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The following safety and warning information outlines crucial risks and precautions associated with the use of bicalutamide (Casodex). It is essential to review these details carefully and discuss any concerns with your healthcare provider.

• Liver Damage: Although uncommon, bicalutamide (Casodex) can lead to severe liver damage, typically within 3 to 4 months of commencing treatment. Regular blood tests will be conducted by your healthcare provider to monitor liver function both before and during the treatment. It is important to inform your provider immediately if you experience fatigue, loss of appetite, nausea, vomiting, dark urine, pain on the right side of the stomach, or yellowing of the eyes or skin, as these may indicate liver issues and could necessitate discontinuation of the medication.

• Serious Bleeding with Warfarin (Coumadin): Use of bicalutamide (Casodex) can increase the risk of serious bleeding if taken concurrently with the anticoagulant warfarin (Coumadin). This risk remains even if your warfarin dose was previously stable. You may need more frequent monitoring of your international normalized ratio (INR) to ensure your warfarin dosage remains appropriate. Seek immediate medical attention if you experience sudden weakness, numbness, severe headache, confusion, dizziness, seizures, visual changes, loss of balance, slurred speech, vomiting blood, or bloody or black stools, as these may be signs of severe bleeding.

• Breast Enlargement and Tenderness: High doses of bicalutamide (Casodex) can cause breast enlargement, tenderness, and pain. Consult your healthcare provider if you experience these symptoms.

• High Blood Sugar: When taken with LHRH agonists, bicalutamide (Casodex) may impair blood sugar control, leading to elevated levels. This is especially important for individuals with diabetes. Blood sugar should be closely monitored, and medication dosages may need adjustment. Notify your healthcare provider if you notice increased thirst, hunger, frequent urination, headaches, or blurred vision.

Contraindications:

• This medication should not be used by females or during pregnancy due to potential serious health risks. Always consult your healthcare provider if any of these conditions apply to you before starting treatment with bicalutamide (Casodex).

When taking this medication, you may experience some common side effects. These include hot flashes, breast swelling or tenderness, nausea, vomiting, constipation, diarrhea, stomach upset, and headache. While these are generally mild, if they persist or worsen, it is important to contact your healthcare provider for advice. Drowsiness, dizziness, and trouble sleeping are also possible but typically not severe.

There are other side effects that some users may encounter, such as whole body pain, back pain, weakness, pelvic pain, swelling in the arms or legs, and frequent urination at night. Additionally, some individuals report feeling flu-like symptoms, dizziness, and experiencing weight changes. If you notice any of these symptoms, especially if they are bothersome, consult your healthcare provider.

On rare occasions, more serious side effects can occur. These include increased thirst or urination, mental and mood changes like anxiety or depression, shortness of breath, increased coughing, unusual tiredness, muscle weakness, and bone or joint pain. Painful or bloody urination, or signs of an infection such as a persistent sore throat, fever, or chills also warrant medical attention.

Severe side effects are very uncommon but require immediate medical care. These include signs of severe liver problems like jaundice, dark urine, or abdominal pain, as well as symptoms of serious bleeding such as unexplained bruising, blood in urine, or tarry stools. Additionally, any symptoms of a serious allergic reaction, such as rash, itching, swelling, severe dizziness, or trouble breathing, should be addressed urgently. Always report any side effects to your healthcare provider, even if they are not listed here, to ensure your safety and well-being.