EVOMELA

Mean (± SD) peak plasma concentrations and AUC 0-inf were 5.8 ± 1.5 mcg/mL and 451 ± 109 mcg*min/mL, respectively, following administration of melphalan 100 mg/m 2 in multiple myeloma patients.

DistributionThe volume of distribution of melphalan ranges from approximately 35.5 to 185.7 L/m 2 . Melphalan penetrates into cerebrospinal fluid (CSF). Protein binding of melphalan ranges from approximately 50% to 90%, primarily to serum albumin (40% to 60%) and to a lesser extent to α1-acid glycoprotei...

14.1 Myeloablative Conditioning in Patients with Multiple Myeloma Undergoing ASCT An open-label, single-arm, non-randomized trial of Evomela was conducted at 5 US centers (NCT 01660633). The 61 patients enrolled had symptomatic multiple myeloma and had at least 2 × 10 6 CD34+ cells/kg cryopreserved stem cells available. The median age was 62 years (range 32 to 73); 57% male, 80% white, 18% black, 2% Asian. Evomela was administered at 100 mg/m 2 /day over 30 minutes by IV infusion for two consecutive days (Day -3 and Day -2) prior to ASCT (Day 0). The objective of the trial was to determine the...

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 Biopharma Inc. at 1-888-292-9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch The following serious adverse reactions are described in more detail in other sectio...

History of serious allergic reaction to melphalan. History of serious allergic reaction to melphalan

Gastrointestinal toxicity: Nausea, vomiting, diarrhea or oral mucositis may occur; provide supportive care using antiemetic and antidiarrheal medications as needed. ( 2.1 , 5.2 ) Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.6 , 8.1 , 8.3 ) Infertility: Melphalan may cause ovarian function suppression or testicular suppression. ...

7 DRUG INTERACTIONS No formal drug interaction studies have been conducted. The development of severe renal impairment has been reported in patients treated with a single dose of intravenous melphalan 140-250 mg/m 2 followed by standard oral doses of cyclosporine. Intravenous melphalan may also reduce the threshold for BCNU lung toxicity.