ZYTIGA® (zye-tee-ga) is a prescription medicine that is used along with prednisone. ZYTIGA® is used to treat men with prostate cancer that has spread to other parts of the body. Learn more about ZYTIGA®.

ZYTIGA® works by interrupting the androgen-making process at an important step. ZYTIGA® interrupts androgen production at 3 sources: the testes, the adrenal glands, AND the tumor itself.

 

ZYTIGA® is different from some medicines that only decrease androgen production in the testes and do not affect the adrenal glands or prostate tumor tissue.

 

Learn how ZYTIGA®works

 

ZYTIGA® may cause serious side effects including:

  • High blood pressure (hypertension), low blood potassium (hypokalemia), fluid retention (edema), and irregular heartbeats.

Please see additional side effects and Important Safety Information.

ZYTIGA® was approved by the FDA based on 3 clinical studies with more than 3,000 men with metastatic prostate cancer, prostate cancer that has spread to other parts of the body, based on the following measures:

OVERALL SURVIVAL

How long men lived taking ZYTIGA® + prednisone vs placebo* + prednisone

DISEASE PROGRESSION

Length of time men lived without their disease getting worse or dying while taking ZYTIGA® + prednisone vs placebo + prednisone

Not all measures are applicable to all clinical trials

*Placebo: An inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment being tested. (National Cancer Institute: NCI Dictionary of Cancer Terms. Bethesda, MD: National Cancer Institute, 2015. Available at www.cancer.gov/dictionary. Accessed September 2019.

As measured by imaging studies.

Oral, once-daily ZYTIGA® has an established safety profile. Learn more about side effects and Important Safety Information and discuss taking ZYTIGA® with your doctor.

ZYTIGA may cause serious side effects including:

  • High blood pressure (hypertension), low blood potassium levels (hypokalemia), fluid retention (edema), and irregular heartbeats can happen during treatment with ZYTIGA®
    Tell your healthcare provider if you get any of the following symptoms:
    • Dizziness
    • Confusion
    • Fast or irregular heartbeats
    • Muscle weakness
    • Feel faint or lightheaded
    • Pain in your legs
    • Headache
    • Swelling in your legs or feet
  • Adrenal problems may happen if you stop taking prednisone, get an infection, or are under stress
  • Liver problems. You may develop changes in liver function blood tests. Your healthcare provider will do blood tests to check your liver before treatment with ZYTIGA® and during treatment with ZYTIGA®. Liver failure may occur, which can lead to death. Tell your healthcare provider if you notice any of the following changes:
    • Yellowing of the skin or eyes
    • Darkening of the urine
    • Severe nausea or vomiting
  • Increased risk of bone fracture and death when ZYTIGA and prednisone or prednisolone, is used in combination with a type of radiation called radium Ra 223 dichloride. Tell your healthcare provider about any other treatments you are taking for prostate cancer

The most common side effects of ZYTIGA® include:

  • Feeling very tired
  • Joint pain
  • High blood pressure
  • Nausea
  • Swelling in your legs or feet
  • Low blood potassium levels
  • Hot flushes
  • Diarrhea
  • Vomiting
  • Infected nose, sinuses, or throat (cold)
  • Cough
  • Headache
  • Low red blood cells (anemia)
  • High blood cholesterol and triglycerides
  • High blood sugar levels
  • Certain other abnormal blood tests

ZYTIGA may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.

 

THESE ARE NOT ALL THE POSSIBLE SIDE EFFECTS OF ZYTIGA®.

FOR MORE INFORMATION, ASK YOUR HEALTHCARE PROVIDER OR PHARMACIST.

 

Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.

 

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

 

Please read the full Prescribing Information and Patient Information for ZYTIGA® and discuss any questions you have with your doctor.

