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Article: The Role of Injectables in the Treatment and Prevention of Cancer-Associated Thrombosis.

Napolitano, Mariasanta / Siragusa, Sergio

2023 Volume 15, Issue 18

Abstract: Cancer-associated thrombosis (CAT) is a leading cause of death among patients with cancer. CAT can manifest itself as venous thromboembolism (VTE), in the form of deep vein thrombosis or pulmonary embolism, or arterial thromboembolism. The ... ...

Abstract	Cancer-associated thrombosis (CAT) is a leading cause of death among patients with cancer. CAT can manifest itself as venous thromboembolism (VTE), in the form of deep vein thrombosis or pulmonary embolism, or arterial thromboembolism. The pathophysiology of CAT is complex and depends on cancer-, patient-, treatment- and biomarkers-related factors. Treatment of VTE in patients with cancer is complex and includes three major classes of anticoagulant agents: heparin and its derivatives, e.g., low molecular weight heparins, direct oral anticoagulants (DOACs), and vitamin K inhibitors. Given the tremendous heterogeneity of clinical situations in patients with cancer and the challenges of CAT, there is no single universal treatment option for patients suffering from or at risk of CAT. Initial studies suggested that patients seemed to prefer an anticoagulant that would not interfere with their cancer treatment, suggesting the primacy of cancer over VTE, and favoring efficacy and safety over convenience of route of administration. Recent studies show that when the efficacy and safety aspects are similar, patients prefer the oral route of administration. Despite this, injectables are a valid option for many patients with cancer.
Language	English
Publishing date	2023-09-20
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers15184640
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Article ; Online: Future directions in acquired hemophilia A.

Siragusa, Sergio / Napolitano, Mariasanta

Blood

2021 Volume 137, Issue 3, Page(s) 294–295

MeSH term(s)	Antibodies, Bispecific ; Antibodies, Monoclonal, Humanized ; Factor VIII ; Hemophilia A/drug therapy ; Humans
Chemical Substances	Antibodies, Bispecific ; Antibodies, Monoclonal, Humanized ; emicizumab (7NL2E3F6K3) ; Factor VIII (9001-27-8)
Language	English
Publishing date	2021-01-21
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	80069-7
ISSN	1528-0020 ; 0006-4971
ISSN (online)	1528-0020
ISSN	0006-4971
DOI	10.1182/blood.2020008379
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Uh III Zs.140: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
Zs.MO 364: Show issues

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Article ; Online: Effect of statin intake on FVIII levels and bleeding outcomes in hypercholesterolemic patients with hemophilia A.

Paciullo, Francesco / Momi, Stefania / Mancuso, Maria Elisa / Santoro, Cristina / Napolitano, Mariasanta / Castaman, Giancarlo / Zanon, Ezio / Contino, Laura / De Cristofaro, Raimondo / Santoro, Rita Carlotta / Gresele, Paolo

Thrombosis research

2024 Volume 236, Page(s) 167–169

MeSH term(s)	Humans ; Hemophilia A/complications ; Hemophilia A/drug therapy ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use ; Hemorrhage ; Factor VIII
Chemical Substances	Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Factor VIII (9001-27-8)
Language	English
Publishing date	2024-03-02
Publishing country	United States
Document type	Letter
ZDB-ID	121852-9
ISSN	1879-2472 ; 0049-3848
ISSN (online)	1879-2472
ISSN	0049-3848
DOI	10.1016/j.thromres.2024.02.028
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Article ; Online: Classification of recombinant factor VIII products and implications for clinical practice: A systematic literature review.

Ay, Cihan / Napolitano, Mariasanta / Hassoun, Abel / Tomic, Radovan / Martin, Cedric / Seifert, Wilfried / Pinachyan, Karen / Oldenburg, Johannes

Haemophilia : the official journal of the World Federation of Hemophilia

2024

Abstract: Introduction: Consensus over the definition of recombinant factor VIII (rFVIII) product classification in haemophilia A is lacking. rFVIII products are often classified as standard half-life (SHL) or extended half-life (EHL); despite this, no ... ...

