Pronunciation:

en-za-LOO-ta-mide

Brand Names:

• Xtandi

Dosage Forms:

• Tablet
• Capsule, Liquid Filled

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Enzalutamide is used to treat castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone), and metastatic castration-sensitive prostate cancer (prostate cancer that has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone). It works to stop the growth of cancer cells by blocking the effects of androgen hormones (eg, testosterone). Enzalutamide is an antiandrogen cancer medicine.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of enzalutamide in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of enzalutamide in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Artemether
• Atazanavir
• Boceprevir
• Daclatasvir
• Dasabuvir
• Delamanid
• Doravirine
• Elbasvir
• Fostemsavir
• Grazoprevir
• Isavuconazonium
• Lenacapavir
• Lorlatinib
• Lumefantrine
• Lurasidone
• Maraviroc
• Mavacamten
• Nirmatrelvir
• Pacritinib
• Ritonavir

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Abemaciclib
• Abiraterone Acetate
• Acalabrutinib
• Adagrasib
• Alfentanil
• Alpelisib
• Amiodarone
• Apixaban
• Apremilast
• Aprepitant
• Aripiprazole
• Atogepant
• Avacopan
• Avapritinib
• Avatrombopag
• Axitinib
• Bedaquiline
• Belumosudil
• Benzhydrocodone
• Bictegravir
• Bortezomib
• Bosentan
• Bosutinib
• Brigatinib
• Buprenorphine
• Cabozantinib
• Cannabidiol
• Capmatinib
• Carbamazepine
• Ceritinib
• Clarithromycin
• Clozapine
• Cobimetinib
• Codeine
• Conivaptan
• Copanlisib
• Crizotinib
• Cyclosporine
• Daridorexant
• Dasatinib
• Deferasirox
• Deflazacort
• Desogestrel
• Dexamethasone
• Dienogest
• Dihydrocodeine
• Dihydroergotamine
• Dofetilide
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Dronedarone
• Drospirenone
• Duvelisib
• Efavirenz
• Elacestrant
• Elexacaftor
• Eliglustat
• Encorafenib
• Entrectinib
• Eravacycline
• Erdafitinib
• Ergotamine
• Erlotinib
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Etravirine
• Everolimus
• Exemestane
• Fedratinib
• Fenfluramine
• Fentanyl
• Fexinidazole
• Finerenone
• Flibanserin
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fostamatinib
• Gemfibrozil
• Gepirone
• Gestodene
• Glasdegib
• Hemin
• Hydrocodone
• Ibrexafungerp
• Ibrutinib
• Idelalisib
• Imatinib
• Indinavir
• Infigratinib
• Istradefylline
• Itraconazole
• Ivabradine
• Ivacaftor
• Ivosidenib
• Ixabepilone
• Ixazomib
• Ketoconazole
• Larotrectinib
• Lefamulin
• Leflunomide
• Lemborexant
• Leniolisib
• Levoketoconazole
• Levonorgestrel
• Linagliptin
• Lopinavir
• Lumateperone
• Lurbinectedin
• Macimorelin
• Macitentan
• Manidipine
• Maribavir
• Medroxyprogesterone
• Meperidine
• Mephenytoin
• Mestranol
• Methadone
• Midostaurin
• Mirtazapine
• Mitapivat
• Mobocertinib
• Modafinil
• Naloxegol
• Nefazodone
• Nelfinavir
• Neratinib
• Netupitant
• Nevirapine
• Nifedipine
• Nilotinib
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Olanzapine
• Olaparib
• Olutasidenib
• Osimertinib
• Oxcarbazepine
• Oxycodone
• Palbociclib
• Paliperidone
• Palovarotene
• Panobinostat
• Pazopanib
• Pemigatinib
• Pentazocine
• Perampanel
• Pexidartinib
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pimozide
• Piperaquine
• Pirtobrutinib
• Pixantrone
• Ponatinib
• Posaconazole
• Pralsetinib
• Pretomanid
• Primidone
• Quetiapine
• Quinidine
• Quizartinib
• Regorafenib
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Rimegepant
• Ripretinib
• Risperidone
• Ritlecitinib
• Rivaroxaban
• Romidepsin
• Ruxolitinib
• Samidorphan
• Saquinavir
• Segesterone
• Selpercatinib
• Selumetinib
• Sildenafil
• Siponimod
• Sirolimus
• Sirolimus Protein-Bound
• Sorafenib
• Sotorasib
• Sparsentan
• Stiripentol
• St John's Wort
• Sufentanil
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tasimelteon
• Tazemetostat
• Telaprevir
• Telithromycin
• Temsirolimus
• Teriflunomide
• Tezacaftor
• Thiotepa
• Ticagrelor
• Tivozanib
• Tofacitinib
• Tolvaptan
• Tramadol
• Tucatinib
• Ubrogepant
• Ulipristal
• Upadacitinib
• Valbenazine
• Vandetanib
• Velpatasvir
• Vemurafenib
• Venetoclax
• Vilazodone
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Voclosporin
• Vonoprazan
• Vorapaxar
• Voriconazole
• Vortioxetine
• Voxelotor
• Voxilaprevir
• Warfarin
• Zanubrutinib
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aripiprazole Lauroxil
• Ospemifene

