For US health-care professionals only. Prescribing Information

Proven prevention of delayed CINV (25-120 h)

One dose of VARUBI® (rolapitant), as part of an antiemetic regimen, significantly improved complete response (CR) rates in the delayed phase of chemotherapy-induced nausea and vomiting (CINV, 25-120 h)1,2

VARUBI met its primary end point of CR (no vomiting or administration of rescue medication) in the delayed phase of CINV in three independent phase 3 studies of highly and moderately emetogenic chemotherapy (HEC and MEC) in a combined 2,402 patients.3

VARUBI increased CR rates (no vomiting or rescue medication) in the delayed phase of CINV1,2

a HEC study 1, 95% CI for delayed CR: 6.3, 22.4; VARUBI n = 264, control n = 262.3 b HEC study 2, 95% CI for delayed CR: 0.3, 16.1; VARUBI n = 271, control n = 273.3 c MEC study, 95% CI for delayed CR: 4.7, 14.8; VARUBI n = 666, control n = 666.3 d Since the start of the study, AC has been reclassified as HEC.4 Types of MEC included in this study were carboplatin, cyclophosphamide (<1,500 mg/m2), and irinotecan.2 AC, anthracycline and cyclophosphamide; CI, confidence interval; CR, complete response (no vomiting or administration of rescue medication); HEC, highly emetogenic chemotherapy; MEC, moderately emetogenic chemotherapy.

Efficacy in multiple-cycle extensions

In HEC studies 1 and 2 and the MEC study, patients had the option of continuing into a multiple-cycle extension for up to 5 additional cycles of chemotherapy, receiving the same treatment as assigned in cycle 1. At days 6 through 8 following initiation of chemotherapy, patients were asked to recall whether they had any episode of vomiting or retching or nausea that interfered with normal daily life.3 Approximately 71%-87% of patients reported no emesis and no nausea interfering with daily life.5

Adverse reactions

  • In patients receiving cisplatin-based highly emetogenic chemotherapy in cycle 1, the most common adverse reactions reported at a frequency of ≥5% and greater than control were neutropenia (9% VARUBI vs 8% control) and hiccups (5% vs 4%).

  • In patients receiving moderately emetogenic chemotherapy and combinations of anthracycline and cyclophosphamide in cycle 1, the most common adverse reactions reported at a frequency of ≥5% and greater than control were decreased appetite (9% VARUBI vs 7% control), neutropenia (7% vs 6%), and dizziness (6% vs 4%).

  • IV administration of VARUBI was associated with infusion‐related symptoms in 2.6% of patients (eg, sensation of warmth, abdominal pain, dizziness, and paresthesia).

Evaluated in three phase 3 pivotal trials

An antiemetic regimen containing VARUBI was compared with an active-controlled antiemetic regimen in three phase 3, double-blind, global clinical trials1-3

5-HT3 RA, 5-hydroxytryptamine-3 (serotonin) receptor antagonist.

All phase 3, placebo-controlled, double-blind, randomized, global clinical trials examined the administration of VARUBI or placebo in combination with granisetron and dexamethasone.1-3

  • Patients were randomized to receive VARUBI or placebo on day 1 prior to chemotherapy1,2
  • Both VARUBI and placebo groups received granisetron and dexamethasone, followed by chemotherapy administration1,2
  • Events of emesis and use of rescue medication were recorded for 5 days1,2

Primary end point was complete response (CR, no vomiting or administration of rescue medication) in the delayed phase of CINV (25-120 h)3

Study design was similar across three phase 3 trials

Study design: HEC studies 1 and 2

a Granisetron dosing on day 1 prior to chemotherapy was 10 mcg/kg IV.1 b Dexamethasone dosing on day 1 prior to chemotherapy was 20 mg PO. Dosing on days 2-4 was 8 mg BID PO.1 5-HT3, 5-hydroxytryptamine-3 (serotonin); BID, twice a day; CR, complete response; HEC, highly emetogenic chemotherapy; IV, intravenous; PO, by mouth; RA, receptor antagonist.

For HEC studies 1 and 2, patients received a chemotherapy regimen that included cisplatin >60 mg/m2.3

Study design: MEC study

a Granisetron dosing on day 1 prior to chemotherapy was 2 mg PO. Granisetron dosing on days 2-3 was 2 mg PO daily.2 b Dexamethasone dosing on day 1 prior to chemotherapy was 20 mg PO.2 5-HT3, 5-hydroxytryptamine-3 (serotonin); CR, complete response; MEC, moderately emetogenic chemotherapy; PO, by mouth; RA, receptor antagonist.

For the MEC study, more than half of patients in the VARUBI and control groups received AC-based chemotherapy (a combination of an anthracycline and cyclophosphamide), which has since been reclassified as highly emetogenic.2,4 Of non–AC-based MEC, carboplatin was the most commonly administered chemotherapy, comprising 29% of patients in the VARUBI group and 31% of patients in the control group.2 Other MEC included cyclophosphamide (<1,500 mg/m2) and irinotecan.2

Patient demographics

The VARUBI and control groups were balanced with respect to age, sex, nationality, alcohol consumption, primary tumor site, and type of chemotherapy administered.1,2