FEATURE
According to Dr. Muffly, if a patient is
“on the bubble” and can go to either a pediat-
ric or adult center, but the adult center lacks
clinical trial options or clinical expertise in
treating ALL, it may make more sense to
send the AYA patient to the pediatric center.
Over time, the barriers that exist
now between pediatric, adult, and AYA
patients may break down, shifting the
question from who “owns” ALL to how
pediatric and adult specialists can work
together to achieve the best outcomes in
patients with ALL under the age of 40 –
regardless of the setting.
“There’s little reason – outside of regu-
latory decisions – to separate this disease
into pediatric or adult spheres,” Dr. Muffly
said. “Pediatric and adult hematologists
and oncologists should be working togeth-
er, learning from each other, and conduct-
ing studies across the age spectrum.”
—By Jill Sederstrom ●
7 DRUG INTERACTIONS
7.1 Effects of Other Drugs on COPIKTRA
CYP3A Inducers: Co-administration with a strong CYP3A inducer decreases duvelisib
area under the curve (AUC) [see Clinical Pharmacology (12.3)], which may reduce
COPIKTRA efficacy. Avoid co-administration of COPIKTRA with strong CYP3A4
inducers. CYP3A Inhibitors: Co-administration with a strong CYP3A inhibitor
increases duvelisib AUC [see Clinical Pharmacology (12.3)], which may increase
the risk of COPIKTRA toxicities. Reduce COPIKTRA dose to 15 mg BID when
co-administered with a strong CYP3A4 inhibitor [see Dosage and Administration (2.4)].
7.2 Effects of COPIKTRA on Other Drugs
CYP3A Substrates: Co-administration with COPIKTRA increases AUC of a sensitive
CYP3A4 substrate [see Clinical Pharmacology (12.3)] which may increase the risk of
toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4
substrate and monitor for signs of toxicities of the co-administered sensitive CYP3A
substrate.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary: Based on findings from animal studies and the mechanism of action,
COPIKTRA can cause fetal harm when administered to a pregnant woman [see
Clinical Pharmacology (12.1)]. There are no available data in pregnant women to
inform the drug-associated risk. 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.
8.2 Lactation
Risk Summary: There are no data on the presence of duvelisib and/or its metabolites
in human milk, the effects on the breastfed child, or on milk production. Because of
the potential for serious adverse reactions from duvelisib in a breastfed child, advise
lactating women not to breastfeed while taking COPIKTRA and for at least 1 month
after the last dose.
8.3 Females and Males of Reproductive Potential
Pregnancy Testing: COPIKTRA can cause fetal harm when administered to a pregnant
woman [see Use in Specific Populations (8.1)]. Conduct pregnancy testing before
initiation of COPIKTRA treatment.
Contraception
Females Based on animal studies, COPIKTRA can cause fetal harm when
administered to a pregnant woman. Advise females of reproductive potential to use
effective contraception during treatment with COPIKTRA and for at least 1 month
after the last dose.
Males Advise male patients with female partners of reproductive potential to use
effective contraception during treatment with COPIKTRA and for at least 1 month
after the last dose.
Infertility Based on testicular findings in animals, male fertility may be impaired by
treatment with COPIKTRA [see Nonclinical Toxicology (13.1)]. There are no data on
the effect of COPIKTRA on human fertility.
8.4 Pediatric Use
Safety and effectiveness of COPIKTRA have not been established in pediatric
patients. Pediatric studies have not been conducted.
8.5 Geriatric Use
Clinical trials of COPIKTRA included 270 (61%) patients that were 65 years of age
and older and 104 (24%) that were 75 years of age and older. No major differences
in efficacy or safety were observed between patients less than 65 years of age and
patients 65 years of age and older.
PM-US-DUV-18-0052
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Mark Your Calendar
AYA: Big Children or Small
Adults? Leukemia Treatment in
Adolescence
Saturday, December 1, 2018,
7:30 a.m. - 9:00 a.m.
Marriott Marquis San Diego Marina,
San Diego Ballroom B
Monday, December 3, 2018,
10:30 a.m. - 12:00 p.m.
Marriott Marquis San Diego Marina,
Pacific Ballroom 21
Management of AYAs with leukemia
requires an understanding of age-
related differences in disease biology,
identification of optimal treatment
regimens based on current evidence,
and the ability to provide adequate
psychosocial support during and after
therapy. In this session, we will continue
to explore why outcomes in AYAs remain
inferior compared with other age groups.
Chair:
Kathryn G. Roberts, PhD,
St. Jude Children’s Research Hospital,
Memphis, TN
Speakers:
Kathryn G. Roberts, PhD,
St. Jude Children’s Research Hospital,
Memphis, TN
Genetics and Prognosis in
Children Versus Adults
K. Scott Baker, MD, MS, Fred
Hutchinson Cancer Research Center,
Seattle, WA
Long-Term Complications in
AYA Leukemia Survivors
Theresa H.M. Keegan, PhD, MS,
University of California – Davis,
Sacramento, CA
Adolescent Angst: Enrollment in
Clinical Trials
ASH Clinical News
161