Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Xtandi

Descriptions


Enzalutamide is used to treat metastatic prostate cancer (cancer that has spread to other parts of the body). This medicine is used in patients who have received other cancer medicines, such as docetaxel.

Enzalutamide is an antiandrogen cancer medicine. It works by blocking the effects of androgen (a male hormone) to stop the growth of prostate cancer cells.

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

This product is available in the following dosage forms:

  • Capsule, Liquid Filled

Before Using

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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of enzalutamide in the elderly.

Pregnancy

Information about this enzalutamide-oral-route
Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breastfeeding

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.

Drug Interactions

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
  • Delamanid
  • Lumefantrine
  • Lurasidone
  • Maraviroc

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.

  • Abiraterone Acetate
  • Alfentanil
  • Apremilast
  • Bedaquiline
  • Bosentan
  • Cabozantinib
  • Carbamazepine
  • Ceritinib
  • Clarithromycin
  • Clozapine
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Cyclosporine
  • Dabrafenib
  • Deferasirox
  • Dexamethasone
  • Dihydroergotamine
  • Dolutegravir
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Efavirenz
  • Elvitegravir
  • Ergotamine
  • Eslicarbazepine Acetate
  • Etravirine
  • Everolimus
  • Exemestane
  • Fentanyl
  • Fosphenytoin
  • Gemfibrozil
  • Hydrocodone
  • Ibrutinib
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Lopinavir
  • Macitentan
  • Mephenytoin
  • Mitotane
  • Modafinil
  • Nafcillin
  • Nefazodone
  • Nelfinavir
  • Nevirapine
  • Nifedipine
  • Nilotinib
  • Oxcarbazepine
  • Pazopanib
  • Perampanel
  • Phenobarbital
  • Phenytoin
  • Pimozide
  • Piperaquine
  • Pixantrone
  • Pomalidomide
  • Ponatinib
  • Posaconazole
  • Primidone
  • Quetiapine
  • Quinidine
  • Regorafenib
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Romidepsin
  • Saquinavir
  • Siltuximab
  • Simeprevir
  • Sirolimus
  • Sorafenib
  • St John's Wort
  • Tacrolimus
  • Tasimelteon
  • Telaprevir
  • Telithromycin
  • Ticagrelor
  • Tofacitinib
  • Trabectedin
  • Ulipristal Acetate
  • Vandetanib
  • Vemurafenib
  • Vilazodone
  • Vinflunine
  • Vorapaxar
  • Voriconazole
  • Vortioxetine
  • Warfarin

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.

  • 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
  • Seizures, history of or
  • Stroke, history of—Use with caution. May cause side effects to become worse.

Proper Use

Take this medicine only as directed by your doctor to benefit your condition as much as possible. 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 the information carefully and make sure you understand it before taking this medicine. If you have any questions, ask your doctor.

You may take this medicine with or without food.

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

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):
    • For prostate cancer:
      • Adults—160 milligrams (mg) 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

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

Women are not supposed to 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. You must use a condom together with a second effective form of birth control during therapy 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, or seizures (very rare). Avoid driving, using machines, or doing anything else that could be dangerous until you know how this medicine affects you.

If you are also using a medicine called a gonadotropin-releasing hormone analog for your prostate cancer, continue using the 2 medicines together. Some examples of these medicines include goserelin, leuprolide, Lupron®, or Zoladex®. Do not stop using these medicines without checking with your doctor first.

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

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

  1. Back pain
  2. bloating or swelling of the face, arms, hands, lower legs, or feet
  3. blood in urine
  4. blurred vision
  5. chest pain
  6. cough
  7. cough with mucus
  8. difficulty breathing
  9. dizziness
  10. fever or chills
  11. headache
  12. loss of bladder control
  13. loss of bowel control
  14. nervousness
  15. no sensation in the legs
  16. painful or difficult urination
  17. pounding in the ears
  18. rapid weight gain
  19. shortness of breath
  20. slow or fast heartbeat
  21. sneezing
  22. sore throat
  23. tightness in the chest
  24. tingling of the hands or feet
  25. unable to move legs
  26. unusual weight gain or loss
  27. wheezing

Less common

  1. Confusion or excitement
  2. fainting
  3. falling
  4. lightheadedness
  5. loss of memory
  6. mental depression or anxiety
  7. nightmares or unusually vivid dreams
  8. problems with memory or attention span
  9. rapid, shallow breathing
  10. trouble performing routine tasks

Rare

  1. Seizures

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

  1. Body aches or pain
  2. bone pain
  3. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  4. diarrhea
  5. difficulty in moving
  6. dry throat
  7. ear congestion
  8. feeling of constant movement of self or surroundings
  9. feeling of warmth
  10. hoarseness
  11. joint pain
  12. lack or loss of strength
  13. loss of voice
  14. muscle pain, stiffness, or weakness
  15. nervousness
  16. pain or tenderness around the eyes and cheekbones
  17. redness of the face, neck, arms and occasionally, upper chest
  18. sensation of spinning
  19. stuffy or runny nose
  20. tender, swollen glands in the neck
  21. trouble with swallowing
  22. trouble sleeping
  23. unusual tiredness or weakness
  24. voice changes

Less common

  1. Bloody nose
  2. dry skin
  3. frequent urination
  4. itching skin
  5. 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.