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Indication
x 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.

See other indications for POMALYST:

Kaposi sarcoma (KS)

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

Prescribing Information

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POMALYST® (pomalidomide) nurse resources.

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.

Quick Links

POMALYST REMS® My Disease & Treatment Brochure Medication Guide

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.

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.

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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.

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Straightforward dosing, based on renal impairment.2

POMALYST® (pomalidomide) Renal Dosing – Recommended Dosage of Pomalyst Based on Renal Function

Capsules shown are not actual size. 1 cycle = 28 days.

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) 4mg, 3mg, 2mg, 1mg Capsule Dosage Strengths
  • 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.

POMALYST® (pomalidomide) Thrombocytopenia Dose Modification Chart

*Permanently discontinue POMALYST if unable to tolerate 1 mg once daily.

  • To initiate a new cycle of POMALYST, the platelet count must be at least 50,000 per mcL2

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.2†

†POMALYST + low-dose dex, n=300; high-dose dex, n=150.

POMALYST® (pomalidomide) Neutropenia Dose Modification Chart

*Permanently discontinue POMALYST if unable to tolerate 1 mg once daily.

‡Fever greater than or equal to 38.5 °C and ANC less than 1000 per mcL.

  • To initiate a new cycle of POMALYST, the neutrophil count must be at least 500 per mcL2

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.2†

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.

†POMALYST + low-dose dex, n=300; high-dose dex, n=150.

POMALYST patient case: managing thrombocytopenia

Female POMALYST® (pomalidomide) Patient

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

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Now Is the Time for a Different IMiD®

Explore the evidence- studies of POMALYST-containing regimens as early as first relapse Explore the evidence- studies of POMALYST-containing regimens as early as first relapse
NCCN Recommendations Chart NCCN Recommendations Chart

Information about DPd 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.

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.

Starting patients on POMALYST

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.bmsremspatientsafety.com or by telephone at 1-888-423-5436.

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

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 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.

Patient Access, Reimbursement, and Co-Pay Support

Available Through

Bristol Myers SquibbTM Access Support® Site

Bristol Myers Squibb is committed to helping appropriate patients initiate and maintain access to our medications during the treatment journey. That’s why we created BMS Access Support®, which offers benefit review, prior authorization assistance, and appeal process support, as well as an easy-to-initiate co-pay assistance process and information on financial support. The BMS Access Support Co-pay Assistance Program assists with out-of-pocket co-payment or co-insurance requirements for eligible, commercially insured patients who have been prescribed certain Bristol-Myers Squibb products, including POMALYST. For more information, visit BMS Access Support, or call BMS Access Support at 1-800-861-0048, 8 AM to 8 PM ET, Monday–Friday.

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
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     

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POMALYST® (pomalidomide) Patient & Caregiver Organizations Icon

Patient & Caregiver Organizations

Learn More
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Specialty Pharmacy Network

Learn More

ANC, absolute neutrophil count; CBC, complete blood count; D/dara, daratumumab; dara SC, daratumumab and hyaluronidase-fihj subcutaneous; d/dex, dexamethasone; EPd, POMALYST + dexamethasone + EMPLICITI® (elotuzumab); FDA, U.S. Food and Drug Administration; IsaPd, POMALYST + dexamethasone + isatuximab-irfc; IV, intravenous; LoT, lines of therapy; MM, multiple myeloma; MR, minimal response; PI, proteasome inhibitor; RRMM, relapsed/refractory multiple myeloma.

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. Daratumumab and hyaluronidase-fihj [package insert]. Horsham, PA: Janssen Biotech, Inc. 6. Bahlis NJ, Siegel D, Schiller G, et al. Pomalidomide, dexamethasone, and daratumumab immediately after lenalidomide-based treatment in patients with multiple myeloma: updated efficacy, safety, and health-related quality of life results from the phase 2 MM-014 trial. Leuk Lymphoma. 2022 Feb 8;1-11. 7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.3.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed December 8, 2022. 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. Bristol-Myers Squibb Co; January 2023.

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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.pomalystrems.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 the REMS Call Center 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.