Coagulation Factor IX ( Recombinant ), Albumin Fusion Protein
The first and only rFIX therapy that delivers high-level protection with up to 14-day dosing *
UP TO
14-DAY DOSING *
ABOVE
5 for 14
% days
ZERO
BLEEDS median AsBR
Greater freedom from infusions
Factor IX ( FIX ) levels above 5 % over 14 days at 75 IU / kg
* In well-controlled patients 12 years and older , defined as 1 month without spontaneous bleeding on a weekly dose of ≤40 IU / kg .
Median annualized spontaneous bleeding rate ( AsBR ) of zero in 7- and 14-day prophylaxis
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 . IDELVION can be selfadministered 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 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 .
Please see brief summary of full prescribing information on following page .
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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 IDL16-03-0077 4 / 2016
Coagulation Factor IX ( Recombinant ), Albumin Fusion Protein
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