Casodex contains bicalutamide, a non-steroidal androgen receptor inhibitor, in the form of a 50 mg tablet. It is intended for oral administration. The active form is the R-enantiomer of bicalutamide, while the S-enantiomer is inactive. Key inactive ingredients include lactose monohydrate, sodium starch glycolate, povidone, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide.

How should I use this medication?

Take this medication by mouth with a glass of water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Get rid any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Breast pain or tenderness
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Unexpected breast tissue growth

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Bone, joint, or muscle pain
• Constipation
• Diarrhea
• Hot flashes
• Nausea
• Swelling of the ankles, hands, or feet
• Unusual weakness or fatigue

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes
• Liver disease
• An unusual or allergic reaction to bicalutamide, other medications, foods, dyes, or preservatives
• If your partner is pregnant or trying to get pregnant

What may interact with this medication?

• Certain medications for sleep or anxiety
• Opioid medications for pain
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication. You may need blood work while taking this medication.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.

Talk to your care team if you or your partner are pregnant or think either of you might be pregnant. This medication can cause serious birth defects. If your partner can get pregnant, use a condom during sex while taking this medication and for 130 days after the last dose.

This medication may cause infertility. Talk with your care team if you are concerned about your fertility.