You Made the Call
We asked, and you answered! Here are a few responses from last month’s “You Make the Call.”
For the full description of the clinical dilemma, and to see how the expert responded, turn to page 65.
Clinical Dilemma:
A patient with IgG lambda multiple
myeloma (diagnosed in 1997) has been
on lenalidomide 10 mg/day since 2013.
His labs show no monoclonal protein and
other parameters suggest that he is in
complete remission. How long should he
continue taking lenalidomide?
I think it would be very useful to assess
minimal residual disease (MRD).
Hervé Avet Loiseau, MD, PhD
Institut Universitaire du Cancer
Toulouse, France
no evidence of MRD by next-generation
sequencing.
Juan M. Alcantar, MD
UCLA Health
Los Angeles, California
I would continue lenalidomide until
disease progression. I would consider
discontinuing lenalidomide if there was
I would stop lenalidomide, because the
patient has been in complete remission
for 12 years (since 2004).
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.
Gilberto de Freitas Colli
Hospital de Câncer de Barretos
São Paulo, Brazil
I would be reluctant to stop lenalidomide
as long as the patient had no major
adverse effects.
Phillip Periman, MD
Texas Oncology-Amarillo Cancer Center
Amarillo, Texas
I would continue lenalidomide if there
are no toxicity issues.
Antoine Sayegh, MD
Kaiser Permanente Medical Center
Roseville, California
I would suggest performing a FDG-PET
scan (higher sensitivity than M-C assay).
Prof. Andrea Gallamini
Lacassagne Cancer Centre
Nice, France
Stop the lenalidomide. He has already
demonstrated that his disease is not
aggressive (19 years) and responded to
several treatments. Monit or him when
the disease progresses, then treat.
Paul Chervenick, MD
H. Lee Moffitt Cancer Center &
Research Institute
Tampa, Florida
I would stop the lenalidomide and
monitor his M protein. Restart when
there is unequivocal progression.
David Baer, MD
Kaiser Permanente Oakland/Richmond
Medical Center
Oakland, California
I would continue lenalidomide if well
tolerated until progression, despite
complete response clinically. In addition to free kappa/lambda ratio, SPEP,
and UPEP, I follow patients with yearly
PET/CT. In my opinion, this is better
than bone survey.
William Caceres
Universidad Central del Caribe
School of Medicine
San Juan, Puerto Rico
I would discontinue lenalidomide,
but I would try to harvest CD34+ cells.
If he relapses, I would go for a second
autologous transplant in early relapse.
Eduardo E. Reynoso, MD
Hospital Espanol de Mexico
Polanco, Mexico
See more reader responses at
ashclinicalnews.org/category/trainingeducation/you-make-the-call.
May 2016