Enzalutamide

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• seizures

• Xtandi^®

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

Enzalutamide is used to treat prostate cancer.

Enzalutamide may also be used for purposes not listed in this medication guide.

Although not for use by women, enzalutamide 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.

Enzalutamide can increase your risk of having a seizure. To make sure this medicine is safe for you, tell your doctor if you have:

• epilepsy or other seizure disorder; or
• a recent head injury, stroke, or brain tumor (in the past 12 months).

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

If you are taking enzalutamide 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 breast-feed while using this medicine.

Enzalutamide is part of the drug class:

• Anti androgens

Common side effects include the following:

• weakness
• tiredness
• joint pain
• muscle weakness or stiffness
• headache
• dizziness
• burning, numbness, or tingling in the arms, hands, or feet
• decreased sense of touch or ability to feel sensation
• hot flashes
• difficulty falling asleep or staying asleep
• anxiety
• difficulty remembering, thinking, or paying attention
• diarrhea
• itching
• dry skin
• nosebleeds
• frequent urination

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose is 160 mg (four 40 mg capsules) taken by mouth once daily. Swallow capsules whole. Enzalutamide can be taken with or without food.

• Keep this medication in the container it came in, tightly closed, and out of reach of children.
• Store at room temperature and away from excess heat and moisture (not in the bathroom).

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

Enzalutamide is used to treat prostate cancer.

Enzalutamide may also be used for purposes not listed in this medication guide.

Antineoplastic agent; a nonsteroidal antiandrogen.1 2 3 4 8

Enzalutamide is used to treat metastatic (cancer that has spread) prostate cancer. It works to stop the growth of cancer cells by blocking the effects of androgen hormones (eg, testosterone). Enzalutamide is an antiandrogen cancer medicine.

enzalutamide is available only with your doctor's prescription.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Shortness of breath.
• A burning, numbness, or tingling feeling that is not normal.
• Blood in the urine.
• Seizures.
• Swelling in the arms or legs.
• Bone pain.
• Memory problems or loss.
• A very bad and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with this medicine. Call your doctor right away if you have signs like feeling confused, lowered alertness, change in eyesight, loss of eyesight, seizures, or very bad headache.
• This medicine may raise the chance of infections. Call your doctor right away if you have signs of infection like fever, chills, sore throat, redness or swelling of the skin.

Preexisting mild-to-moderate impairment (CrCl 30 to 89 mL/minute): No initial dosage adjustment necessary.

Preexisting severe impairment (CrCl <30 mL/minute), including end-stage renal disease (ESRD): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Preexisting mild, moderate, or severe impairment (Child-Pugh class A, B, or C): No dosage adjustment necessary.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture; keep bottle tightly closed.

Data not available.

This drug is not indicated for use in female patients. Excreted into human milk: Unknown Excreted into animal milk: Data not available The effects in the nursing infant are unknown.