ASH Clinical News ACN_5.6_Full_Issue_Digital | Page 19
UP FRONT
important to work with national and in-
ternational associations, like the NCI, the
American Association for Cancer Research,
the Association for Patient Oriented Re-
search, and others. My roles within those
organizations were essential to my success
as an academician.
In a typical day, what is your rose
and what is your thorn?
At this point in my career, I’m fortunate
that I can choose how to structure my day,
so I do exactly what I want. That’s not to
say that there aren’t pesky problems that
come up, or that every committee is my fa-
vorite, but I set my days how I want them.
What you do outside of work,
if you have the time?
Oh, I work all the time – seven days a week.
My personal trainer comes twice a
week, and, for years, my husband and I
did tandem biking, so I guess one could
consider that my hobby. My husband is
a human geneticist, is 86, and also still
works full-time. Our areas of science don’t
entirely overlap, but it is nice that we can
“talk shop” together.
What is one thing about you
that people would be surprised
to learn?
My husband is from Finland. So, we have
CHOOSE THE DOSE THAT BEST MEETS YOUR PATIENT’S NEEDS
IMiD-CONTAINING
IMiD-FREE
KRd27 TWICE WEEKLY
Kd56 TWICE WEEKLY
Kd70 ONCE WEEKLY
Infusion time 10 minutes 30 minutes 30 minutes
KYPROLIS 20 mg/m Days 1 and 2 of Cycle 1 to
priming dose evaluate tolerability 20 mg/m Days 1 and 2 of Cycle 1 to
evaluate tolerability 20 mg/m 2 Day 1 of Cycle 1 to evaluate
tolerability
56 mg/m 2 starting Day 8 of Cycle 1 70 mg/m 2 starting Day 8 of Cycle 1
• Administer 56 mg/m 2 2 consecutive days
each wk for 3 wks
• Follow with 12-day rest period, as part of
28-day tx cycle
• Continue until disease progression or
unacceptable toxicity occurs • Administer 70 mg/m 2 1 day each wk
for 3 wks
• Follow with 13-day rest period, as part
of 28-day tx cycle
• For Cycles 10 and beyond, dexamethasone
is not given on Day 22
• Continue until disease progression or
unacceptable toxicity occurs
®
2
Target KYPROLIS ® 27 mg/m 2 starting Day 8 of Cycle 1
therapeutic dose
Treatment • Administer 27 mg/m 2 2 consecutive days
schedule
each wk for 3 wks
• Follow with 12-day rest period, as part of
28-day tx cycle
• From Cycle 13, omit Day 8 and 9 doses
• Continue until disease progression or
unacceptable toxicity occurs
• Discontinue KYPROLIS ® after Cycle 18
2
Refer to lenalidomide and/or dexamethasone Prescribing Information.
MANAGE HYDRATION THROUGHOUT TREATMENT:
Adequate hydration is required prior to dosing in Cycle 1, especially in patients at high risk of tumor lysis syndrome or renal toxicity.
• The recommended hydration includes both oral fl uids (30 mL per kg at least 48 hours before Cycle 1, Day 1) and IV fl uids (250 mL to 500 mL of appropriate IV
fl uid prior to each dose in Cycle 1)
• If needed, give an additional 250 mL to 500 mL of IV fl uids following KYPROLIS ® administration
• Continue oral and/or IV hydration, as needed, in subsequent cycles
• Monitor patients for evidence of volume overload and adjust hydration to individual patient needs, especially in patients with or at risk for cardiac failure
Refer to the full Prescribing Information and Dosing and Administration Guide for more information.
IMiD = immunomodulatory drugs; Kd = KYPROLIS ® +dexamethasone; KRd = KYPROLIS ® +lenalidomide and dexamethasone; wk = week; wks = weeks; tx = treatment; IV = intravenous.
• Patients using hormonal contraception associated with a risk of thrombosis
should consider an alternative method of effective contraception during
treatment.
Infusion Reactions
• 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.
Hemorrhage
• 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.
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.
Hepatic Toxicity and Hepatic Failure
• 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.
Thrombotic Microangiopathy
• 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.
Posterior Reversible Encephalopathy Syndrome (PRES)
• 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.
Increased Fatal and Serious Toxicities in Combination
with Melphalan and Prednisone in Newly Diagnosed
Transplant-ineligible Patients
• 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.
Embryo-fetal Toxicity
• 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.
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.
Please see Brief Summary of full Prescribing
Information on adjacent pages.
Reference: KYPROLIS ® (carfi lzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc.
subsidiary.
LEARN MORE AT
KYPROLIS-HCP.COM
© 2019 Amgen Inc. All rights reserved. USA-171-80635 Printed in USA
three houses in Finland where we spend our
summers. But, it’s not a summer vacation – I
still work the same amount, just with differ-
ent scenery and in a different time zone.
What does a perfect Sunday look
like for you?
I’m sure readers can guess my answer by
now … working. I have no commitments
on the weekends, so I can get caught up
with work, which always feels good. ●