For US healthcare professionals only. Prescribing Information

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Proven.

Prevention of delayed CINV (25-120 h) across 3 pivotal trials1-3

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To request samples of VARUBI® or contact a VARUBI sales representative, call 877-VARUBI1 (877-827-8241).

CINV, chemotherapy-induced nausea and vomiting

References: 1. VARUBI® Prescribing Information, TerSera Therapeutics LLC 2. 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 randomised, active-controlled, double-blind, phase 3 trials. Lancet Oncol. 2015;16(9):1079-1089. 3. 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. Lancet Oncol. 2015;16(9):1071-1078.

Indication and Important Safety Information for VARUBI® (rolapitant)

Indication

  • VARUBI 180 mg (two 90-mg tablets), 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:

  • With known hypersensitivity to any component of the product
  • 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

  • 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%)

Other Drug Interactions

  • Strong CYP3A4 inducers: Avoid use of VARUBI in patients who require chronic administration of strong CYP3A4 inducers (e.g., 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 (e.g., methotrexate, topotecan, or irinotecan) and P-gp substrates (e.g., 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

Additional Important Safety Information for VARUBI IV

  • Contraindications: VARUBI IV is contraindicated in patients with known hypersensitivity to soybean oil
  • Warnings and Precaution: Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported with VARUBI IV, most often immediately following initiation of infusion. If symptoms occur, stop the infusion, initiate appropriate medical management, and permanently discontinue VARUBI IV
  • Adverse Reactions: IV administration of VARUBI was associated with infusion-related symptoms in 2.6% of patients (e.g., sensation of warmth, abdominal pain, dizziness, and paresthesia)

Please see the Prescribing Information for more information.

Individual patient results may vary.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also contact TerSera Therapeutics at 1-913-647-6204 or tersera@medinfodept.com.