The Society Pages
Leukemia Research
Foundation Names Allison
Parise and Mary Phelan
Lappe 2016 Nurses of the Year
Allison Parise, RN, BSN, from the Ann
& Robert H. Lurie Children’s Hospital of
Chicago, and Mary Phelan Lappe, BSN,
RN, OCN, from the University of Chicago
Medical Center, were named the 2016
Nurses of the Year by the Leukemia
Research Foundation (LRF).
The award has been presented annually since 1996 to recognize hematology−oncology nurses who give their
time, compassion, and heart to their
jobs. Nurses are nominated by patients,
families, or colleagues, and LRF selects
its winners.
Terry Park, Ms. Parise’s colleague,
nominated her and said, “Compassionate, knowledgeable, selfless, enthusias-
tic, empathetic, holistic, and committed
are the words [that] quickly come to
mind when I think of what [Ms. Parise]
represents each day at work.”
Sonali M. Smith, MD, director of the
lymphoma program at the University of
Chicago Medical Center, nominated Ms.
Lappe and said, “She takes her role as a
nurse as a deeply personal commitment
to educating, comforting, [and] caring
for patients, and in general improv-
IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein]
Lyophilized Powder for Solution for Intravenous Injection
Initial U.S. Approval: 2016
-------------------------DOSAGE FORMSAND STRENGTHS---------------------IDELVION is available as a lyophilized powder in single-use vials containing
nominally 250, 500, 1000 or 2000 IU.
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.
------------------------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 exceed infusion rate of 10 mL per
minute.
Control and prevention of bleeding episodes and perioperative
management:
• Dosage and duration of treatment with IDELVION depends on the severity
of the Factor IX deficiency, the location and extent of bleeding, and the
patient’s clinical condition, age and recovery of Factor IX.
• Determine the initial dose using the following formula:
• Required Dose (IU) = Body Weight (kg) x Desired Factor IX rise (% of
normal or IU/dL) x (reciprocal of recovery (IU/kg per IU/dL))
• Adjust dose based on the patient’s clinical condition and response.
Routine prophylaxis:
• Patients ≥12 years of age: 25-40 IU/kg body weight every 7 days. (2.1)
Patients who are well-controlled on this regimen may be switched to a
14-day interval at 50-75 IU/kg body weight.
• Patients <12 years of age: 40-55 IU/kg body weight every 7 days.
----------------------------ADVERSE REACTIONS--------------------------------The most common adverse reaction (incidence ≥1%) reported in clinical trials
was headache.
To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring
Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800FDA-1088 or www.fda.gov/medwatch.
----------------------USE IN SPECIFIC POPULATIONS--------------------------• Pediatric: Higher dose per kilogram body weight or more frequent dosing
may be needed.
Based on March 2016 version.
ing every aspect of their experience as
cancer patients. She helps our patients
develop trust in the care team and in
the university at large.”
Sources: The Chicago Tribune, October 24, 2016; Leukemia Research
Foundation, 2016.
David A. Williams Named
First Chief Scientific Officer
of Boston Children’s Hospital
David A. Williams,
MD, director of clinical and translational
research and president
of the Dana-Farber
Cancer Center and
David A. Williams, MD Boston Children’s
Hospital, was named
the first chief scientific
officer of Boston Children’s Hospital. Dr.
Williams is tasked with enhancing the
hospital’s precision medicine capabilities, while advocating for the interests
of the hospital’s research community.
Dr. Williams founded the DanaFarber Cancer Institute/Boston
Children’s Hospital’s gene therapy
program, which has seven open clinical
trials and is one of the nation’s most
robust pediatric gene therapy programs.
“Research is a critical part of
our hospital’s mission,” said Sandra
Fenwick, president and chief executive
officer of Boston Children’s Hospital.
“[Dr. Williams’] passion, and one
goal in his new position, is to help
drive innovation through translation
of Boston Children’s outstanding
biomedical discovery research to benefit
patients and, in turn, to use our unique
patient populations to drive additional
discoveries.”
“I have spent my career traversing
the bridge between basic discovery research and the clinic,” said Dr. Williams.
“The creation of this position underscores Boston Children’s commitment
to research as the driving force of medical progress, and I am honored to serve
as its first chief scientific officer.” ●
Source: Dana-Farber/Boston Children’s press release, November 4, 2016.
December 2016