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POMALYST®
(pomalidomide)
Drug Showcase
Introduction
 Brand name: POMALYST®
 Generic name: pomalidomide
 Approval: 2013
 Manufacturer: Celgene Corp
Indication, Dosage & Administration
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
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
Use in Specific Populations
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
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
Clinical Pharmacology
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)
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%
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
Warnings & Precautions
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
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
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
Clinical Safety & Efficacy
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
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).
Common Adverse Events, >25%
POMALYST
(N = 107)
POMALYST + Low dose Dex
(N=112)
• Fatigue and asthenia (55%)
• Neutropenia (52%)
• Anemia (38%)
• Thrombocytopenia (25%)
• Constipation (36%)
• Diarrhea (34%)
• Nausea (36%)
• Upper respiratory tract infection
(32%)
• Back pain (32%)
• Dyspnea (34%)
• Fatigue and asthenia (63%)
• Pyrexia (30%)
• Neutropenia (47%)
• Anemia (39%)
• Constipation (35%)
• Diarrhea (33%)
• Pneumonia (29%)
• Upper respiratory tract infection
(25%)
• Back pain (30%)
• Dyspnea (45%)
Drug Storage & Supply
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
References
 POMALYST® (pomalidomide) [package insert]. Celgene
Corporation. Summit, NJ.
http://pomalyst.com/docs/prescribing_information.pdf
 Truven Health Analytics. Red Book Online® Search. Micromedex.

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Pomalyst showcase 6.5

  • 2. Introduction  Brand name: POMALYST®  Generic name: pomalidomide  Approval: 2013  Manufacturer: Celgene Corp
  • 3. Indication, Dosage & Administration
  • 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
  • 6. Use in Specific Populations
  • 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
  • 17. Clinical Safety & Efficacy
  • 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).
  • 20. Common Adverse Events, >25% POMALYST (N = 107) POMALYST + Low dose Dex (N=112) • Fatigue and asthenia (55%) • Neutropenia (52%) • Anemia (38%) • Thrombocytopenia (25%) • Constipation (36%) • Diarrhea (34%) • Nausea (36%) • Upper respiratory tract infection (32%) • Back pain (32%) • Dyspnea (34%) • Fatigue and asthenia (63%) • Pyrexia (30%) • Neutropenia (47%) • Anemia (39%) • Constipation (35%) • Diarrhea (33%) • Pneumonia (29%) • Upper respiratory tract infection (25%) • Back pain (30%) • Dyspnea (45%)
  • 21. Drug Storage & Supply
  • 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.