Enzalutamide Oral Capsules

What is this medication?

ENZALUTAMIDE (EN za LOO ta mide) blocks the effect of the male hormone called testosterone. It treats certain types of prostate cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): XTANDI

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bone problems
• brain tumor
• head injury
• heart disease
• high blood pressure
• high cholesterol
• stroke
• seizures
• an unusual or allergic reaction to enzalutamide, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medicine. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your health care provider tells you to stop.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• artemether
• certain antivirals for HIV or hepatitis such as atazanavir, daclatasvir, doravirine, elbasvir; grazoprevir, fostemsavir, lopinavir, nelfinavir, paritaprevir, rilpivirine, ritonavir, and tipranavir
• certain medicines for fungal infections such as isavuconazonium and voriconazole
• lonafarnib
• lorlatinib
• lurasidone
• praziquantel
• ranolazine

This medicine may interact with the following medications:

• alfentanil
• certain medications for seizures such as carbamazepine, phenobarbital, and phenytoin
• clopidogrel
• cyclosporine
• ergot alkaloids such as dihydroergotamine, ergotamine
• fentanyl
• gemfibrozil
• midazolam
• omeprazole
• pimozide
• quinidine
• rifabutin
• rifampin
• rifapentine
• St. John's Wort
• sirolimus
• tacrolimus
• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

This medicine should not be used in women. Men should not father a child while taking this medicine and for 3 months after stopping it. There is potential for serious harm to an unborn child. Talk to your health care provider for more information.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• changes in vision
• confusion
• falls
• loss of memory
• pain or tightness in the chest, neck, back, or arms
• seizures
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• blood in the urine
• diarrhea
• dizziness
• edema (sudden weight gain; swelling of the ankles, feet, hands or other unusual swelling; trouble breathing)
• headache
• hot flashes (flushing of skin, increased sweating)
• joint pain
• lack or loss of appetite
• pain, tingling, numbness in the hands or feet
• unusually weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Keep the container tightly closed. Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.