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What is Varubi?

VARUBI contains rolapitant, a substance P/neurokinin 1 (NK1) receptor antagonist. Rolapitant hydrochloride is chemically described as (5S,8S)-8- { [(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]methyl]}-8-phenyl-1,7-diazaspiro[4.5]decan-2-one hydrochloride. Its empirical formula is CHFNO. HCl.HO, and its structural formula is:

Rolapitant hydrochloride is a white to off-white powder, with a molecular weight of 554.95. Solubility of rolapitant hydrochloride in aqueous solution is pH-dependent and is more soluble at lower pH. Rolapitant has good solubility in common pharmaceutical solvents such as ethanol, propylene glycol and 40% hydroxypropyl beta-cyclodextrin.

What does Varubi look like?

What are the available doses of Varubi?

VARUBI tablets: 90 mg rolapitant; film-coated capsule shaped, blue tablets, debossed with T0101 on one side and 100 on the other side.

VARUBI injectable emulsion: 166.5 mg/92.5 mL (1.8 mg/mL) rolapitant as a sterile, translucent white homogeneous liquid with some opalescence in a single-dose vial.

What should I talk to my health care provider before I take Varubi?

How should I use Varubi?

VARUBI 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.

The recommended dosage of VARUBI tablets and VARUBI injectable emulsion in adults in combination with a 5-HT receptor antagonist and dexamethasone for the prevention of nausea and vomiting with emetogenic cancer chemotherapy is shown in Table 1. There is no drug interaction between rolapitant and dexamethasone, so no dosage adjustment for dexamethasone is required. Administer a dexamethasone dose of 20 mg on Day 1

Administer VARUBI prior to the initiation of each chemotherapy cycle, but at no less than 2 week intervals.

Administer VARUBI tablets without regards to meals.

What interacts with Varubi?

Sorry No Records found

What are the warnings of Varubi?

Sorry No Records found

What are the precautions of Varubi?

Sorry No Records found

What are the side effects of Varubi?

Sorry No records found

What should I look out for while using Varubi?

VARUBI is contraindicated in patients:

What might happen if I take too much Varubi?

There are no data on overdose with VARUBI.

There is no antidote for VARUBI overdose. Discontinue VARUBI in the event of overdose, and institute general supportive measures and close observation.

How should I store and handle Varubi?

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].Butalbital and Acetaminophen, 50 mg/ 325 mg: White, capsule shaped tablet debossed “LL 721” on one side and plain on the other, in bottles of 100 tablets (NDC 70362-721-01).ALLZITAL (butalbital and acetaminophen, 25 mg/ 325 mg): White, capsule shaped tablet debossed “LL 722” on one side and plain on the other, in bottles of 100 tablets (NDC 70362-722-01).Butalbital and Acetaminophen, 50 mg/ 325 mg: White, capsule shaped tablet debossed “LL 721” on one side and plain on the other, in bottles of 100 tablets (NDC 70362-721-01).ALLZITAL (butalbital and acetaminophen, 25 mg/ 325 mg): White, capsule shaped tablet debossed “LL 722” on one side and plain on the other, in bottles of 100 tablets (NDC 70362-722-01).


Clinical Information

Chemical Structure

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Clinical Pharmacology

Rolapitant is a selective and competitive antagonist of human substance P/NK1 receptors. Rolapitant does not have significant affinity for the NK2 or NK3 receptors or for a battery of other receptors, transporters, enzymes and ion channels. Rolapitant is also active in animal models of chemotherapy-induced emesis.

Non-Clinical Toxicology
VARUBI is contraindicated in patients:

The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.

Butalbital and acetaminophen may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.

Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization These reactions have occurred during or soon after the infusion of VARUBI injectable emulsion. Most reactions have occurred within the first few minutes of administration. Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock.

Consult with patients to determine if the patient is hypersensitive to any component of the product (including soybean oil). Furthermore, as cross reactions to other allergens is possible, patients with known allergies to legumes or other related allergens should be monitored closely. Patients with a potential hypersensitivity should not be administered VARUBI injectable emulsion

Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment with VARUBI injectable emulsion

If anaphylaxis or any other serious hypersensitivity/infusion reaction occurs:

The following adverse reactions are discussed in greater detail in other sections of the labeling:



This information is obtained from the National Institute of Health's Standard Packaging Label drug database.

While we update our database periodically, we cannot guarantee it is always updated to the latest version.



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