VARUBI SIDE EFFECTS
- Generic Name: rolapitant tablets
- Brand Name: Varubi
- Drug Class: Antiemetic Agents, NK1 Receptor Antagonists
SIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Interaction with CYP2D6 Substrates
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In 4 controlled clinical trials in patients receiving emetogenic cancer chemotherapy, VARUBI was given in combination with a 5-HT3 receptor antagonist and dexamethasone. On Day 1 of Cycle 1 of chemotherapy, 1567 patients were treated with VARUBI and 1198 of these patients continued into the optional multiple cycle extension for up to 6 cycles of chemotherapy. The median number of cycles administered 180 mg of VARUBI was four. VARUBI 180 mg was administered to 1294 patients.
In Cycle 1 adverse reactions were reported in approximately 7% of patients treated with VARUBI compared with approximately 6% of patients treated with control therapy. The most common adverse reactions reported with an incidence of ≥3% and greater than control are listed in Table 1 and Table 2.
Table 1: Most Common Adverse Reactions in Patients Receiving Cisplatin-Based HighlyEmetogenic Chemotherapy (Cycle 1)*
| VARUBI Regimen (VARUBI, Dexamethasone, and5-HT3 Receptor Antagonist) N = 624 |
Control (Placebo, Dexamethasone, and 5-HT3 Receptor Antagonist) N = 627 |
|
| Neutropenia | 9% | 8% |
| Hiccups | 5% | 4% |
| Abdominal Pain | 3% | 2% |
| * all reactions occurring at ≥3% in the VARUBI group and for which the rate for VARUBI exceeds the rate for control | ||
Table 2: Most Common Adverse Reactions in Patients Receiving Moderately Emetogenic Chemotherapy and Combinations of Anthracycline and Cyclophosphamide (Cycle 1)*
| VARUBI Regimen (VARUBI, Dexamethasone, and5-HT3 Receptor Antagonist) N = 670 |
Control (Placebo, Dexamethasone, and5-HT3 Receptor Antagonist) N = 674 |
|
| Decreased appetite | 9% | 7% |
| Neutropenia | 7% | 6% |
| Dizziness | 6% | 4% |
| Dyspepsia | 4% | 2% |
| Urinary tract infection | 4% | 3% |
| Stomatitis | 4% | 2% |
| Anemia | 3% | 2% |
| *all reactions occurring at ≥3% in the VARUBI group and for which the rate for VARUBI exceeds the rate for control. | ||
Adverse reactions in the multiple-cycle extensions of highly and moderately emetogenic chemotherapy studies for up to 6 cycles of chemotherapy were generally similar to that observed in Cycle 1.
SRC: NLM .