Xtandi

Generic name: Enzalutamide
Dosage form: capsules (40mg), tablets (40mg, 80mg)

Usage of 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.

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:

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 the FDA at 1-800-FDA-1088.

Before taking Xtandi

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 to use Xtandi

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.

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.

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.

Disclaimer

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