EVOMELA SIDE EFFECTS

  • Generic Name: melphalan for injection, for intravenous use
  • Brand Name: Evomela
  • Drug Class: Antineoplastics, Alkylating
Last updated on MDtodate: 10/05/2022

SIDE EFFECTS

The following serious adverse reactions are described in more detail in other sections of the prescribing information.

  • Bone Marrow Suppression
  • Gastrointestinal Toxicity
  • Hepatotoxicity
  • Hypersensitivity
  • Secondary Malignancies

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of Evomela may not reflect the rates observed in practice.

The most common adverse reactions observed in at least 50% of patients with multiple myeloma treated with Evomela were neutrophil count decreased, white blood cell count decreased, lymphocyte count decreased, platelet count decreased, diarrhea, nausea, fatigue, hypokalemia, anemia, and vomiting.

Myeloablative Conditioning In Multiple Myeloma Patients Undergoing ASCT

The safety of Evomela was evaluated in 61 patients with multiple myeloma in a single arm clinical trial in which patients were administered Evomela at a dosage of 100 mg/m²/day administered over ~30 minutes (range: 24-48 minutes) by intravenous (IV) infusion for 2 consecutive days (Day -3 and Day -2) prior to autologous stem cell transplant (ASCT, Day 0) [see Clinical Studies].

Table 1 summarizes the adverse reactions from the single-arm trial in patients with multiple myeloma. Severe myelosuppression is expected and these adverse reactions are not listed below.

Table 1 : Non-hematologic Adverse Reactions in ≥ 25% of Patients with Multiple Myeloma Who Received Evomela Conditioning for ASCT

Adverse Reactions Number (%) of Patients
(N=61)
All Grades Grade 3 or 4
All Adverse Reactions 61 61
Diarrhea 57 (93%) 2 (3%)
Nausea 55 (90%) 1 (2%)
Fatigue 47 (77%) 1 (2%)
Hypokalemia 45 (74%) 17 (28%)
Vomiting 39 (64%) 0 (0%)
Hypophosphatemia 30 (49%) 29 (48%)
Decreased Appetite 30 (49%) 0 (0%)
Pyrexia 29 (48%) 2 (3%)
Constipation 29 (48%) 0 (0%)
Febrile Neutropenia 25 (41%) 17 (28%)
Mucosal Inflammation 23 (38%) 6 (10%)
Dizziness 23 (38%) 0 (0%)
Edema Peripheral 20 (33%) 0 (0%)
Stomatitis 17 (28%) 3 (5%)
Abdominal Pain 17 (28%) 0 (0%)
Dysgeusia 17 (28%) 0 (0%)
Dyspepsia 16 (26%) 0 (0%)

 

Serious Adverse Reactions

Twelve (20%) patients experienced a treatment emergent serious adverse reaction while on study. The most common serious adverse reactions (>1 patient, 1.6%) were pyrexia, hematochezia, febrile neutropenia, and renal failure. Treatment-related serious adverse reactions reported in >1 patient were pyrexia (n=2, 3%), febrile neutropenia (n=2, 3%), and hematochezia (n=2, 3%).

 

SRC: NLM .