ASH Clinical News ACN_4.14_Full Issue_web | Page 167

BACK of the BOOK
Trisha Greenhalgh,
OBE, FRCP, FRCGP,
FMedSci
@trishgreenhalgh
Doctor: Don’t confuse your
Google search with my 6y at
medical school.
Patient: Don’t confuse the 1-hour
lecture you had on my condition
with my 20y of living with it.
Caroline Bartman,
PhD-candidate
@Caroline_Bartma
Do you sometimes wonder if the
NIH is a really sophisticated plot
orchestrated by mice so they can
get us to cure their diseases and
understand their genetics?
Sachin H. Jain, MD
@sacjai
One of the biggest problems we
have is the declining length of
physician office visits. While it may be
fine for some patients, patients with
complex and chronic disease need
more time from their physicians, not
less. Care must be customized and
adapted to patient needs.
@medicalaxioms
Don’t adjust the dose of a
medicine your patient doesn’t take.
CMYK
MORE CONVENIENT: Once-weekly dosing means 50% fewer KYPROLIS ® infusions
NEW dosing option: 70 mg/m 2 Kd once weekly
KYPROLIS ®
infusion time 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
Continued on page 169
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BETTER CONVENIENCE
Kd70
Medical Axioms