ASH Clinical News ACN_5.1_Digital | Page 15
UP FRONT
school, I showed up to an exam on the
wrong day because I read the calendar
wrong, and the test administrator turned
me away. It was devastating. So, I learned
to hide the fact that I was dyslexic.
But, in the past couple of years, I hit
a brick wall and realized that I had to tell
my boss because, of course, the higher
I went in my career, the harder it was to
cover up these challenges.
When I started telling people about
this, I noticed that people were more
understanding about some of my quirks.
Like, now they know why I need infor-
mation presented a certain way with
visual cues, need frequent reminders, or
why I spend extra time making sure that
I’m dotting my i’s and crossing my t’s
before I send an email. I’m great with the
big picture, but I need partners who have
affinity for the smaller details. Before,
they might have been aggravated by
these things, or just assumed that I was
extremely demanding, but now they un-
derstand that this is part of the structure
that I’ve created for myself to be able to
do things more efficiently.
Living with dyslexia and ADHD also
taught me that everybody struggles with
something – sometimes we know what it
is, and sometimes we don’t. This is what
makes us human – to our colleagues and
our patients. If I can’t disclose what I’m
NEW dosing option: 70 mg/m 2 Kd once weekly
Priming dose
of KYPROLIS ® Target therapeutic
dose of KYPROLIS ®
30 minutes 20 mg/m 2 on Day 1
of Cycle 1 to
evaluate tolerability 70 mg/m 2 starting on
Day 8 of Cycle 1
Treatment schedule
Administer KYPROLIS ® (70 mg/m 2 )
on 1 day each week for 3 weeks followed
by a 13-day rest period as part of a 28-day
treatment cycle
Continue until disease progression or
unacceptable toxicity occurs
Refer to the dexamethasone Prescribing Information for other concomitant medications.
References: 1. Amgen Inc. “FDA approves KYPROLIS ® (carfi lzomib) once-weekly 70 mg/m 2 in combination with dexamethasone (Kd70) for patients with relapsed
or refractory multiple myeloma.” News release; October 1, 2018. 2. KYPROLIS ® (carfi lzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc.
subsidiary. 3. Moreau P, Mateos M-V, Berenson JR, et al. Once weekly versus twice weekly carfi lzomib dosing in patients with relapsed and refractory multiple
myeloma (A.R.R.O.W.): interim analysis results of a randomised, phase 3 study. Lancet Oncol. 2018;19:953-964.
IMPORTANT SAFETY INFORMATION FOR KYPROLIS (cont.)
• Patients using hormonal contraception associated with a risk of
thrombosis should consider an alternative method of effective
contraception during treatment.
Posterior Reversible Encephalopathy Syndrome (PRES)
Infusion Reactions • Cases of PRES have occurred in patients receiving KYPROLIS. If PRES
is suspected, discontinue and evaluate with appropriate imaging. The
safety of reinitiating KYPROLIS is not known.
Hemorrhage • In a clinical trial of transplant-ineligible patients with newly diagnosed
multiple myeloma comparing KYPROLIS, melphalan, and prednisone
(KMP) vs bortezomib, melphalan, and prednisone (VMP), a higher
incidence of serious and fatal adverse events was observed in patients in
the KMP arm. KMP is not indicated for transplant-ineligible patients with
newly diagnosed multiple myeloma.
• Infusion reactions, including life-threatening reactions, have occurred.
Symptoms include fever, chills, arthralgia, myalgia, facial fl ushing,
facial edema, vomiting, weakness, shortness of breath, hypotension,
syncope, chest tightness, or angina. These reactions can occur
immediately following or up to 24 hours after administration. Premedicate
with dexamethasone to reduce the incidence and severity of infusion
reactions. Inform patients of the risk and of symptoms and seek
immediate medical attention if they occur.
• Fatal or serious cases of hemorrhage have been reported. Hemorrhagic
events have included gastrointestinal, pulmonary, and intracranial
hemorrhage and epistaxis. Promptly evaluate signs and symptoms
of blood loss. Reduce or withhold dose as appropriate.
Increased Fatal and Serious Toxicities in Combination with
Melphalan and Prednisone in Newly Diagnosed Transplant-
ineligible Patients
Embryo-fetal Toxicity
Hepatic Toxicity and Hepatic Failure • KYPROLIS can cause fetal harm when administered to a pregnant woman.
• Females of reproductive potential should be advised to avoid becoming
pregnant while being treated with KYPROLIS and for 6 months following
the fi nal dose. Males of reproductive potential should be advised to avoid
fathering a child while being treated with KYPROLIS and for 3 months
following the fi nal dose. If this drug is used during pregnancy, or if
pregnancy occurs while taking this drug, the patient should be apprised
of the potential hazard to the fetus.
Thrombotic Microangiopathy ADVERSE REACTIONS
The most common adverse reactions in the combination therapy trials:
anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia, pyrexia,
insomnia, muscle spasm, cough, upper respiratory tract infection,
hypokalemia.
Thrombocytopenia
• KYPROLIS causes thrombocytopenia with recovery to baseline platelet
count usually by the start of the next cycle. Monitor platelet counts
frequently during treatment. Reduce or withhold dose as appropriate.
• Cases of hepatic failure, including fatal cases, have occurred. KYPROLIS
can cause increased serum transaminases. Monitor liver enzymes
regularly regardless of baseline values. Reduce or withhold dose as
appropriate.
• Cases of thrombotic microangiopathy, including thrombotic
thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS),
including fatal outcome, have occurred. Monitor for signs and symptoms
of TTP/HUS. Discontinue if diagnosis is suspected. If the diagnosis of TTP/
HUS is excluded, KYPROLIS may be restarted. The safety of reinitiating
KYPROLIS is not known.
Please see Brief Summary of full Prescribing Information on
adjacent pages.
© 2018 Amgen Inc. All rights reserved. 09/18 USA-171-80362 Printed in USA
h s
MORE CONVENIENT: Once-weekly dosing means 50% fewer KYPROLIS ® infusions
KYPROLIS ®
infusion time
To read more from our interview
with Dr. Osunkwo, and learn about
the mentors and advisors who
she says “taught her how to be a
doctor,” visit ashclinicalnews.org/
pulling-back-the-curtain.
CMYK
BETTER CONVENIENCE
Kd70
dealing with to other people, then I’m not
really being true to myself. ●