Xtandi Warnings and Precautions

By reviewing the warnings and precautions for Xtandi, you can help reduce your chance of developing seizures, drug interactions, and other complications. Your risk may be minimized by talking to your healthcare provider about your medical history, including any problems you might have with your liver or any allergies you may have.


What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Xtandi® (enzalutamide) if you have:
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Ever had a seizure
  • Had a brain injury, especially with loss of consciousness
  • Had a stroke or "mini-stroke" (transient ischemic attack, or TIA)
  • Been told you have a brain arteriovenous malformation (an abnormal connection between arteries and veins in the brain)
  • Brain tumors
  • A partner who is pregnant or may become pregnant
  • Any allergies, including to foods, dyes, or preservatives.
Xtandi is not for use in women. However, if you are a woman and your healthcare provider has recommended this medication, let him or her know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Precautions and Warnings for Xtandi

Some warnings and precautions to be aware of prior to taking this medication include the following:
  • Although rare, Xtandi has been reported to cause seizures, even in people who have never had a seizure before. Because of the risk for seizures from this medication, you should avoid doing activities where a sudden loss of consciousness could harm you or someone else, such as driving.
  • This medication may be used in combination with a gonadotropin-releasing hormone (GnRH) agonist medication. If you take a GnRH, you will need to continue taking it during Xtandi treatment, unless your healthcare provider tells you otherwise.
  • Xtandi is a pregnancy Category X medication. It is not for use in women, and may harm an unborn baby if given to a pregnant woman (see Xtandi and Pregnancy).
  • It is unknown if Xtandi passes through breast milk. This drug is not approved for use in women (see Xtandi and Breastfeeding).
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