For US health-care professionals only. Prescribing Information

VARUBI IV is the first NK-1 RA in a ready-to-use vial1-3

  • Injectable emulsion does not require reconstitution
  • Single-dose vial
  • Free of polysorbate 80

Please see complete dosing and administration information in the Prescribing Information.

IV, intravenous; NK-1, neurokinin 1; RA, receptor antagonist.

Because delayed CINV shouldn't define her.

See the defining features of VARUBI

Indication: VARUBI® (rolapitant), in combination with other antiemetic agents, is indicated in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

Contraindication: VARUBI is contraindicated in patients receiving thioridazine, a CYP2D6 substrate. A significant increase in plasma concentrations of thioridazine may result in QT prolongation and Torsades de Pointes.

CINV, chemotherapy-induced nausea and vomiting.

Despite antiemetic treatment,More than half are still suffering4

The numbers will surprise you

The majority of patients undergoing highly or moderately emetogenic chemotherapy (HEC or MEC) experience delayed chemotherapy-induced nausea and vomiting (CINV)—even when prescribed a 5-hydroxytryptamine-3 (serotonin) receptor antagonist (5-HT3 RA) and a corticosteroid.4

National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Antiemesis recognizes The need for prevention of delayed CINV5

VARUBI® (rolapitant) as part of an antiemetic regimen:Proven protection with one dose1

Discover how your patients may benefit

Warnings and precautions

Interaction with CYP2D6 substrates with a narrow therapeutic index

  • The inhibitory effect of VARUBI on CYP2D6 lasts for at least 7 days and may last longer after administration of a single dose of VARUBI
  • Avoid use of VARUBI in patients who are receiving pimozide, a CYP2D6 substrate. An increase in plasma concentrations of pimozide may result in QT prolongation
  • Monitor for adverse reactions if concomitant use of VARUBI and other CYP2D6 substrates with a narrow therapeutic index cannot be avoided

Indication and Important Safety Information for VARUBI® (rolapitant)

Indication

  • VARUBI, in combination with other antiemetic agents, is indicated in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy

Contraindication

  • VARUBI is contraindicated in patients taking CYP2D6 substrates with a narrow therapeutic index, such as thioridazine and pimozide. VARUBI can significantly increase the plasma concentrations of thioridazine and pimozide, which may result in QT prolongation and Torsades de Pointes.

Warnings and Precautions

Interaction with CYP2D6 substrates

  • VARUBI is a moderate inhibitor of CYP2D6 and significantly increases the plasma concentrations of CYP2D6 substrates for at least 28 days, with inhibitory effects expected to persist for an unknown duration.
  • Monitor for adverse reactions when VARUBI is coadministered with CYP2D6 substrates without a narrow therapeutic index (avoid coadministration with CYP2D6 substrates with a narrow therapeutic index, thioridazine and pimozide; see Contraindication). Consider interactions with CYP2D6 substrates before starting treatment with VARUBI.

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).

Other Drug Interactions

  • Strong CYP3A4 inducers: Avoid use of VARUBI in patients who require chronic administration of strong CYP3A4 inducers (eg, rifampin) as significantly reduced plasma concentrations of VARUBI can decrease the efficacy of VARUBI.
  • BCRP and P-gp substrates with a narrow therapeutic index: Oral VARUBI is an inhibitor of breast cancer resistance protein (BCRP) and P-glycoprotein (P-gp). Increased plasma concentrations of BCRP substrates (eg, methotrexate, topotecan, or irinotecan) and P-gp substrates (eg digoxin) with a narrow therapeutic index may result in potential adverse reactions. Monitor for adverse reactions related to the concomitant drug if use with VARUBI cannot be avoided. Monitor digoxin concentrations with concomitant use of VARUBI, and adjust the dosage as needed to maintain therapeutic concentrations.
  • Warfarin: Monitor INR and prothrombin time and adjust the dosage of warfarin, as needed, to maintain target INR.

Please see Prescribing Information.

References: 1. VARUBI [package insert]. Waltham, MA: TESARO, Inc.; 2017. 2. EMEND for injection [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.; 2017. 3. AKYNZEO [package insert]. Iselin, NJ: Helsinn Therapeutics, Inc; 2016. 4. Grunberg SM, Deuson RR, Mavros P, et al. Incidence of chemotherapy-induced nausea and emesis after modern antiemetics. Cancer. 2004;100(10):2261-2268. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Antiemesis v.2.2017. © National Comprehensive Cancer Network, Inc., 2017. All rights reserved. Accessed May 31, 2017. 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.