Nikolić, Neda

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Pharmacokinetic characterization, benefits and barriers of subcutaneous administration of monoclonal antibodies in oncology

Homšek, Ana; Spasić, Jelena; Nikolić, Neda; Stanojković, Tatjana; Jovanović, Marija; Miljković, Branislava; Vučićević, Katarina

(SAGE Publications Ltd, 2023)

TY  - JOUR
AU  - Homšek, Ana
AU  - Spasić, Jelena
AU  - Nikolić, Neda
AU  - Stanojković, Tatjana
AU  - Jovanović, Marija
AU  - Miljković, Branislava
AU  - Vučićević, Katarina
PY  - 2023
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/4325
AB  - Objective: Therapeutic monoclonal antibodies in oncology are slowly becoming the dominant treatment option for many different cancer types. The main route of administration, infusion, requires extensive product preparations, patient hospitalization and close monitoring. Patient comfort improvement, staff workload reduction and cost savings dictated the development of subcutaneous formulations. The aim of this review is to present pharmacokinetic characteristics of subcutaneous products, discuss the differences between intravenous and subcutaneous routes and to point out the advantages as well as challenges of administration route shift from the formulation development and pharmacometric angle. Data sources: Food and Drug administration's Purple book database and electronic medicines compendium were used to identify monoclonal antibodies in oncology approved as subcutaneous forms. Using keywords subcutaneous, monoclonal antibodies, pharmacokinetics, model, as well as specific drugs previously identified, both PubMed and ScienceDirect databases were researched. Data summary: There are currently six approved subcutaneous onco-monoclonal antibodies on the market. For each of them, exposure to the drug was similar in relation to infusion, treatment effectiveness was the same, administration was well tolerated by the patients and costs of the medical service were reduced. Conclusion: Development of subcutaneous forms for existing and emerging new monoclonal antibodies for cancer treatment as well as shifting from administration via infusion should be encouraged due to patient preference, lower costs and overall lack of substantial differences in efficacy and safety between the two routes.
PB  - SAGE Publications Ltd
T2  - Journal of Oncology Pharmacy Practice
T1  - Pharmacokinetic characterization, benefits and barriers of subcutaneous administration of monoclonal antibodies in oncology
VL  - 29
IS  - 2
SP  - 431
EP  - 440
DO  - 10.1177/10781552221137702
ER  - 
@article{
author = "Homšek, Ana and Spasić, Jelena and Nikolić, Neda and Stanojković, Tatjana and Jovanović, Marija and Miljković, Branislava and Vučićević, Katarina",
year = "2023",
abstract = "Objective: Therapeutic monoclonal antibodies in oncology are slowly becoming the dominant treatment option for many different cancer types. The main route of administration, infusion, requires extensive product preparations, patient hospitalization and close monitoring. Patient comfort improvement, staff workload reduction and cost savings dictated the development of subcutaneous formulations. The aim of this review is to present pharmacokinetic characteristics of subcutaneous products, discuss the differences between intravenous and subcutaneous routes and to point out the advantages as well as challenges of administration route shift from the formulation development and pharmacometric angle. Data sources: Food and Drug administration's Purple book database and electronic medicines compendium were used to identify monoclonal antibodies in oncology approved as subcutaneous forms. Using keywords subcutaneous, monoclonal antibodies, pharmacokinetics, model, as well as specific drugs previously identified, both PubMed and ScienceDirect databases were researched. Data summary: There are currently six approved subcutaneous onco-monoclonal antibodies on the market. For each of them, exposure to the drug was similar in relation to infusion, treatment effectiveness was the same, administration was well tolerated by the patients and costs of the medical service were reduced. Conclusion: Development of subcutaneous forms for existing and emerging new monoclonal antibodies for cancer treatment as well as shifting from administration via infusion should be encouraged due to patient preference, lower costs and overall lack of substantial differences in efficacy and safety between the two routes.",
publisher = "SAGE Publications Ltd",
journal = "Journal of Oncology Pharmacy Practice",
title = "Pharmacokinetic characterization, benefits and barriers of subcutaneous administration of monoclonal antibodies in oncology",
volume = "29",
number = "2",
pages = "431-440",
doi = "10.1177/10781552221137702"
}
Homšek, A., Spasić, J., Nikolić, N., Stanojković, T., Jovanović, M., Miljković, B.,& Vučićević, K.. (2023). Pharmacokinetic characterization, benefits and barriers of subcutaneous administration of monoclonal antibodies in oncology. in Journal of Oncology Pharmacy Practice
SAGE Publications Ltd., 29(2), 431-440.
https://doi.org/10.1177/10781552221137702
Homšek A, Spasić J, Nikolić N, Stanojković T, Jovanović M, Miljković B, Vučićević K. Pharmacokinetic characterization, benefits and barriers of subcutaneous administration of monoclonal antibodies in oncology. in Journal of Oncology Pharmacy Practice. 2023;29(2):431-440.
doi:10.1177/10781552221137702 .
Homšek, Ana, Spasić, Jelena, Nikolić, Neda, Stanojković, Tatjana, Jovanović, Marija, Miljković, Branislava, Vučićević, Katarina, "Pharmacokinetic characterization, benefits and barriers of subcutaneous administration of monoclonal antibodies in oncology" in Journal of Oncology Pharmacy Practice, 29, no. 2 (2023):431-440,
https://doi.org/10.1177/10781552221137702 . .
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