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

Rolapitant may also be used for purposes not listed in this medication guide.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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

You may take rolapitant with or without food.

You should not take rolapitant 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 rolapitant. Your doctor may change your treatment plan if you also use:

• pimozide; or

• thioridazine.

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

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.

rolapitant 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 rolapitant dose is important for rolapitant to be effective.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

For at least 1 month after you use rolapitant, 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: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Rolapitant may cause serious side effects. 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 side effects of rolapitant 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 rolapitant, 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 can affect 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.

Keep all appointments with your doctor.

Do not let anyone else take your medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.