Rolapitant

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

Rolapitant may also be used for reasons not mentioned in this medication guide.

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

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

You can take rolapitant with or without food.

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

You will receive other medication to prevent nausea or vomiting. Continue 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.

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

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.

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 right away 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.

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

Oral: 180 mg orally within 2 hours prior to initiation of chemotherapy on Day 1Parenteral: 166.5 mg via IV infusion (over 30 minutes) within 2 hours prior to initiation of chemotherapy on Day 1ADDITIONAL 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 dayModerately Emetogenic Cancer Chemotherapy (MEC):-Day 1: Dexamethasone 20 mg orally 30 minutes prior to chemotherapy; 5-HT3 antagonist per treatment guidelinesComments:-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

Call your doctor for instructions if you forget to take the tablets at the right time before chemotherapy. The timing of your rolapitant dose is important for rolapitant to work effectively.

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

For at least 1 month after you use rolapitant, do not use any cough or cold medicine that contains dextromethorphan. Talk to your doctor about how to best treat a cough due to the common cold.

For at least 28 days after you use rolapitant, it may impact other medications you are taking.

Sometimes, it is not safe to take certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medications less effective.

Many drugs can affect rolapitant, and some should not be taken at the same time. Inform your doctor about all your current medications and any medicine you begin or stop using. This includes prescription and over-the-counter medications, vitamins, and herbal products. Not all possible interactions are listed here.