For US healthcare 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
*treatment-related adverse events

The most common adverse reactions (≥3%) observed in clinical trials with VARUBI during cycle 1 with cytotoxic chemotherapy4

Adverse reactions Cisplatin-based HEC
Adverse reactions MEC, carboplatin and combinations of anthracycline and cyclophosphamide

a Types of MEC included in this study were carboplatin, cyclophosphamide (<1,500 mg/m2), irinotecan, pemetrexed, oxaliplatin, doxorubicin, epirubicin, ifosfamide, cisplatin, and mitoxantrone.2 Since the time of this study, both carboplatin dosed at area under the curve (AUC) ≥4 and any combination of anthracycline and cyclophosphamide (AC) have been reclassified as HEC.2,5 b VARUBI, dexamethasone, and a 5-HT3 RA. c Placebo, dexamethasone, and a 5-HT3 RA. Common reactions (≥3%) shown in the table include those in which the rate for VARUBI exceeded the rate for active 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

IV safety profile

  • In healthy subjects receiving the recommended therapeutic dose of VARUBI injectable emulsion, infusion-related adverse reactions were reported in 2.6% (2/78) of subjects during the infusion and included sensation of warmth, abdominal pain, dizziness, and paresthesia
  • Since VARUBI injectable emulsion is the same active substance (rolapitant) as VARUBI tablets, adverse reactions associated with VARUBI tablets might also be expected to occur with VARUBI injectable emulsion

IV postmarketing experience4

  • The following adverse reactions have been identified during post-approval use of VARUBI injectable emulsion: hypersensitivity reactions including anaphylaxis, anaphylactoid reactions, and anaphylactic shock including back pain and chest pain, abdominal pain, erythema, feeling hot, generalized flushing, and dizziness
  • Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure
  • In postmarketing experience, severe systemic reactions have occurred within minutes of the start of infusion with VARUBI injectable emulsion

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

References: 1. Rapoport BL, Chasen MR, Gridelli C, et al. Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of cisplatin-based highly emetogenic chemotherapy in patients with cancer: two randomized, active-controlled, double-blind, phase 3 trials [published online August 11, 2015]. Lancet Oncol. doi:10.1016/S1470-2045(15)00035-2. 2. Schwartzberg LS, Modiano MR, Rapoport BL, et al. Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens in patients with cancer: a randomised, active-controlled, double-blind, phase 3 trial [published online August 11, 2015]. Lancet Oncol. doi:10.1016/S1470-2045(15)00034-0. 3. Rapoport B, Chua D, Poma A, Arora S, Wang Y, Fein LE. Study of rolapitant, a novel, long-acting, NK-1 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting (CINV) due to highly emetogenic chemotherapy (HEC) [published online May 5, 2015]. Support Care Cancer. doi:10.1007/s00520-015-2738-1. 4. VARUBI [package insert]. Waltham, MA: TESARO, Inc.; 2018. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Antiemesis v.2.2015. © National Comprehensive Cancer Network, Inc., 2015. All rights reserved. Accessed October 13, 2015. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.