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Precautions and Warnings With Enzalutamide

Even though enzalutamide can be an effective form of chemotherapy, it may increase the risk for seizures or other potentially serious complications. This medicine may not be safe for men who have a history of seizures or those with kidney disease. Precautions and warnings with enzalutamide also apply to men who have certain allergies or who are taking certain medications.

 

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking enzalutamide (Xtandi®) 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.
 
Enzalutamide 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 Enzalutamide Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this medication include the following:
 
  • Although rare, enzalutamide 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 enzalutamide treatment, unless your healthcare provider tells you otherwise.
   
  • Enzalutamide 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 this medication passes through breast milk. Enzalutamide is not approved for use in women (see Xtandi and Breastfeeding).
 
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