Content deleted Content added
Tag: Reverted |
Citation bot (talk | contribs) Removed parameters. | Use this bot. Report bugs. | Suggested by Jay8g | Category:CS1 maint: PMC embargo expired | #UCB_Category |
||
| (6 intermediate revisions by 6 users not shown) | |||
Line 1:
{{Short description|Pharmaceutical drug}}
{{cs1 config|name-list-style=vanc|display-authors=6}}
{{Drugbox
| Verifiedfields = changed
Line 26 ⟶ 27:
<!-- Legal status -->
| legal_AU = S4
| legal_AU_comment = <ref>https://www.tga.gov.au/resources/artg/231139 {{Bare URL inline|date=August 2024}}</ref>
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->
| legal_BR_comment =
Line 81 ⟶ 82:
'''Palivizumab''', sold under the brand name '''Synagis''', is a [[monoclonal antibody]] produced by [[recombinant DNA]] technology used to prevent severe disease caused by [[respiratory syncytial virus]] (RSV) infections.<ref name="Synagis SmPC" /><ref name="Synagis EPAR" /> It is recommended for infants at high-risk for RSV due to conditions such as [[Preterm birth|prematurity]] or other medical problems including heart or lung diseases.<ref name="Synagis SmPC" /><ref name="Synagis EPAR" />
The most common side effects include [[fever]] and [[rash]].<ref name="Synagis SmPC" /><ref name="Synagis EPAR">{{cite web | title=Synagis EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/synagis | access-date=20 August 2020}} Text was copied from this source which is
Palivizumab is a [[Humanized antibody|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%.<ref>{{Cite journal|date=2021|title=Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany|url=https://clinicaltrials.gov/ct2/show/NCT01155193 |website=ClinicalTrials.gov}}</ref> Palivizumab is dosed once a month via [[intramuscular injection|intramuscular (IM) injection]], to be administered throughout the duration of the RSV season, which in based on past trends has started in Mid-September to Mid-November.<ref name="Synagis SmPC" /><ref>{{cite journal | vauthors = Borchers AT, Chang C, Gershwin ME, Gershwin LJ | title = Respiratory syncytial virus--a comprehensive review | journal = Clinical Reviews in Allergy & Immunology | volume = 45 | issue = 3 | pages = 331–379 | date = December 2013 | pmid = 23575961 | pmc = 7090643 | doi = 10.1007/s12016-013-8368-9 }}</ref><ref>{{Cite web|last=CDC|date=2020-12-18|title=Trends and Surveillance for RSV in the US.|url=https://www.cdc.gov/rsv/research/us-surveillance.html|access-date=2021-08-10|website=Centers for Disease Control and Prevention|language=en-us}}</ref>
Line 93 ⟶ 94:
* children less than two years of age and with hemodynamically significant congenital heart disease.<ref name="Synagis EPAR" />
The [[American Academy of Pediatrics]] has published guidelines for the use of palivizumab. The most recent updates to these recommendations are based on new information regarding RSV seasonality, palivizumab pharmacokinetics, the incidence of [[bronchiolitis]] hospitalizations, the effect of [[Gestational age (obstetrics)|gestational age]] and other risk factors on RSV hospitalization rates, the mortality of children hospitalized with RSV infection, the effect of [[Preventive healthcare|prophylaxis]] on wheezing, and palivizumab-resistant RSV isolates.<ref name="2014 Pediatrics">{{cite journal | vauthors = Brady MT, Byington CL, Davies HD, Edwards KM, Jackson MA, Maldonado YA, Murray DL, Orenstein WA, Rathore MH, Sawyer MH, Schutze GE
=== RSV Prophylaxis ===
All infants younger than one year who were born at <29 weeks (i.e. ≤28 weeks, 6 days) of gestation are recommended to use palivizumab. Infants younger than one year with [[bronchopulmonary dysplasia]] (i.e. who were born at <32 weeks gestation and required supplemental oxygen for the first 28 days after birth) and infants younger than two years with [[bronchopulmonary dysplasia]] who require medical therapy (e.g. supplemental oxygen, [[Glucocorticoid|glucocorticoids]], diuretics) within six months of the anticipated RSV season are recommended to use palivizumab as prophylaxis.<ref name="2014 Pediatrics" /> Taking palivizumab prophylactically decreases the number of RSV infections, decreases wheezing, and may decrease the rate of hospitalization attributed to RSV.<ref>{{cite journal | vauthors = Andabaka T, Nickerson JW, Rojas-Reyes MX, Rueda JD, Bacic Vrca V, Barsic B | title = Monoclonal antibody for reducing the risk of respiratory syncytial virus infection in children | journal = The Cochrane Database of Systematic Reviews | issue = 4 | pages = CD006602 | date = April 2013 | pmid = 23633336 | doi = 10.1002/14651858.cd006602.pub4 }}</ref><ref name="
