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Xtandi

Generic Name: enzalutamide (ENZ a LOOT a mide)
Brand Name: Xtandi

Medically reviewed by Philip Thornton, DipPharm. Last updated on June 3, 2020.

What is Xtandi?

Xtandi (enzalutamide) is an anti-androgen. It works in the body by preventing the actions of androgens (male hormones).

Xtandi is used to treat prostate cancer when surgery or other medicines have not worked or have stopped working.

Xtandi is also used to treat prostate cancer that has spread to other parts of the body (metastatic).

Warnings

Although not for use by women, Xtandi can cause birth defects if the mother or the father is taking this medicine. Use a condom and one other form of birth control to prevent pregnancy during your treatment, and for at least 3 months after your treatment ends.

Xtandi may cause side effects on your spinal cord. Stop taking this medicine and call your doctor at once if you have severe low back pain, trouble walking or standing up, pain or weakness in your lower body, severe and worsening numbness or tingling, or sudden loss of bladder or bowel control.

Before taking this medicine

You should not use Xtandi if you are allergic to enzalutamide.

To make sure Xtandi is safe for you, tell your doctor if you have ever had:

  • a seizure;

  • a head injury, stroke, or brain tumor;

  • heart disease, circulation problems;

  • high blood pressure;

  • diabetes; or

  • high cholesterol or triglycerides (a type of fat in the blood).

Although not for use by women, Xtandi can cause birth defects if the mother or the father is taking this medicine. Do not use this medicine if you are pregnant.

If you are taking Xtandi and your sexual partner could become pregnant, use a condom and one other form of birth control to prevent pregnancy during treatment. Keep using these birth control methods for at least 3 months after your treatment ends. Tell your doctor at once if a pregnancy occurs while either parent is being treated with enzalutamide.

Although this medicine is not for use by women, it is not known whether enzalutamide passes into breast milk or if it could harm a nursing baby. You should not breastfeed while using this medicine.

How should I take Xtandi?

Take Xtandi exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Xtandi with or without food. Take the medicine at the same time each day.

Do not crush, break, or dissolve a capsule. Swallow the capsule whole.

Prostate cancer is sometimes treated with a combination of drugs. Use all medications as directed by your doctor. Do not change your doses or medication schedule without your doctor's advice.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Dosing information

Usual Adult Dose for Prostate Cancer:

160 mg (four 40 mg capsules) orally once a day

Use: Metastatic castration-resistant prostate cancer

What happens if I miss a dose?

Take the missed dose if you remember it later in the day. Skip the missed dose if it is almost time for your next day's dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose could cause you to have a seizure.

What to avoid

This medication can make you dizzy, and may cause you to have a seizure or suddenly become unconscious. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness can cause falls, accidents, bone fractures, or severe injuries.

Even without dizziness, taking Xtandi could increase your risk of falls or bone fractures. Avoid activities or situations that may lead to injury or falls.

Xtandi side effects

Get emergency medical help if you have signs of an allergic reaction to Xtandi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Xtandi may cause side effects on your spinal cord. Stop taking this medicine and call your doctor at once if you have:

  • dizziness, spinning sensation;

  • a seizure (black-out or convulsions);

  • confusion, thinking problems, severe headache, vision problems;

  • weakness, loss of consciousness;

  • red or pink urine;

  • heart problems - chest pain, shortness of breath (even with mild exertion);

  • increased blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or

  • signs of a lung infection - fever, cough with yellow or green mucus, stabbing chest pain, wheezing, feeling short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Xtandi side effects may include:

  • feeling weak or tired;

  • constipation, diarrhea;

  • loss of appetite;

  • flushing (redness, hot feeling);

  • back pain, joint pain; or

  • high blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Xtandi?

Enzalutamide can increase your risk of having a seizure. This effect may be more likely if you also use certain other medicines that increase seizure risk. Tell your doctor if you are using an antibiotic, an antidepressant, asthma medication (a bronchodilator), birth control pills or hormone replacement, insulin or oral diabetes medicine, a steroid, or medicine to treat mental illness.

Many drugs can interact with enzalutamide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Xtandi. Give a list of all your medicines to any healthcare provider who treats you.

Popular FAQ

Prostate cancer cells, like bacteria, can evolve over time and become resistant to treatments, including the hormone therapy and androgen receptor inhibitor Xtandi (enzalutamide). The cancer cells work to reprogram their environment and develop strategies that enable them to transform and survive.

If treatment with Xtandi stops working then other treatments may be offered, such as:

  • Chemotherapy
  • Immunotherapy
  • Targeted therapy
  • Radiotherapy

Stopping treatment with Xtandi may also result in an antiandrogen withdrawal response (AAWR), which can cause the cancer to stop growing or shrink for the period of time. Continue reading

Xtandi is typically taken until prostate cancer starts to progress or spread (metastasize), or until the patient can no longer tolerate therapy because of the side effects or adverse events it causes.

In clinical trials, Xtandi was effective at delaying the time to disease progression in men with advanced prostate cancer. In men who had not received prior treatment with chemotherapy, Xtandi was also effective at delaying the need for treatment with a cytotoxic chemotherapy agent.

In the AFFIRM trial, treatment with Xtandi extended life by almost 5 months in men with metastatic castration-resistant prostate cancer. Continue reading

Xtandi is an androgen receptor inhibitor or anti-androgen. Androgens are a group of hormones, which includes testosterone, that stimulate prostate cancer cells to grow.

Xtandi works by blocking the action of androgens at the androgen receptor - reducing how often androgens can connect with the receptor - which helps prevent prostate cancer cells from growing and spreading. Continue reading

A decrease in prostate-specific antigen (PSA) levels is seen in some men with advanced prostate cancer who are treated with Xtandi (enzalutamide).

Levels of PSA in the blood can become elevated when there is a problem with the prostate, such as when prostate cancer develops. Monitoring PSA levels in the blood is one of the methods used to determine how prostate cancer is responding to treatment with Xtandi. Continue reading

Xtandi (enzalutamide) is used to treat three forms of advanced prostate cancer including:

  1. Non-metastatic castration-resistant prostate cancer (nmCRP)
  2. Metastatic castration-resistant prostate cancer (mCRPC)
  3. Metastatic castration-sensitive prostate cancer (mCSPC)
Continue reading

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Xtandi only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.