Zytiga (Abiraterone Acetate)

Johnson & Johnson Healthcare Products, Division of

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Miscellaneous Antineoplastics

Cancer-Prostate

This medication is used along with prednisone to treat men with prostate cancer that has spread to other areas of the body and has not responded to surgical treatment that lowers testosterone levels. Abiraterone belongs to a class of drugs known as anti-androgens (anti-testosterone). Testosterone, a natural hormone, helps prostate cancer to grow and spread. Abiraterone works by blocking the production of testosterone, thereby slowing the growth and spread of prostate cancer.

Read the Patient Information Leaflet if available from your pharmacist before you start taking abiraterone and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth on an empty stomach, as directed by your doctor, usually once daily. Do not eat for at least 2 hours before and 1 hour after taking abiraterone. Taking abiraterone with food greatly increases the amount of this drug in your body and increases the risk of side effects. Swallow whole. Do not crush or chew before swallowing. Pregnant women should wear gloves if handling the tablets. If the tablet is crushed or broken, women who are pregnant or who may become pregnant should not handle it or breathe the dust from it (see also Precautions section). Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not stop any medications for your prostate cancer unless told to do so by your doctor. Stopping your medications could allow the cancer to spread more rapidly.

Headache, hot flushes, joint pain, heartburn or cold-like symptoms may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication. Tell your doctor right away if you have any serious side effects, including: increased urination, painful urination, fast/irregular heartbeat, muscle cramps/weakness, leg pain, swelling in legs/feet, bone fractures. Get medical help right away if you have any very serious side effects, including: chest pain, feeling short of breath while at rest, persistent nausea/vomiting, loss of appetite, severe abdominal/stomach pain, yellowing eyes/skin, dark urine. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Other medications can affect the removal of abiraterone from your body, which may affect how abiraterone works. Examples include rifamycins (such as rifabutin), drugs used to treat seizures (such as carbamazepine, phenytoin, phenobarbital), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. If you miss more than one dose, talk to your doctor right away.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.