Rolapitant (Intravenous)

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

This medicine is given only by or under the direct supervision of your doctor.

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.

If you plan to have children, talk with your doctor before receiving this medicine. Some women receiving 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 weigh the risks of taking the medicine against the benefits it will provide. Here are some important considerations for this medicine:

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 may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how age affects the use of rolapitant injection in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems for older adults that would limit the use of rolapitant injection. 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 during 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 there could be an interaction. If you receive this medicine, it is crucial for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been highlighted for their potential importance but may not include all possibilities.

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 your other medicines.

• Eliglustat
• Pimozide
• Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but it may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of 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 drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or frequency of 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 around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

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

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

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

More common

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

Less common

• Bladder pain
• Bloody or cloudy urine
• Difficult, burning, or painful urination
• Frequent urge to urinate
• Troubled breathing with exertion

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 tell you how to prevent or reduce 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

• Belching
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• Feeling of warmth
• 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

Pharmacologic Class: Neurokinin-1 Receptor Antagonist

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed into one of your veins.

This medicine must be given slowly, so the IV tube will have to stay in place for 30 minutes. It will be given on the first day of your chemotherapy session, within 2 hours before the start of treatment.

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