EVOMELA SIDE EFFECTS
- Generic Name: melphalan for injection, for intravenous use
- Brand Name: Evomela
- Drug Class: Antineoplastics, Alkylating
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 .