Optimum Dosage Regimen of Palivizumab?

Zaaijer, Hans L.; Vandenbroucke-Grauls, Christina M. J. E.; Franssen, Ejf

doi:10.1097/00007691-200206000-00020

Cited by 17 publications

(15 citation statements)

References 4 publications

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“…Standard dosing is 15 mg/kg administered intramuscularly every 30 days during RSV season for a maximum of five doses. Some Canadian programs administer the second dose 20 days after the first dose to prevent a low trough level; (6,7) however, there are no data showing an increased RSV hospitalization rate before the second dose. Palivizumab is available in 50 mg or 100 mg vials.…”

Section: Palivizumabmentioning

confidence: 99%

Preventing hospitalizations for respiratory syncytial virus infection

Robinson¹,

Saux²

2015

Paediatrics &Amp; Child Health

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EPIDEMIOLOGyRespiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections (LRTIs) in young children worldwide, with almost all experiencing their first RSV infection by two years of age. In developed countries, 1% to 3% of all infants are hospitalized with RSV infection. In Canada, the RSV season typically begins in November or December and persists for four to five months. The present statement replaces four previous position statements from the Canadian Paediatric Society on this topic(1-4) because there is evidence that the risk of RSV hospitalization does not warrant the use of palivizumab in many children for whom it was previously recommended. PREVENTING RSV HOSPITALIZATIONS Instructions for parentsYoung infants (and their siblings) should not be in contact with individuals with respiratory tract infections whenever practical. A Cochrane review suggests that hand hygiene in the home decreases the spread of respiratory tract infections in children. (5) Breastfeeding and avoidance of cigarette smoke are also presumed to decrease the incidence and/or severity of viral respiratory tract infections. PalivizumabPalivizumab, a humanized murine monoclonal immunoglobulin G-1 directed against an epitope on the F glycoprotein of RSV, is produced by recombinant DNA technology, and has 95% human and 5% murine amino acid sequences. Rare cases of anaphylaxis are the only recognized serious adverse event. Standard dosing is 15 mg/kg administered intramuscularly every 30 days during RSV season for a maximum of five doses. Some Canadian programs administer the second dose 20 days after the first dose to prevent a low trough level;(6,7) however, there are no data showing an increased RSV hospitalization rate before the second dose. Palivizumab is available in 50 mg or 100 mg vials. Drug costs for five doses of palivizumab for an infant with a mean weight of 5 kg are approximately $5,600, assuming no waste.Palivizumab use in Canada is directed by provincial or territorial programs. When practitioners have questions about eligibility, they should contact their local program; contact information is available through neonatal care units. Some programs routinely begin prophylaxis in November or December. Others use laboratory surveillance from local laboratories or from the national Respiratory Virus Detection Surveillance System (www.phac-aspc. gc.ca/bid-bmi/dsd-dsm/rvdi-divr/index-eng.php) to determine when to start palivizumab. The latter strategy is more complicated to organize than having a uniform start and stop date, but has been demonstrated to save drug costs in a recent Canadian study.(8) Table 1 summarizes the results of randomized controlled trials (RCTs) investigating palivizumab, demonstrating a reduction in hospitalizations of approximately 80% in infants with prematurity but without chronic lung disease of prematurity (CLD), of 40% in infants with CLD, and of 45% in children with congenital heart disease (CHD). Efficacy was not demonstrated in the CHD subgroup with cyanotic heart...

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Section: Palivizumabmentioning

confidence: 99%

Preventing hospitalizations for respiratory syncytial virus infection

Robinson¹,

Saux²

2015

Paediatrics &Amp; Child Health

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“…However, children born very prematurely (gestational age ≤30 weeks) seem to achieve optimal protective serum levels of antibodies only after the second dose of palivizumab. This has important implications for the timing and dosing of palivizumab in these children 32 33…”

Section: Discussionmentioning

confidence: 99%

Passive immunisation against respiratory syncytial virus: a cost-effectiveness analysis

Rietveld

Steyerberg

Polder

et al. 2010

Archives of Disease in Childhood

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“…We modeled the palivizumab concentration over time using a compartment model 24 in which palivizumab is eliminated exponentially after an injection (eAppendix 1 in the Supplement). The half-life of palivizumab was assumed to be 20 days based on the US Food and Drug Administration label.…”

Section: Methodsmentioning

confidence: 99%

Efficacy and Optimization of Palivizumab Injection Regimens Against Respiratory Syncytial Virus Infection

2015

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IMPORTANCE Infection with the respiratory syncytial virus (RSV) is the leading cause of hospitalizations in children, accounting for more than 90 000 hospitalizations every year in the United States. For children who are at risk for severe RSV infections, the American Academy of Pediatrics recommends immunoprophylaxis with a series of up to 5 injections of the antibody palivizumab administered monthly, beginning on November 1 of each year. However, many practitioners initiate injections at the onset of RSV season as indicated by local surveillance. OBJECTIVES To evaluate the effectiveness of current regimens for palivizumab injections across different cities and to design an optimized regimen. DESIGN, SETTING, AND PARTICIPANTS We performed a mathematical modeling study of the risk for hospitalization due to RSV infection. The model accounted for the pharmacokinetics of the antibody, the timing of the injections, and seasonal patterns of RSV, including geographic and year-to-year variability. We used the model to estimate the efficacy of current regimens, including the American Academy of Pediatrics recommendation, and to design a more effective injection regimen, the optimized fixed start (OFS), which uses city-specific initiation dates. Participants were the approximately 700 000 individuals who had specimens tested for RSV by National Respiratory and Enteric Virus Surveillance System laboratories in 18 US cities from July 1, 1994, through June 30, 2011 (a total of 725 741 tests). INTERVENTIONS Different palivizumab injection regimens. MAIN OUTCOMES AND MEASURES The primary outcome measure was reduction in hospitalizations due to RSV infections. The secondary measures were cost (number of palivizumab doses) and duration of protection (in days). RESULTS The American Academy of Pediatrics–recommended 5-injection regimen is expected to reduce hospitalization risk by a median of 2.7% (range, −2.2% to 6.1%) compared with the conventional regimen based on RSV surveillance. The 5-injection OFS regimen is expected to further reduce risk by a median of 6.8% (range, 4.9% to 14.8%), and the 4-injection OFS regimen is expected to achieve efficacy comparable to that of the conventional 5-injection regimen while reducing costs by 20%. CONCLUSIONS AND RELEVANCE Modified palivizumab regimens can improve protection for children at risk for severe outcomes of RSV infection and thereby lower rates of hospitalization due to RSV.

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Optimum Dosage Regimen of Palivizumab?

Cited by 17 publications

References 4 publications

Preventing hospitalizations for respiratory syncytial virus infection

Preventing hospitalizations for respiratory syncytial virus infection

Passive immunisation against respiratory syncytial virus: a cost-effectiveness analysis

Efficacy and Optimization of Palivizumab Injection Regimens Against Respiratory Syncytial Virus Infection

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