A single oral dose as part of an antiemetic regimen

VARUBI® (rolapitant) is administered approximately 1 to 2 hours before chemotherapy1

No dose adjustment of dexamethasone is required with VARUBI, as there are no drug interactions between VARUBI and dexamethasone.1
VARUBI product
VARUBI is supplied as a single dose wallet card containing two 90-mg tablets.
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Combined antiemetic regimen dosing with VARUBI, a 5-HT3 RA, and dexamethasone1

For the prevention of delayed nausea and vomiting associated with highly and moderately emetogenic chemotherapy (HEC and MEC)

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5-HT3, 5-hydroxytryptamine-3 (serotonin); HEC, highly emetogenic chemotherapy; MEC, moderately emetogenic chemotherapy; RA, receptor antagonist.

 

Drug interactions

 
 
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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 receiving thioridazine, a CYP2D6 substrate. A significant increase in plasma concentrations of thioridazine may result in QT prolongation and Torsades de Pointes

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

Adverse reactions

  • In patients receiving cisplatin-based highly emetogenic chemotherapy in cycle 1, the most common adverse reactions reported at an incidence of ≥5% and a frequency 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 an incidence of ≥5% and a frequency greater than control were decreased appetite (9% VARUBI vs 7% control), neutropenia (7% vs 6%), and dizziness (6% vs 4%)

Drug interactions

  • VARUBI is an inhibitor of breast cancer resistance protein (BCRP) and P-glycoprotein (P-gp). Increased plasma concentrations of BCRP and P-gp substrates 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
  • 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
 

Please see full Prescribing Information.

 
 

Reference: 1. VARUBI [package insert]. Waltham, MA: TESARO, Inc.; 2015.

 
 
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Indication and Important Safety Information for VARUBI® (rolapitant)   button arrow