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:

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IS YOUR PATIENT PROGRESSING ON REVLIMID® (lenalidomide)?

Now Is the Time for a Different IMiD®.*

*In patients with RRMM who received REVLIMID® (lenalidomide) and a PI.

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.

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.

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.

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.

Dara SC is associated with the following Warnings and Precautions: Hypersensitivity and Other Administration Reactions, Cardiac Toxicity in Patients With Light Chain (AL) Amyloidosis, Neutropenia, Thrombocytopenia, Embryo-Fetal Toxicity, Interference With Cross-Matching and Red Blood Cell Antibody Screening, and Interference With Determination of Complete Response.

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) Play Icon

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

D/dara, daratumumab; dara SC, daratumumab and hyaluronidase-fihj subcutaneous; d/dex, dexamethasone; DPd, POMALYST + dexamethasone + daratumumab; LoT, lines of therapy; MM, multiple myeloma; Pd, POMALYST + dexamethasone; Pd + dara SC, POMALYST + dexamethasone + daratumumab and hyaluronidase-fihj subcutaneous formulation; PI, proteasome inhibitor; RRMM, relapsed/refractory multiple myeloma; SC, subcutaneous.

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 randomized, 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. 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; January 2023.

DPd

The EQUULEUS trial evaluated the efficacy and safety of DPd.3

EQUULEUS Trial

Pd + dara SC

The APOLLO trial evaluated the efficacy and safety of Pd + dara SC vs Pd.4

APOLLO Trial

Additional information for DPd

The MM-014 trial evaluated the efficacy and safety of DPd.5

MM-014 Trial