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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A well-established safety profile.1

8% of patients discontinued POMALYST® (pomalidomide) + dex (Pd) due to adverse reactions.

aSerious adverse reactions were reported in at least 3 patients in the POMALYST + low-dose dex arm, AND at least 1% higher than the high-dose dex arm percentage.

Data cutoff: March 1, 2013.

Full Adverse Reactions Table

Grade 3 or 4 adverse reactions1

  • (≥15% in the POMALYST + low-dose dex arm and ≥1% higher than the high-dose dex alone) included neutropenia (48%), thrombocytopenia (22%), and pneumonia (16%)

Dose modifications due to adverse reaction(s)1

  • 67% of trial patients experienced at least one dose interruption of POMALYST, while 27% of patients experienced at least 1 dose reduction of POMALYST and 8% discontinued treatment with POMALYST
  • The median time to first dose interruption and first dose reduction of POMALYST was 4.1 weeks and 4.5 weeks, respectively


New occurrences of common (≥10%) adverse events over the first 5 cycles of Pd treatment.3

Bars represent the percentage of patients with each adverse event. Numbers above bars represent the n for each adverse event. In the POMALYST arm, 67% of patients had a dose interruption and 27% had a dose reduction of POMALYST.

Analysis Limitations: MM-003 trial captured all TEAEs. “New occurrences” is defined as first occurrence of indicated TEAE at the given treatment cycle. The additional analysis examined the AEs that occurred in greater than or equal to 10% of patients in the Pd arm. The AEs that met this requirement included neutropenia, anemia, thrombocytopenia, fatigue, pyrexia, constipation, diarrhea, leukopenia, and dyspnea. AEs were analyzed in terms of treatment-emergent adverse events (TEAEs), which were defined as any AEs that occurred or worsened on or after the start of the study drug through 30 days after the last dose of the study drug. In addition, any AE with an onset date beyond this time frame and that was assessed by the investigator as related to study drug was considered a TEAE. If the subject experienced multiple TEAEs under the same system organ class or preferred term, then the subject was counted only once. This exploratory analysis should not be interpreted to determine a difference of AE rates between treatment cycles.

AE, adverse event; dex, dexamethasone; Pd, POMALYST + dexamethasone; TEAE, treatment-emergent adverse event.

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. Data on file. Celgene Corporation, a Bristol Myers Squibb company.

Learn more about POMALYST once-daily
oral dosing and dose modification.1

See Doublet Dosing