See other indications for POMALYST:

Kaposi sarcoma (KS)

This website is intended for U.S. Healthcare Professionals.

Indication Prescribing Information

This website is intended for U.S. Healthcare Professionals.

REQUEST A REP

POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

This website is best viewed
using the horizontal display
on your tablet device.

This website is best viewed
using the vertical display
on your mobile device.

Resources for healthcare professionals.

Important tools for HCPs.

POMALYST® (pomalidomide) Patient Resources Icon

Dosing Guide

View the recommended dosing schedule and dose modifications.

Download
POMALYST® (pomalidomide) Full Prescribing Information Icon

Full Prescribing
Information

Explore the full Prescribing Information, including Boxed WARNINGS.

Download
POMALYST® (pomalidomide) Patient Resources Icon

Patient Resources

Share helpful tools and resources for your patients.

Access
POMALYST REMS® Icon

POMALYST REMS®

POMALYST is available only through a restricted distribution program. Here’s a resource to help you learn more.

Download

Listen to expert perspectives on the use of POMALYST (pomalidomide) in the treatment of relapsed/refractory multiple myeloma in patients who received REVLIMID® (lenalidomide)* and a PI.

Review the expansion of data for POMALYST-containing
regimens, as early as first relapse and in later relapse, after lenalidomide and a PI.

Watch a Video on Combination Regimens with POMALYST® (pomalidomide) (pomalidomide)

Review the expansion of data for POMALYST-containing
regimens, as early as first relapse and in later relapse.

Dr. David Siegel reviews POMALYST data across four trials over 10 years.

This video should be watched in its entirety. Topics are presented for your information only.

Video Chapters

Watch Next:
Choosing a POMALYST Triplet

Now Playing

Now Playing

Meet Dr. Siegel

Now Playing

Now Playing

MM-003 Trial: 5 Median Prior LoT

Now Playing

Now Playing

EQUULEUS Trial: 4 Median Prior LoT

Now Playing

Now Playing

APOLLO Trial: 2 Median Prior LoT

Now Playing

Now Playing

MM-014 Trial: 1 Median Prior LoT

Now Playing

Now Playing

Conclusion and Important Safety Information

Watch Next

Watch Next

Choosing a POMALYST Triplet
View Video Transcript

Indications

POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

POMALYST + dexamethasone + daratumumab (DPd) is indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

POMALYST + dexamethasone + daratumumab and hyaluronidase-fihj (Pd + dara SC) is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.

Limitations of Use: Daratumumab and hyaluronidase-fihj is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

Information about DPd and Pd + dara SC does not appear in the POMALYST Prescribing Information (PI). Please see the daratumumab and dara SC full PIs for a complete discussion of Important Safety Information at www.darzalexhcp.com/iv and www.darzalexhcp.com/faspro, respectively.

Selected Important Safety Information

POMALYST Boxed WARNINGS: EMBRYO-FETAL TOXICITY, A RESTRICTED DISTRIBUTION PROGRAM – the POMALYST REMS®, and VENOUS AND ARTERIAL THROMBOEMBOLISM.

CONTRAINDICATIONS FOR DARATUMUMAB AND DARA SC

Daratumumab and dara SC are contraindicated in patients with a history of severe hypersensitivity (e.g., anaphylactic reactions) to daratumumab, hyaluronidase, or any of the components of the formulation.

POMALYST Boxed WARNINGS

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.

POMALYST is only available through a restricted distribution program called POMALYST REMS®.

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.

POMALYST Foundational Studies

Dr. Jeffrey Matous presents further insight into the two studies that led to the approval of POMALYST as a doublet and triplet therapy for RRMM.

This video should be watched in its entirety. Topics are presented for your information only.

Watch a Video on Triplets with POMALYST® (pomalidomide) (pomalidomide)
Watch Next:
Mechanism of Action

View Video Transcript

Hide Video Transcript

My name is Dr. Jeff Matous. I’m from the Colorado Blood Cancer Institute in Denver, and I see many patients with multiple myeloma every day. The treatment landscape for myeloma has evolved rapidly in the past few years. Because of that, it’s important for me and the medical community to stay up-to-date on currently approved therapy options that may benefit our patients.

