Enzalutamide, Oral

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KEY POINTS

• This medicine is taken by mouth to treat prostate cancer. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• 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: antiandrogen; antineoplastic (anticancer)

Generic and brand names: enzalutamide, oral; Xtandi

What is this medicine used for?

This medicine is taken by mouth to treat advanced prostate cancer.

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
• A stroke or transient ischemic attack (TIA), brain injury, or brain tumor
• Seizures

Males who are sexually active: Men should use a condom and another form of birth control during treatment and for 3 months after you stop treatment. If your sexual partner gets pregnant while you are using this medicine or during the 3 months after you stop taking this medicine, tell your healthcare provider right away.

Females of childbearing age: This medicine should NOT be taken by women. Do NOT take this medicine if you are pregnant. This medicine has been reported to cause birth defects. Do not breast-feed while taking this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine and other cancer medicines exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider’s approval.

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

This medicine is usually taken once a day. Take the medicine at the same time each day. You may take this medicine with or without food. Swallow the capsules whole. Do not open, crush, or chew them.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one 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 may include: seizures.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may cause posterior reversible encephalopathy syndrome. If you have vision changes, seizures, confusion, or a severe headache, contact your healthcare provider right away.

This medicine may make you dizzy or drowsy, or make it more likely that you will fall. Do not drive or operate machinery unless you are fully alert.

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.): Seizures; chest pain; any pain that is severe and continues; severe diarrhea; fever; cough or sore throat; severe weakness or tiredness; confusion; hallucinations (seeing or hearing things that are not there); swelling of the hands, ankles, or feet; trouble breathing; trouble urinating or any change in urinating; pink or red urine; numbness or tingling in hands or feet; back pain with weakness or numbness in your lower legs; severe dizziness or fainting; falls.

Other: Diarrhea, constipation, flushing, trouble sleeping, weakness or tiredness, dry or itchy skin, nervousness, dizziness, runny or stuffy nose, joint or muscle pain, loss of appetite, headache.

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:

• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), silodosin (Rapaflo), and tamsulosin (Flomax)
• Antianxiety medicines such as alprazolam (Xanax), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), and midazolam (Versed)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), dronedarone (Multaq), and quinidine
• Antibiotics such as bedaquiline (Sirturo), chloramphenicol, clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), nafcillin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as citalopram (Celexa), escitalopram (Lexapro), nefazodone, and trazodone
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), clozapine (Clozaril, FazaClo), haloperidol (Haldol), lurasidone (Latuda), and pimozide (Orap)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and simeprevir (Olysio)
• Apremilast (Otezla)
• Aprepitant (Emend)
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as abiraterone (Zytiga), axitinib (Inlyta), bortezomib (Velcade), bosutinib (Bosulif), cabozantinib (Cometriq), ceritinib (Zykadia), crizotinib (Xalkori), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), pazopanib (Votrient), ponatinib (Iclusig), sorafenib (Nexavar), sunitinib (Sutent), vandetanib (Caprelsa), vemurafenib (Zelboraf), and vincristine (Marqibo)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), gemfibrozil (Lopid), lovastatin (Altoprev), and simvastatin (Zocor)
• Dexamethasone
• Diabetes medicines such as linagliptin (Tradjenta), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Ivacaftor (Kalydeco)
• Macitentan (Opsumit)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), dipyridamole (Persantine), rivaroxaban (Xarelto), ticagrelor (Brilinta), vorapaxar (Zontivity), and warfarin (Coumadin)
• Medicines to treat pulmonary hypertension such as bosentan (Tracleer), sildenafil (Revatio), and tadalafil (Adcirca)
• Migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal) and ergotamine (Ergomar)
• Pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), methadone (Dolophine, Methadose), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Ranolazine (Ranexa)
• Roflumilast (Daliresp)
• Sleeping pills such as flurazepam and zolpidem (Ambien, Edluar, Intermezzo)
• St. John's wort
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)

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.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.