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain injury, history of or
• Brain tumor, history of or
• Diabetes or
• Dyslipidemia (high cholesterol in the blood) or
• Hypertension (high blood pressure) or
• Seizures, history of or
• Stroke, history of or
• Transient ischemic attack, recent—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take your medicine at the same time each day with or without food.

Swallow the capsule whole. Do not chew, dissolve, or open it.

Swallow the tablet whole. Do not crush, break, or chew it.

If you are taking 2 cancer medicines, follow your doctor's instructions on when to take them.

Your doctor may give you other medicines (eg, gonadotropin-releasing hormone) unless you had a surgery to lower the amount of testosterone in your body.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules and tablets):
  • For prostate cancer:
    • Adults—160 milligrams (mg) (two 80-mg tablets or four 40-mg tablets or four 40-mg capsules) once a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Women should not use this medicine, especially women who are pregnant or able to become pregnant. This medicine can harm an unborn baby. It can also cause birth defects if the father is using it when his sexual partner becomes pregnant. Men with female partners must use a condom together with a second effective form of birth control during treatment with this medicine and for 3 months after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

This medicine may cause dizziness, tiredness, muscle weakness, seizures (very rare), and an increased risk for falls and fractures. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause a nerve problems called posterior reversible encephalopathy syndrome (PRES). Check with your doctor right away if you have seizures, headache, confusion, unusual drowsiness, dullness, tiredness, weakness, feeling of sluggishness, or blurred vision.

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a fast heartbeat, fever, joint pain, stiffness, or swelling, rash, redness of the skin, swelling of the eyelids, face, tongue, lips, hands, or feet, tightness in the chest, or trouble with breathing or swallowing.

Enzalutamide may cause heart problems including ischemic heart disease. Check with your doctor right away if you have chest pain or discomfort or pain or discomfort in the arms, jaw, back, or neck.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Back pain

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine

blurred vision

chest pain

chills

cough with mucus

difficulty with breathing

dizziness

fever

loss of bladder or bowel control

nervousness

painful or difficult urination

pounding in the ears

slow or fast heartbeat

sore throat

tingling of the hands or feet

unable to move the legs

unusual weight gain or loss

Less common

Anxiety

confusion or excitement

depression

fainting

falling

lightheadedness

loss of memory

memory or attention span problems

nightmares or vivid dreams

rapid, shallow breathing

Rare

Seizures

Incidence not known

Headache

hives, itching, skin rash

hoarseness

irritation

joint pain, stiffness, or swelling

redness of the skin

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

trouble breathing or swallowing

unusual drowsiness, tiredness, weakness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Body aches or pain

bone pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

diarrhea

difficulty having a bowel movement

difficulty with moving

dry throat

ear congestion

feeling of constant movement of self or surroundings

feeling of warmth

lack or loss of strength

loss of voice

muscle pain, stiffness, or weakness

pain or tenderness around the eyes and cheekbones

sensation of spinning

stuffy or runny nose

tender, swollen glands in the neck

trouble sleeping

Less common

Bloody nose

dry skin

frequent urination

pale-colored urine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.