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Defibrotide

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https://www.readbyqxmd.com/read/28205194/novel-and-expanded-oncology-drug-approvals-of-2016-part-2-new-options-in-the-management-of-hematologic-malignancies
#1
REVIEW
Todd C Knepper, James Saller, Christine M Walko
The recent past has brought pharmacotherapeutic advances that benefit patients with hematologic malignancies. In 2016, two novel hematology drugs were approved and four previously approved hematology drugs were granted expanded use for the treatment of appropriate patient populations by the US Food and Drug Administration. These new approvals and indications represent significant steps forward in patient management: they include the first-in-class B-cell lymphoma 2 inhibitor, venetoclax, the newest targeted therapy available for the treatment of hematologic malignancies; and nivolumab, the first immune checkpoint inhibitor to be approved for treatment of a hematologic malignancy...
February 15, 2017: Oncology (Williston Park, NY)
https://www.readbyqxmd.com/read/28115278/the-role-of-thromboelastography-teg-in-pediatric-patients-with-sinusoidal-obstructive-syndrome-receiving-defibrotide
#2
Joanna L Gendreau, Christine Knoll, Roberta H Adams, Leon L Su
Sinusoidal obstructive syndrome (SOS) is a potentially fatal form of hepatic injury following hematopoietic stem cell transplant (HSCT). Patients can develop liver dysfunction, portal hypertension, ascites, coagulopathies, and multi-system organ failure. The mortality rate of severe SOS has been reported as high as 98% by Day 100 post-transplant. Defibrotide, which is now approved for the treatment of SOS, has significantly decreased mortality. Defibrotide is a polynucleotide with pro-fibrinolytic, anti-ischemic, and anti-inflammatory activity...
January 20, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28099080/catastrophic-antiphospholipid-syndrome-candidate-therapies-for-a-potentially-lethal-disease
#3
Ozan Unlu, Doruk Erkan
Catastrophic antiphospholipid syndrome (CAPS) is a potentially lethal disease that presents with rapidly progressive multiple organ thromboses. Anticoagulation, corticosteroids, intravenous immunoglobulin, and plasma exchange are the most commonly used treatments for CAPS patients. However, the high mortality despite these medications necessitates new treatment strategies. Following a brief review of current diagnostic and management strategies, we discuss the candidate therapies, i.e., hydroxychloroquine, rituximab, eculizumab, sirolimus, and defibrotide, that can be considered in CAPS patients refractory to traditional treatment...
January 14, 2017: Annual Review of Medicine
https://www.readbyqxmd.com/read/28092357/risk-of-sinusoidal-obstruction-syndrome-in-allogeneic-stem-cell-transplantation-after-prior-gemtuzumab-ozogamicin-treatment-a-retrospective-study-from-the-acute-leukemia-working-party-of-the-ebmt
#4
G Battipaglia, M Labopin, A Candoni, R Fanin, J El Cheikh, D Blaise, M Michallet, A Ruggeri, N Contentin, J M Ribera, M Stadler, J Sierra, P A von dem Borne, A Bloor, G Socié, A Nagler, M Mohty
Gemtuzumab ozogamicin (GO) may increase the risk of sinusoidal obstruction syndrome (SOS) when used prior to allogeneic stem cell transplantation (HSCT). We assessed SOS incidence and outcomes after HSCT of 146 adults, with a median age of 50 years, previously receiving GO. SOS prophylaxis was used in 69 patients (heparin n=57, ursodeoxycholic acid n=8, defibrotide n=4). Cumulative incidence (CI) of SOS was 8% (n=11), with death in 3 patients. Median interval between last GO dose and HSCT was 130 days. Overall survival (OS) and SOS incidence did not differ for patients receiving GO ⩽3...
January 16, 2017: Bone Marrow Transplantation
https://www.readbyqxmd.com/read/28092354/use-of-defibrotide-to-treat-transplant-associated-thrombotic-microangiopathy-a-retrospective-study-of-the-paediatric-diseases-and-inborn-errors-working-parties-of-the-european-society-of-blood-and-marrow-transplantation
#5
L Yeates, M A Slatter, S Bonanomi, F L W I Lim, S Y Ong, A Dalissier, W Barberi, A Shulz, M Duval, C Heilmann, A Willekens, W H Y Hwang, C Uderzo, P Bader, A R Gennery
No abstract text is available yet for this article.
January 16, 2017: Bone Marrow Transplantation
https://www.readbyqxmd.com/read/28008770/the-budget-impact-and-cost-effectiveness-of-defibrotide-for-treatment-of-veno-occlusive-disease-with-multi-organ-dysfunction-in-patients-post-hematopoietic-stem-cell-transplant
#6
David L Veenstra, Gregory F Guzauskas, Kathleen F Villa, Denise M Boudreau
BACKGROUND: A Phase-3 study of defibrotide compared with historical controls demonstrated a 23% improvement in 100-day survival post-hematopoietic stem cell transplantation (HSCT) among patients with veno-occlusive disease with multi-organ dysfunction (VOD with MOD). AIM: To estimate the budget impact and cost-effectiveness of introducing defibrotide to a transplant center. METHODS: We developed a budget impact model from the perspective of a bone-marrow transplant center...