One of those treatments I use as a foundational therapy is POMALYST, either as part of a doublet regimen in combination with dexamethasone or as a triplet regimen with dexamethasone and daratumumab for patients who have received prior lenalidomide and a proteasome inhibitor.

Before we review the efficacy and safety data for a POMALYST-based triplet regimen, let’s review some Important Safety Information for POMALYST.

POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

POMALYST + dexamethasone + daratumumab is indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

Information about POMALYST + dexamethasone + daratumumab does not appear in the POMALYST Prescribing Information (PI). Please see the daratumumab full PI for a complete discussion of Important Safety Information at www.darzalexhcp.com/iv.

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.

POMALYST is only available through a restricted distribution program called POMALYST REMS®.

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.

Please see important safety information throughout this video and full prescribing information for POMALYST, including Boxed WARNINGS, at www.POMALYSTHCP.com.

POMALYST was studied in a Phase 3, multicenter, randomized, open-label trial of POMALYST + low-dose dexamethasone vs high-dose dexamethasone in patients with relapsed/refractory multiple myeloma who had received at least 2 prior treatment regimens, including REVLIMID (generic name lenalidomide) and bortezomib, and demonstrated disease progression on or within 60 days from the last therapy. A total of 455 patients were enrolled in the study.

Some key exclusion criteria included serum bilirubin greater than 2.0 mg/dL, AST/ALT greater than 3.0 times the upper limit of normal, and CrCl less than 45 mL/min.

The primary endpoint was progression-free survival, or PFS. A secondary endpoint was overall survival, or OS. Treatment continued until disease progression.

Patients in the POMALYST + low-dose dexamethasone arm received 4 mg of POMALYST orally on Days 1 to 21 of 28-day cycles with 40 mg of dexamethasone once daily on specified days in the cycle, as seen here. Patients in the high-dose dexamethasone arm received 40 mg of dexamethasone once daily on specified days in each 28-day cycle, as seen here.

Patients older than 75 years of age received 20 mg of dexamethasone, with the same respective dosing schedules.

Patients receiving POMALYST, as well as any other patient with a history of deep venous thrombosis or pulmonary embolism, were required to receive prophylaxis or antithrombotic treatment.

In the study, the majority of patients were refractory to REVLIMID, bortezomib, or both.

Study results demonstrated a 30% reduced risk of death for POMALYST + low-dose dexamethasone vs high-dose dexamethasone. The median OS for POMALYST + low-dose dexamethasone was 12.4 months vs 8.0 months for high-dose dexamethasone.

For the primary endpoint, POMALYST + low-dose dexamethasone doubled the median PFS of high-dose dexamethasone (3.6 vs 1.8 months).

Recently, there was a study proving the safety and efficacy of a POMALYST-based triplet regimen in patients with relapsed/refractory myeloma.

POMALYST plus low-dose dexamethasone was studied in combination with daratumumab in a trial of 103 patients without a comparator arm. This trial led to the FDA approval of this POMALYST-based triplet regimen.

The median patient age in the trial was 64 years, and all of the patients enrolled had previously received REVLIMID.

89% of the patients enrolled in the trial were refractory to REVLIMID, while 71% were refractory to bortezomib, and 64% of patients were refractory to both REVLIMID and bortezomib.

Patients received 4 mg of POMALYST once daily for Days 1-21 during a repeated 28-day cycle in combination with 40 mg of low-dose oral or intravenous dexamethasone per week.

In addition to POMALYST and low-dose dexamethasone, patients received 16 mg/kg of daratumumab as an infusion based on the schedule shown on screen.

On days with a daratumumab infusion, patients received 20 mg of dexamethasone as a pre-infusion medication, with the rest administered the day after the daratumumab infusion. Additional information on reduced doses of dexamethasone is shown at the bottom of the screen.

Patients in the trial were treated until disease progression.

Now that we’ve reviewed the study design and dosing information, let’s dive into the efficacy results and safety profile for POMALYST plus low-dose dexamethasone in combination with daratumumab.

59% of patients studied in the trial achieved a response with POMALYST plus low-dose dexamethasone in combination with daratumumab, with 42% reaching a very good partial response or better.

The median time to response was 1 month, while the median duration of response was 13.6 months.

Patients in the study were treated for a median of 6 months, and 13% of these patients discontinued treatment due to adverse reactions.

