Welcome to PS-Pomalidomide REMS
Important information about pomalidomide and PS-Pomalidomide Risk Evaluation and Mitigation Strategy (REMS)
- Pomalidomide is contraindicated in pregnant females and females capable of becoming pregnant. Females of reproductive potential may be treated with pomalidomide provided adequate precautions are taken to avoid pregnancy
- To avoid embryo-fetal exposure, pomalidomide is only available under a restricted distribution program called “PS-Pomalidomide REMS”
- Only prescribers and pharmacies certified by PS-Pomalidomide REMS can prescribe and dispense pomalidomide to patients who are enrolled and meet all the conditions of PS-Pomalidomide REMS
The goals of the PS-Pomalidomide REMS are as follows:
- To prevent the risk of embryo-fetal exposure to pomalidomide
- To inform prescribers, patients, and pharmacists of the serious risks and safe-use conditions for pomalidomide
The PS-Pomalidomide REMS includes both POMALYST® (pomalidomide) and generic pomalidomide products. The pomalidomide manufacturers have a contractual agreement for administration of the PS-Pomalidomide REMS. All manufacturers retain responsibility for the actions described in the REMS.
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