See other indications for POMALYST:

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

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.

POMALYST
Perspectives

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

Choosing a POMALYST-Containing Regimen

Dr. David Siegel summarizes the expansion of POMALYST data across four trials and shares his insights about a POMALYST-containing regimen, including use as early as first relapse, after lenalidomide and a PI.

Watch a Video on POMALYST® (pomalidomide) MOA Play Icon

Mechanism of Action

Explore the mechanism of action of POMALYST.

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

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.

Now Playing

Now Playing

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

Meet Dr. Siegel

Now Playing

Now Playing

MM-003 Trial: 5 Median Prior LoT Thumbnail

MM-003 Trial: 5 Median Prior LoT

Now Playing

Now Playing

EQUULEUS Trial: 4 Median Prior LoT Thumbnail

EQUULEUS Trial: 4 Median Prior LoT

Now Playing

Now Playing

APOLLO Trial: 2 Median Prior LoT

APOLLO Trial: 2 Median Prior LoT

Now Playing

Now Playing

MM-014 Trial: 1 Median Prior LoT Thumbnail

MM-014 Trial: 1 Median Prior LoT

Now Playing

Now Playing

Conclusion and Important Safety Information Thumbnail

Conclusion and Important Safety Information

Watch Next

Watch Next

Watch a Video on POMALYST® (pomalidomide) MOA

Mechanism of Action

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® (pomalidomide) Patient Resources Icon

Resources and tools for healthcare providers

Access HCP Tools

Resources and tools for nurses and their patients

Get Started

Resources and tools for nurses and their patients

Get Started

dex, dexamethasone; DPd, POMALYST + dexamethasone + daratumumab; HCP, healthcare provider; LoT, lines of therapy; MM, multiple myeloma; Pd, POMALYST + dexamethasone; PI, proteasome inhibitor; RRMM, relapsed/refractory multiple myeloma.

References: 1. POMALYST [package insert]. Summit, NJ: Celgene Corp. 2. 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 randomised, open-label, phase 3 trial. Lancet Oncol. 2013;14(11):1055-1066. 3. Daratumumab [package insert]. Horsham, PA: Janssen Biotech, Inc. 4. Daratumumab and hyaluronidase-fihj [package insert]. Horsham, PA: Janssen Biotech, Inc. 5. 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. Online ahead of print. doi: 10.1080/10428194.2022.2030477. 6. 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. 7. Bristol-Myers Squibb Co; November 2022.