December 23, 2016: Journal of Medical Economics
https://www.readbyqxmd.com/read/27939616/defibrotide-in-severe-sinusoidal-obstruction-syndrome-medicine-and-economic-issues
#7
Julie Steelandt, François Bocquet, Anne-Laure Cordonnier, Charlotte De Courtivron, Isabelle Fusier, Pascal Paubel
In Europe, Defitelio (defibrotide) has a Market Authorization in curative treatment of severe sinusoidal obstruction syndrome (SOS) but not in prophylaxis (2013). In France, defibrotide has had a compassionate-use program since 2009. Today, the high cost of defibrotide remains a major hurdle for hospital budgets. Medicine and economic issues were evaluated for the 39 hospitals of the French Public Assistance-Hospitals of Paris (AP-HP). We analyzed literature reviews, consumption, and expenditures through AP-HP data in 2014 and patient profiles with defibrotide in the corresponding diagnostic-related groups (DRGs) and consulted a board of hematologists...
February 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/27928191/defibrotide
#8
Danial E Baker, Kendra Demaris
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 are available online to subscribers...
November 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/27892944/veno-occlusive-disease-sinusoidal-obstruction-syndrome-after-haematopoietic-stem-cell-transplantation-middle-east-north-africa-regional-consensus-on-prevention-diagnosis-and-management
#9
A H Al Jefri, H Abujazar, A Al-Ahmari, A Al Rawas, Z Al Zahrani, A Alhejazi, M A Bekadja, A Ibrahim, M Lahoucine, S Ousia, A Bazarbachi
Veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) of the liver is a serious, early complication of haematopoietic stem cell transplantation (HSCT), severe and very severe forms of which are associated with a high mortality rate. A wide variety of patient, disease and treatment-related risk factors for VOD/SOS have been identified. Several bodies have published recommendations for the diagnosis, prevention and management of VOD/SOS following HSCT. A group of regional experts have developed a consensus statement on the diagnosis, prevention and management of VOD/SOS in the Middle East and North Africa region to help in the management of HSCT patients in the region...
November 28, 2016: Bone Marrow Transplantation
https://www.readbyqxmd.com/read/27870480/pharmacokinetics-and-safety-of-defibrotide-in-healthy-japanese-subjects
#10
Kazuo Umemura, Takayuki Iwaki, Toshimi Kimura, Chitose Ogawa, Takahiro Fukuda, Shuichi Taniguchi, Keizo Horibe, Hiroaki Goto, Kenichi Yoshimura, Yasutaka Watanabe, Chika Nitani, Atsushi Kikuta
No abstract text is available yet for this article.
November 2016: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/27843363/defibrotide-in-the-treatment-of-hepatic-veno-occlusive-disease
#11
REVIEW
Alessandro Fulgenzi, Maria Elena Ferrero
Hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), represents the most frequent complication in patients in early phase following hematopoietic stem-cell transplantation (HSCT). In its severe form, VOD/SOS can be associated with multiorgan failure and with a mortality rate >80% by day +100. Defibrotide (DF) (a mixture of 90% single-stranded phosphodiester oligonucleotides and 10% double-stranded phosphodiester oligonucleotides derived from controlled depolarization of porcine intestinal mucosal DNA) has been proposed for the treatment of SOS due to its ability to restore thrombo-fibrinolytic balance and protect endothelial cells...
2016: Hepatic Medicine: Evidence and Research
https://www.readbyqxmd.com/read/27721142/defibrotide-for-the-management-of-sinusoidal-obstruction-syndrome-in-patients-who-undergo-haemopoietic-stem-cell-transplantation
#12
REVIEW
John Coutsouvelis, Sharon Avery, Michael Dooley, Carl Kirkpatrick, Andrew Spencer
Sinusoidal obstruction syndrome, previously known as veno-occlusive disease (VOD/SOS), is a complication in patients undergoing haemopoietic stem cell transplantation (HSCT). Severe VOD/SOS, including progression to multi-organ failure, has resulted in a mortality of greater than 80%. Defibrotide's varying pharmacological actions, particularly on endothelial cells, make it is a useful agent to consider for prophylaxis and treatment of VOD/SOS. Barriers to its routine use include the high acquisition cost and the fact that neither the oral or parenteral formulations are licensed products in many countries at this time...
November 2016: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/27603963/in-brief-defibrotide-defitelio-for-hepatic-veno-occlusive-disease
#13
(no author information available yet)
No abstract text is available yet for this article.
