Pronunciation:

RAY-dee-um Ra 223 dye-KLOR-ide

Brand Names:

• Xofigo

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Radiopharmaceutical, Antineoplastic

Uses of This Medicine:

Radium Ra 223 dichloride injection is used to treat men with castration-resistant (resistant to medical or surgical treatments to lower testosterone) prostate cancer that has spread to the bones but not to other organs. It is a radiopharmaceutical agent. Radiopharmaceuticals are radioactive agents that are used to find and treat certain diseases.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of radium Ra 223 dichloride injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of radium Ra 223 dichloride injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone Acetate

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow problems or
• Leukopenia (low white blood cells) or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.

Drink plenty of fluids. You may become dehydrated while you are receiving this medicine.

Your family members must not be exposed to radiation from this medicine. The fluids from your body can transfer radiation to another person who touches them. Practice good hygiene while you receive this medicine and for at least 1 week after your last dose. Flush the toilet several times after each use. Wash clothes that are soiled with stool or urine promptly and separately from other clothes.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

This medicine can cause birth defects if the father is using it when his sexual partner becomes pregnant. If you are sexually active with a female who could become pregnant, use a condom during treatment with this medicine and for 6 months after the last dose. Your sexual partner must also use an effective form of birth control during treatment and for 6 months after the last dose. If a pregnancy occurs while you are receiving this medicine, tell your doctor right away.

Xofigo® can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may increase your risk for fractures when used with abiraterone (Zytiga®) plus prednisone or prednisolone.

Check with your doctor right away if you have confusion, decrease in the amount of urine, dizziness, dry mouth, fainting, increased heart rate, lightheadedness, rapid breathing, sunken eyes, thirst, or unusual tiredness or weakness. These may be symptoms of dehydration.

Check with your doctor right away if you have bloody urine, decrease in the amount of urine, swelling of the face, fingers, or lower legs, trouble breathing, or weight gain. These could be symptoms of kidney problems.

You will be exposed to radiation with this medicine. Talk to your doctor if you have concerns about this.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

chest pain

chills

cough

fever

lower back or side pain

painful or difficult urination

pale skin

pinpoint red spots on the skin

rapid weight gain

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

tingling of the hands or feet

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Confusion

decreased frequency or amount of urine

dizziness

dry mouth

fainting

high fever

hoarseness

increase in heart rate

increased blood pressure

increased thirst

lightheadedness

loss of appetite

nausea

rapid breathing

sunken eyes

thirst

vomiting

weight gain

wrinkled skin

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

More common

Diarrhea

Less common

Redness, pain, and swelling at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with 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.