4. Indication
POMALYST is indicated for the treatment of multiple myeloma in patients
who have:
◦ Received at least two prior therapies, including lenalidomide and
bortezomib, and
◦ Demonstrated disease progression on or within 60 days of completion of
the last therapy
5. Dosage and Administration
Recommended Dose
◦ 4 mg orally once daily on Days 1-21 of repeated 28-day cycle
Administration
◦ To be administered until disease progression
◦ Must be administered with dexamethasone
◦ Must be taken with water
◦ Should be taken without food (either 2 hours before or after a meal)
Dose Modifications
◦ Please see full Prescribing Information for dose modification guidelines
associated with:
Hematologic toxicities: neutropenia or thrombocytopena
◦ Grade 3 or 4 toxicities (other than neutropenia or thrombocytopenia)
Hold POMALYST
When toxicity has resolved to Grade 2 or less, restart at 1 mg less than
previous dose
Discontinue if toxicities occur after dose reduction to 1 mg
7. Considerations for Special Populations
Patient Group Recommendations
Pregnancy Category X
• POMALYST is contraindicated during pregnancy
• If used during pregnancy or if patient becomes
pregnant during treatment, patient should be apprised
of the potential hazard to the fetus
• If pregnancy occurs during treatment, discontinue
drug
Nursing mothers • It is unknown whether or not POMALYST is excreted in
human milk
• Decision to discontinue nursing or discontinue therapy
should be made considering the importance of the
drug to the mother
Pediatric Safety and effectiveness has not been established in
patients <18 years of age
8. Considerations for Special Populations (cont.)
Patient Group Recommendations
Females of
Reproductive
Potential & Males
• Females of reproductive potential must avoid
pregnancy by abstaining or using two methods of
reliable birth control
• Contraception should begin 4 weeks before initiating
POMALYST, during therapy and 4 weeks after
discontinuing therapy
Geriatric • No dose adjustment is required based on age
• In the study, patients >65 years of age were more
likely to experience pneumonia
Renal Impairment • Safety and efficacy have not been evaluated
• Avoid use in patients with serum creatinine >3 mg/dL
Hepatic Impairment • Safety and efficacy have not been evaluated
• Avoid use in patients with serum bilirubin >2 mg/dL
and AST/ALT >3x upper limits of normal
10. Mechanism of Action
POMALYST is an immunomodulatory agent with antineoplastic activity
◦ Thalidomide analogue
As shown in in vitro celullar assays
◦ Inhibited proliferation of lenalidomide-resistant multiple myeloma cell
lines
◦ Induced tumor cell apoptosis when combined with dexamethasone in
both lenalidomide-sensitive and lenalidomide-resistant cell lines
◦ Enhanced T cell- and natural killer cell-mediated activity
◦ Inhibited monocyte production of pro-inflammatory cytokines (eg, TNF-
alpha and interluekin-6)
11. Pharmacokinetics
Parameters Values
Time to Peak 2-3 hours
Volume of distribution 62L-138L (steady state)
Protein binding • 12% to 44%
• Not concentration dependent
Metabolism • Hepatic
• Primarily via CYP1A2, CYP3A4
Half-life elimination • 9.5 hours (healthy patients)
• 7.5 hours (multiple myeloma patients)
Excretion • Feces: 15%
• Urine: 73%
12. Drug Interactions
No formal studies have been completed
CYP3A, CYP1A2, P-gp inhibitors
◦ Co-administration with strong CYP3A, CYP1A2, or P-gp inhibitors could
increase exposure to POMALYST
◦ Combination should be avoided
CYP3A, CYP1A2, P-gp inducers
◦ Co-administration with strong CYP3A, CYP1A2, or P-gp inducers could
decrease POMALYST exposure
◦ Combination should be avoided
Dexamethasone
◦ Did not affect POMALYST pharmacokinetics
Smoking
◦ May reduce effectiveness of POMALYST
14. Contraindications, Warnings and Precautions
Contraindications
◦ POMALYST is contraindicated in women who are pregnant
◦ If drug is used during pregnancy or patient becomes pregnant, patient should
