Varubi (Oral)

Rolapitant is used along with other medicines (for example, dexamethasone) to prevent delayed nausea and vomiting caused by cancer treatments (chemotherapy). Rolapitant is a substance P/neurokinin 1 (NK1) receptor antagonist. It works by blocking the signals to the brain that lead to nausea and vomiting.

This medicine is available only with your doctor's prescription.

Check with your doctor if severe nausea and vomiting continue after leaving the hospital or cancer treatment center.

Do not take this medicine if you are also using pimozide (Orap®) or thioridazine (Mellaril®). Using these medicines together may cause serious unwanted effects, including heart rhythm problems.

Talk with your doctor before using this medicine if you plan to have children. Some women who use this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine against the benefits it may provide. For this medicine, here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, like to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies done on how rolapitant affects children. Its safety and effectiveness in children have not been established. This medicine should not be given to children younger than 2 years old.

Geriatric

Studies done so far have not shown any specific problems in older adults that would limit the benefits of rolapitant. However, older patients may be more sensitive to the effects of this medicine compared to younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could occur. In these situations, your doctor may want to adjust the dose, or take other precautions. When using this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The interactions listed are chosen based on their potential importance and are not necessarily complete.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to prescribe this medication or may change some of the other medicines you are taking.

• Eliglustat
• Pimozide
• Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both medicines.

• Abametapir
• Amphetamine
• Benzphetamine
• Carbamazepine
• Clozapine
• Codeine
• Dextroamphetamine
• Dextromethorphan
• Digoxin
• Dihydrocodeine
• Fedratinib
• Fexinidazole
• Fluoxetine
• Fosnetupitant
• Fosphenytoin
• Hydroxyamphetamine
• Itraconazole
• Lisdexamfetamine
• Mavacamten
• Methamphetamine
• Nebivolol
• Netupitant
• Omaveloxolone
• Oxycodone
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• Rosuvastatin
• St John's Wort
• Tamoxifen
• Tramadol

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both medicines.

• Docetaxel
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Epirubicin
• Etoposide
• Fluorouracil
• Irinotecan
• Irinotecan Liposome
• Methotrexate
• Topotecan

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime or with certain types of food, as interactions may happen. Using alcohol or tobacco with certain medicines can also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine is used. Make sure to inform your doctor if you have any other medical conditions, especially:

• Liver disease, severe—Use with caution. This may worsen the condition.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may occur, but if they do, they might need medical attention.

Check with your doctor right away if any of the following side effects happen:

More common

• Black, tarry stools
• Chills
• Cough
• Difficult, burning, or painful urination
• Fever
• Lower back or side pain
• Pale skin
• Sore throat
• Trouble breathing
• Ulcers, sores, or white spots in the mouth
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Less common

• Bladder pain
• Bloody or cloudy urine
• Frequent urge to urinate

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to suggest ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Decreased appetite
• Dizziness

Less common

• Acid or sour stomach
• Belching
• Heartburn
• Hiccups
• Indigestion
• Stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Varubi

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiemetic

Pharmacologic Class: Neurokinin-1 Receptor Antagonist

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Each single-dose packet contains two 90-mg tablets for a total dose of 180 mg. Take both tablets in the packet unless directed by your doctor to take a different dose

This medicine should come with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For prevention of nausea and vomiting caused by chemotherapy: Adults—180 milligrams (mg) (2 tablets) taken 2 hours before starting cancer treatment. Do not take this medicine more than one time every 14 days. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Will a single dose of Varubi stop vomiting for days?
• How long does a dose of Varubi last?