You Made the Call
We asked, and you answered! Here are a few responses
from this month’s “You Make the Call.”
Clinical Dilemma:
IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein]
Lyophilized Powder for Solution for Intravenous Injection
Initial U.S. Approval: 2016
A 41-year-old male with Wilson’s disease and resulting
cirrhosis and hypersplenism with a chronic pancytopenia now has worsening leukopenia. He is continuing chronic zinc therapy for his Wilson’s disease. I am
concerned that his zinc therapy has resulted in copper
depletion as a cause for his worsened
neutropenia. A vitamin B12 level
and folic acid are normal, his LDH is
normal, and his absolute reticulocyte
count is 160,000 (6.4%). I am inter-------------------------DOSAGE FORMSAND STRENGTHS---------------------ested in further thoughts on evaluaIDELVION is available as a lyophilized powder in single-use vials containing
nominally 250, 500, 1000 or 2000 IU.
tion and treatment.
BRIEF SUMMARY OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use IDELVION
safely and effectively. See full prescribing information for IDELVION.
-----------------------------CONTRAINDICATIONS ------------------------------Do not use in patients who have had life-threatening hypersensitivity reactions
to IDELVION or its components, including hamster proteins.
----------------------------INDICATIONS AND USAGE--------------------------IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIXFP), a recombinant human blood coagulation factor, 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
Limitations of Use:
IDELVION is not indicated for immune tolerance induction in patients with
Hemophilia B.
--------------------------WARNINGS AND PRECAUTIONS----------------------• Hypersensitivity reactions, including anaphylaxis, are possible. Should
symptoms occur, discontinue IDELVION and administer appropriate
treatment.
• Development of neutralizing antibodies (inhibitors) to IDELVION may
occur. If expected Factor IX plasma recovery in patient plasma is not
attained, or if bleeding is not controlled with an appropriate dose,
perform an assay that measures Factor IX inhibitor concentration.
• Thromboembolism (e.g., pulmonary embolism, venous thrombosis,
and arterial thrombosis) may occur when using Factor IX-containing
products.
• Nephrotic syndrome has been reported following immune tolerance
induction with Factor IX-containing products in hemophilia B patients
with Factor IX inhibitors and a history of allergic reactions to Factor IX.
• Factor IX activity assay results may vary with the type of activated partial
thromboplastin time reagent used.
For the full description of the clinical dilemma, and to
see how the expert responded, turn to page 51.
------------------------DOSAGE AND ADMINISTRATION-----------------------For intravenous use after reconstitution only.
Each vial of IDELVION is labeled with the actual Factor IX potency in
international units (IU).
• One IU of IDELVION per kg body weight is expected to increase the
circulating activity of Factor IX as follows:
° Adolescents and adults: 1.3 IU/dL per IU/kg
° Pediatrics (<12 years): 1 IU/dL per IU/kg
• Administer intravenously. Do not e