Palivizumab
(Synonyms: MEDI 493) 目录号 : GC68300Palivizumab (MEDI 493) 是一种人源化呼吸道合胞病毒单克隆抗体，可减少呼吸道合胞病毒感染 (RSV)。
Cas No.:188039-54-5
Sample solution is provided at 25 µL, 10mM.
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Quality Control & SDS
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Palivizumab (MEDI 493), a humanized respiratory syncytial virus monoclonal antibody, reduces respiratory syncytial virus (RSV) infection[1].
[1]. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. The IMpact-RSV Study Group. Pediatrics. 1998 Sep;102(3 Pt 1):531-7.
| Cas No. | 188039-54-5 | SDF | Download SDF |
| 别名 | MEDI 493 | ||
| 分子式 | 分子量 | ||
| 溶解度 | 储存条件 | Store at -20°C | |
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每只动物给药体积 | ul | |
动物数量 | 只 |
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工作液浓度： mg/ml；
DMSO母液配制方法： mg 药物溶于 μL DMSO溶液（母液浓度 mg/mL，
体内配方配制方法：取 μL DMSO母液，加入 μL PEG300，混匀澄清后加入μL Tween 80，混匀澄清后加入 μL saline，混匀澄清。
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2.
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Palivizumab for preventing severe respiratory syncytial virus (RSV) infection in children
Cochrane Database Syst Rev 2021 Nov 16;11(11):CD013757.PMID:34783356DOI:10.1002/14651858.CD013757.pub2.
Background: Respiratory viruses are the leading cause of lower respiratory tract infection (LRTI) and hospitalisation in infants and young children. Respiratory syncytial virus (RSV) is the main infectious agent in this population. Palivizumab is administered intramuscularly every month during five months in the first RSV season to prevent serious RSV LRTI in children. Given its high cost, it is essential to know if Palivizumab continues to be effective in preventing severe RSV disease in children. Objectives: To assess the effects of Palivizumab for preventing severe RSV infection in children. Search methods: We searched CENTRAL, MEDLINE, three other databases and two trials registers to 14 October 2021, together with reference checking, citation searching and contact with study authors to identify additional studies. We searched Embase to October 2020, as we did not have access to this database for 2021. Selection criteria: We included randomised controlled trials (RCTs), including cluster-RCTs, comparing Palivizumab given at a dose of 15 mg/kg once a month (maximum five doses) with placebo, no intervention or standard care in children 0 to 24 months of age from both genders, regardless of RSV infection history. DATA COLLECTION AND ANALYSIS: We used Cochrane's Screen4Me workflow to help assess the search results. Two review authors screened studies for selection, assessed risk of bias and extracted data. We used standard Cochrane methods. We used GRADE to assess the certainty of the evidence. The primary outcomes were hospitalisation due to RSV infection, all-cause mortality and adverse events. Secondary outcomes were hospitalisation due to respiratory-related illness, length of hospital stay, RSV infection, number of wheezing days, days of supplemental oxygen, intensive care unit length of stay and mechanical ventilation days. Main results: We included five studies with a total of 3343 participants. All studies were parallel RCTs, assessing the effects of 15 mg/kg of Palivizumab every month up to five months compared to placebo or no intervention in an outpatient setting, although one study also included hospitalised infants. Most of the included studies were conducted in children with a high risk of RSV infection due to comorbidities like bronchopulmonary dysplasia and congenital heart disease. The risk of bias of outcomes across all studies was similar and predominately low. Palivizumab reduces hospitalisation due to RSV infection at two years' follow-up (risk ratio (RR) 0.44, 95% confidence interval (CI) 0.30 to 0.64; 5 studies, 3343 participants; high certainty evidence). Based on 98 hospitalisations per 1000 participants in the placebo group, this corresponds to 43 (29 to 62) per 1000 participants in the Palivizumab group. Palivizumab probably results in little to no difference in mortality at two years' follow-up (RR 0.69, 95% CI 0.42 to 1.15; 5 studies, 3343 participants; moderate certainty evidence). Based on 23 deaths per 1000 participants in the placebo group, this corresponds to 16 (10 to 27) per 1000 participants in the Palivizumab group. Palivizumab probably results in little to no difference in adverse events at 150 days' follow-up (RR 1.09, 95% CI 0.85 to 1.39; 3 studies, 2831 participants; moderate certainty evidence). Based on 84 cases per 1000 participants in the placebo group, this corresponds to 91 (71 to 117) per 1000 participants in the Palivizumab group. Palivizumab probably results in a slight reduction in hospitalisation due to respiratory-related illness at two years' follow-up (RR 0.78, 95% CI 0.62 to 0.97; 5 studies, 3343 participants; moderate certainty evidence). Palivizumab may result in a large reduction in RSV infection at two years' follow-up (RR 0.33, 95% CI 0.20 to 0.55; 3 studies, 554 participants; low certainty evidence). Based on 195 cases of RSV infection per 1000 participants in the placebo group, this corresponds to 64 (39 to 107) per 1000 participants in the Palivizumab group. Palivizumab also reduces the number of wheezing days at one year's follow-up (RR 0.39, 95% CI 0.35 to 0.44; 1 study, 429 participants; high certainty evidence). Authors' conclusions: The available evidence suggests that prophylaxis with Palivizumab reduces hospitalisation due to RSV infection and results in little to no difference in mortality or adverse events. Moreover, Palivizumab results in a slight reduction in hospitalisation due to respiratory-related illness and may result in a large reduction in RSV infections. Palivizumab also reduces the number of wheezing days. These results may be applicable to children with a high risk of RSV infection due to comorbidities. Further research is needed to establish the effect of Palivizumab on children with other comorbidities known as risk factors for severe RSV disease (e.g. immune deficiencies) and other social determinants of the disease, including children living in low- and middle-income countries, tropical regions, children lacking breastfeeding, living in poverty, or members of families in overcrowded situations.
