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 DOWNLOAD PRESCRIBING INFORMATION *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.