September 12, 2016: Medical Letter on Drugs and Therapeutics
https://www.readbyqxmd.com/read/27574402/pharmacokinetic-profile-of-defibrotide-in-patients-with-renal-impairment
#14
Paola Tocchetti, Elena Tudone, Jean-Francois Marier, Thomas C Marbury, Katie Zomorodi, Mark Eller
Hepatic veno-occlusive disease, also called sinusoidal obstruction syndrome (VOD/SOS), is an unpredictable, potentially life-threatening complication of hematopoietic stem cell transplant conditioning. Severe VOD/SOS, generally associated with multiorgan dysfunction (pulmonary or renal dysfunction), may be associated with >80% mortality. Defibrotide, recently approved in the US, has demonstrated efficacy treating hepatic VOD/SOS with multiorgan dysfunction. Because renal impairment is prevalent in patients with VOD/SOS, this Phase I, open-label, two-part study in adults examined the effects of hemodialysis and severe or end-stage renal disease (ESRD) on defibrotide pharmacokinetics (PK)...
2016: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/27559192/sugammadex
#15
Dennis J Cada, Terri L Levien, Danial E Baker
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...
July 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/27531791/-delayed-hepatic-veno-occlusive-disease-after-haploidentical-hematopoietic-stem-cell-transplantation-a-report-of-six-cases
#16
Hui-Zhu Kang, Xiao-Li Zheng, Zhi-Dong Wang, Dong-Mei Han, Li Ding, Heng-Xiang Wang
OBJECTIVE: To evaluate the morbidity, risk factors, clinical characterisitics, treatments and prognosis of delayed hepatic veno-occlusive disease(HVOD) after haploidentical hematopoietic stem cell transplantation (hi-HSCT). METHODS: The clinical data of 208 patients undergoing hi-HSCT were retrospectively analyzed. RESULTS: Six patients were diagnosed with delayed VOD, among them 4 patients were moderate VOD and 2 patients were severe VOD...
August 2016: Zhongguo Shi Yan Xue Ye Xue za Zhi
https://www.readbyqxmd.com/read/27496218/high-variability-in-the-reported-management-of-hepatic-veno-occlusive-disease-in-children-after-hematopoietic-stem-cell-transplantation
#17
Micah A Skeens, Jennifer McArthur, Ira M Cheifetz, Christine Duncan, Adrienne G Randolph, Joseph Stanek, Leslie Lehman, Rajinder Bajwa
Veno-occlusive disease (VOD) is a potentially fatal complication of hematopoietic stem cell transplantation (HSCT). Patients with VOD are often critically ill and require close collaboration between transplant physicians and intensivists. We surveyed members of a consortium of pediatric intensive care unit (PICU) and transplant physicians to assess variability in the self-reported approach to the diagnosis and management of VOD. An internet-based self-administered survey was sent to pediatric HSCT and PICU providers from September 2014 to February 2015...
October 2016: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/27408516/pharmaceutical-approval-update
#18
Mary Choy
Defibrotide sodium (Defitelio) for hepatic veno-occlusive disease; emtricitabine/tenofovir alafenamide (Descovy) for human immunodeficiency virus infection; and infliximabdyyb (Inflectra) for Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
July 2016: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/27397724/defibrotide-for-the-treatment-of-hepatic-veno-occlusive-disease-final-results-from-the-international-compassionate-use-program
#19
Selim Corbacioglu, Enric Carreras, Mohamad Mohty, Antonio Pagliuca, Jaap Jan Boelens, Gandhi Damaj, Massimo Iacobelli, Dietger Niederwieser, Eduardo Olavarría, Felipe Suarez, Tapani Ruutu, Leo Verdonck, Robin Hume, Bijan Nejadnik, Chinglin Lai, Giorgia Finetto, Paul Richardson
Hepatic veno-occlusive disease, also called sinusoidal obstruction syndrome (VOD/SOS), is an unpredictable and potentially fatal complication of hematopoietic cell transplantation (HCT) or nontransplantation-associated chemotherapy/radiotherapy. In cases of severe hepatic VOD/SOS, typically defined by associated multiorgan failure (MOF, also known as multiorgan dysfunction), mortality exceeds 80%. Preclinical and early clinical data have provided a rationale for defibrotide treatment in hepatic VOD/SOS. Based on this evidence and in recognition of the dismal prognosis for these patients, defibrotide was made available through an international multicenter compassionate-use program conducted from December 1998 to March 2009...
October 2016: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/27384426/mesenchymal-stromal-cells-protect-endothelial-cells-from-cytotoxic-t-lymphocyte-induced-lysis
#20
E F Cahill, T Sax, I Hartmann, S Haffner, E Holler, B Holler, R Huss, C Günther, O Parolini, W Kolch, G Eissner
The integrity of the vasculature plays an important role in the success of allogeneic organ and haematopoietic stem cell transplantation. Endothelial cells (EC) have previously been shown to be the target of activated cytotoxic T lymphocytes (CTL) resulting in extensive cell lysis. Mesenchymal stromal cells (MSC) are multipotent cells which can be isolated from multiple sites, each demonstrating immunomodulatory capabilities. They are explored herein for their potential to protect EC from CTL-targeted lysis...
September 2016: Scandinavian Journal of Immunology
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