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Indication Prescribing Information

This site is intended for US audiences only.

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® (pomalidomide) nurse resources.

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Get to know POMALYST

You’re a champion who performs an essential role to support your patients’ needs, and that means there’s little time for anything else. This page is designed so you have answers to help you educate patients about their disease and manage their care. From clinical trials data to patient support, it’s here—so you can help your patients with relapsed/refractory multiple myeloma (RRMM) continue treatment with POMALYST where appropriate.

Defining RRMM

Talking with patients about RRMM

What is RRMM?

More likely than not, this is a question you’ve heard before. RRMM is defined as MM that has become nonresponsive or progressive on therapy, or within 60 days of the last treatment, in patients who had achieved a minimal response (MR) or better on prior therapy.1 Help your patients understand what RRMM is and ensure that they know there are therapies approved specifically for RRMM.

Below are links to some informative materials for your patients with RRMM:

POMALYST® (pomalidomide) Patient Website Icon

POMALYST.com
for Patients

For a patient-friendly explanation of what RRMM is and additional resources, visit the patient website.

View
POMALYST® (pomalidomide) Patient Stories Icon

Patient Stories

Relapse is a scary time for patients. But they’re not alone. Hear patients whose disease has progressed speak honestly and openly about continuing their journeys with POMALYST.

See Their Stories

Dosing POMALYST

Helping patients stay on therapy

Straightforward dosing, based on renal impairment.2

POMALYST can be taken at home or wherever is convenient
for your patient.2

  • Recommended dosage for POMALYST is 4 mg once daily orally with or without food on Days 1-21 of each 28-day cycle
  • Give POMALYST in combination with dex
  • In the doublet Phase 3 trial, low-dose dex was given on Days 1, 8, 15, and 22 of a 28-day cycle
    • Dex 40 mg for patients ≤75 years
    • Dex 20 mg for patients >75 years
  • Repeat until disease progression or unacceptable toxicity. Dose interruptions and modifications may be required

Tailor the POMALYST dosage to your patients’ needs.2

POMALYST® (pomalidomide) Tablets

  • The recommended starting dose of POMALYST is 4 mg.
  • Additional strengths of 3 mg, 2 mg, and 1 mg are available for dose modification.

Dose modifications may help patients stay on therapy.

  • To initiate a new cycle of POMALYST, the platelet count must be at least 50,000 per mcL.2

In MM-003, thrombocytopenia of any grade was reported in 30% of patients treated with POMALYST + low-dose dex vs 29% treated with high-dose dex.3†

*Permanently discontinue POMALYST if unable to tolerate 1 mg once daily.
†POMALYST + low-dose dex, n=300; high-dose dex, n=150.

  • To initiate a new cycle of POMALYST, the neutrophil count must be at least 500 per mcL.2

In MM-003, neutropenia of any grade was reported in 51% of patients treated with POMALYST + low-dose dex vs 21% treated with high-dose dex.3§

‡Permanently discontinue POMALYST if unable to tolerate 1 mg once daily.
§POMALYST + low-dose dex, n=300; high-dose dex, n=150.

Important Dosing Information

  • POMALYST may be taken with or without food. Inform patients not to break, chew or open the capsules. Swallow capsules whole with water.
  • Monitor CBCs every week for the first 8 weeks and monthly thereafter. Patients may require dose interruption and/or modification.
  • Monitor liver function tests monthly. Stop POMALYST upon elevation of liver enzymes and evaluate. After return to baseline values, treatment at a lower dose may be considered.
  • Reduce POMALYST dose to 3 mg orally daily in patients with mild to moderate hepatic impairment and to 2 mg in patients with severe hepatic impairment.
  • 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.
  • Reduce POMALYST dose to 3 mg orally daily in patients with severe renal impairment requiring dialysis. Take dose of POMALYST following hemodialysis on hemodialysis days.

Permanently discontinue POMALYST for angioedema, anaphylaxis, Grade 4 rash, skin exfoliation, bullae, or any other severe dermatologic reaction.

For other Grade 3 or 4 toxicities2:

  • Hold treatment. Restart treatment at 1 mg less than the previous dose when the toxicity has resolved to less than or equal to Grade 2 at the physician’s discretion.

ANC, absolute neutrophil count; CBC, complete blood count; dex, dexamethasone.

POMALYST patient case: managing thrombocytopenia

POMALYST® (pomalidomide) Patient

Learn how dose modification can help keep a patient with thrombocytopenia on treatment.

