Netupitant/Palonosetron, Oral

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KEY POINTS

• This medicine is taken by mouth to prevent nausea and vomiting caused by chemotherapy or radiation therapy. Take it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may cause life-threatening problems if you take this medicine with certain other medicines. 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: NK1 receptor antagonist/5-HT3 receptor antagonist; antiemetic (antinausea)

Generic and brand names: netupitant/palonosetron, oral; Akynzeo

What is this medicine used for?

This medicine is given to prevent nausea and vomiting caused by chemotherapy or radiation therapy.

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?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver or kidney disease

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. 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.

Take this medicine about 1 hour before you have chemotherapy. You may take this medicine with or without food.

What if I miss a dose?

If you miss a dose, take it as soon as you remember. If you are not sure of what to do if you miss a dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as antidepressants, migraine medicines, pain medicines, some cough medicines, and St. John’s wort. Make sure that your providers know ALL of the medicines that you take. Contact your healthcare provider right away if you have:

• Restlessness
• Hallucinations
• Loss of coordination
• Stiff muscles
• Fast heartbeat
• Rapid changes in blood pressure or dizziness
• Increased body temperature, sweating, or flushing
• Nausea
• Vomiting
• Diarrhea

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; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Fast heartbeat; severe dizziness or fainting; trouble breathing; chest pain; yellowing of your skin or eyes; trouble urinating; severe stomach pain or swelling; severe headache; hallucinations; unusual restlessness; loss of coordination; stiff muscles; increased sweating; seizures; diarrhea, nausea, or vomiting.

Other: Mild headache, heartburn, tiredness, weakness, constipation, skin redness.

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:

• Antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, clonazepam (Klonopin), diazepam (Valium), midazolam (Versed), and triazolam (Halcion)
• Antibiotics such as azithromycin (Zithromax, Zmax), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), isoniazid, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), mirtazapine (Remeron), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, venlafaxine (Effexor), and vilazodone (Viibryd)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), terbinafine (Lamisil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Apomorphine (Apokyn)
• Bladder control medicines such as darifenacin (Enablex), fesoterodine (Toviaz), and tolterodine (Detrol)
• Bosentan (Tracleer)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Buspirone
• Cancer medicines such as abiraterone (Zytiga), bicalutamide (Casodex), bosutinib (Bosulif), crizotinib (Xalkori), enzalutamide (Xtandi), ibrutinib (Imbruvica), imatinib (Gleevec), lapatinib (Tykerb), nilotinib (Tasigna), sunitinib (Sutent), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lomitapide (Juxtapid), lovastatin (Altoprev), and simvastatin (Zocor)
• Dexamethasone
• Dextromethorphan, an ingredient in many cough, cold, or allergy medicines such as Robitussin-DM
• Diabetes medicines such as nateglinide (Starlix), repaglinide (Prandin), and saxagliptin (Onglyza)
• Doxepin (Silenor)
• Enlarged prostate medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), and tamsulosin (Flomax)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Eszopiclone (Lunesta)
• Heart medicines such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dronedarone (Multaq), eplerenone (Inspra), isosorbide (Dilatrate, Isordil, Monoket), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Ivacaftor (Kalydeco)
• Linezolid (Zyvox)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis) and rivaroxaban (Xarelto)
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Naloxegol (Movantik)
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Quinine
• Simeprevir (Olysio)
• St. John’s wort
• Tofacitinib (Xeljanz)

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. 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.