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

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    Evomela® 4-hour stability, Propylene Glycol free.

    Evomela®

    Stable by design.

    Indications and Usage

    Evomela® is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.

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    WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, AND LEUKEMOGENICITY

    • Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) melphalan to oral melphalan have shown more myelosuppression with the IV formulation. Monitor hematologic laboratory parameters.
    • Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation of melphalan. Discontinue treatment with Evomela® for serious hypersensitivity reactions.
    • Melphalan produces chromosomal aberrations in vitro and in vivo. Evomela® should be considered potentially leukemogenic in humans.

    Evomela® Stability

    • Evomela® has a propylene glycol–free formulation1-3
    • Reconstituted product stable for 24 hours at refrigerated temperature (5°C/41°F), without precipitation1
    • Reconstituted product stable for 1 hour at room temperature1
    • Admixture solution is stable for 4 hours at room temperature in addition to the 1 hour following reconstitution1
    • Administration recommendation: infuse over 30 minutes for conditioning treatment1
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    RECONSTITUTION GUIDE
    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, Aljitawi 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.

    Evomela® Bioequivalence

    • Evomela® was FDA approved based, in part, on its bioequivalence to Alkeran via the 505(b)(2) New Drug Application regulatory pathway1-4
    • Evomela® has a PK profile comparable to conventional IV melphalan2
    See PK Comparison
    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. FDA. Center for Drug Evaluation and Research. Evomela® Drug Application. 2016.
    4. Hari P, Aljitawi 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.

    Evomela® Efficacy & Safety

    • Evomela® has a proven safety and efficacy profile for myeloablative conditioning in multiple myeloma patients undergoing ASCT1
    • Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) melphalan to oral melphalan have shown more myelosuppression with the IV formulation. Monitor hematologic laboratory parameters1
    • Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation of melphalan. Discontinue treatment with Evomela® for serious hypersensitivity reactions1
    • Melphalan produces chromosomal aberrations in vitro and in vivo. Evomela® should be considered potentially leukemogenic in humans1
    LEARN MORE
    Reference
    1. Evomela® Prescribing Information. Acrotech Biopharma Inc. 
    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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