Since the risk of RSV decreases after the first year following birth, the use of palivizumab for children more than 12 months of age is generally not recommended with the exception of premature infants who need supplemental oxygen, bronchodilator therapy, or [[Corticosteroid|steroid therapy]] at the time of their second RSV season.<ref name="2014 Pediatrics" />
Line 109 ⟶ 110:
=== RSV Treatment ===
Because palivizumab is a passive antibody, it is ineffective in the treatment of RSV infection, and its administration is not recommended for this indication.<ref name="2014 Pediatrics" /> A 2019 (updated in 2023) Cochrane review found no differences in palivizumab and placebo on outcomes of mortality, length of hospital stay, and adverse events in infants and children aged up to 3 years old with RSV.<ref>{{cite journal | vauthors = Sanders SL, Agwan S, Hassan M, Bont LJ, Venekamp RP | title = Immunoglobulin treatment for hospitalised infants and young children with respiratory syncytial virus infection | journal = The Cochrane Database of Systematic Reviews | volume = 2023 | issue = 10 | pages = CD009417 | date = October 2023 | pmid = 37870128 | pmc = 10591280 | doi = 10.1002/14651858.CD009417.pub3
== Contraindications ==
Line 132 ⟶ 133:
==== Mechanism of action ====
Palivizumab is a monoclonal antibody that targets the [[Respiratory syncytial virus F protein|fusion (F) glycoprotein]] on the surface of RSV, and deactivates it.<ref name="
=== Pharmacokinetics ===
==== Absorption ====
A 2008 meta-analysis found that palivizumab
==== Distribution ====
The [[volume of distribution]] is approximately 4.1 liters.<ref name="
==== Clearance ====
Palivizumab has a drug clearance (CL) of approximately 198 ml/day. The half-life of this drug is approximately 20 days with three doses sustaining body concentrations that will last the entire RSV season (5 to 6 months). A 2008 meta-analysis estimated clearance in the pediatric population by considering maturation of CL and body weight which showed a significant reduction compared to adults.<ref name="
==Society and Culture==
=== Cost ===
Palivizumab is a relatively expensive medication, with a 100-mg vial ranging from $904 to $1866.<ref>{{cite journal | vauthors = Mac S, Sumner A, Duchesne-Belanger S, Stirling R, Tunis M, Sander B | title = Cost-effectiveness of Palivizumab for Respiratory Syncytial Virus: A Systematic Review | journal = Pediatrics | volume = 143 | issue = 5 | pages = e20184064 | date = May 2019 | pmid = 31040196 | doi = 10.1542/peds.2018-4064 | doi-access = free }}</ref> Multiple studies done by both the manufacturer and independent researchers to determine the cost-effectiveness of palivizumab have found conflicting results. The heterogeneity between these studies makes them difficult to compare. Given that there is no consensus about the cost-effectiveness of palivizumab, usage largely depends on the location of care and individual risk factors.<ref>{{cite journal | vauthors = Andabaka T, Nickerson JW, Rojas-Reyes MX, Rueda JD, Bacic Vrca V, Barsic B | title = Monoclonal antibody for reducing the risk of respiratory syncytial virus infection in children | journal = The Cochrane Database of Systematic Reviews | issue = 4 | pages = CD006602 | date = April 2013 | pmid = 23633336 | doi = 10.1002/14651858.cd006602.pub4 }}</ref><ref name="
A 2013 meta-analysis reported that palivizumab prophylaxis was a dominant strategy with an incremental cost-effectiveness ratio of $2,526,203 per [[Quality-adjusted life year|quality-adjusted life-year]] (QALY). It also showed an [[incremental cost-effectiveness ratio]] for preterm infants between $5188 and $791,265 per [[Quality-adjusted life year|QALY]], from the payer perspective.<ref>{{cite journal | vauthors = Mac S, Sumner A, Duchesne-Belanger S, Stirling R, Tunis M, Sander B | title = Cost-effectiveness of Palivizumab for Respiratory Syncytial Virus: A Systematic Review | journal = Pediatrics | volume = 143 | issue = 5 | pages = e20184064 | date = May 2019 | pmid = 31040196 | doi = 10.1542/peds.2018-4064 | doi-access = free }}</ref> However, as previously stated, the cost-effectiveness of palivizumab is undecided, and this meta-analysis is only one example of society can benefit from palivizumab prophylaxis.
