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Xtandi

Pronunciation: ex-TAN-dee
Generic name: enzalutamide
Dosage form: capsules (40mg), tablets (40mg, 80mg)
Drug classes: Antiandrogens, Hormones / antineoplastics

Medically reviewed by Philip Thornton, DipPharm. Last updated on Nov 21, 2023.

What is Xtandi?

Xtandi is an androgen receptor inhibitor used to treat certain prostate cancers. Xtandi works by preventing the actions of androgens (male hormones), to help control cancer growth and decrease tumor size.

Xtandi is used when prostate cancer no longer responds to hormone therapy or surgical treatment. Xtandi is also used when prostate cancer has spread to other parts of the body, and it responds to hormone therapy or surgical treatment to lower testosterone. Xtandi is also used for patients who have cancer that responds to hormone therapy or surgical treatment to lower testosterone, and their cancer has not spread to other parts of the body, but they are at high risk of cancer spreading to other parts of the body.

Xtandi became an FDA-approved medicine on August 31, 2012.

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 lower 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:

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.

You may need to take two 80mg tablets or four 40mg tablets or capsules at the same time once a day to get a full dose.

Swallow the Xtandi tablet or capsule whole. Do not break, chew, or crush a tablet. Do not chew, open, or dissolve a capsule.

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.
Comments:

Patients with castration-resistant prostate cancer (CRPC) or metastatic castration-sensitive prostate cancer (mCSPC) receiving Xtandi should also receive a gonadotropic-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

Patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) with a high risk of biochemical recurrence (BCR) may be treated with Xtandi with or without a GnRH analog. For patients who receive Xtandi with or without a GnRH analog, treatment can be suspended if the prostate-specific antigen (PSA) is undetectable (< 0.2 ng/mL) after 36 weeks of therapy. Reinitiate treatment when PSA has increased to ≥ 2.0 ng/mL for patients who had prior radical prostatectomy or ≥ 5.0 ng/mL for patients who had prior primary radiation therapy.

Xtandi is available in 40 mg capsules, 40mg tablets, and 80mg tablets.

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 for 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

Enzalutamide can increase your risk of seizure. Avoid any activity that could be dangerous if you have a seizure or lose consciousness.

Avoid driving or hazardous activity until you know how Xtandi will affect you. Dizziness or drowsiness can cause falls, accidents, 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

Stop taking Xtandi and get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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:

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

Common Xtandi side effects may include:

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 the 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.

Storage

Ingredients

Xtandi capsules

Active ingredient: enzalutamide

Inactive ingredients: caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, black iron oxide.

Xtandi tablets

Active ingredient: enzalutamide

Inactive ingredients: hypromellose acetate succinate, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, and magnesium stearate.

The tablet film coat contains hypromellose, talc, polyethylene glycol, titanium dioxide, and ferric oxide.

Company

Manufactured for and Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062.

Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062 Pfizer Inc., New York, NY 10017.

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 (enzalutamide) and Zytiga (abiraterone acetate) are both drugs that are used in the treatment of prostate cancer. Results from various analyses indicate that Xtandi is more effective than Zytiga in patients with castration-resistant prostate cancer that has spread or metastasized, although it’s more commonly associated with fatigue. 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 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

Xtandi (enzalutamide) is used to treat certain types of advanced prostate cancer including:

  • castration-resistant prostate cancer (CRPC)
  • metastatic castration-sensitive prostate cancer (mCSPC)
  • non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR)
Continue reading

More FAQ

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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.