%, respectively) compared with those who received placebo (25% and 10%, respectively).

MONITORING

Observe injection site for induration and swelling.