be apprised of the risk to the fetus
Embryo-Fetal Toxicity
◦ POMALYST is a thalidomide-analogue; thalidomide causes severe birth defects
or embryo-fetal death
◦ Pregnancy should be avoided during POMALYST therapy and at least 4 weeks
after completing therapy
◦ POMALYST is present in male semen
Males must always use latex or synthetic condoms during sexual contact
with females of reproductive potential during and 28 days after therapy
Males taking POMALYST should not donate sperm
◦ Blood donation
Blood should not be donated during treatment and up to 1 month after
completing treatment since exposed blood may be transferred to a pregnant
female
15. POMALYST REMS™ Program
Due to embyro-fetal risk, POMALYST is only available through POMALYST
REMS
Requirements include:
◦ Prescribers must be certified with the REMS program
◦ Patients must sign a Patient-Prescriber agreement and comply with
REMS requirements
Includes pregnancy testing and contraception requirements
◦ Pharmacist must be certified with the REMS program
May only dispense POMALYST to patients authorized to receive
POMALYST
15
16. Warnings and Precautions
Venous Thromboembolism
◦ Consider concomitant anti-
coagulation prophylaxis based on
patient’s risk
Hematologic Toxicity
◦ Neutropenia, anemia, and
thrombocytopenia were most
commonly reported
◦ Monitor complete blood counts
weekly for first 8 weeks, then
monthly thereafter
◦ Dose may require adjustment or
holding
Hypersensitivity
◦ Risk may be higher in patients
who experienced hypersensitivity
with thalidomide or lenalidomide
Dizziness and Confusional State
◦ Patients should avoid any
medications or situations that
may cause dizziness or lead to
confusion without proper medical
advice
Neuropathy
◦ Patients may experience
neuropathy or peripheral
neuropathy
Second Primary Malignancy Risk
◦ Cases of acute myelogenous
leukemia have been reported in
patients receiving POMALYST
16
18. Trial 1 Information
Objective
◦ Evaluate the safety and efficacy of POMALYST alone or in combination with low
dose dexamethasone (Low-dose Dex)
Study Design
◦ Multicenter, randomized, open label, phase 2 study
Patient Population and Treatment
◦ Patients enrolled had relapsed multiple myeloma, were refractory to their last
myeloma therapy and received lenalidomide and bortezomib
Relapse was defined as achieving at least stable disease for at least one
treatment cycle to at least one prior regimen before disease progressed
Refractory was defined as disease progression on or within 60 days of last
therapy
◦ Regimen: POMALYST 4mg, once daily for 21 days (of 28-day cycle), alone or
in combination with low dose dexamethasone (Low dose Dex)
Low dose Dex schedule: Days 1, 8, 15 and 22 of 28-day cycle
Patients ≤75 years of age received 40 mg daily; >70 years of age received
20 mg daily
19. Trial 1: Results
Overall response rate did not differ based on prior anti-myeloma therapy
19
Response POMALYST*
(N=108)
POMALYST/Low dose
Dex (N=113)
Overall Response Rate,
n (%)
(95% CI)
8 (7.4%)
(3.3-14.1)
33 (29.2%)
(21.0-38.5)
Complete Response,
n (%)
0 (0%) 1 (0.9%)
Partial Response,
n (%)
8 (7.4%) 32 (28.3%)
Duration of Response,
Median (months),
(95% CI)
NE 7.4
(5.1-9.2)
*Results are prior to the addition of dexamethasone.
CI=confidence interval; NE=not established (median has not yet been reached).
22. Supply and Pricing Specifications
How supplied
o 1-mg, 2-mg, 3-mg, and 4-mg capsules: 21-count and 100-
count bottle
Storage and Handing
◦ Store at room temperature
◦ Capsules should not be opened or crushed
◦ If powder comes in contact with skin, wash immediately with
soap and water
◦ If powder comes in contact with mucous membranes, flush with
water
Drug Pricing
o AWP/unit price: $596.88/capsule
23. References
POMALYST® (pomalidomide) [package insert]. Celgene
Corporation. Summit, NJ.
http://pomalyst.com/docs/prescribing_information.pdf
Truven Health Analytics. Red Book Online® Search. Micromedex.