For US health-care professionals only. Prescribing Information

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 in cycle 1.4

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

You may report side effects to the FDA at 1-800-FDA-1088 or You may also report side effects to TESARO, Inc., at 1-844-4-TESARO (1-844-483-7276).