Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433.
GriffinMPYuanYTakasT, et al.; Nirsevimab Study Group. Single-dose nirsevimab for prevention of RSV in preterm infants. N Engl J Med. 2020;383(5):415-425. doi:10.1056/NEJMoa1913556
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HammittLLDaganRYuanY, et al.; MELODY Study Group. Nirsevimab for prevention of RSV in healthy late-preterm and term infants. N Engl J Med. 2022;386(9):837-846. doi:10.1056/NEJMoa2110275
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ZhuQMcLellanJSKallewaardNL, et al. A highly potent extended half-life antibody as a potential RSV vaccine surrogate for all infants. Sci Transl Med. 2017;9(388):eaaj1928. doi:10.1126/scitranslmed.aaj1928
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DomachowskeJBKhanAAEsserMT, et al. Safety, tolerability and pharmacokinetics of MEDI8897, an extended half-life single-dose respiratory syncytial virus prefusion f-targeting monoclonal antibody administered as a single dose to healthy preterm infants. Pediatr Infect Dis J. 2018;37(9):886-892. doi:10.1097/INF.0000000000001916
7.
WilkinsDYuanYChangY, et al. Durability of neutralizing RSV antibodies following nirsevimab administration and elicitation of the natural immune response to RSV infection in infants. Nat Med. 2023;29(5):1172-1179. doi:10.1038/s41591-023-02316-5
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AhaniBTuffyKMAksyukAA, et al. Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials. Nat Commun. 2023;14(1):4347. doi:10.1038/s41467-023-40057-8
DomachowskeJBChangYAtanasovaV, et al.; MEDLEY Study Group. Safety of re-dosing nirsevimab prior to RSV season 2 in children with heart or lung disease. J Pediatric Infect Dis Soc. 2023;12:477-480. doi:10.1093/jpids/piad052
JonesJMFleming-DutraKEPrillMM, et al. Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(34):920-925. doi:10.15585/mmwr.mm7234a4
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AstraZeneca. A study to evaluate the safety of MEDI8897 for the prevention of medically attended respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in high-risk children. ClincialTrials.gov identifier: NCT03959488. Updated June 18, 2023. Accessed August 18, 2023. https://classic.clinicaltrials.gov/ct2/show/study/NCT03959488
14.
DomachowskeJMadhiSASimõesEAF, et al.; MEDLEY Study Group. Safety of nirsevimab for RSV in infants with heart or lung disease or prematurity. N Engl J Med. 2022;386(9):892-894. doi:10.1056/NEJMc2112186
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MullerWJMadhiSASeoane NuñezB, et al.; MELODY Study Group. Nirsevimab for prevention of RSV in term and late-preterm infants. N Engl J Med. 2023;388(16):1533-1534. doi:10.1056/NEJMc2214773
16.
Sanofi Pasteur. Study of a single intramuscular dose of nirsevimab in the prevention of hospitalization due to respiratory syncytial virus (RSV) infection in healthy term and preterm infants during the first year of life (VAS00006). ClincialTrials.gov identifier: NCT05437510. Updated August 30, 2023. Accessed September 1, 2023. https://clinicaltrials.gov/study/NCT05437510
17.
EspositoSAbu-RayaBBonanniP, et al. Coadministration of anti-viral monoclonal antibodies with routine pediatric vaccines and implications for nirsevimab use: a white paper. Front Immunol. 2021;12:708939. doi:10.3389/fimmu.2021.708939
