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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POMALYST® (pomalidomide):
convenient once-daily oral dosing.

Straightforward dosing, based on renal impairment.

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

  • For patients with severe renal impairment requiring dialysis, take POMALYST following hemodialysis on the day of dialysis
  • 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 dexamethasone (dex)
    • In the Phase 3 MM-003 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


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.


  • 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 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.

AUC, area under the curve; dex, dexamethasone; FDA, US Food and Drug Administration; Pd, POMALYST + dexamethasone.

Reference: 1. POMALYST [package insert]. Summit, NJ. Celgene Corp.

Dose modifications may help
patients stay on therapy.

View Dose Modifications