In multiple myeloma, a high-dose conditioning treatment prior to stem cell transplant
Prescribing Information Important Safety Information

    Evomela® Bioequivalence

    Evomela®—Bioequivalent to conventional IV melphalan based on Phase IIa cross-over study2

    Evomela® was FDA approved based, in part, on its bioequivalence to Alkeran via the 505(b)(2) New Drug Application regulatory pathway.1-4

    Evomela® has a PK profile comparable to conventional IV melphalan2

    Bioequivalent to conventional IV melphalan based on Phase IIa cross-over study2

    Mean (+/- s.e.m.) melphalan plasma concentration-time profiles following infusion of Evomela® and Alkeran. Alkeran (melphalan) is a registered trademark of GlaxoSmithKline, distributed by ApoPharma USA Inc.

    Selected Important Safety Information

    Warnings and Precautions

    Bone Marrow Suppression:
    • For patients receiving Evomela® as part of a conditioning regimen, myeloablation occurs in all patients. Do not begin the conditioning regimen if a stem cell product is not available for rescue. Monitor complete blood counts, provide supportive care for infections, anemia and thrombocytopenia until there is adequate hematopoietic recovery.
    References
    1. Evomela® Prescribing Information. Acrotech Biopharma Inc.
    2. Aljitawi OS, Ganguly S, Abhyankar SH, et al. Phase IIa cross-over study of propylene glycol-free melphalan (LGD-353) and alkeran in multiple myeloma autologous transplantation. Bone Marrow Transplant. 2014;49(8):1042-1045.
    3. Hari P. Aijitawi OS. Arce-Lara C. et al. A phase IIb. multicenter. open-label. safety. and efficacy study of high-dose. propylene glycol-free melphalan hydrochloride for injection (Evomela®) for myeloablative conditioning in multiple myeloma patients undergoing autologous transplantation. Biol Blood Marrow Transplant. 2015:21(12):2100-2105.
    4. FDA. Center for Drug Evaluation and Research. Evomela® Drug Application. 2016.
    Important Safety Information
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    Important Safety Information
    Warnings and Precautions

    Bone Marrow Suppression: For patients receiving EVOMELA as part of a conditioning regimen, myeloablation occurs in all patients. Do not begin the conditioning regimen if a stem cell product is not available for rescue. Monitor complete blood counts, provide supportive care for infections, anemia and thrombocytopenia until there is adequate hematopoietic recovery.

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