Varubi (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 signals to the brain that lead to nausea and vomiting.

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

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 must weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know about any other allergies, including those to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have been no appropriate studies on how rolapitant injection affects children. Its safety and effectiveness in this age group have not been established.

Geriatric

Current studies have not found any specific problems in 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 not enough studies in women to determine if there is any risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction could happen. In these cases, your doctor may need to adjust the dose or take other precautions. When you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the following medicines. The following interactions have been chosen based on their potential importance and are not necessarily a complete list.

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

• 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.

• 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 option for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both.

• 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 certain foods due to possible 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 conditions may affect the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

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

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

Contact your doctor right away if you experience any of the following side effects:

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 disappear during treatment as your body gets used to the medicine. Your health care professional may also have ways to prevent or lessen some of these side effects. Talk to your health care professional if any of the following side effects persist, are bothersome, or if you have questions about them:

More common

• Decreased appetite
• Dizziness

Less common

• Belching
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling sensations
• Feeling of warmth
• Heartburn
• Hiccups
• Indigestion
• Stomach discomfort, upset, or pain

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

Call your doctor for medical advice about side effects. You can 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.

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