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Enzalutamide Oral Capsule (ENZALUTAMIDE - ORAL)

For treating cancer.

Brand Name(s): Xtandi

Generic Name: Enzalutamide

Instructions

Swallow the medicine without crushing or chewing it.

This medicine may be taken with or without food.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Keep using this medicine for the full number of days that it is prescribed. Do not stop the medicine even if you start to feel better.

Keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than once during 24 hours.

Cautions

This medicine is not approved for use by women.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine is associated with a rare but very serious medical condition. Please speak with your doctor about symptoms you should look out for while on this medicine. Notify your doctor immediately if you develop those symptoms.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

This medicine is associated with an increased risk for seizures. Please ask your doctor whether you may be at risk for having a seizure while on this medicine.

Do not use the medication any more than instructed.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

Contact your doctor if you develop any signs of a new infection such as fever, cough, sore throat, or chills.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Do not use this medicine if you are pregnant. If you become pregnant, contact your doctor immediately.

This medicine can cause birth defects. Speak with your doctor about birth control methods that should be used while on this medicine.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Men with a pregnant partner must wear a condom during sexual activity while taking this medicine and for 3 months after stopping to prevent harm to the developing baby.

Men with a female partner who is of childbearing age must use a condom and a second form of birth control during sexual activity while taking this medicine and for 3 months after stopping to prevent pregnancy.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • dizziness
  • lack of energy and tiredness
  • feeling of heat or flushing
  • headaches
  • high blood pressure
  • problems with sexual functions or desire
  • stomach upset or abdominal pain
  • weakness

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • back pain
  • loss of balance
  • chest or jaw pain
  • changes in memory, mood, or thinking
  • confusion
  • swelling of the legs, feet, and hands
  • numbness or tingling in hands and feet
  • severe or persistent headache
  • mood changes
  • joint or muscle pain
  • seizures
  • shortness of breath
  • sweating
  • blood in urine
  • blurring or changes of vision

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.