Demonstrated tolerability profile for VARUBI® (rolapitant)
Patients from three phase 3 trials (highly emetogenic chemotherapy [HEC] studies 1 and 2 and moderately emetogenic chemotherapy [MEC] study) and one phase 2 HEC trial were included in the safety population1-3
Adverse reactions with VARUBI were reported by approximately 7% of patients versus approximately 6% of patients receiving control
The most common adverse reactions (≥3%) observed in clinical trials with VARUBI during cycle 1 with cytotoxic chemotherapy4
a The VARUBI regimen consisted of VARUBI, dexamethasone, and a 5-HT3 receptor antagonist.4
b The active control regimen consisted of placebo, dexamethasone, and a 5-HT3 receptor antagonist.4
c Since the start of the study, AC has been reclassified as HEC.5 Types of MEC included in this study were carboplatin, cyclophosphamide (<1,500 mg/m2), and irinotecan.2
Common reactions (≥3%) shown in the tables include those in which the rate for VARUBI exceeded the rate for control.
5-HT3, 5-hydroxytryptamine-3 (serotonin); AC, anthracycline and cyclophosphamide; HEC, highly emetogenic chemotherapy; MEC, moderately emetogenic chemotherapy.
Safety in multiple-cycle extensions
Adverse reactions in the multiple-cycle extensions of HEC and MEC studies for up to 6 cycles of chemotherapy were generally similar to those observed in cycle 1.4
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.4