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

   www.accessdata.fda.gov › drugsatfda_docs › label

   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 › labelThis label may not be the latest approved by FDA. For current...

   www.accessdata.fda.gov › drugsatfda_docs › label

   POMALYST is a thalidomide analogue indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease...

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

   www.accessdata.fda.gov › drugsatfda_docs › label

   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...

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

   www.fda.gov › drugs › electronic-drug-registration-and-listing-system-edrls

   • Αποθηκευμένο αντίγραφο

   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 use...

5. www.bms.com › assets › bmsPRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr...

   www.bms.com › assets › bms

   25 Ιαν 2024 · POMALYST® (pomalidomide) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. • Potential for human birth defects, stillbirths, and spontaneous abortions (see

6. packageinserts.bms.com › medguide › medguide_pomalystPOMALYST Medication Guide - BMS

   packageinserts.bms.com › medguide › medguide_pomalyst

   What is the most important information I should know about POMALYST (pomalidomide)? Before you begin taking POMALYST, you must read and agree to all of the instructions in the POMALYST REMS® program. For more information, call 1-888-423-5436 or go to www.pomalystrems.com.

7. fda.report › media › 84979MEDICATION GUIDE POMALYST (POM-uh-list) (pomalidomide) capsules...

   fda.report › media › 84979

   How should I take POMALYST? Take POMALYST exactly as prescribed and follow all the instructions of the POMALYST REMS program. • Swallow POMALYST capsules whole with water 1 time a day. Do not break, chew, or open your capsules. • Do not open the POMALYST capsules or handle them any more than needed.