For: Multiple Myeloma
Evomela (melphalan) is an alkylating agent used as a high-dose conditioning treatment prior to stem cell transplantation in patients with multiple myeloma (MM), and for the palliative treatment of patients with MM for whom oral therapy is not appropriate. These highlights do not include all the information needed to use EVOMELA® safely and effectively. See full prescribing information for EVOMELA.
EVOMELA (melphalan) for injection, for intravenous use.
Initial U.S. Approval: 1964
WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, AND LEUKEMOGENICITY
See full prescribing information for complete boxed warning.
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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. (5.1)
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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. (5.4)
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Melphalan produces chromosomal aberrations in vitro and in vivo. Evomela should be considered potentially leukemogenic in humans. (5.5)
RECENT MAJOR CHANGES
Dosage and Administration (2.4) 09/2017
INDICATIONS AND USAGE
Evomela is an alkylating drug indicated for:
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use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. (1.1)
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the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. (1.2)
DOSAGE AND ADMINISTRATION
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For Conditioning Treatment, the recommended dose of Evomela is 100 mg/m2/day administered over 30 minutes by intravenous infusion for 2 consecutive days (Day -3 and Day -2) prior to autologous stem cell transplantation (ASCT, Day 0). (2.1)
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For Palliative Treatment, the recommended dose of Evomela is 16 mg/m2 administered as a single intravenous infusion over 15-20 minutes at 2-week intervals for 4 doses, then, after adequate recovery from toxicity, at 4-week intervals. (2.2)
DOSAGE FORMS AND STRENGTHS
For Injection: 50 mg per vial, lyophilized powder in a single-dose vial for reconstitution. (3)
CONTRAINDICATIONS
History of serious allergic reaction to melphalan
WARNINGS AND PRECAUTIONS
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Gastrointestinal toxicity: Nausea, vomiting, diarrhea or oral mucositis may occur; provide supportive care using antiemetic and antidiarrheal medications as needed. (2.1, 5.2)
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Embryo-fetal toxicity: Can cause fetal harm. Advise of potential risk to fetus and to avoid pregnancy. (5.6, 8.1, 8.3)
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Infertility: Melphalan may cause ovarian function suppression or testicular suppression. (5.7)
ADVERSE REACTIONS
Most common adverse reactions observed in at least 50% of patients treated with Evomela are neutrophil count decreased, white blood cell count decreased, lymphocyte count decreased, platelet count decreased, diarrhea, nausea, fatigue, hypokalemia, anemia, and vomiting. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Acrotech at 1-888-292-9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS
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Nursing mothers: Advise women against breastfeeding while being treated with Evomela. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 8/2019