Varubi intravenous

In the U.S.

• Varubi

Available Dosage Forms:

• Emulsion

Therapeutic Class: Antiemetic

Pharmacologic Class: Neurokinin-1 Receptor Antagonist

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

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rolapitant injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rolapitant injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

• Thioridazine

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

• Amphetamine
• Benzphetamine
• Carbamazepine
• Dextroamphetamine
• Digoxin
• Fosphenytoin
• Lisdexamfetamine
• Methamphetamine
• Nebivolol
• Netupitant
• Phenytoin
• Pimozide
• Rifampin
• Rosuvastatin
• St John's Wort

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

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.

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:

• 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

• Bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• frequent urge to urinate
• troubled breathing with exertion

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:

• Decreased appetite
• dizziness

• 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.