XTANDI

Generic Name/API: enzalutamide

Manufacturer: Astellas Pharma

Dosage Forms & Strength & Pack Size:
• Capsules: 40 mg, 112’s

Storage:
Store XTANDI capsules and tablets at 20°C to 25°C (68°F to 77°F) in a dry place and keep the
container tightly closed. Excursions permitted from 15°C to 30°C (59°F to 86°F).
Swallow capsules or tablets whole. Do not chew, dissolve or open the capsules. Do not cut, crush, or chew the tablets.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION
What is XTANDI?
XTANDI is a prescription medicine used to treat men with prostate cancer that:

no longer responds to a hormone therapy or surgical treatment to lower testosterone
OR
has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone
OR
has not spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone, and who are at high risk of cancer spreading to other parts of the body.
It is not known if XTANDI is safe and effective in females or children.

IMPORTANT SAFETY INFORMATION
What should I tell my doctor before taking XTANDI?
Tell your doctor about all your medical conditions, including if you:

Have a history of seizures, brain injury, stroke, or brain tumors.
Have a history of heart disease, have high blood pressure, or have abnormal amounts of fat or cholesterol in your blood (dyslipidemia).
Are pregnant or plan to become pregnant. XTANDI can cause harm to your unborn baby and loss of pregnancy (miscarriage).
Have a partner who is pregnant or may become pregnant.
Males who have female partners who are able to become pregnant should use effective birth control (contraception) during treatment with XTANDI and for 3 months after the last dose.
Males must use a condom during sex with a pregnant female.
Are breastfeeding or plan to breastfeed. It is not known if XTANDI passes into your breast milk.
Take other medicines. XTANDI may affect the way other medicines work, and other medicines may affect how XTANDI works. These include prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not start or stop any medicine without talking to your doctor.

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