RAY-dee-um Ra 223 dye-KLOR-ide
Radium Ra 223 dichloride injection is used to treat men with metastatic prostate cancer that has spread to the bones but to no 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 a doctor.
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:
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.
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.
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.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
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.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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:
A doctor or other trained health professional will give you this medicine in a hospital or cancer clinic. This medicine is given through a needle placed in one of your veins.
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.
Your doctor will 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 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 therapy and for 6 months after the last dose. Your sexual partner must also use an effective form of birth control during therapy and for 6 months after your 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:
Check with your doctor right away if you have confusion, a decrease in urine, dizziness, dry mouth, fainting, an 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, a decrease in 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.
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:
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:
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.