Rolapitant, Oral

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KEY POINTS

• This medicine is taken by mouth to prevent nausea and vomiting from chemotherapy. Take it exactly as directed. Do not start or stop taking any other medicines while you are taking this medicine without the approval of your healthcare provider.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antiemetic (antinausea)

Generic and brand names: rolapitant, oral; Varubi

What is this medicine used for?

This medicine is taken by mouth to prevent nausea and vomiting that can happen during or after chemotherapy. It is usually taken along with 2 other medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver disease

Do not take this medicine if you also take thioridazine or pimozide. Taking these medicines together can cause serious or life-threatening heart rhythm problems.

Pregnancy and breast-feeding: Tell your healthcare provider if you are pregnant, or plan to become pregnant, or are breast-feeding. This medicine should be used during pregnancy only if clearly needed. It is not known whether this medicine will harm an unborn baby. This medicine passes into your breast milk. Do not breast-feed while you are taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine at the exact dosages and at the exact times as prescribed by your healthcare provider. The success of this treatment depends on taking these medicines in the proper dosages and at the proper times. Do not take more or less or take it longer than prescribed. Ask your healthcare provider or pharmacist about anything you do not understand.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Take it with a full glass of water.

Do not start taking this medicine if you already have nausea and vomiting.

What if I miss a dose?

If you miss a dose, contact your healthcare provider right away for advice.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

Do not start or stop taking any other medicines while you are taking this medicine without the approval of your healthcare provider.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Slow, fast, or irregular heartbeat; severe dizziness or fainting; unexplained fever, cough, or sore throat; trouble breathing; pain when urinating; severe mouth sores; unusual tiredness or weakness.

Other: Hiccups, loss of appetite, nausea, stomach pain, mild dizziness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods, may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as ciprofloxacin (Cipro), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), and rifapentine (Priftin)
• Antidepressants such as amitriptyline, desipramine, fluoxetine (Prozac), fluvoxamine (Luvox), nefazodone, nortriptyline, and vilazodone (Viibryd)
• Antipsychotic medicines such as aripiprazole (Abilify), haloperidol (Haldol), iloperidone (Fanapt), lurasidone (Latuda), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), and thioridazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Bosentan (Tracleer)
• Cancer medicines such as bosutinib (Bosulif), ceritinib (Zykadia), docetaxel (Docefrez, Taxotere), enzalutamide (Xtandi), etoposide, imatinib (Gleevec), irinotecan (Camptosar), mitotane (Lysodren), paclitaxel (Abraxane, Taxol), tamoxifen, topotecan (Hycamtin), vinblastine, and vincristine (Marqibo)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lovastatin (Altoprev), and rosuvastatin (Crestor)
• Cimetidine (Tagamet)
• Colchicine (Colcrys)
• Dextromethorphan, an ingredient in many cough, cold, or allergy medicines such as Robitussin-DM
• Diabetes medicines such as linagliptin (Tradjenta), saxagliptin (Onglyza), and sitagliptin (Januvia)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Heart medicines such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), metoprolol (Lopressor, Toprol), mexiletine, nicardipine (Cardene), procainamide, quinidine, ranolazine (Ranexa), timolol, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Hormonal birth control pills, implants, shots, patches, vaginal rings, and hormones such as conjugated estrogens (Premarin) and estradiol (Climara, Estrace, Estraderm, Vivelle)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Ledipasvir/sofosbuvir (Harvoni)
• Lumacaftor/ivacaftor (Orkambi)
• Malaria medicines such as chloroquine, primaquine, and quinine
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), dabigatran (Pradaxa), edoxaban (Savaysa), and rivaroxaban (Xarelto)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Naloxegol (Movantik)
• Pain medicines such as morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Silodosin (Rapaflo)
• St. John's wort
• Tetrabenazine (Xenazine)
• Tolvaptan (Samsca)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.