Evomela

EVOMELA Stability

EVOMELA—Stable by design

Healthcare professionals involved with melphalan preparation and administration can have access to a formulation with 4-hour admixture stability. EVOMELA offers the therapeutic benefits you expect, with stability that allows for scheduling flexibility.1

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  • Bioequivalent to conventional IV melphalan2
  • The only IV melphalan product that is FDA approved for use as a high-dose conditioning treatment in patients with multiple myeloma undergoing autologous stem cell transplantation1,3
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  • 24-hour stability after reconstitution when refrigerated at 5°C
    • 1-hour stability after reconstitution at room temperature1
  • Propylene glycol—free formulation1
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  • 4-hour admixture stability opens a 4-hour window of time to complete an infusion1
  • Administration recommendations:
    • Infuse over 30 minutes for conditioning treatment1,4
    • Infuse over 15–20 minutes for palliative treatment1

Selected Important Safety Information

Contraindications

  • History of serious allergic reaction to melphalan.

Warnings and Precautions

Secondary Malignancies:
  • Secondary malignancies such as myeloproliferative syndrome or acute leukemia have been reported in multiple myeloma patients treated with melphalan-containing chemotherapy regimens. The potential benefit of EVOMELA therapy must be considered against the possible risk of the induction of a secondary malignancy.
Embryo-Fetal Toxicity:
  • EVOMELA can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to avoid pregnancy during and after treatment with EVOMELA. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, advise the patient of potential risk to the fetus.
Infertility:
  • Melphalan-based chemotherapy regimens have been reported to cause suppression of ovarian function in premenopausal women, resulting in persistent amenorrhea in approximately 9% of patients. Reversible or irreversible testicular suppression has also been reported.

EVOMELA—4‐hour admixture stability1

As a reconstituted drug product:

  • Stable for 24 hours at 5°C (41°F)—without precipitation1
  • Stable for 1 hour at room temperature1

As an admixture:

  • Stable for 4 hours at room temperature after reconstitution1

Preparation and Administration1

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Important Preparation and Administration Information

  • EVOMELA is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
  • EVOMELA is light sensitive. Retain in original carton until use.1
  • Do not mix EVOMELA with other melphalan hydrochloride for injection drug products.1
  • EVOMELA may cause local tissue damage should extravasation occur. Do not administer by direct injection into a peripheral vein. Administer EVOMELA by injecting slowly into a fast-running IV infusion via a central venous access line.1
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.1

EVOMELA—A propylene glycol–free formulation1

EVOMELA is formulated with a modified cyclodextrin, Betadex Sulfobutyl Ether Sodium1,5

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  • The modified cyclodextrin forms reversible inclusion complexes with melphalan that improve solubility and stability in aqueous solutions5
  • Once in the bloodstream, the cyclodextrin rapidly dissociates from melphalan due to dilution by blood5

Selected Important Safety Information

Warnings and Precautions

Gastrointestinal Toxicity:
  • For patients receiving EVOMELA as part of a conditioning regimen, nausea, vomiting, mucositis, and diarrhea may occur in over 50% of patients. Use prophylactic antiemetic medication. Provide supportive care for nausea, vomiting, diarrhea, and mucositis. The frequency of grade 3/4 mucositis in clinical studies was 13%. Provide nutritional support and analgesics for patients with severe mucositis.
  • For patients receiving EVOMELA as palliative treatment, nausea and vomiting, diarrhea, and oral ulceration may occur. Use prophylactic antiemetics. Provide supportive care for nausea, vomiting, diarrhea and mucositis.

References

  1. EVOMELA [prescribing information]. Irvine, CA: Spectrum Pharmaceuticals; March 2016.
  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. Melphalan Hydrochloride for Injection [prescribing information]. Mylan Institutional LLC; August 2012.
  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.
  5. Stella VJ, He Q. Cyclodextrins. Toxicol Pathol. 2008;36(1):30-42.