ASH News Daily 2017 - Issue 3 - B-39

ASH News Daily

Monday, December 11, 2017

Page B-39
®

career-

enhancemenT
awardS

ASH Scholars
«« From Page B-30

Alice Mims, MD, MSCR
Dr. Mims is an assistant professor at The Ohio State University
(OSU) specializing in treating patients with myeloid malignancies,
focusing particularly on AML.
She earned her MD and MS in

clinical research from the Medical
University of South Carolina. She
completed a medical oncology/
NIH T32 fellowship at Ohio State
University with
a major research
focus on manipulating microRNA
in AML as potential
therapeutic
targets. From her
research projects
and under the mentorship of Drs.
William Blum and John Byrd, she
has received the Conquer Cancer
Foundation Young Investigator

Award, Alliance Clinical Scholar
Award, and participated in the
ASH Clinical Research Training
Institute. For her Scholar Award
project, Dr. Mims will be assessing
immunologic and molecular-based
differences between younger and
older patients with favorable risk
AML to determine variants that
may explain worse outcomes in
older patients. Further exploration
will occur as an arm of the Leukemia and Lymphoma Society's Beat
AML Umbrella Study through targeting CD200 in older AML patient
for which Dr. Mims is the author/
lead investigator. Dr. Mims is hon-

CALQUENCE® (acalabrutinib) capsules, for oral use
Table 3: Hematologic Adverse Reactions Reported* in ≥ 20% of Patients with MCL
in Trial LY-004
Hematologic
Adverse Reactions

CALQUENCE 100 mg twice daily
N=124
All Grades (%)

Grade ≥ 3 (%)

Hemoglobin decreased

Platelets decreased

Neutrophils decreased

* Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03;
based on laboratory measurements and adverse reactions.

Increases in creatinine 1.5 to 3 times the upper limit of normal occurred in 4.8% of patients.
DRUG INTERACTIONS
Strong CYP3A Inhibitors
Clinical * Co-administration of CALQUENCE with a strong CYP3A inhibitor
Impact
(itraconazole) increased acalabrutinib plasma concentrations [see
Clinical Pharmacology (12.3) in the full Prescribing Information].
* Increased acalabrutinib concentrations may result in increased toxicity.
Prevention or * Avoid co-administration of strong CYP3A inhibitors with CALQUENCE.
Management * Alternatively, if the inhibitor will be used short-term, interrupt
CALQUENCE [see Dosage and Administration (2.2) in the full
Prescribing Information].
Moderate CYP3A Inhibitors
Clinical * Co-administration of CALQUENCE with a moderate CYP3A inhibitor
Impact
may increase acalabrutinib plasma concentrations [see Clinical
Pharmacology (12.3) in the full Prescribing Information].
* Increased acalabrutinib concentrations may result in increased toxicity.
Prevention or * When CALQUENCE is co-administered with moderate CYP3A inhibitors,
Management
reduce acalabrutinib dose to 100 mg once daily.
Strong CYP3A Inducers
Clinical * Co-administration of CALQUENCE with a strong CYP3A inducer
Impact
(rifampin) decreased acalabrutinib plasma concentrations [see
Clinical Pharmacology (12.3) in the full Prescribing Information].
* Decreased acalabrutinib concentrations may reduce
CALQUENCE activity.
Prevention or * Avoid co-administration of strong CYP3A inducers with CALQUENCE.
Management * If a strong CYP3A inducer cannot be avoided, increase the acalabrutinib
dose to 200 mg twice daily.
Gastric Acid Reducing Agents
* Co-administration of CALQUENCE with a proton pump inhibitor,
H2-receptor antagonist, or antacid may decrease acalabrutinib
plasma concentrations [see Clinical Pharmacology (12.3) in the
full Prescribing Information].
Clinical
* Decreased acalabrutinib concentrations may reduce
Impact
CALQUENCE activity.
* If treatment with a gastric acid reducing agent is required, consider
using a H2-receptor antagonist (e.g., ranitidine or famotidine) or an
antacid (e.g., calcium carbonate).
Antacids
H2-receptor
Prevention or
antagonists
Management
Proton pump
inhibitors

Separate dosing by at least 2 hours [see Dosage and
Administration (2.2) in the full Prescribing Information].
Take CALQUENCE 2 hours before taking the H2-receptor
antagonist [see Dosage and Administration (2.2) in the
full Prescribing Information].
Avoid co-administration. Due to the long-lasting
effect of proton pump inhibitors, separation of doses
may not eliminate the interaction with CALQUENCE.

USE IN SPECIFIC POPULATIONS
Pregnancy
Risk Summary
Based on findings in animals, CALQUENCE may cause fetal harm when administered to
a pregnant woman. There are no available data in pregnant women to inform the drugassociated risk. In animal reproduction studies, administration of acalabrutinib to pregnant
rabbits during organogenesis resulted in reduced fetal growth at maternal exposures (AUC)
approximately 4 times exposures in patients at the recommended dose of 100 mg twice daily
(see Data). Advise pregnant women of the potential risk to a fetus.
The estimated background risk of major birth defects and miscarriage for the indicated
population is unknown. All pregnancies have a background risk of birth defect, loss, or other
adverse outcomes. In the U.S. general population, the estimated background risk of major birth
defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
US-14432_US-14202 Calquence ASH News Daily 2017.indd 4

