This medicine is an androgen biosynthesis inhibitor used to treat a certain type of prostate cancer that has spread to other parts of the body. It is used along with another medicine (prednisone). It may also be used for other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. AN ADDITIONAL PATIENT INFORMATION LEAFLET is available with this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this information. TAKE THIS MEDICINE ON AN EMPTY STOMACH at least 1 hour before or 2 hours after eating. Do NOT take it with food. The amount of this medicine in your body may be increased if you take it with food. This may increase the risk of side effects. SWALLOW WHOLE with water. Do not break, crush, or chew before swallowing. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss more than 1 dose, contact your doctor.
Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking atazanavir, carbamazepine, carvedilol, chlorpromazine, clarithromycin, desipramine, dextromethorphan, encainide, flecainide, iloperidone, indinavir, itraconazole, ketoconazole, maprotiline, metoprolol, nefazodone, nelfinavir, nortriptyline, paroxetine, phenobarbital, phenytoin, pimozide, propafenone, propranolol, rifabutin, rifampin, rifapentine, risperidone, ritonavir, saquinavir, telithromycin, tetrabenazine, thioridazine, or voriconazole. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including low blood potassium levels, allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of liver problems, heart problems (eg, heart failure, irregular heartbeat), recent heart attack, high blood pressure, adrenal gland problems, pituitary gland problems, or fluid-retention or swelling (edema). USE OF THIS MEDICINE IS NOT RECOMMENDED if you have severe liver problems or if the patient is a woman, especially one who is pregnant or may become pregnant. Use of this medicine in CHILDREN is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions about taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include cold-like symptoms; cough; diarrhea; flushing of the skin; heartburn; joint swelling, discomfort, or pain; or mild muscle discomfort. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bone pain; chest pain or discomfort; confusion; fast or irregular heartbeat; fever, chills, or persistent sore throat; muscle pain, weakness, or cramping; severe or persistent headache, dizziness, or lightheadedness; shortness of breath; sudden or unexplained weight gain; swelling of the hands, ankles, legs, or feet; symptoms of liver problems (eg, dark urine; loss of appetite; pale stools; unusual nausea, stomach pain, or tiredness; yellowing of the skin or eyes); or urination problems (eg, difficult, increased, or painful urination). AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
If overdose is suspected, contact your local poison control center or emergency room immediately.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.