Clinical Innovators
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partisan warfare and are obscured
by the fog of political combat.
In this kind of environment, it is
impossible to correct the flaws that
inevitably occur with a legislation
of this complexity with the
technical corrections that would
normally occur. If the Affordable
Care Act succeeds, it will do so
under the most adverse political
circumstances imaginable.
The Commonwealth Fund
frequently considers
American health-care
policy in a global context,
providing important
international comparisons.
What do you see as special
about the United States
health-care context?
Cross-national comparisons
conducted by the Fund highlight
the many ways in which our
system lags behind other countries
in the developed world. In one
report, we compared the health
systems in 11 industrialized
countries, and we have repeatedly
found that the U.S. system ranks
last on composite measures of
quality, efficiency, and ac cess
to services. These reports have
exploded the myth that we have
“the best health system in the
world.” We spend at least double
the amount on health-care per
person of any other developed
nation, and we perform less
well on measures of health
and longevity – a finding also
documented by the Institute of
Medicine.
We are unlikely to ever
import wholesale the systemic
approaches of other countries,
but their examples serve as
concrete, real proof that we can
T:7”
This brief summary does not include all the
information needed to use POMALYST®
(pomalidomide) safely and effectively. See full
Prescribing Information for POMALYST.
WARNING: EMBRYO-FETAL TOXICITY and
VENOUS THROMBOEMBOLISM
Embryo-Fetal Toxicity
• POMALYST is contraindicated in pregnancy.
POMALYST is a thalidomide analogue.
Thalidomide is a known human teratogen that
causes severe birth defects or embryo-fetal
death. In females of reproductive potential,
obtain 2 negative pregnancy tests before
starting POMALYST treatment.
• Females of reproductive potential must use
2 forms of contraception or continuously
abstain from heterosexual sex during and for
4 weeks after stopping POMALYST treatment
[see Contraindications (4), Warnings and
Precautions (5.1), and Use in Specific
Populations (8.1, 8.6)].
POMALYST is only available through a restricted
distribution program called POMALYST REMS™
[see Warnings and Precautions (5.2)].
Venous Thromboembolism
• Deep venous thrombosis (DVT) and pulmonary
embolism (PE) occur in patients with multiple
myeloma treated with POMALYST. Prophylactic
anti-thrombotic measures were employed in
the clinical trial. Consider prophylactic
measures after assessing an individual
patient’s underlying risk factors [see Warnings
and Precautions (5.3)].
2 DOSAGE AND ADMINISTRATION
2.1 Multiple Myeloma
Females of reproductive potential must have
negative pregnancy testing and use contraception
methods before initiating POMALYST [see
Warnings and Precautions (5.1) and Use in Specific
Populations (8.6)].
The recommended starting dose of POMALYST is
4 mg once daily orally on Days 1-21 of repeated
28-day cycles until disease progression.
POMALYST may be given in combination with
dexamethasone [see Clinical Studies (14.1)].
POMALYST may be taken with water. Inform
patients not to break, chew, or open the capsules.
POMALYST should be taken without food (at least
2 hours before or 2 hours after a meal).
Table 1: Dose Modification Instructions for
POMALYST for Hematologic Toxicities
Toxicity
Neutropenia
• ANC <500 per mcL or
febrile neutropenia
(fever more than or
equal to 38.5°C and
ANC <1,000 per mcL)
• ANC return to more
than or equal to
500 per mcL
Dose Modification
• For each subsequent
drop <500 per mcL
• Return to more than or
equal to 500 per mcL
Interrupt POMALYST
treatment
Resume POMALYST
treatment at 1 mg less
than the previous dose
Thrombocytopenia
• Platelets <25,000 per
mcL
Interrupt POMALYST
treatment, follow CBC
weekly
Resume POMALYST
treatment at 3 mg daily
• Platelets return to
>50,000 per mcL
Interrupt POMALYST
treatment, follow CBC
weekly
Resume POMALYST
treatment at 3 mg daily
• For each subsequent
drop <25,000 per mcL
• Return to more than
or equal to 50,000 per
mcL
Interrupt POMALYST
treatment
Resume POMALYST
treatment at 1 mg less
than previous dose
ANC, absolute neutrophil count.
For other Grade 3 or 4 toxicities, hold treatment and
restart treatment at 1 mg less than the previous
dose when toxicity has resolved to less than or
equal to Grade 2 at the physician’s discretion.
To initiate a new cycle of POMALYST, the neutrophil
count must bePrint-only content
at least 500 per mcL and the platelet
count must be at least 50,000 per mcL. If toxicities
occur after dose reductions to 1 mg, then
discontinue POMALYST.
