Pomalidomide, previously known as CC-4047 or actimid, is a potent immunomodulatory molecule that exhibits antineoplastic activity for the treatment of hematological malignancies, especially relapsed and refractory multiple myeloma (MM). As a derivative of thalidomide, pomalidomide has a similar chemical structure as thalidomide except for the addition of two oxo groups in the phthaloyl ring and an amino group at the fourth position. Generally, as an immunomodulatory molecule, pomalidomide demonstrates antitumor activity through a mechanism of blocking the tumor microenvironment by modulation of tumor-supporting cytokines (TNF-α, IL-6, IL-8 and VEGF), directly down-regulating key functions of tumor cells, and engaging support from non-immune host cells.

Pomalidomide is used to treat multiple myeloma (cancer resulting from a progressive blood disease). Pomalidomide is usually given after at least two other medications have been tried without success.

Pomalidomide is also used to treat AIDS-related Kaposi sarcoma when other medications did not worked or have stopped working. pomalidomide can also be used to treat Kaposi Sarcoma in adults who are HIV-negative.

Pomalidomide is available only from a certified pharmacy under a special program. You must be registered in the program and agree to use birth control measures as required.

Pomalidomide may also be used for purposes not listed in this medication guide.

Pomalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or father is taking pomalidomide at the time of conception or during pregnancy. Even one dose of pomalidomide can cause major defects of the baby’s arms and legs, bones, ears, eyes, face, and heart. Never use pomalidomide if you are pregnant. Tell your doctor right away if your period is late while taking pomalidomide.

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Proposal 18 Quality Consistency Evaluation projects which have approved 4, and 6 projects are under approving.

Advanced international quality management system has laid solid foundation for sales.

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Professional Regulatory Affairs team supports the quality demands during the application and registration.

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