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.
- with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Breakthrough Therapy Approval*
THE ONLY ONCE-DAILY ORAL TREATMENT FOR KAPOSI SARCOMA (KS)1**
POMALYST is the first FDA-approved KS treatment in over 20 years for HIV+ after failure of HAART or
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*Approved under the Breakthrough Designation Program. This approval based on overall response rate and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
**POMALYST is administered at 5 mg once daily on Days 1-21 of repeated 28-day cycles
NCCN Clinical Practice Guidelines In Oncology® recommend pomalidomide (POMALYST) + HAART as the only preferred subsequent systemic therapy option for relapsed or refractory AIDS-related KS.††To view the most recent and complete version of the NCCN Guidelines®, go online to NCCN.org.
CBC, complete blood count; NCCN®, National Comprehensive Cancer Network®.
Getting Your Patients Started on POMALYST
Recommended Dosage of POMALYST:
5 mg Once Daily
On Days 1-21 of Repeated 28-day cycles until disease progression or unacceptable toxicity. POMALYST can be taken at home or wherever is convenient for your patient. Continue HAART as HIV treatment in patients with AIDS-related KS.
Get certified for the POMALYST
POMALYST is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) program called “POMALYST REMS.” You must be certified before prescribing.LEARN MORE
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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 2 weeks for the first 12 weeks and monthly thereafter. Withhold, reduce the dose, or permanently discontinue POMALYST based on the severity of the reaction.
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, moderate or 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 4 mg orally daily in patients with severe renal impairment requiring dialysis. Take dose of POMALYST following hemodialysis on hemodialysis days.