Cyproterone (Oral, Intramuscular)

Cyproterone is used to treat cancer of the prostate gland. The prostate gland is present only in males; therefore, females do not get prostate cancer.

This medicine blocks the effects of the male hormone testosterone in the body. This reduces the amount of testosterone produced in the body and is one way to treat this type of cancer.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may cause some people to become drowsy, dizzy, or less alert than they normally are. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Cyproterone may cause your skin to be more sensitive to sunlight than it usually is. Exposure to sunlight, even for short periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may need a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

While you are taking cyproterone, be careful to limit the amount of alcohol you drink.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide. Here are some important points to discuss:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have only been done in adult patients, and there is no specific information comparing the use of cyproterone in children to its use in other age groups.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be known if they work the same way in older people as they do in younger adults, or if they cause different side effects or problems. There is no specific information comparing the use of cyproterone in the elderly with its use in other age groups.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating food or specific types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Blood clots (or a history of) or
• Circulation disease (or a history of) or
• Stroke (or a history of)—If these conditions are present, cyproterone may have a higher chance of causing blood clotting problems.

• Cardiac disease—May worsen the condition.

• Depressive tendencies—May lead to depression occurring.

• Type 2 diabetes mellitus—May cause uncontrolled diabetes by increasing blood and urine sugar levels.

• Liver disease—Effects of cyproterone may be heightened due to slower removal from the body.

Along with its necessary effects, this medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Contact your doctor as soon as possible if you experience any of the following side effects:

Less common

• Abdominal pain or tenderness
• agitation
• back pain
• black, tarry stools
• blisters on the skin
• bloody urine
• blurred vision
• chest pain
• chills
• clay-colored stools
• confusion
• cough
• dark urine
• decreased appetite
• decreased urine output
• difficulty swallowing
• dilated neck veins
• dizziness
• drowsiness
• dry mouth
• fainting or feeling light-headed when suddenly getting up from a lying or sitting position
• fast heartbeat
• fatigue
• fever
• flushed, dry skin
• fruit-like breath odor
• general feeling of discomfort or illness
• hallucinations
• sudden and severe headache
• hives
• inability to speak
• increased blood pressure
• increased hunger
• increased thirst
• increased urination
• irregular breathing
• irregular heartbeat
• itching
• loss of consciousness
• lower back or side pain
• mood or mental changes
• nausea and vomiting
• painful or difficult urination
• pains in the chest, groin, or legs, especially in the calves
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, thickened, or scaly skin
• seizures
• shortness of breath
• skin rash
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stiff neck
• stomachache
• sudden loss of coordination
• sweating
• swelling of the feet or lower legs
• swollen and/or painful glands
• temporary blindness
• tightness in the chest
• unexplained weight loss
• unusual bleeding or bruising
• vision changes
• sudden and severe weakness in one arm and/or leg
• wheezing
• yellow eyes or skin

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your healthcare professional may also have ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Decreased interest in sexual intercourse
• inability to have or maintain an erection
• increase in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• loss of sexual ability, desire, drive, or performance
• swelling of the breasts or breast soreness in both females and males
• unexpected or excess milk flow from breasts

Less common

• Bleeding, blistering, burning, coldness, or discoloration of the skin
• change in walking and balance
• clumsiness or unsteadiness
• hair loss
• inability to move legs or arms
• increased sensitivity of skin to sunlight
• increase in bowel movements
• loose stools
• loss of strength or energy
• muscle pain or weakness
• paralysis of one side of the body
• redness or other discoloration of the skin
• severe sunburn
• soft stools
• tiredness or weakness
• unusual increase in hair growth
• weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

At first, cyproterone often causes loss of strength and energy or tiredness. However, these effects are lessened after about the third month of treatment and it is very important that you continue to receive this medication.

This medication should not be discontinued even if improvement of the disease occurs.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For treating prostate cancer:Adults—100 to 200 milligrams (mg) per day divided into 2 to 3 doses. Take after meals.

• For injection dosage form:For treating prostate cancer:Adult—300 milligrams (mg) injected into a muscle once a week.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.