Shown here are the adverse reactions of any grade that occurred in more than 20% of patients treated with POMALYST plus low-dose dexamethasone in combination with daratumumab. The most common adverse reactions occurring in at least 50% of patients were neutropenia, lymphopenia, thrombocytopenia, anemia, infusion reactions, fatigue, and upper respiratory tract infection. Grade 3/4 hematologic adverse reactions that occurred in at least 20% of patients are also shown at the bottom of the screen.

The overall incidence of adverse reactions was 49%. Serious adverse reactions reported in ≥5% of patients included pneumonia, which occurred in 7% of patients.

There are certain Warnings and Precautions to keep in mind when using daratumumab, including:

  • Infusion-related reactions
  • Interference with cross-matching and red blood cell antibody screening
  • Neutropenia
  • Thrombocytopenia
  • Interference with determination of complete response
  • and Embryo-fetal toxicity

We’ll discuss more information about the Warnings and Precautions for this regimen later on in this presentation.

The results of this trial show that POMALYST plus low-dose dexamethasone in combination with daratumumab is a treatment option for patients who are refractory to REVLIMID and who have received a prior proteasome inhibitor.

Some patients may not be a candidate for a triplet regimen. For those who are likely to benefit from a doublet, consider using POMALYST in combination with low-dose dexamethasone, an all-oral regimen for relapsed/refractory multiple myeloma.

To learn more about the overall survival and safety data from the Phase 3 trial for POMALYST + low-dose dexamethasone, please visit POMALYST.com.

The results of both POMALYST plus low-dose dexamethasone and POMALYST plus dexamethasone in combination with daratumumab support the use of POMALYST as a therapy in patients with relapsed/refractory multiple myeloma who have received prior lenalidomide and a proteasome inhibitor.

Now, let’s review some Important Safety Information for POMALYST.

POMALYST has boxed warnings for embryo-fetal toxicity and venous and arterial thromboembolism.

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.

POMALYST is only available through a restricted distribution program called POMALYST REMS®.

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.

CONTRAINDICATIONS FOR POMALYST

  • Pregnancy: POMALYST can cause fetal harm and is contraindicated in females who are pregnant. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus.
  • Hypersensitivity: POMALYST is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, anaphylaxis) to pomalidomide or any of the excipients.

CONTRAINDICATIONS FOR DARATUMUMAB

  • Daratumumab is contraindicated in patients with a history of severe hypersensitivity (e.g., anaphylactic reactions) to daratumumab or any of the components of the formulation.

WARNINGS AND PRECAUTIONS FOR POMALYST

  • Embryo-Fetal Toxicity & Females of Reproductive Potential: See Boxed WARNINGS
    • Males: Pomalidomide is present in the semen of patients receiving the drug. Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking POMALYST and for up to 4 weeks after discontinuing POMALYST, even if they have undergone a successful vasectomy. Males must not donate sperm.
    • Blood Donation: Patients must not donate blood during treatment with POMALYST and for 4 weeks following discontinuation of POMALYST therapy because the blood might be given to a pregnant female patient whose fetus must not be exposed to POMALYST.
  • POMALYST REMS Program: See Boxed WARNINGS
    • Prescribers and pharmacies must be certified with the POMALYST REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive POMALYST. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements.
    • Further information about the POMALYST REMS program is available at www.CelgeneRiskManagement.com or by telephone at 1-888-423-5436.
  • Venous and Arterial Thromboembolism: See Boxed WARNINGS. Patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors.
  • Increased Mortality With Pembrolizumab: In clinical trials in patients with multiple myeloma, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.
  • Hematologic Toxicity: Neutropenia (46%) was the most frequently reported Grade 3 or 4 adverse reaction in patients taking POMALYST in clinical trials, followed by anemia and thrombocytopenia. Monitor complete blood counts weekly for the first 8 weeks and monthly thereafter. Patients may require dose interruption and/or modification.
  • Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with POMALYST. Elevated levels of alanine aminotransferase and bilirubin have also been observed in patients treated with POMALYST. Monitor liver function tests monthly. Stop POMALYST upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered.
  • Severe Cutaneous Reactions: Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. These reactions can be fatal. Consider POMALYST interruption or discontinuation for Grade 2 or 3 skin rash. Permanently discontinue POMALYST for Grade 4 rash, exfoliative or bullous rash, or any other severe cutaneous reactions such as SJS, TEN or DRESS.
  • Dizziness and Confusional State: In patients taking POMALYST in clinical trials, 14% experienced dizziness (1% Grade 3 or 4) and 7% a confusional state (3% Grade 3 or 4). Instruct patients to avoid situations where dizziness or confusional state may be a problem and not to take other medications that may cause dizziness or confusional state without adequate medical advice.
  • Neuropathy: In patients taking POMALYST in clinical trials, 18% experienced neuropathy (2% Grade 3 in one trial) and 12% peripheral neuropathy.
  • Second Primary Malignancies (SPMs): Cases of acute myelogenous leukemia have been reported in patients receiving POMALYST as an investigational therapy outside of multiple myeloma.
  • Tumor Lysis Syndrome (TLS): TLS may occur in patients treated with POMALYST. Patients at risk are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken.
  • Hypersensitivity: Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to POMALYST have been reported. Permanently discontinue POMALYST for angioedema or anaphylaxis.

