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What is Xtandi (enzalutamide)?
Xtandi is a medication prescribed for male patients to treat prostate cancer. Xtandi belongs to the drug class, antiandrogen. Antiandrogens or androgen antagonists work by blocking male hormones (androgen) in the body.
What are the Indications for Xtandi?
Xtandi is an approved medication used as part of a treatment plan to treat prostate cancer when it does not respond to treatment to lower testosterone or when cancer does respond to hormone therapy or other treatment but has already spread throughout the body.
Xtandi assists the body by preventing androgens and androgen receptors from binding to slow and stop cancer cells from growing. Xtandi is approved to treat:
- Metastatic castration-sensitive prostate cancer (mCSPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
Xtandi is not recommended if you are allergic to Xtandi or any ingredients in Xtandi.
How is Xtandi used?
Xtandi tablets should be stored at room temperature between 59°F and 86°F (15°C – 30°C).
Keep out of reach of children.
Take Xtandi by mouth once daily, as directed by your doctor, with or without food, at the same time every day. Swallow the tablet or capsule whole. Do not chew or crush the tablet or capsule.
If you miss a dose, take it as soon as you remember. If it is past the day you should have taken Xtandi, skip the missed dose, and take your next dose at your next scheduled time.
Xtandi is available as
- Capsules: 40 mg
- Tablets: 40 mg, 80 mg
The recommended dosage is 160 mg once daily. Depending on the dosage form, you will need to take two to three tablets or capsules of Xtandi daily. Xtandi may be taken with other medications and treatments such as gonadotropin-releasing hormone (GnRH) therapy.
Do not change your dosage and take more than what is prescribed without consulting with your doctor. If you took more than prescribed, contact your doctor or seek emergency medical care right away.
It’s important to understand that although Xtandi is FDA approved, it comes with side effects that may or may not affect you.
Before starting Xtandi, you should discuss possible side effects with your doctor or pharmacist.
Common Side Effects
Not all side effects require medical attention. As your body adjusts to Xtandi, side effects may go away.
Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own:
- Weak or tired
- Loss of appetite
- High blood pressure
- Joint or back pain
Serious Side Effects
Severe adverse reactions while taking Xtandi can occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:
- Severe allergic reaction: severe rash or itching, swelling in the face, lips, tongue, or throat, rapid heartbeat, fainting or dizziness, or problems breathing or swallowing.
- Posterior reversible encephalopathy syndrome (PRES): headache, decreased alertness, confusion, or vision problems such as blurred vision and reduced eyesight
- Falls and fractures
The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.
Warnings & Precautions
Before taking Xtandi, tell your doctor or pharmacist:
- If you are allergic to any medications such as Xtandi
- If you have or have had heart disease
- If you have or have had high blood pressure or dyslipidemia
- If you have or have had seizures, stroke, brain injury, or tumors
- If you have a partner who is pregnant or plans to become pregnant
Falls and fractures
Taking Xtandi may increase your risk of falls and fractures. Studies show the risk increase is not associated with seizures or loss of consciousness. Take precautions and avoid or reduce activities that could lead to falls.
Taking Xtandi may increase your risk of heart problems and diseases such as blockage of the arteries which can lead to death.
Symptoms of heart problems include chest pain or discomfort including while at rest and shortness of breath. Contact your doctor right away if you experience any symptoms.
Posterior reversible encephalopathy syndrome (PRES)
Taking Xtandi may increase your risk of developing PRES, a neurological disorder.
Symptoms of PRES include headache, decreased alertness, lethargy, confusion, or vision problems such as blurred vision, blindness, and reduced eyesight. Stop taking Xtandi if you experience any symptoms and contact your doctor right away. Your doctor may order an MRI to confirm the diagnosis of PRES.
Taking Xtandi may increase your risk of seizures. If you experience any symptoms, discontinue Xtandi and contact your doctor or seek emergency medical care right away. Studies show discontinuing Xtandi resolved seizures in patients who only had seizures while taking Xtandi.
Taking Xtandi may affect the ability to conceive children. Contact your doctor if you have any questions or concerns regarding fertility.
Pregnant or planning to become pregnant
Use effective contraceptives while taking Xtandi to prevent pregnancy in female partners. While Xtandi has not been determined to be safe or effective in female patients, studies in animal reproductions determine that Xtandi may result in loss of pregnancy and may even cause harm or defects to the unborn child.
Even after discontinuing Xtandi, continue to use contraceptives for up to 3 months.
Interactions & Contraindications
Before taking Xtandi, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.
Taking Xtandi in combination with amlodipine may decrease the effectiveness of amlodipine. Your doctor will review and adjust your medication or dose as needed.
Taking Xtandi in combination with gemfibrozil may increase the effect of Xtandi resulting in the increase of possible severe side effects. Your doctor will review and adjust your medications or dose as needed.
Taking Xtandi in combination with rifampin may decrease the effect of Xtandi. Your doctor will review and adjust your medications or dose as needed.
Taking Xtandi in combination with Eliquis may decrease the effectiveness of Eliquis in preventing blood clots. Your doctor will review and adjust your medication or dose as needed.
Taking Xtandi in combination with oxycodone may decrease the effectiveness of oxycodone in managing your pain. You may experience withdrawal symptoms including fever, chills, flushing or hotness, yawning, restlessness, excessive sweating, body aches, rapid heartbeat, nausea, loss of appetite, irritability, depression, anxiety, and tremor.
However, discontinuing Xtandi while taking oxycodone may increase the effect of oxycodone resulting in an overdose. Your doctor will review and adjust your medication or dose as needed.