IDELVION — the only rFIX therapy that delivers high steady-state factor levels with up to 14-day dosing *
You Made the Call
We asked , and you answered ! Here are a few responses from this month ’ s “ You Make the Call .”
For the full description of the clinical dilemma , and to see how the expert responded , turn to page 29 .
Clinical Dilemma :
A 53-year-old patient presented with proximal deep vein thrombosis and was discharged home on apixaban 10 mg twice daily . The patient presented to the emergency room three days later with sudden onset shortness of breath . The computed tomography angiography was positive for pulmonary embolism . Is this failure of novel oral anticoagulant ?
I have used decitabine to cytoreduce the marrow and allow more effective erythropoiesis and have seen good palliation . I would also try epoetin alfa up to 100,000 U weekly .
Stephen Mayer , MD , PhD Colorado Permanente Medical Group
Lone Tree , CO
A clinical trial is the first preference . I also suggest azacitidine or low-dose decitabine with close monitoring of his counts . Usha Venkatraj , MD Hope Cancer Center College Station , TX
I would give azacitadine / decitabine to this patient .
Satvir Singh , MD Snellville , GA
5-azacitidine ; red blood cell transfusions prn . David Harrison
If the patient meets criteria for intermediate or high risk , I would consider azacitidine . If not , then supportive care ( transfusions ) with iron management as needed .
Blair Ernst , MSc Trillium Health Partners
Mississauga , Canada
IDELVION — the only rFIX therapy that delivers high steady-state factor levels with up to 14-day dosing *
This is probably erythroid aplasia , parvo-induced . I suggest treatment with gammaglobulins .
Víctor Salinas Rojas , MD Hospital Español
Mexico City , Mexico
See more reader responses at ashclinicalnews . org / category / training-education / you-make-the-call .
5-azacitidine . Joseph Lebowicz , MD
Hematology Oncology Associates of Brooklyn Brooklyn , NY
If the patient is otherwise in good health with good organ function , a trial of decitabine or azacitidine is reasonable .
Juan M . Alcantar , MD UCLA Health
Los Angeles , CA
I would treat with the goal to make him transfusion independent . With an erythropoietin level > 500 mIU / mL , EPO supplements may not add much benefit . My choice would be a hypomethylating agent such as azacitidine SQ . This drug could make him transfusion independent and possibly prevent or delay potential transformation to AML .
Alejandro Calvo , MD Kettering Cancer and Blood Specialists
Kettering , OH
I would prescribe 5-azacitidine . No erythropoietin . Age more or less precludes transplantation .
Henrik Hjorth-Hansen , MD , PhD St . Olavs Hospital and Institute of Cancer Research and Molecular Medicine Norwegian University of Science and Technology
Trondheim , Norway
14-DAY DOSING
WITH HIGH LEVEL PROTECTION
Dosing schedule that meets your patients ’ needs
Important Safety Information
IDELVION is indicated in children and adults with hemophilia B ( congenital Factor IX deficiency ) for :
• On-demand control and prevention of bleeding episodes
• Perioperative management of bleeding
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
IDELVION is not indicated for induction of immune tolerance in patients with hemophilia B .
IDELVION is contraindicated in patients who have had life-threatening hypersensitivity to the product or its components , including hamster proteins .
IDELVION is for intravenous use only .
21 % FIX LEVELS
WITH PROPHYLACTIC
High and sustained Factor IX levels at steady state in clinical trials 1 ,†
IDELVION can be self-administered or administered by a caregiver with training and approval from a healthcare provider or hemophilia treatment center . Higher dose per kilogram body weight or more frequent dosing may be needed for pediatric patients .
Hypersensitivity reactions , including anaphylaxis , are possible . Advise patients who self-administer to immediately report symptoms of hypersensitivity , including angioedema , chest tightness , hypotension , generalized urticaria , wheezing , and dyspnea . If symptoms occur , discontinue IDELVION and administer appropriate treatment .
Development of neutralizing antibodies ( inhibitors ) to IDELVION may occur . If expected Factor IX activity plasma levels
Zero median annualized spontaneous bleeding rate ( AsBR ) when dosed at 7 or 14 days in clinical trials
Find out more about high and sustained factor levels at IdelvionHCP . com
are not attained or bleeding is not controlled with appropriate dose , perform an assay to measure Factor IX inhibitor concentration . Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used .
Thromboembolism ( eg , pulmonary embolism , venous thrombosis , and arterial thrombosis ) can occur when using Factor IX-containing products . In addition , nephrotic syndrome has been reported following immune tolerance induction in hemophilia B patients with Factor IX inhibitors and allergic reactions to Factor IX .
The most common adverse reaction ( incidence ≥1 %) reported in clinical trials was headache .
* In well-controlled patients 12 years and older , defined as 1 month without spontaneous bleeding on a weekly dose of ≤40 IU / kg .
†
Steady-state levels measured FIX at trough levels before each infusion every four weeks until week 92 at 7-day prophylaxis and week 104 at 14-day prophylaxis . FIX levels were 13 % when dosed every 14 days .
Reference : 1 . Data on file . Available from CSL Behring as DOF IDL-002 .
Please see brief summary of full prescribing information on following page .
USE1
,†
ZERO
BLEEDS
MEDIAN ASBR
I would treat the patient with decitabine or 5-azacitidine .
Poly Bunpa Phnom Penh , Cambodia
ASHClinicalNews . org
IDELVION is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC . IDELVION ® is a registered trademark of CSL Behring Recombinant Facility AG . Biotherapies for Life ® is a registered trademark of CSL Behring LLC .
© 2016 CSL Behring LLC 1020 First Avenue , PO Box 61501 , King of Prussia , PA 19406-0901 USA www . CSLBehring-us . com www . IDELVION . com IDL16-12-0160 12 / 2016
Coagulation Factor IX ( Recombinant ), Albumin Fusion Protein
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