WARNINGS AND PRECAUTIONS FOR DARATUMUMAB

  • Infusion-Related Reactions: Daratumumab can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life-threatening and fatal outcomes have been reported. Interrupt daratumumab infusion for infusion-related reactions of any severity. Permanently discontinue the infusion in case of anaphylactic reactions or life-threatening infusion reactions and institute appropriate emergency care.
  • Interference With Cross-Matching and Red Blood Cell Antibody Screening: Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test), which may persist for up to 6 months after the last daratumumab infusion. Type and screen patients prior to starting treatment. Inform blood banks that a patient has received daratumumab.
  • Neutropenia: Monitor complete blood cell counts periodically during treatment. Monitor patients with neutropenia for signs of infection. Consider withholding daratumumab until recovery of neutrophils.
  • Thrombocytopenia: Monitor complete blood cell counts periodically during treatment. Consider withholding daratumumab until recovery of platelets.
  • Interference With Determination of Complete Response: Daratumumab can interfere with the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise pregnant women of the potential risk to a fetus and advise females of reproductive potential to use effective contraception.

ADVERSE REACTIONS FOR POMALYST + dexamethasone
The most common adverse reactions for POMALYST (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, and pyrexia.

In the phase III trial, nearly all patients treated with POMALYST + low-dose dex experienced at least one adverse reaction (99%). Adverse reactions (≥15% in the POMALYST + low-dose dex arm and ≥2% higher than control) included neutropenia (51%), fatigue and asthenia (47%), upper respiratory tract infection (31%), thrombocytopenia (30%), pyrexia (27%), dyspnea (25%), diarrhea (22%), constipation (22%), back pain (20%), cough (20%), pneumonia (19%), bone pain (18%), edema peripheral (17%), peripheral neuropathy (17%), muscle spasms (15%), and nausea (15%). Grade 3 or 4 adverse reactions (≥15% in the POMALYST + low-dose dex arm and ≥1% higher than control) included neutropenia (48%), thrombocytopenia (22%), and pneumonia (16%).

ADVERSE REACTIONS FOR POMALYST + dexamethasone + daratumumab
The most common adverse reactions (≥20%) included neutropenia (95%), lymphopenia (94%), thrombocytopenia (75%), anemia (57%), infusion reactions (50%), fatigue (50%), upper respiratory tract infection (50%), cough (43%), diarrhea (38%), constipation (33%), dyspnea (33%), nausea (30%), muscle spasms (26%), pyrexia (25%), back pain (25%), insomnia (23%), arthralgia (22%), vomiting (21%), dizziness (21%), and chills (20%). Grade 3 or 4 hematology laboratory abnormalities included: neutropenia (82%), lymphopenia (71%), anemia (30%), and thrombocytopenia (20%).

DRUG INTERACTIONS FOR POMALYST

Avoid concomitant use of POMALYST with strong inhibitors of CYP1A2. If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce POMALYST dose to 2 mg.