Download

Clinical Study Data on POMALYST

Approved and recommended in multiple treatment regimens2,4-7

POMALYST: FDA approved in a doublet and multiple triplet
regimens2,4-6

POMALYST® (pomalidomide) Triplet Regimens Graphic

A patient’s tolerance for increased toxicity should be considered.8

  • To view the most recent and complete version of the guidelines, go online to NCCN.org.

NCCN=National Comprehensive Cancer Network® (NCCN®)

NCCN Recommendations ChartAfter two prior therapies, including lenalidomide and a PI.
#After two prior therapies, including an IMiD and a PI with disease progression on/within 60 days of completion of last therapy.

Proven efficacy in multiple treatment regimens

A proven doublet in RRMM2

POMALYST 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.

View Doublet Data

Multiple proven triplets in RRMM4-6

In patients with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, POMALYST and dexamethasone can be combined with EMPLICITI, daratumumab (dara), or isatuximab-irfc (isa).

Proven triplet data with POMALYST

POMALYST + dexamethasone + daratumumab (DPd)

The EQUULEUS trial evaluated
the efficacy and safety of
POMALYST + dex + dara.4

EQUULEUS Data

POMALYST + dexamethasone + EMPLICITI (EPd)

The ELOQUENT-3 trial evaluated
the efficacy and safety of
POMALYST + dex + EMPLICITI.5

ELOQUENT-3 Data

POMALYST + dexamethasone + isatuximab-irfc (IsaPd)

The ICARIA-MM trial evaluated
the efficacy and safety of
POMALYST + dex + isa.6

ICARIA-MM Data

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

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.

Daratumumab is associated with the following Warnings and Precautions: 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.

EMPLICITI with POMALYST and dexamethasone is associated with Warnings and Precautions related to: Infusion Reactions, Infections, Second Primary Malignancies, Hepatotoxicity, Interference With Determination of Complete Response, Pregnancy/Females and Males of Reproductive Potential, and Adverse Reactions. Please see detailed Important Safety Information.

CONTRAINDICATIONS FOR ISATUXIMAB-IRFC

  • Isatuximab-irfc is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients.

Isatuximab-irfc is associated with the following Warnings and Precautions: Infusion-Related Reactions, Neutropenia, Second Primary Malignancies, Laboratory Test Interference With Serological Testing (Indirect Antiglobulin Test), Laboratory Test Interference With Serum Protein Electrophoresis and Immunofixation Tests, Embryo-Fetal Toxicity.

ANC, absolute neutrophil count; CBC, complete blood count; dara, daratumumab; dex, dexamethasone; FDA, U.S. Food & Drug Administration; IMiD, immunomodulatory; isa, isatuximab; MM, multiple myeloma; RRMM, relapsed/refractory multiple myeloma.

Starting POMALYST

Getting started with the POMALYST Risk Evaluation and Mitigation Strategy (POMALYST REMS®)

Learn more about
POMALYST REMS to
help patients navigate
the program.
POMALYST REMS Patient Resources

REMS Companion App

An overview of the REMS Companion App and instructions on how to download, log in, and use the app.

Download

Starting patients on POMALYST

POMALYST REMS

Because of the embryo-fetal risk, POMALYST is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) program 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-Physician 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, and males must comply with contraception requirements.
  • Pharmacies must be certified with the POMALYST REMS program; must only dispense to patients who are authorized to receive POMALYST; and must comply with REMS requirements.

Further information about the POMALYST REMS program is available at:
www.CelgeneRiskManagement.com or by telephone at 1-888-423-5436.

WARNINGS AND PRECAUTIONS
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. POMALYST is only available through the POMALYST REMS program.

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 females with regular menstrual cycles, or every 2 weeks in females with irregular menstrual cycles.

Males

Pomalidomide is present in the semen of patients receiving the drug. Therefore, 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. Male patients taking POMALYST must not donate sperm.

Blood Donation

Patients must not donate blood during treatment with POMALYST and for 1 month following discontinuation of POMALYST therapy because the blood might be given to a pregnant female patient whose fetus must not be exposed to POMALYST.

Access and Financial Resources

Learn about the enrollment process

BMS Access Support® Can Provide
Patient Access and Reimbursement Assistance

Bristol Myers Squibb is committed to helping patients gain access to their prescribed BMS medications. That’s why we offer BMS Access Support. BMS Access Support provides resources to help patients understand their insurance coverage. In addition, we can share information on sources of financial support, including co-pay assistance for eligible commercially insured patients.

BMS Support Center Icon

How BMS Access Support May Help

Find out how BMS can work with patients and their healthcare
providers to help access a prescribed BMS medication.

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Financial Support Options

There may be programs and services that could help with the
cost of treatment. Learn about what options are available.

