Rolapitant
Rolapitant is an anti-nausea medicine (an NK1 receptor blocker) used with other medicines to prevent delayed nausea and vomiting after cancer chemotherapy in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Rolapitant: Patient Information Guide
A plain-language walkthrough of Rolapitant — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Rolapitant is used for
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Rolapitant is used to prevent chemotherapy-related nausea and vomiting.
- Varubi tablets (oral) are used in adults, together with other anti-nausea medicines, to prevent delayed nausea and vomiting from initial and repeat courses of emetogenic cancer chemotherapy.
- This includes, but is not limited to, highly emetogenic chemotherapy.
How Rolapitant works
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Rolapitant is a selective NK1 receptor blocker. It competes with substance P, a natural chemical linked to chemotherapy-induced vomiting, for its receptor. It crosses into the brain and occupies NK1 receptors there. It does not have significant affinity for NK2 or NK3 receptors.
How Rolapitant is taken (dosage)
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Varubi tablets are taken by mouth as one dose before chemotherapy, within 2 hours of the start. They can be taken with or without food.
- Taken before each chemotherapy cycle, at least 2 weeks apart.
- Used with a 5-HT3 receptor antagonist and dexamethasone.
- Dexamethasone dosing is set by your prescriber. Follow your care team's directions.
Rolapitant side effects in detail
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In studies, Varubi was given with other anti-nausea medicines. Common side effects were:
- Neutropenia (low white blood cell count)
- Hiccups
- Abdominal pain
- Decreased appetite
- Dizziness
- Indigestion (dyspepsia)
- Urinary tract infection
- Mouth sores (stomatitis)
- Anemia (low red blood cells)
The most serious concern is a dangerous heart rhythm problem if Varubi is combined with thioridazine or pimozide. Report side effects to your care team.
Rolapitant warnings and precautions
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- CYP2D6 interactions: Varubi raises levels of drugs broken down by CYP2D6 for at least 28 days, possibly longer.
- Thioridazine and pimozide: contraindicated because of QT prolongation and Torsades de Pointes.
- Severe liver impairment: avoid use; monitor for side effects if it cannot be avoided.
- Young children: contraindicated under 2 years of age.
Rolapitant interactions: what it interacts with
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Varubi can change how other medicines behave, so check your full medicine list.
- Thioridazine, pimozide: dangerous heart rhythm effects; do not combine.
- Other CYP2D6 medicines: levels may rise for 28+ days.
- Methotrexate, topotecan, irinotecan: levels may rise (BCRP).
- Digoxin: levels may rise (P-gp), so levels need monitoring.
- Warfarin: INR and prothrombin time should be monitored.
- Rifampin and similar strong CYP3A4 inducers: can lower Varubi levels and reduce its effect.
- Dexamethasone: no dose change is needed because of Varubi.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
Before taking Rolapitant
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- Do not use with thioridazine or pimozide.
- Not for children under 2; safety and effectiveness in children are not established.
- Pregnancy: human data are limited.
- Breastfeeding: effects on milk or infants are unknown; discuss with your doctor.
- Animal studies showed reversible reduced fertility in females.
- Older adults: no overall differences seen, but some may be more sensitive.
- Mild or moderate liver impairment: no dose change needed. Severe: avoid.
Rolapitant overdose: if you take too much
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There are no data on Varubi overdose and no antidote. If an overdose happens, Varubi is stopped and general supportive care and close observation are given.
Pharmacodynamics: what Rolapitant does in the body
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Rolapitant crosses the blood-brain barrier and occupies NK1 receptors in the brain, with higher doses occupying more. At the usual dose, occupancy was 73% at 120 hours in healthy people. At four times the recommended dose, it did not prolong the QT interval to a clinically relevant extent.
Pharmacokinetics: how your body processes Rolapitant
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After a dose, rolapitant appears in the blood within 30 minutes and peaks in about 4 hours. A high-fat meal does not significantly change absorption. It has a long half-life of about 7 days and is broken down mainly by CYP3A4 into an active metabolite. It leaves the body mainly through the liver and bile, with most found in the feces.
How to store Rolapitant
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Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15°C to 30°C (59°F to 86°F) .
📄 Written from Rolapitant’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Rolapitant: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Rolapitant — the kind of thing our pharmacy team would talk through with you at the counter.
What is Varubi for?
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How and when do I take it?
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What side effects should I expect?
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Are there medicines I can't take with it?
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Is it safe in pregnancy or while breastfeeding?
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Can children take it?
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Is Rolapitant available over the counter?
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When was Rolapitant first available?
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Who makes Rolapitant?
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💬 Answers drafted from Rolapitant’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Rolapitant on HelloPharmacist
💊 Rolapitant forms and strengths (how it comes)
Rolapitant is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Varubi is used with other anti-nausea medicines in adults to prevent delayed nausea and vomiting from emetogenic cancer chemotherapy.
- Varubi is taken by mouth as a single dose within 2 hours before chemotherapy starts.
- Varubi can be taken with or without food.
- Varubi is given before each chemotherapy cycle, at least 2 weeks apart.
📊 Rolapitant on the U.S. market: products, makers and brands
How Rolapitant appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Rolapitant products
A representative set of FDA-listed product records for Rolapitant — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 90 mg | Oral | Luria Therapeutics LLC × 2 listings | NDA | View NDC → |
| 90 mg | — | Patheon Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 90 mg | Oral | TerSera Therapeutics LLC | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | MSN Laboratories Private Limited | BULK INGREDIENT | View NDC → |
| 100 kg/100 kg | — | Teva Czech Industries s.r.o | BULK INGREDIENT | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Rolapitant NDCs →
📈 Rolapitant side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Rolapitant — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Rolapitant in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Rolapitant FDA approval history
How Rolapitant went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Rolapitant recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1665496 2 dose forms · 2 strengths
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Dose form (SCDF) Injection RxCUI 1986884No current FDA listingClinical drug / strength (SCD) 92.5 ML rolapitant 1.8 MG/MLRxCUI 1986885 -
Dose form (SCDF) Oral Tablet RxCUI 1665501In current FDA listingsClinical drug / strength (SCD) 90 MGRxCUI 1665503
Look up RxCUI 1665496 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Rolapitant supply and shortage status
Whether Rolapitant is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Rolapitant brand names
🏭 Who makes Rolapitant: manufacturers and labelers
Rolapitant drug class (RxNorm)
Rolapitant belongs to the Substance P/Neurokinin-1 Receptor Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Rolapitant page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. TerSera Therapeutics LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.