USE IN SPECIFIC POPULATIONS FOR POMALYST

  • Pregnancy: See Boxed WARNINGS. If pregnancy does occur during treatment, immediately discontinue the drug and refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. There is a POMALYST pregnancy exposure registry that monitors pregnancy outcomes in females exposed to POMALYST during pregnancy as well as female partners of male patients who are exposed to POMALYST. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to POMALYST to the FDA via the MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation, at 1-888-423-5436.
  • Lactation: There is no information regarding the presence of pomalidomide in human milk, the effects of POMALYST on the breastfed child, or the effects of POMALYST on milk production. Pomalidomide was excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for adverse reactions in a breastfed child from POMALYST, advise women not to breastfeed during treatment with POMALYST.
  • Pediatric Use: Safety and effectiveness have not been established in pediatric patients.
  • Geriatric Use: No dosage adjustment is required for POMALYST based on age. Patients >65 years of age were more likely than patients ≤65 years of age to experience pneumonia.
  • Renal Impairment: For patients with severe renal impairment requiring dialysis, reduce the recommended dosage to 3 mg orally daily. Take dose of POMALYST following hemodialysis on hemodialysis days.
  • Hepatic Impairment: In patients with mild to moderate hepatic impairment, reduce POMALYST dosage to 3 mg daily and to 2 mg orally daily in patients with severe hepatic impairment.
  • Smoking Tobacco: Advise patients that smoking may reduce the efficacy of POMALYST. Cigarette smoking reduces pomalidomide AUC due to CYP1A2 induction.

Please see Important Safety Information throughout this video and full Prescribing Information for POMALYST, including Boxed WARNINGS, at www.POMALYSTHCP.com.

Information about POMALYST + dexamethasone + daratumumab does not appear in the POMALYST Prescribing Information (PI). Please see the daratumumab full PI for a complete discussion of Important Safety Information at www.darzalexhcp.com/iv.

I hope you’ve found the information in this video valuable. As a reminder, please visit POMALYST.com for more information or contact your local Celgene representative.

References:

  1. POMALYST [package insert]. Summit, NJ: Celgene Corp.
  2. Data on file. Bristol-Myers Squibb Co; 2018.
  3. Daratumumab [package insert]. Horsham, PA: Janssen Biotech, Inc.

POMALYST®, POMALYST REMS®, REVLIMID®, and associated logos are trademarks of Celgene Corporation, a Bristol Myers Squibb company.
Other trademarks are property of their respective owners.
© 2021 Bristol-Myers Squibb Company. 10/21 2204-US-2100219

Video Chapters

View Video Chapter List

Hide Video Chapter List

Meet Dr. Matous

Indications and Boxed WARNINGS for POMALYST

A Foundation of POMALYST (Trial Design)

Pd Demonstrated Efficacy

Building on a Proven Foundation: DPd Trial Design

Established Efficacy and Safety with DPd

Consider a POMALYST Regimen for RRMM

Indications and Important Safety Information

Watch Next

Mechanism of Action

*Please see full Prescribing Information, including Boxed WARNINGS, for REVLIMID.

Mechanism of Action

Explore the mechanism of action of POMALYST.

Based on preclinical in vivo and in vitro studies, the mechanism of action statements are not meant to imply clinical outcomes.

Watch a Video on POMALYST® (pomalidomide) MOA
Watch Next:
Choosing a POMALYST-containing regimen

View Video Transcript

Hide Video Transcript

Pomalidomide is an immunomodulatory agent with antineoplastic activity [1].

Pomalidomide has been shown to have in vitro activity that overcomes lenalidomide resistance [1]. In addition to the immunomodulatory and antineoplastic activity, pomalidomide demonstrated antiangiogenic activity in an in vitro umbilical cord model and in vivo [1,2].

The antineoplastic activity of pomalidomide has been established in in vitro cellular assays. Pomalidomide has been shown to inhibit proliferation and induce apoptosis of hematopoietic tumor cells [1].

Pomalidomide also inhibited the proliferation of lenalidomide-resistant multiple myeloma cell lines [1].

Pomalidomide synergized with dexamethasone and induced tumor cell apoptosis in both lenalidomide-resistant and lenalidomide-sensitive cell lines [1].

Pomalidomide has been shown to have immunomodulatory activity [1]. Pomalidomide enhanced T cell- and natural killer cell-mediated immunity [1].

It also inhibited production of proinflammatory cytokines, such as TNF-α and IL-6, by monocytes [1,2].