Line 154 ⟶ 155:
The disease burden of RSV in young infants and its global prevalence have prompted attempts for vaccine development. As of 2019, there was no approved vaccine for RSV prevention.<ref>{{cite book | vauthors = Shafique M, Zahoor MA, Arshad MI, Aslam B, Siddique AB, Rasool AH, Qamar MU, Usman M | chapter =Hurdles in Vaccine Development against Respiratory Syncytial Virus|date=2019-10-30| chapter-url=https://www.intechopen.com/books/the-burden-of-respiratory-syncytial-virus-infection-in-the-young/hurdles-in-vaccine-development-against-respiratory-syncytial-virus| title = The Burden of Respiratory Syncytial Virus Infection in the Young| veditors = Resch B |publisher=IntechOpen|language=en|doi=10.5772/intechopen.87126|isbn=978-1-78984-642-3|access-date=2021-08-03|doi-access=free}}</ref> A formalin-inactivated RSV vaccine (FIRSV) was studied in the 1960s. The immunized children who were exposed to the virus in the community developed an enhanced form of RSV disease presented by [[Wheeze|wheezing]], fever, and [[bronchopneumonia]]. This enhanced form of the disease led to 80% hospitalization in the recipients of FIRSV compared to 5% in the control group. Additionally, 2 fatalities occurred among the vaccine recipients upon reinfection in subsequent years.<ref>{{cite journal | vauthors = Kim HW, Canchola JG, Brandt CD, Pyles G, Chanock RM, Jensen K, Parrott RH | title = Respiratory syncytial virus disease in infants despite prior administration of antigenic inactivated vaccine | journal = American Journal of Epidemiology | volume = 89 | issue = 4 | pages = 422–434 | date = April 1969 | pmid = 4305198 | doi = 10.1093/oxfordjournals.aje.a120955 }}</ref> Subsequent attempts to develop an attenuated live virus vaccine with optimal [[immune response]] and minimal [[reactogenicity]] have been unsuccessful.<ref name="pmid24362694">{{cite book | vauthors = Karron RA, Buchholz UJ, Collins PL | chapter = Live-Attenuated Respiratory Syncytial Virus Vaccines | series = Current Topics in Microbiology and Immunology | title = Challenges and Opportunities for Respiratory Syncytial Virus Vaccines | volume = 372 | pages = 259–284 | date = 2013 | pmid = 24362694 | pmc = 4794267 | doi = 10.1007/978-3-642-38919-1_13 | publisher = Springer Berlin Heidelberg | isbn = 978-3-642-38918-4 | veditors = Anderson L, Graham BS | place = Berlin, Heidelberg }}</ref> Further research on animal subjects suggested that intravenously administered immunoglobulin with high RSV neutralizing activity can protect against RSV infection.<ref>{{cite journal | vauthors = Boukhvalova MS, Yim KC, Blanco J | title = Cotton rat model for testing vaccines and antivirals against respiratory syncytial virus | journal = Antiviral Chemistry & Chemotherapy | volume = 26 | pages = 2040206618770518 | date = 2018-01-01 | pmid = 29768937 | pmc = 5987903 | doi = 10.1177/2040206618770518 }}</ref> In 1995, the [[Food and Drug Administration|U.S. Food and Drug Administration]] (FDA) approved the use of RespiGam (RSV-IGIV) for the prevention of serious lower respiratory tract infection caused by RSV in children younger than 24 months of age with [[bronchopulmonary dysplasia]] or a history of [[Preterm birth|premature birth]].<ref>{{cite journal | vauthors = Pollack P, Groothuis JR | title = Development and use of palivizumab (Synagis): a passive immunoprophylactic agent for RSV | journal = Journal of Infection and Chemotherapy | volume = 8 | issue = 3 | pages = 201–206 | date = September 2002 | pmid = 12373481 | doi = 10.1007/s10156-002-0178-6 | s2cid = 39331984 }}</ref> The success of the RSV-IGIV demonstrated efficacy in immunoprophylaxis and prompted research into further technologies. Thus, Palivizumab was developed as an antibody that was found to be fifty times more potent than its predecessor. This antibody has been widely used for RSV since 1998 when it was approved.<ref name = "Dessain_2021">{{Cite book |url= https://www.worldcat.org/oclc/209988317 |title=Human antibody therapeutics for viral disease|date=2021|publisher=Springer Verlag| vauthors = Dessain SK |isbn=978-3-540-72146-8|location=Berlin|oclc=209988317}}</ref>
Palivizumab, originally known as MEDI-493, was developed as an RSV immune prophylaxis tool that was easier to administer and more effective than the current tools of that time (the 1990s).<ref name = "Dessain_2021" /> It was developed over a 10-year period by MedImmune Inc. by combining human and mouse DNA.<ref>{{cite journal | vauthors = Johnson S, Oliver C, Prince GA, Hemming VG, Pfarr DS, Wang SC, Dormitzer M, O'Grady J, Koenig S, Tamura JK, Woods R, Bansal G, Couchenour D, Tsao E, Hall WC, Young JF
== References ==
Line 168 ⟶ 169:
[[Category:Drugs developed by AstraZeneca]]
[[Category:Biotechnology]]
[[Category:Respiratory syncytial virus]]
| |||