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Optimizing Bleed Protection With an Extended Half-Life Factor IX TherapyTuesday, June 22, 202112:00 PMVinod Balasa, MDCompleted
Optimizing Bleed Protection With an Extended Half-Life Factor IX TherapyWednesday, July 28, 202112:00 PMMark Reding, MDRegister




IMPORTANT SAFETY INFORMATION

IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP), 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 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.

The formation of neutralizing antibodies (inhibitors) to Factor IX has been reported with IDELVION. 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.

INDICATIONS

IDELVION is indicated in children and adults with hemophilia B (congenital Factor IX deficiency) for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to reduce the frequency of bleeding episodes

IDELVION is not indicated for induction of immune tolerance in patients with hemophilia B.

Please see full prescribing information for IDELVION.

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

IDELVION is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC.
IDELVION® is a registered trademark of CSL Behring Lengnau AG.
Biotherapies for Life® is a registered trademark of CSL Behring LLC.
©2021 CSL Behring LLC.
1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USA
www.CSLBehring.com • www.IDELVION.com • USA-IDL-0074-APR21
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