Literature Scan
Investigating How Patients With
Hemophilia Manage Pain
As the life expectancy of
people with hemophilia has
increased, patients are living
longer with disease-associated
pain, particularly in their joints.
According to the results of a
national survey of patients
with hemophilia published
in Haemophilia, patients use
a variety of strategies to deal
with their acute and chronic
pain, while also experiencing
psychological issues, functional
disability, and reduced health-
related quality of life.
The variable use of pain manage-
ment strategies among the survey
population suggests that clinical pain
assessment tools are insufficient for
developing better pain management
programs, noted the authors, led by
Michelle Witkop, DNP, from the
Munson Medical Center in Traverse
City, Michigan.
The investigators reported
results from the Pain, Functional
T:7”
POMALYST ® (pomalidomide) capsules, for oral use 2.2 Dose Adjustments for Toxicities
The following is a Brief Summary; refer to full
Prescribing Information for complete product
information. Table 1: Dose Modification Instructions for
POMALYST for Hematologic Toxicities
WARNING: EMBRYO-FETAL TOXICITY and
VENOUS AND ARTERIAL 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, 8.3)].
POMALYST is only available through a restricted
distribution program called POMALYST REMS
[see Warnings and Precautions (5.2)].
Venous and Arterial Thromboembolism
• Deep venous thrombosis (DVT), pulmonary
embolism (PE), myocardial infarction, and
stroke occur in patients with multiple myeloma
treated with POMALYST. Prophylactic
antithrombotic measures were employed in
clinical trials. Thromboprophylaxis is
recommended, and the choice of regimen
should be based on assessment of the
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
(8.3)].
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 should be given in combination with
dexamethasone.
POMALYST may be taken with water. Inform patients
not to break, chew, or open the capsules. POMALYST
may be taken with or without food.
Dose Modification
• Interrupt POMALYST
treatment, follow CBC
weekly
• Resume POMALYST
treatment at 3 mg daily
• For each subsequent • Interrupt POMALYST
drop <500 per mcL
treatment
• Return to more than or • Resume POMALYST
equal to 500 per mcL
treatment at 1 mg less
than the previous dose
Thrombocytopenia
• Platelets <25,000 per
mcL
• Platelets return to
>50,000 per mcL
• Interrupt POMALYST
treatment, follow CBC
weekly
• Resume POMALYST
treatment at 3 mg daily
• For each subsequent • Interrupt POMALYST
drop <25,000 per mcL treatment
• Resume POMALYST
• Return to more than
or equal to 50,000 per treatment at 1 mg less
than previous dose
mcL
ANC, absolute neutrophil count
To initiate a new cycle of POMALYST, the neutrophil
count must be 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.
Permanently discontinue POMALYST for angioedema,
skin exfoliation, bullae, or any other severe
dermatologic reaction [see Warnings and
Precautions (5.6)].
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.
2.3 Dosage Adjustment for Strong CYP1A2
Inhibitors
Avoid concomitant use of POMALYST with strong
inhibitors of CYP1A2. Consider alternative treatments.
If a strong CYP1A2 inhibitor must be used, reduce
POMALYST dose by 50% [see Drug Interactions (7.1)].
2.4 Dosage Adjustment for Patients with Severe
Renal Impairment on Hemodialysis
For patients with severe renal impairment requiring
dialysis, the recommended starting dose is 3 mg
daily (25% dose reduction). Take POMALYST after
completion of dialysis procedure on hemodialysis
days. [see Use in Specific Populations (8.6)].
2.5 Dosage Adjustment for Patients with Hepatic
Impairment
For patients with mild or moderate hepatic impairment
(Child-Pugh classes A or B), the recommended
starting dose is 3 mg daily (25% dose reduction).
For patients with severe hepatic impairment
(Child-Pugh class C), the recommended dose is
2 mg (50% dose reduction) [see Use in Specific
Populations (8.7)].
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 risk to a fetus.
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 Strate