Expert consensus on Palivizumab use for respiratory syncytial virus in developed countries
Paediatr Respir Rev 2020 Feb;33:35-44.PMID:31060948DOI:10.1016/j.prrv.2018.12.001.
Respiratory syncytial virus (RSV) infection is a leading cause of hospitalisation in early childhood and Palivizumab is the only licensed intervention for prevention. Palivizumab guidelines should reflect the latest evidence, in addition to cost-effectiveness and healthcare budgetary considerations. RSV experts from Europe, Canada and Israel undertook a systematic review of the evidence over the last 5 years and developed recommendations regarding prophylaxis in industrialised countries. Almost 400 publications were reviewed. This group recommended Palivizumab for: preterm infants (<29 and ≤31 weeks gestational age [wGA] and ≤9 and ≤6 months of age, respectively; high-risk 32-35wGA), former preterm children ≤24 months with chronic lung disease/bronchopulmonary dysplasia, children ≤24 months with significant congenital heart disease; and other high-risk populations, such as children ≤24 months with Down syndrome, pulmonary/neuromuscular disorders, immunocompromised, and cystic fibrosis. Up to 5 monthly doses should be administered over the RSV season. It is our impression that the adoption of these guidelines would help reduce the burden of RSV.
Palivizumab
Drugs 1999 Aug;58(2):305-11; discussion 312-3.PMID:10473022DOI:10.2165/00003495-199958020-00009.
The humanised monoclonal antibody Palivizumab has been developed for prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants at high risk; RSV is the most common cause of lower respiratory tract infections in infants. Palivizumab specifically inhibits an epitope at the A antigenic site of the F protein of RSV subtypes A and B. RSV replication was inhibited in nasal and tracheal aspirates from infants receiving Palivizumab 15 mg/kg. Mean 30-day trough serum concentrations of Palivizumab were consistently about 70 mg/L in infants receiving repeated intramuscular or intravenous Palivizumab 15 mg/kg. This is above the target serum concentration of 40 mg/L estimated to reduce pulmonary RSV replication by >99% in animal studies. In a large multicentre trial in 1502 infants at high risk of RSV infection, intramuscular Palivizumab 15 mg/kg more than halved the incidence of RSV-attributable hospitalisation to 4.8% compared with 10.6% in placebo recipients. In the same group of high-risk infants, Palivizumab significantly decreased total days in hospital attributable to RSV infection, days with increased supplemental oxygen requirement, days with moderate to severe lower respiratory tract infections and the incidence of admissions to intensive care. It had no effect on the incidence or total number of days of ventilation. Palivizumab was well tolerated during clinical trials in infants at risk of RSV infection. The incidence of adverse events was similar in placebo (10%) and Palivizumab (11%) groups. Fever, irritability and injection site reaction were the most commonly reported adverse events.
Cost-effectiveness of Palivizumab for Respiratory Syncytial Virus: A Systematic Review
Pediatrics 2019 May;143(5):e20184064.PMID:31040196DOI:10.1542/peds.2018-4064.
Context: Palivizumab prophylaxis is used as passive immunization for respiratory syncytial virus (RSV). However, because of its high cost, the value of this intervention is unclear. Objective: To systematically review the cost-effectiveness of Palivizumab prophylaxis compared with no prophylaxis in infants <24 months of age. Data sources: Medline, Embase, and Cochrane Library up to August 2018. Study selection: Two reviewers independently screened results to include economic evaluations conducted between 2000 and 2018 from Organization for Economic Cooperation and Development countries. Data extraction: Two reviewers independently extracted outcomes. Quality appraisal was completed by using the Joanna Briggs Institute checklist. Costs were adjusted to 2017 US dollars. Results: We identified 28 economic evaluations (20 cost-utility analyses and 8 cost-effectiveness analyses); most were from the United States (n = 6) and Canada (n = 5). Study quality was high; 23 studies met >80% of the Joanna Briggs Institute criteria. Palivizumab prophylaxis ranged from a dominant strategy to having an incremental cost-effectiveness ratio of $2 526 203 per quality-adjusted life-year (QALY) depending on study perspective and targeted population. From the payer perspective, the incremental cost-effectiveness ratio for preterm infants (29-35 weeks' gestational age) was between $5188 and $791 265 per QALY, with 90% of estimates <$50 000 per QALY. Influential parameters were RSV hospitalization reduction rates, Palivizumab cost, and discount rate. Limitations: Model design heterogeneity, model parameters, and study settings were barriers to definitive conclusions on Palivizumab's economic value. Conclusions: Palivizumab as RSV prophylaxis was considered cost-effective in prematurely born infants, infants with lung complications, and infants from remote communities.
Palivizumab: an overview
Hosp Med 1999 Dec;60(12):873-7.PMID:10707171DOI:10.12968/hosp.1999.60.12.1254.
Respiratory syncytial virus (RSV) affects almost all children in their first 2 years of life and can cause severe or even life-threatening disease in some at-risk infants. Treatment is limited and there is currently no safe or effective vaccine. However, a new monoclonal antibody, Palivizumab, reduces RSV hospitalization by 55% in at-risk groups if given prophylactically throughout the RSV season.