Varubi blocks the actions of chemicals in the body that trigger nausea and vomiting.

Varubi is used together with other medicines to prevent nausea and vomiting caused by cancer chemotherapy.

It is not known if Varubi is safe and effective in children.

Varubi can cause a rapid and severe allergic reaction. Tell your doctor if you have a history of allergies to any food or medicines.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Take Varubi tablets exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Varubi is usually given on Day 1 of your chemotherapy treatment.

You may take the tablets with or without food.

You should not take Varubi more than once every 14 days.

You will be given other medication to prevent nausea or vomiting. Keep using these medicines for as long as your doctor has prescribed.

Store at room temperature away from moisture and heat. Keep each tablet in the foil blister pack until you are ready to take the medicine.

Usual Adult Dose for Nausea/Vomiting -- Chemotherapy Induced:

Oral: 180 mg orally within 2 hours prior to initiation of chemotherapy on Day 1

Parenteral: 166.5 mg via IV infusion (over 30 minutes) within 2 hours prior to initiation of chemotherapy on Day 1

ADDITIONAL MEDICATIONS:
Highly Emetogenic Cancer Chemotherapy (HEC):
-Day 1: Dexamethasone 20 mg orally 30 minutes prior to chemotherapy; 5-HT3 antagonist per treatment guideline
-Days 2 to 4: Dexamethasone 8 mg orally 2 times a day

Moderately Emetogenic Cancer Chemotherapy (MEC):
-Day 1: Dexamethasone 20 mg orally 30 minutes prior to chemotherapy; 5-HT3 antagonist per treatment guidelines

Comments:
-Additional 5-HT3 antagonist doses may be administered per treatment and manufacturer guidelines.
-The manufacturer product information for appropriate dosing information for these drugs.
-This dose should be given at the beginning of chemotherapy, and at no less than 2-week intervals.

Use: In combination with other antiemetic agents for prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including HEC

Some medicines can cause unwanted or dangerous effects when used with Varubi. Your doctor may change your treatment plan if you also use:

• pimozide; or

• thioridazine.

Varubi is not approved for use by anyone younger than 2 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver disease; or

• if you use a blood thinner (such as warfarin) and you have routine "INR" or prothrombin time tests.

Tell your doctor if you are pregnant or breastfeeding.

This medicine may affect fertility (your ability to have children) for a short time.

Call your doctor for instructions if you forget to take the tablets at the correct time before chemotherapy. The timing of your dose is important for this medicine to be effective.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

For at least 1 month after you use Varubi, avoid using any cough or cold medicine that contains dextromethorphan. Talk to your doctor about how to best treat a cough due to the common cold.

Get emergency medical help if you have signs of an allergic reaction to Varubi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pain or burning when you urinate;

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or

• low white blood cell counts - fever, swollen gums, painful mouth sores, skin sores, cold or flu symptoms, cough, trouble breathing.

Common Varubi side effects may include:

• low blood cell counts;

• painful urination;

• mouth sores;

• hiccups;

• dizziness; or

• stomach pain, indigestion, loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For at least 28 days after you use Varubi, it could affect other medicines you are using.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs may interact with rolapitant, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.