Abstract	Introduction: Consensus over the definition of recombinant factor VIII (rFVIII) product classification in haemophilia A is lacking. rFVIII products are often classified as standard half-life (SHL) or extended half-life (EHL); despite this, no universally accepted definition currently exists. One proposed definition includes half-life, area under the curve, and technology designed to extend half-life; however, the International Society on Thrombosis and Haemostasis defines activity over time as the most intuitive information for building treatment regimens and the World Federation of Hemophilia describes rFVIII product classification in terms of infusion frequency. Aim: To summarise published data on the clinical and pharmacokinetic criteria used to define rFVIII product classification. Methods: PubMed and EMBASE database searches of English-language articles (2002-2022) were conducted using search strings to identify the relevant population, intervention, and outcomes (e.g., clinical and pharmacokinetic parameters). Articles then underwent title/abstract and full-text screens. Results: Among 1147 identified articles, 62 were included. Half-life was the most widely reported outcome with no clear trends or product groupings observed. No clear groupings emerged among other outcomes, including infusion frequency, consumption, and efficacy. As activity over time was reported in few articles, further investigation of its relevance to rFVIII product classification is warranted. Conclusion: The findings of this systematic literature review suggest that parameters other than half-life might be important for the development of a comprehensive and clinically relevant rFVIII product classification definition. There seems to be an opportunity to consider parameters that are clinically meaningful and useful for shared decision-making in haemophilia A treatment.
Language	English
Publishing date	2024-03-29
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1229713-6
ISSN	1365-2516 ; 1351-8216 ; 1355-0691
ISSN (online)	1365-2516
ISSN	1351-8216 ; 1355-0691
DOI	10.1111/hae.15001
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Zs.A 4249: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 450: Show issues

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Article: Clostridium difficile

Mattana, Marta / Tomasello, Riccardo / Cammarata, Claudia / Di Carlo, Paola / Fasciana, Teresa / Giordano, Giulio / Lucchesi, Alessandro / Siragusa, Sergio / Napolitano, Mariasanta

Microorganisms

2022 Volume 10, Issue 8

Abstract: ... C. ... ...

Abstract	C. difficile
Language	English
Publishing date	2022-08-10
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2720891-6
ISSN	2076-2607
ISSN	2076-2607
DOI	10.3390/microorganisms10081624
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Article ; Online: The important impact of dental care on haemostatic treatment burden in patients with mild haemophilia.

Raso, Simona / Napolitano, Mariasanta / Sirocchi, Davide / Siragusa, Sergio / Hermans, Cedric

Haemophilia : the official journal of the World Federation of Hemophilia

2022 Volume 28, Issue 6, Page(s) 996–999

Abstract: Background: Mild haemophilia (MH) is mainly characterized by haemorrhages secondary to surgery/invasive procedures or trauma. Haemostatic treatment in MH ranges from on demand to short prophylaxis according to the type of bleeding events and the basal ... ...

Abstract	Background: Mild haemophilia (MH) is mainly characterized by haemorrhages secondary to surgery/invasive procedures or trauma. Haemostatic treatment in MH ranges from on demand to short prophylaxis according to the type of bleeding events and the basal clotting factor level. Oral surgery and dental extractions can represent a frequent haemostatic challenge in MH requiring appropriate treatment. However, only few studies on limited numbers of patients are available in the literature regarding the implications of dental management in patients with MH. Objectives: The purpose of the study was to evaluate the impact of dental care on the burden of haemostatic treatment in patients affected by MH. Methods: We conducted a retrospective multicentre study evaluating adult patients with MH regularly examined at the Haemophilia Treatment Centres (HTCs) of the Saint-Luc University Hospital, Brussels (Belgium) and of Paolo Giaccone Hospital, Palermo (Italy). The population consisted of 107 male patients with MH, with a mean age of 39 years (range 18-81 years). Results: The majority of patients (86/107, 79%) needed at least one treatment within the study period, and 44% (38/86) of them received haemostatic therapy for dental care. Haemostatic therapy in our study varied from antifibrinolytic therapy alone and perioperative factor replacement to the absence of treatment at all. The great majority of oral interventions (27/42, 64%) were managed with clotting factor concentrate. Conclusion: This study demonstrates that dental care currently represents a major reason for haemostatic treatments in patients with MH. Maintaining good oral health appears as a priority to minimize avoidable replacement therapy and optimize resources.
MeSH term(s)	Adult ; Humans ; Male ; Adolescent ; Young Adult ; Middle Aged ; Aged ; Aged, 80 and over ; Hemophilia A/therapy ; Hemophilia A/drug therapy ; Hemostatics/therapeutic use ; Antifibrinolytic Agents/therapeutic use ; Blood Coagulation Factors/therapeutic use ; Hemorrhage/prevention & control ; Dental Care ; Factor VIII/therapeutic use
Chemical Substances	Hemostatics ; Antifibrinolytic Agents ; Blood Coagulation Factors ; Factor VIII (9001-27-8)
Language	English
Publishing date	2022-07-25
Publishing country	England
Document type	Multicenter Study ; Journal Article
ZDB-ID	1229713-6
ISSN	1365-2516 ; 1351-8216 ; 1355-0691
ISSN (online)	1365-2516
ISSN	1351-8216 ; 1355-0691
DOI	10.1111/hae.14626
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Zs.A 4249: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Prolonged anticoagulant treatment in patients with cancer: Where do we stand?