Videos and Reimbursement Resources Icons

Additional Resources

We provide videos, tools, and other resources that may help
with your access and reimbursement needs.

Have Questions About Our Program or Possible Financial Support?

If you have questions about coverage for a prescribed BMS medication, BMS Access Support may be able to help. Patients and their healthcare provider can complete an enrollment form to learn about programs that may be of assistance. Visit our website or contact BMS Access Support to learn more.

Mobile Phone Icon

Call Bristol Myers Squibb Access Support at
1-800-861-0048, 8 AM to 8 PM ET, Monday–Friday

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Visit www.BMSAccessSupport.com

The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and the patient. Bristol Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item.

Patient Resources and Tools

Find information and support for patients living with RRMM

Additional POMALYST resources and tools for patients and caregivers

PATIENT AND CAREGIVER MATERIALS AVAILABLE FOR DOWNLOAD

Getting My Medication Brochure

Getting My Medication

A brochure patients can use to make sure they receive their medication.

Download
POMALYST® (pomalidomide) Medication Guide

Medication Guide

Contains FDA-approved information that can help patients learn about POMALYST.

Download
POMALYST® (pomalidomide) Treatment Overview Brochure

My Disease & Treatment

This brochure can help patients learn about their disease, treatment, and how to get ongoing support.

Download
Caregiver Brochure

Taking Care

A caregiver’s guide to supporting someone with multiple myeloma.

Download
Lab Results Tracker Brochure

Lab Results Tracker

A guide to help patients understand and track their multiple myeloma blood tests.

Download
Conversation Starter Brochure

Conversation Starter

Questions a patient or caregiver can ask to help them talk with healthcare providers about multiple myeloma and disease treatment.

Download
REMS Companion App Icon

REMS Companion App

An overview of the REMS Companion App and instructions on how to download, log in, and use the app.

Download

HELPFUL INFORMATION AND TOOLS

POMALYST® (pomalidomide) FAQ Icon

Frequently Asked Questions

View
POMALYST® (pomalidomide) Dosing & Treatment Calendar

Customizable
Treatment Calendar

Access
POMALYST® (pomalidomide) Patient & Caregiver Organizations Icon

Patient & Caregiver Organizations

Learn More
POMALYST® (pomalidomide) Patient Stories Icon

Inspiring Patient Stories

View
Specialty Pharmacy Network Icon

Specialty Pharmacy Network

Learn More

References: 1. Sonneveld P, Broijl A. Treatment of relapsed and refractory multiple myeloma. Haematologica. 2016;101(4):396-406. 2. POMALYST [package insert]. Summit, NJ: Celgene Corp. 3. San Miguel J, Weisel K, Moreau P, et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomized, open-label, phase 3 trial. Lancet Oncol. 2013;14(11)1055-1066. 4. Daratumumab [package insert]. Horsham, PA: Janssen Biotech, Inc. 5. EMPLICITI [package insert]. Princeton, NJ: Bristol-Myers Squibb Company. 6. Isatuximab-irfc [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC. 7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Multiple Myeloma V.1.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed August 16, 2021. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. 8. Mikhael J, Ismaila N, Cheung MC, et al. Treatment of multiple myeloma: ASCO and CCO Joint Clinical Practice Guideline. J Clin Oncol. 2019;37(14)1228-1263.

Hear a thought leader’s perspective on
triplet regimens with POMALYST.

Learn More

Indications for POMALYST and EMPLICITI

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.

EMPLICITI® (elotuzumab) is indicated in combination with POMALYST and dexamethasone 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 Indication

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

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.

POMALYST + dexamethasone + isatuximab-irfc Indication

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

Important Safety Information for POMALYST, EMPLICITI, daratumumab, dara SC, and isatuximab-irfc

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.

CONTRAINDICATIONS FOR ISATUXIMAB-IRFC

  • Isatuximab-irfc is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients.