Data
Animal Data
In a combined fertility and embryo-fetal development study in female rats, acalabrutinib was
administered orally at doses up to 200 mg/kg/day starting 14 days prior to mating through
gestational day [GD] 17. No effects on embryo-fetal development and survival were
observed. The AUC at 200 mg/kg/day in pregnant rats was approximately 16-times the AUC
in patients at the recommended dose of 100 mg twice daily. The presence of acalabrutinib and
its active metabolite were confirmed in fetal rat plasma.
In an embryo-fetal development study in rabbits, pregnant animals were administered
acalabrutinib orally at doses up to 200 mg/kg/day during the period of organogenesis (from
GD 6-18). Administration of acalabrutinib at doses ≥ 100 mg/kg/day produced maternal
toxicity and 100 mg/kg/day resulted in decreased fetal body weights and delayed skeletal
ossification. The AUC at 100 mg/kg/day in pregnant rabbits was approximately 4-times the
AUC in patients at 100 mg twice daily.
Lactation
Risk Summary
No data are available regarding the presence of acalabrutinib or its active metabolite in human
milk, its effects on the breastfed child, or on milk production. Acalabrutinib and its active
metabolite were present in the milk of lactating rats. Due to the potential for adverse reactions
in a breastfed child from CALQUENCE, advise lactating women not to breastfeed while taking
CALQUENCE and for at least 2 weeks after the final dose.
Pediatric Use
The safety and efficacy of CALQUENCE in pediatric patients have not been established.
Geriatric Use
Eighty (64.5%) of the 124 MCL patients in clinical trials of CALQUENCE were 65 years of
age or older, and 32 patients (25.8%) were 75 years of age or older. No clinically relevant
differences in safety or efficacy were observed between patients ≥ 65 years and younger.
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Hemorrhage
Inform patients to report signs or symptoms of severe bleeding. Inform patients that
CALQUENCE may need to be interrupted for major surgeries [see Warnings and Precautions
(5.1) in the full Prescribing Information].
Infections
Inform patients to report signs or symptoms suggestive of infection [see Warnings and
Precautions (5.2) in the full Prescribing Information].
Cytopenias
Inform patients that they will need periodic blood tests to check blood counts during
treatment with CALQUENCE [see Warnings and Precautions (5.3) in the full Prescribing
Information].
Second Primary Malignancies
Inform patients that other malignancies have been reported in patients who have been treated
with CALQUENCE, including skin cancer. Advise patients to use sun protection [see Warnings
and Precautions (5.4) in the full Prescribing Information].
Atrial Fibrillation and Flutter
Counsel patients to report any signs of palpitations, lightheadedness, dizziness, fainting,
shortness of breath, and chest discomfort [see Warnings and Precautions (5.5) in the full
Prescribing Information].
Dosing Instructions
Instruct patients to take CALQUENCE orally twice daily, about 12 hours apart. CALQUENCE
may be taken with or without food. Advise patients that CALQUENCE capsules should be
swallowed whole with a glass of water, without being opened, broken, or chewed [see
Dosage and Administration (2.1) in the full Prescribing Information].
Missed Dose
Advise patients that if they miss a dose of CALQUENCE, they may still take it up to
3 hours after the time they would normally take it. If more than 3 hours have elapsed, they
should be instructed to skip that dose and take their next dose of CALQUENCE at the usual
time. Warn patients they should not take extra capsules to make up for the dose that they
missed [see Dosage and Administration (2.1) in the full Prescribing Information].
Drug Interactions
Advise patients to inform their healthcare providers of all concomitant medications, including
over-the-counter medications, vitamins and herbal products [see Drug Interactions (7) in the
full Prescribing Information].
Lactation
Advise women not to breastfeed during treatment with CALQUENCE and for at least 2 weeks
after the final dose [see Use in Specific Populations (8.2) in the full Prescribing Information].
Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
Under license of Acerta Pharma B.V.
CALQUENCE is a registered trademark of the AstraZeneca group of companies.
©AstraZeneca 2017
10/17 US-14202 11/17

11/10/17 3:00 PM

ored to receive the ASH Scholar
Award in support of her research
endeavors and in the common goal
to improve outcomes for AML patients.
Hong Zheng, MD, PhD
Dr. Zheng is an assistant professor of medicine, microbiology, and
immunology at Penn State Cancer
Institute, Penn State University College of Medicine. She received an
MD in clinical medicine from Capital Medical University in China and
a PhD in immunology at the University of Connecticut. She completed
residency in internal medicine at
Penn State Hershey Medical Center
and clinical fellowship in hematology/oncology at Yale University. She
is board certified
in hematology and
medical
oncology. Clinically she
cares for patients
with hematologic
malignancies
in
general and acute
leukemia in particular. Her research
focus is transplantation immunology and developmental therapeutics for leukemia.
Her study is dedicated to improving
the understanding of the complex
immune response involved in leukemia pathogenesis and allogeneic
hematopoietic stem cell transplantation, and subsequently develop effective leukemia therapeutics. Currently she is involved in developing
early-phase clinical studies testing
the safety and efficacy of immunotherapy for leukemia. Her laboratory studies involve investigation
of targeting T cell inhibitory mechanisms as a strategy to improve antileukemia immunity.

Back This Year:
The ASH
Whiteboard
The theme this year is "resilience." With a global audience of 27,000 hematologists,
the annual meeting is the
perfect opportunity to spark
conversations to learn from
and inspire each other. At this
year's meeting, we are asking attendees how they build
resilience in the face of factors that might contribute to
professional burnout. Visit
the whiteboard in ASH Central (Hall B1), and share your
thoughts on how you build
resilience, balancing out your
frustrations with healthy and
positive activities.

Table of Contents for the Digital Edition of ASH News Daily 2017 - Issue 3