Napolitano, Mariasanta / Siragusa, Sergio

Thrombosis research

2017 Volume 158, Page(s) 152–153

MeSH term(s)	Anticoagulants/pharmacology ; Anticoagulants/therapeutic use ; Humans ; Neoplasms/drug therapy ; Neoplasms/pathology
Chemical Substances	Anticoagulants
Language	English
Publishing date	2017-09-08
Publishing country	United States
Document type	Editorial
ZDB-ID	121852-9
ISSN	1879-2472 ; 0049-3848
ISSN (online)	1879-2472
ISSN	0049-3848
DOI	10.1016/j.thromres.2017.09.009
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Article ; Online: The Effect of Fluctuating Temperature on the Stability of Turoctocog Alfa for Hemophilia A.

Napolitano, Mariasanta / Nøhr, Anne Mette

Drugs in R&D

2019 Volume 19, Issue 4, Page(s) 381–390

Abstract: Background and objective: Factor VIII (FVIII) is indicated for the prevention or treatment of bleeding in patients with hemophilia A. FVIII product stability under high and fluctuating temperatures is important, particularly for patients who reside in, ... ...

Abstract	Background and objective: Factor VIII (FVIII) is indicated for the prevention or treatment of bleeding in patients with hemophilia A. FVIII product stability under high and fluctuating temperatures is important, particularly for patients who reside in, or travel to, regions with high ambient temperatures, as they may remove their product from the refrigerator and return it, unused, multiple times. We evaluated the effect of variable temperature storage conditions, including up to 40 °C, on the stability of the recombinant FVIII product, turoctocog alfa. Methods: Turoctocog alfa dry powder stability was assessed when moved between storage conditions of 5 °C (ambient humidity) and 40 °C (75% relative humidity) multiple times over a 2-month period, followed by long-term storage at 40 °C for 3 months and 5 °C for 1 month. Three product strengths (250, 1500, and 3000 IU), including the lowest and highest doses, were evaluated. Stability assessments included potency, purity, oxidized forms, high molecular weight protein (HMWP), and water content. Results: Overall, the three doses of turoctocog alfa tested remained stable under varying temperature conditions, without any potency or purity impairment, nor were any major increases in oxidized forms, HMWP, or water content observed. All results were within shelf-life specification limits. Conclusion: The results demonstrated that turoctocog alfa can be subjected to variable storage conditions, including cycling between 5 °C and ≤ 40 °C, and subsequent storage for 3 months up to 40 °C, without loss of stability. This suggests that turoctocog alfa may offer greater product storage flexibility for patients in everyday practice, with a potential reduction in wastage.
MeSH term(s)	Cold Temperature ; Drug Stability ; Drug Storage ; Factor VIII/chemistry ; Factor VIII/standards ; Factor VIII/therapeutic use ; Hemophilia A/drug therapy ; Hot Temperature ; Humans ; Molecular Weight ; Oxidation-Reduction ; Recombinant Proteins/chemistry ; Recombinant Proteins/standards ; Recombinant Proteins/therapeutic use ; Time Factors
Chemical Substances	Recombinant Proteins ; recombinant factor VIII N8 ; Factor VIII (9001-27-8)
Language	English
Publishing date	2019-11-28
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2020476-0
ISSN	1179-6901 ; 1174-5886
ISSN (online)	1179-6901
ISSN	1174-5886
DOI	10.1007/s40268-019-00290-3
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Article ; Online: Gilteritinib and the risk of intracranial hemorrhage: a case series of a possible, under-reported side effect.