WARNINGS AND PRECAUTIONS FOR POMALYST AND EMPLICITI

  • 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 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.
    • In the ELOQUENT-2 trial (EMPLICITI + lenalidomide + dexamethasone vs lenalidomide + dexamethasone) (N=635), AST/ALT >3X the upper limit, total bilirubin >2X the upper limit, and alkaline phosphatase <2X the upper limit were 2.5% (EMPLICITI arm) vs 0.6% (control arm). Of 8 patients experiencing hepatotoxicity, 2 patients discontinued treatment while 6 patients had resolution and continued. Stop EMPLICITI upon ≥Grade 3 elevation of liver enzymes. Continuation of treatment may be considered after return to baseline values. 
  • Infusion Reactions:
    • Infusion reactions were reported in 3.3% of patients treated with EMPLICITI in the ELOQUENT-3 trial [EMPLICITI + pomalidomide + dexamethasone (EPd) vs pomalidomide + dexamethasone (Pd)].
    • The only infusion reaction symptom was chest discomfort (2%), which was Grade 1. All the patients who experienced an infusion reaction had them during the first treatment cycle.
    • If a Grade 2 or higher infusion reaction occurs, interrupt the EMPLICITI infusion and institute appropriate medical and supportive measures. If the infusion reaction recurs, stop the EMPLICITI infusion and do not restart it on that day. Severe infusion reactions may require permanent discontinuation of EMPLICITI therapy and emergency treatment.
    • Premedicate with dexamethasone, H1 blocker, H2 blocker, and acetaminophen prior to EMPLICITI infusion.
  • Infections:
    • In the ELOQUENT-3 trial (N=115), infections were reported in 65% of patients in both the EPd arm and the Pd arm. Grade 3-4 infections were reported in 13% (EPd) and 22% (Pd). Discontinuations due to infections were 7% (EPd) and 5% (Pd). Fatal infections were 5% (EPd) and 3.6% (Pd). Opportunistic infections were reported in 10% (EPd) and 9% (Pd). Herpes zoster was reported in 5% (EPd) and 1.8% (Pd). 
    • Monitor patients for development of infections and treat promptly.
  • 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.
    • In the EMPLICITI ELOQUENT-3 trial (N=115), invasive SPMs were 0% (EPd) and 1.8% (Pd).
    • 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.
  • Interference With Determination of Complete Response: EMPLICITI is a humanized IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein.
  • 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: 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.

WARNINGS AND PRECAUTIONS FOR ISATUXIMAB-IRFC

  • Infusion-Related Reactions: In case of Grade ≥2, interrupt isatuximab-irfc and manage medically. Permanently discontinue for Grade 4 infusion-related reactions or anaphylactic reaction.
  • Neutropenia: Monitor complete blood cell counts periodically during treatment. Monitor patients with neutropenia for signs of infection. Isatuximab-irfc dose delays and the use of colony-stimulating factor may be required to allow improvement of neutrophil count.
  • Second Primary Malignancies: Monitor patients for the development of second primary malignancies.
  • Laboratory Test Interference:
    • Interference With Serological Testing (Indirect Antiglobulin Test): Isatuximab-irfc may result in a false positive indirect antiglobulin test (indirect Coombs test). Type and screen patients prior to starting treatment. Inform blood banks that a patient has received isatuximab-irfc.
    • Interference With Serum Protein Electrophoresis and Immunofixation Tests: Isatuximab-irfc may interfere with the assays used to monitor M-protein, which may impact the determination of complete response.
  • Embryo-Fetal Toxicity: Can cause fetal harm.

ADVERSE REACTIONS FOR POMALYST AND EMPLICITI

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%).

Serious adverse reactions in the EMPLICITI ELOQUENT-3 trial were 22% (EPd) and 15% (Pd). The most frequent serious adverse reactions in the EPd arm compared to the Pd arm were: pneumonia (13%, 11%) and respiratory tract infection (7%, 3.6%).

The most common adverse reactions in EPd arm (≥20% EPd) and Pd, respectively, were constipation (22%, 11%) and hyperglycemia (20%, 15%).

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%).

ADVERSE REACTIONS FOR POMALYST + dexamethasone + isatuximab-irfc (Pd-Isa)

The most common adverse reactions (≥20% of patients receiving Pd-Isa or Pd, respectively) were upper respiratory tract infection (57%, 42%), infusion-related reactions (38%, 0%), pneumonia (31%, 23%), and diarrhea (26%, 19%). The most common hematology laboratory abnormalities (≥80% of patients) were hemoglobin decreased (99%, 97%), neutrophils decreased (96%, 92%), lymphocytes decreased (92%, 92%), and platelets decreased (84%, 79%).

Serious adverse reactions in >5% of patients who received Pd-Isa included pneumonia (26%), upper respiratory tract infections (7%), and febrile neutropenia (7%).

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 AND EMPLICITI

  • 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.
  • Pregnancy and EMPLICITI Use: There are no available data on EMPLICITI use in pregnant women to inform a drug-associated risk of major defects and miscarriage.
  • Lactation: There is no information regarding the presence of pomalidomide or elotuzumab in human milk, the effects of POMALYST or EMPLICITI on the breastfed child, or the effects of POMALYST or EMPLICITI 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 or POMALYST in combination with EMPLICITI.
  • 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 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, and full Prescribing Information for EMPLICITI.

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

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