2.3 Dose Adjustment for Strong CYP1A2 Inhibitors
in the Presence of Strong CYP3A4 and P-gp
Inhibitors
Avoid co-administration of strong inhibitors of
CYP1A2. If necessary to co-administer strong
inhibitors of CYP1A2 in the presence of strong
inhibitors of CYP3A4 and P-gp, reduce POMALYST
dose by 50%. No clinical efficacy or safety data
exist [see Drug Interactions (7.1) and Clinical
Pharmacology (12.3)].
4 CONTRAINDICATIONS
Pregnancy
POMALYST can cause fetal harm when administered
to a pregnant female [see Warnings and Precautions
(5.1) and Use in Specific Populations (8.1)].
POMALYST is contraindicated in females who are
pregnant. Pomalidomide is a thalidomide analogue
and is teratogenic in both rats and rabbits when
administered during the period of organogenesis. If
this drug is used during pregnancy or if the patient
becomes pregnant while taking this drug, the patient
should be apprised of the potential hazard to a fetus.
5 WARNINGS AND PRECAUTIONS
5.1 Embryo-Fetal Toxicity
POMALYST is a thalidomide analogue and is
contraindicated for use during pregnancy.
Thalidomide is a known human teratogen that
causes severe birth defects or embryo-fetal death
[see Use in Specific Populations (8.1)]. POMALYST
is only available through the POMALYST REMS
program [see Warnings and Precautions (5.2)].
Females of Reproductive Potential
Females of reproductive potential must avoid
pregnancy while taking POMALYST and for at least
4 weeks after completing therapy.
Females must commit either to abstain
continuously from heterosexual sexual intercourse
or to use 2 methods of reliable birth control,
beginning 4 weeks prior to initiating treatment with
POMALYST, during therapy, during dose
interruptions, and continuing for 4 weeks following
discontinuation of POMALYST therapy.
Two negative pregnancy tests must be obtained
prior to initiating therapy. The first test should be
performed within 10-14 days and the second test
within 24 hours prior to prescribing POMALYST
therapy, and then weekly during the first month,
then monthly thereafter in women with regular
menstrual cycles, or every 2 weeks in women with
irregular menstrual cycles [see Use in Specific
Populations (8.6)].
Males
Pomalidomide is present in the semen of patients
receiving the drug. Therefore, males must always
use a latex or synthe tic condom during any sexual
contact with females of reproductive potential while
taking POMALYST and for up to 28 days after
discontinuing POMALYST, even if they have
undergone a successful vasectomy. Male patients
taking POMALYST must not donate sperm [see Use
in Specific Populations (8.6)].
Blood Donation
Patients must not donate blood during treatment
with POMALYST and for 1 month following
discontinuation of the drug because the blood
might be given to a pregnant female patient whose
fetus must not be exposed to POMALYST.
5.2 POMALYST REMS™ Program
Because of the embryo-fetal risk [see Warnings and
Precautions (5.1)], POMALYST is available only
through a restricted program under a Risk
Evaluation and Mitigation Strategy (REMS) called
“POMALYST REMS.”
Required components of the POMALYST REMS
program include the following:
• Prescribers must be certified with the POMALYST
REMS program by enrolling and complying with
the REMS requirements.
• Patients must sign a Patient-Prescriber agreement
form and comply with the REMS requirements. In
particular, female patients of reproductive potential
who are not pregnant must comply with the
pregnancy testing and contraception requirements
[see Use in Specific Populations (8.6)] and males
must comply with contraception requirements
[see Use in Specific Populations (8.6)].
• Pharmacies must be certified with the POMALYST
REMS program, must only dispense to patients
who are authorized to receive POMALYST, and
comply with REMS requirements.
Further information about the POMALYST REMS
program is available
www.CelgeneRiskManagement.com or by telephone
at 1-888-423-5436.
5.3 Venous Thromboembolism
Patients receiving POMALYST have developed
venous thromboembolic events (VTEs) (venous
thromboembolism) reported as serious adverse
reactions. In the trial, all patients were required to
receive prophylaxis or anti-thrombotic treatment;
81% used aspirin, 16% warfarin, 21% heparin, and
3% clopidogrel. The rate of deep vein thrombosis
or pulmonary embolism was 3%. Consider anticoagulation prophylaxis after an assessment of
each patient’s underlying risk factors.
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1 INDICATIONS AND USAGE
1.1 Multiple Myeloma
POMALYST is indicated for patients with multiple
myeloma who have received at least two prior
therapies including lenalidomide and bortezomib
and have demonstrated disease progression on or
within 60 days of completion of the last therapy.
Approval is based on response rate [see Clinical
Studies (14.1)]. Clinical benefit, such as
improvement in survival or symptoms, has not
been verified.
2.2 Dose Adjustments for Toxicities