Perrone, Salvatore / Imperatore, Stefano / Sucato, Giuseppe / Notarianni, Ermanno / Corbingi, Andrea / Andriola, Costanza / Napolitano, Mariasanta / Pulsoni, Alessandro / Molica, Matteo

Annals of hematology

2023 Volume 102, Issue 11, Page(s) 3025–3030

Abstract: Gilteritinib is currently approved for patients with relapsed/refractory AML with FLT3 mutations, based on the positive results of the pivotal ADMIRAL study. In ADMIRAL trial, no increased risk of bleeding was reported, but in the previous dose finding ... ...

Abstract	Gilteritinib is currently approved for patients with relapsed/refractory AML with FLT3 mutations, based on the positive results of the pivotal ADMIRAL study. In ADMIRAL trial, no increased risk of bleeding was reported, but in the previous dose finding study, a single event of intracranial hemorrhage (ICH) was registered after exposure to subtherapeutic doses of gilteritinib. Here, we report the first case series on five ICHs diagnosed in patients with FLT3-mutated AML, occurred within the first month of exposure to gilteritinib. Our cohort included 24 patients treated in three Italian centers. Most of these ICH cases were non-severe and self-limiting, while one was fatal. This link with ICHs remains in any case uncertain for the presence of active AML. We further reported that an analysis of the post-marketing surveillance data (EudraVigilance) retrieved other 11 cases of ICHs present in the database after gilteritinib treatment. A causality assessment was performed according to the Dx3 method to evaluate the possibility that ICHs might be an actual side effect of gilteritinib. In conclusion, further research is needed to elucidate the potential role of gilteritinib in the pathogenesis of ICHs.
Language	English
Publishing date	2023-08-22
Publishing country	Germany
Document type	Journal Article
ZDB-ID	1064950-5
ISSN	1432-0584 ; 0939-5555 ; 0945-8077
ISSN (online)	1432-0584
ISSN	0939-5555 ; 0945-8077
DOI	10.1007/s00277-023-05392-2
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Article: Recombinant FVIII Products (Turoctocog Alfa and Turoctocog Alfa Pegol) Stable Up to 40°C.

Napolitano, Mariasanta / Olsen, Arne Agerlin / Nøhr, Anne Mette / Eichler, Hermann

Journal of blood medicine

2021 Volume 12, Page(s) 9–20

Abstract: Purpose: The stability under high-temperature conditions of factor VIII (FVIII) concentrates for replacement therapy is of critical importance to patients, particularly those who reside in, or travel to, regions with high ambient temperatures. Concerns ... ...

Abstract	Purpose: The stability under high-temperature conditions of factor VIII (FVIII) concentrates for replacement therapy is of critical importance to patients, particularly those who reside in, or travel to, regions with high ambient temperatures. Concerns about product stability may limit or prevent access to treatment for patients and may limit their ability to live a close-to-normal life. This study evaluated the effect of hot and humid storage conditions on the long-term stability of the recombinant FVIII products, turoctocog alfa and turoctocog alfa pegol. Methods: Turoctocog alfa samples were assessed for stability at 30°C for 9 months or 40°C for 3 months following storage at 5°C for 21 or 27 months, respectively, while turoctocog alfa pegol samples were assessed at 30°C for 12 months or 40°C for 3 months following storage at 5°C for 18 or 27 months, respectively. In addition, turoctocog alfa and turoctocog alfa pegol dry powders were evaluated for stability at 5°C/ambient humidity (AH) for 30 months, 30°C/75% relative humidity (RH) for 12 months and 40°C/75% RH for 6 months. Both studies utilized a range of product strengths. Key stability assessments included oxidized forms, potency, water content and high molecular weight protein (HMWP). Results: Both turoctocog alfa and turoctocog alfa pegol remained stable following storage at 40°C/75% RH for 3 months, and at single temperatures (5°C/AH, 30 and 40°C/75% RH), without any major increase in HMWP or any impairment of potency or water content. Conclusion: Turoctocog alfa and turoctocog alfa pegol offer stability at 40°C for up to 3 months without jeopardizing the quality of each product. These stability characteristics may offer patients flexibility with product storage and daily use.
Language	English
Publishing date	2021-01-25
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2587464-0
ISSN	1179-2736
ISSN	1179-2736
DOI	10.2147/JBM.S284060
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