Pomalidomide also demonstrated antiangiogenic properties [1,2]. This activity is supported by an in vivo mouse tumor model and an in vitro umbilical cord model [1].

Pomalidomide is an immunomodulatory and antineoplastic agent with in vitro activity that overcomes lenalidomide resistance [1]. Based on pre-clinical findings, pomalidomide, in combination with low-dose dexamethasone, was evaluated in a Phase 3 multi-center, randomized, open-label study [1].

[Voiceover does not read the disclaimer]

[copy]

Please see accompanying full Prescribing Information, including Boxed WARNINGS.

[Voiceover does not read the references]

References:

  1. POMALYST (pomalidomide) Capsules PI.
  2. Terpos E, Kanellias N, Christoulas D, et al. Pomalidomide: a novel drug to treat relapsed and refractory multiple myeloma. Onco Targets Ther. 2013;6:531-538.

[Voiceover does not read end matter]

© 2015 Celgene Corporation 12/15 US-POM150057

DPd, POMALYST + dexamethasone + daratumumab; EPd, POMALYST + dexamethasone + EMPLICITI® (elotuzumab); LoT, lines of therapy; Pd, POMALYST + dexamethasone; PI, proteasome inhibitor; RRMM, relapsed/refractory multiple myeloma.

†Patients must have also received a PI.

Share helpful tools and resources for your patients.

View Patient Resources

POMALYST Indication

POMALYST® (pomalidomide) is a thalidomide analogue indicated for the treatment of adult patients:

  • in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

POMALYST + dexamethasone + daratumumab Indication (DPd)

POMALYST + dexamethasone + daratumumab is indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

POMALYST + dexamethasone + daratumumab and hyaluronidase-fihj injection for subcutaneous use (dara SC) Indication (Pd + dara SC)

POMALYST + dexamethasone + daratumumab and hyaluronidase-fihj is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.

Limitations of Use:
Daratumumab and hyaluronidase-fihj is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

Information about DPd and Pd + dara SC does not appear in the POMALYST Prescribing Information (PI). Please see the daratumumab and dara SC full PIs for a complete discussion of Important Safety Information at www.darzalexhcp.com/iv and www.darzalexhcp.com/faspro, respectively.

Important Safety Information for POMALYST, daratumumab, and dara SC

POMALYST Boxed WARNINGS

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.

POMALYST is only available through a restricted distribution program called POMALYST REMS®.

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.

CONTRAINDICATIONS FOR POMALYST

  • Pregnancy: POMALYST can cause fetal harm and is contraindicated in females who are pregnant. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus.
  • Hypersensitivity: POMALYST is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, anaphylaxis) to pomalidomide or any of the excipients.

CONTRAINDICATIONS FOR DARATUMUMAB

  • Daratumumab is contraindicated in patients with a history of severe hypersensitivity (e.g., anaphylactic reactions) to daratumumab or any of the components of the formulation.

CONTRAINDICATIONS FOR DARA SC

  • Daratumumab and hyaluronidase-fihj is contraindicated in patients with a history of severe hypersensitivity (e.g., anaphylactic reactions) to daratumumab, hyaluronidase, or any of the components of the formulation.

