Prescription medicine
Rolapitant Brand names: Varubi
Rolapitant (Varubi) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the rolapitant FDA label on DailyMed (effective August 19, 2020, TerSera Therapeutics LLC); the NDA 206500 record on Drugs@FDA; every rolapitant label on DailyMed.
Highlights of the record
FDA label of August 19, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVARUBI ® is indicated in combination with other antiemetic agents 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.
Forms and strengths
- 90 mg
Tablet.
On the market
- Earliest approval on file
- September 1, 2015 Varubi, Tersera; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 9, 2029 Varubi tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 538 through July 30, 2026
What is rolapitant used for?
From the label: indications and usageVARUBI ® is indicated in combination with other antiemetic agents 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. VARUBI is a substance P/neurokinin 1 (NK1) receptor antagonist indicated in combination with other antiemetic agents 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.
FDA pharmacologic class: Substance P/Neurokinin-1 Receptor Antagonist.
Source: FDA drug label (Varubi), TerSera Therapeutics LLC, effective August 19, 2020 (SPL set a52896cd-4a98-49b8-82db-bf1985a64d97), via openFDA; the full label on DailyMed
Is there a generic for rolapitant (Varubi)?
No generic rolapitant is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Varubi tablets: the compound patent runs to August 19, 2028, and the last listed entry to October 9, 2029; a patent listed only for Varubi injection runs to July 14, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the rolapitant label say about other medicines?
The rolapitant label names 11 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Dexamethasone | drug interactions | Therefore, no dosage adjustment for dexamethasone (CYP3A4 substrate) is needed when co-administered with VARUBI [see Dosage and Administration (2) ]. |
| Dextromethorphan | drug interactions | The inhibition of CYP2D6 persisted on Day 28 with a 2.3-fold increase in dextromethorphan concentrations, the last time point measured. |
| Digoxin | drug interactions | P-gp Substrates with a Narrow Therapeutic Index (e.g. digoxin) Clinical Impact: Increased plasma concentrations of P-gp substrates (e.g., digoxin) may result in potential adverse reactions. Intervention: Monitor digoxin concentrations with concomitant use of VARUBI and adjust the dosage as needed to maintain therapeutic concentrations. … |
| Irinotecan | drug interactions | Clinical Impact: Increased plasma concentrations of BCRP substrates (…) may result in potential adverse reactions. Intervention: Monitor for adverse reactions related to the concomitant drug if use of VARUBI cannot be avoided. Use the lowest effective dose of rosuvastatin (see prescribing information for additional information on … |
| Methotrexate | drug interactions | Clinical Impact: Increased plasma concentrations of BCRP substrates (…) may result in potential adverse reactions. Intervention: Monitor for adverse reactions related to the concomitant drug if use of VARUBI cannot be avoided. Use the lowest effective dose of rosuvastatin (see prescribing information for additional information on … |
| Pimozide | contraindications | CONTRAINDICATIONS VARUBI is contraindicated in patients taking CYP2D6 substrates with a narrow therapeutic index, such as thioridazine and pimozide. |
| Rifampin | drug interactions | Clinical Impact: Co-administration of VARUBI with rifampin can significantly reduce the plasma concentrations of rolapitant and decrease the efficacy of VARUBI. Intervention: Avoid the use of VARUBI in patients who require chronic administration of strong CYP3A4 inducers. |
| Rosuvastatin | drug interactions | Clinical Impact: Increased plasma concentrations of BCRP substrates (…) may result in potential adverse reactions. Intervention: Monitor for adverse reactions related to the concomitant drug if use of VARUBI cannot be avoided. Use the lowest effective dose of rosuvastatin (see prescribing information for additional information on … |
| Thioridazine | contraindications | CONTRAINDICATIONS VARUBI is contraindicated in patients taking CYP2D6 substrates with a narrow therapeutic index, such as thioridazine and pimozide. |
| Topotecan | drug interactions | Clinical Impact: Increased plasma concentrations of BCRP substrates (…) may result in potential adverse reactions. Intervention: Monitor for adverse reactions related to the concomitant drug if use of VARUBI cannot be avoided. Use the lowest effective dose of rosuvastatin (see prescribing information for additional information on … |
| Warfarin | drug interactions | Warfarin Clinical Impact: Although co-administration of intravenous rolapitant (…), which has a higher C max than oral VARUBI, with warfarin did not substantially increase the systemic exposure to S-warfarin, the active enantiomer, the effects on INR and prothrombin … Intervention: Monitor INR and prothrombin time and adjust the dosage of warfarin, as needed with concomitant use of VARUBI, to maintain the target INR range. |
Source: FDA drug label (Varubi), TerSera Therapeutics LLC, effective August 19, 2020 (SPL set a52896cd-4a98-49b8-82db-bf1985a64d97), via openFDA; the full label on DailyMed
What do FAERS reports show for rolapitant?
The FDA Adverse Event Reporting System holds 538 reports that list rolapitant among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 163 are coded as a death and 115 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other substance p/neurokinin-1 receptor antagonists
- the pharmacologic class, with prices and generics
- Rolapitant side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other