Before taking ZYTIGA®, tell your healthcare provider about all of your medical conditions, including if you:

  • Have heart problems
  • Have liver problems
  • Have a history of adrenal problems
  • Have a history of pituitary problems
  • Are receiving any other treatment for prostate cancer
  • Are pregnant or plan to become pregnant. ZYTIGA® can cause harm to your unborn baby and loss of pregnancy (miscarriage). Females who are or may become pregnant should not handle ZYTIGA® uncoated tablets or other ZYTIGA® tablets if broken, crushed, or damaged without protection, such as gloves
  • 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 ZYTIGA® and for 3 weeks after the last dose of ZYTIGA®
  • Are breastfeeding or plan to breastfeed. It is not known if ZYTIGA® passes into your breast milk

Tell your healthcare provider about all the medicines you take or treatments you receive including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZYTIGA® can interact with many other medicines.

Take ZYTIGA® plus prednisone exactly as your healthcare provider tells you to.

Learn more about taking ZYTIGA®

If you are taking ZYTIGA®:

  • Take ZYTIGA® and prednisone exactly as your healthcare provider tells you
  • Take your prescribed dose of ZYTIGA® one time a day. Your healthcare provider may change your dose if needed
  • Do not change or stop taking your prescribed dose of ZYTIGA® or prednisone without talking to your healthcare provider first
  • Take ZYTIGA® on an empty stomach, at least 1 hour before or at least 2 hours after a meal. Do not take ZYTIGA® with food. Taking ZYTIGA® with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects
  • Swallow ZYTIGA® tablets whole. Do not crush or chew tablets
  • Take ZYTIGA® tablets with water
  • If you miss a dose of ZYTIGA® or prednisone, take your prescribed dose the following day. If you miss more than 1 dose, tell your healthcare provider right away
  • Your healthcare provider will do blood tests to check for side effects

If you miss a dose of ZYTIGA® or prednisone, take your prescribed dose the following day. If you miss more than 1 dose, tell your healthcare provider right away.

Learn more about taking ZYTIGA®

    ZYTIGA® is not for use in women or children.

     

    It is not known if ZYTIGA® is safe and effective in females or children. Women who are pregnant or women who may be pregnant should not handle ZYTIGA® 250 mg uncoated tablets or other ZYTIGA® tablets if broken, crushed, or damaged without protection, e.g., gloves.
    Keep ZYTIGA® and all medicines out of the reach of children.

    Paying for your treatment doesn’t have to be complicated. Janssen CarePath can identify cost support options that may help with managing your out-of-pocket costs for ZYTIGA®—whether you have commercial or private health insurance, government-funded healthcare coverage such as Medicare or Medicaid, or have no insurance coverage.

    Start with Janssen CarePath

     

    A personally assigned Janssen CarePath Care Coordinator will work closely with you and your doctor to help you get started and stay on track.

     

    If you have commercial or private health insurance and need help paying for ZYTIGA®, the Janssen CarePath Savings Program may be able to help. If you don’t have commercial or private health insurance, Janssen CarePath can provide information about other resources that may help with your out-of-pocket medication costs. You may also find help from the programs and resources found on JanssenPrescriptionAssistance.com.

    Janssen CarePath Care Coordinators are available as a convenient resource and can assist you with:

    Paying for ZYTIGA®: Identifying cost support options that may help with managing your out-of-pocket costs-whether you have commercial or private health insurance, government coverage such as Medicare or Medicaid, or have no insurance coverage.

    Getting Started: Reviewing your health plan benefits and insurance coverage for ZYTIGA®, offering treatment education resources, and identifying and coordinating with a specialty pharmacy to arrange shipment of your ZYTIGA® medication.

    Staying on Track: Connecting you with ongoing support to help you stay on track with ZYTIGA® treatment, such as personalized prescription reminders. and educational materials delivered to your email or front door.

    Call a Janssen CarePath Care Coordinator at 855-ZYTIGA-1 (855-998-4421), Monday–Friday, 8:00 AM–8:00 PM ET. Multilingual phone support is available.