WARNINGS AND PRECAUTIONS FOR POMALYST

  • Embryo-Fetal Toxicity & Females of Reproductive Potential: See Boxed WARNINGS for POMALYST
    • Males: Pomalidomide is present in the semen of patients receiving the drug. Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking POMALYST and for up to 4 weeks after discontinuing POMALYST, even if they have undergone a successful vasectomy. Males must not donate sperm.
    • Blood Donation: Patients must not donate blood during treatment with POMALYST and for 4 weeks following discontinuation of POMALYST therapy because the blood might be given to a pregnant female patient whose fetus must not be exposed to POMALYST.
  • POMALYST REMS Program: See Boxed WARNINGS
    • Prescribers and pharmacies must be certified with the POMALYST REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive POMALYST. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements.
    • Further information about the POMALYST REMS program is available at www.CelgeneRiskManagement.com or by telephone at 1-888-423-5436.
  • Venous and Arterial Thromboembolism: See Boxed WARNINGS for POMALYST. Patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors.
  • Increased Mortality With Pembrolizumab: In clinical trials in patients with multiple myeloma, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.
  • Hematologic Toxicity: Neutropenia (46%) was the most frequently reported Grade 3 or 4 adverse reaction, followed by anemia and thrombocytopenia. Monitor complete blood counts weekly for the first 8 weeks and monthly thereafter. Patients may require dose interruption and/or modification.
  • Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with POMALYST. Elevated levels of alanine aminotransferase and bilirubin have also been observed in patients treated with POMALYST. Monitor liver function tests monthly. Stop POMALYST upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered.
  • Severe Cutaneous Reactions: Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with POMALYST. DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. These reactions can be fatal. Consider POMALYST interruption or discontinuation for Grade 2 or 3 skin rash. Permanently discontinue POMALYST for Grade 4 rash, exfoliative or bullous rash, or any other severe cutaneous reactions such as SJS, TEN or DRESS.
  • Dizziness and Confusional State: In patients taking POMALYST in clinical trials, 14% experienced dizziness (1% Grade 3 or 4) and 7% a confusional state (3% Grade 3 or 4). Instruct patients to avoid situations where dizziness or confusional state may be a problem and not to take other medications that may cause dizziness or confusional state without adequate medical advice.
  • Neuropathy: In patients taking POMALYST in clinical trials, 18% experienced neuropathy (2% Grade 3 in one trial) and 12% peripheral neuropathy.
  • Second Primary Malignancies (SPMs):
    • Cases of acute myelogenous leukemia have been reported in patients receiving POMALYST as an investigational therapy outside of multiple myeloma.
    • Monitor patients for the development of SPMs.
  • Tumor Lysis Syndrome (TLS): TLS may occur in patients treated with POMALYST. Patients at risk are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken.
  • Hypersensitivity: Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to POMALYST have been reported. Permanently discontinue POMALYST for angioedema or anaphylaxis.

WARNINGS AND PRECAUTIONS FOR DARATUMUMAB

  • Infusion-Related Reactions: Daratumumab can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life-threatening and fatal outcomes have been reported. Interrupt daratumumab infusion for infusion-related reactions of any severity. Permanently discontinue the infusion in case of anaphylactic reactions or life-threatening infusion reactions and institute appropriate emergency care.
  • Interference With Cross-Matching and Red Blood Cell Antibody Screening: Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test), which may persist for up to 6 months after the last daratumumab infusion. Type and screen patients prior to starting treatment. Inform blood banks that a patient has received daratumumab.
  • Neutropenia: Monitor complete blood cell counts periodically during treatment. Monitor patients with neutropenia for signs of infection. Consider withholding daratumumab until recovery of neutrophils.
  • Thrombocytopenia: Monitor complete blood cell counts periodically during treatment. Consider withholding daratumumab until recovery of platelets.
  • Interference With Determination of Complete Response: Daratumumab can interfere with the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise pregnant women of the potential risk to a fetus and advise females of reproductive potential to use effective contraception.

WARNINGS AND PRECAUTIONS FOR DARA SC

  • Hypersensitivity and Other Administration Reactions: Daratumumab and hyaluronidase-fihj can cause systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions. Fatal reactions have been reported with daratumumab-containing products, including daratumumab and hyaluronidase-fihj. Permanently discontinue daratumumab and hyaluronidase-fihj for life-threatening reactions.
  • Cardiac Toxicity in Patients With Light Chain (AL) Amyloidosis: Monitor patients with cardiac involvement more frequently for cardiac adverse reactions and administer supportive care as appropriate.
  • Neutropenia: Monitor complete blood cell counts periodically during treatment. Monitor patients with neutropenia for signs of infection. Consider withholding daratumumab and hyaluronidase-fihj to allow recovery of neutrophils.
  • Thrombocytopenia: Monitor complete blood cell counts periodically during treatment. Consider withholding daratumumab and hyaluronidase-fihj to allow recovery of platelets.
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise pregnant women of the potential risk to a fetus and advise females of reproductive potential to use effective contraception.
  • Interference With Cross-Matching and Red Blood Cell Antibody Screening: Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test), which may persist for up to 6 months after the last daratumumab administration. Type and screen patients prior to starting treatment. Inform blood banks that a patient has received daratumumab and hyaluronidase-fihj.
  • Interference With Determination of Complete Response: Daratumumab can interfere with the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.

