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  1. www.accessdata.fda.gov › drugsatfda_docs › labelReference ID: 4201583 - Food and Drug Administration

    POMALYST is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a...

  2. www.accessdata.fda.gov › drugsatfda_docs › labelHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not...

    POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe life-threatening birth defects (4, 5.1, 8.1). For females...

  3. www.fda.gov › drugs › electronic-drug-registration-and-listing-system-edrlsForm FDA 2656 | FDA - U.S. Food and Drug Administration

    To apply for a waiver from the requirement to electronically submit drug establishment registration and drug listing information, provide a written request with a complete explanation of why...

  4. www.accessdata.fda.gov › drugsatfda_docs › psgPomalidomide

    Pomalyst® was approved with a Risk Evaluation and Mitigation Strategy (REMS), including elements to assure safe use (ETASU). All pertinent elements of the REMS must be incorporated into the...

  5. www.pomalyst.com › what-is-pomalystWhat Is POMALYST® (pomalidomide)?

    Learn more about FDA-approved therapy combinations, including POMALYST, to treat multiple myeloma. POMALYST REMS ® Program. Learn how to enroll in the POMALYST REMS program for multiple myeloma.

  6. dailymed.nlm.nih.gov › dailymed › drugInfoDailyMed - POMALYST- pomalidomide capsule

    24 Μαρ 2023 · See full prescribing information for POMALYST. POMALYST® (pomalidomide) capsules, for oral use ... BOXED WARNING (What is this?) Embryo-Fetal Toxicity - • POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal ...

  7. www.pomalysthcp.comPOMALYST® (pomalidomide) for Multiple Myeloma | for HCPs

    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.

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