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The safety and warning information for bicalutamide (Casodex) provides essential guidelines to ensure its safe use. Please carefully review the following points and discuss any concerns with your healthcare provider:

• Liver Damage: Bicalutamide (Casodex) can infrequently cause significant liver damage, typically within 3 to 4 months of starting treatment. Regular blood tests will be conducted by your healthcare provider to monitor liver function before and during treatment. Promptly inform your provider if you experience symptoms such as fatigue, loss of appetite, nausea, vomiting, dark urine, right-sided abdominal pain, or yellowing of the eyes or skin. You may need to discontinue the medication if liver issues occur.

• Serious Bleeding with Warfarin (Coumadin): There is an increased risk of severe bleeding when bicalutamide (Casodex) is used concurrently with the blood thinner warfarin (Coumadin), even if your warfarin dosage was previously stable. Monitor your international normalized ratio (INR) more frequently to ensure appropriate warfarin dosing. Seek immediate medical attention if you experience sudden weakness, numbness, severe headache, confusion, dizziness, seizures, vision changes, loss of balance, slurred speech, vomiting blood, or bloody or tarry stools.

• Breast Enlargement and Tenderness: Higher-than-recommended doses of bicalutamide (Casodex) may lead to breast enlargement, tenderness, and pain. Consult your healthcare provider if you notice these symptoms.

• High Blood Sugar: When taken with LHRH agonists, bicalutamide (Casodex) can lead to difficulty in managing blood sugar levels, potentially resulting in high blood sugar. Enhanced monitoring of blood sugar levels is advised, especially for diabetic patients. Your medication dosage may need adjustments. Report increased thirst, hunger, frequent urination, headaches, or blurry vision to your provider.

Contraindications: Bicalutamide (Casodex) is contraindicated in females and during pregnancy due to potential health risks. If any of these conditions apply, consult your healthcare provider prior to use.

Common side effects:

• hot flashes
• body and back pain
• weakness
• constipation
• pelvic pain
• nausea
• swelling in the arms or legs
• difficulty breathing
• frequent nighttime urination
• blood in the urine
• diarrhea
• stomach pain
• dizziness

Less common but important to monitor:

• rash
• bone pain
• cough
• urinary tract infection symptoms
• breast tenderness
• sensation of 'pins and needles'
• weight loss
• heartburn
• chest pain
• headache
• flu-like symptoms

Serious side effects:

• jaundice
• dark urine
• upper stomach pain
• serious bleeding
• persistent bleeding or bruising
• vomiting blood
• tarry stools
• severe dizziness
• trouble breathing
• swelling of the face, tongue, or throat

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Warfarin
• Acenocoumarol
• Phenprocoumon