ADVERSE REACTIONS

POMALYST:
The most common adverse reactions for POMALYST (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, and pyrexia.

In the phase III trial, nearly all patients treated with POMALYST + low-dose dex experienced at least one adverse reaction (99%). Adverse reactions (≥15% in the POMALYST + low-dose dex arm and ≥2% higher than control) included neutropenia (51%), fatigue and asthenia (47%), upper respiratory tract infection (31%), thrombocytopenia (30%), pyrexia (27%), dyspnea (25%), diarrhea (22%), constipation (22%), back pain (20%), cough (20%), pneumonia (19%), bone pain (18%), edema peripheral (17%), peripheral neuropathy (17%), muscle spasms (15%), and nausea (15%). Grade 3 or 4 adverse reactions (≥15% in the POMALYST + low-dose dex arm and ≥1% higher than control) included neutropenia (48%), thrombocytopenia (22%), and pneumonia (16%).

ADVERSE REACTIONS FOR POMALYST + dexamethasone + daratumumab

The most common adverse reactions (≥20%) included neutropenia (95%), lymphopenia (94%), thrombocytopenia (75%), anemia (57%), infusion reactions (50%), fatigue (50%), upper respiratory tract infection (50%), cough (43%), diarrhea (38%), constipation (33%), dyspnea (33%), nausea (30%), muscle spasms (26%), pyrexia (25%), back pain (25%), insomnia (23%), arthralgia (22%), vomiting (21%), dizziness (21%), and chills (20%). Grade 3 or 4 hematology laboratory abnormalities included: neutropenia (82%), lymphopenia (71%), anemia (30%), and thrombocytopenia (20%).

ADVERSE REACTIONS FOR POMALYST + dexamethasone + dara SC

The most common adverse reactions (≥20%) included fatigue (46%), pneumonia (38%), upper respiratory tract infection (36%), and diarrhea (22%). Grade 3 or 4 hematology laboratory abnormalities included: decreased neutrophils (84%), decreased leukocytes (64%), decreased lymphocytes (59%), decreased platelets (19%), and decreased hemoglobin (16%).

DRUG INTERACTIONS FOR POMALYST

Avoid concomitant use of POMALYST with strong inhibitors of CYP1A2. If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce POMALYST dose to 2 mg.

USE IN SPECIFIC POPULATIONS FOR POMALYST

  • Pregnancy: See Boxed WARNINGS for POMALYST. If pregnancy does occur during treatment, immediately discontinue the drug and refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. There is a POMALYST pregnancy exposure registry that monitors pregnancy outcomes in females exposed to POMALYST during pregnancy as well as female partners of male patients who are exposed to POMALYST. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to POMALYST to the FDA via the MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-423-5436.
  • Lactation: There is no information regarding the presence of pomalidomide in human milk, the effects of POMALYST on the breastfed child, or the effects of POMALYST on milk production. Pomalidomide was excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for adverse reactions in a breastfed child from POMALYST, advise women not to breastfeed during treatment with POMALYST.
  • Pediatric Use: Safety and effectiveness have not been established in pediatric patients.
  • Geriatric Use: No dosage adjustment is required for POMALYST based on age. Patients >65 years of age were more likely than patients ≤65 years of age to experience pneumonia.
  • Renal Impairment: For patients with severe renal impairment requiring dialysis, reduce POMALYST dosage to 3 mg orally daily. Take dose of POMALYST following hemodialysis on hemodialysis days.
  • Hepatic Impairment: For patients with mild to moderate hepatic impairment, reduce POMALYST dosage to 3 mg orally daily and to 2 mg orally daily in patients with severe hepatic impairment.
  • Smoking Tobacco: Advise patients that smoking may reduce the efficacy of POMALYST. Cigarette smoking reduces pomalidomide AUC due to CYP1A2 induction.

Please see full Prescribing Information for POMALYST, including Boxed WARNINGS.

Information about DPd and Pd + dara SC does not appear in the POMALYST Prescribing Information (PI). Please see the daratumumab and dara SC full PIs for a complete discussion of Important Safety Information at www.darzalexhcp.com/iv and www.darzalexhcp.com/faspro, respectively.