Rolapitant (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 trigger 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 will weigh the risks of taking the medicine against the benefits it may provide. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional about any other allergies you have, such as 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 on how rolapitant affects children. Its safety and effectiveness have not been established. This medicine should not be given to children younger than 2 years old.

Geriatric

Studies have not shown any specific problems that would limit the use of rolapitant in elderly patients. However, older adults may be more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are no adequate studies to determine the risk to infants when this medication is used during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together with caution. If you are taking this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or 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 adjust the dose or how often you use one or both of the 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 modify the dose or frequency of use for one or both of the 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 around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Liver disease, severe—Use with caution. It may worsen this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

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 occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or 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.