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Xofigo

Generic Name: radium ra 223 dichloride (Intravenous route)

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

Commonly used brand name(s)

In the U.S.

  • Xofigo

Available Dosage Forms:

  • Solution

Uses For Xofigo

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.

Slideshow: Flashback: FDA Drug Approvals 2013

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

Before Using Xofigo

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.

Pediatric

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.

Geriatric

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.

Pregnancy

Pregnancy Category Explanation
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.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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. Tell 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 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 Xofigo

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.

Precautions While Using Xofigo

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:

  • 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.

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.

Xofigo Side Effects

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
  • shortness of breath
  • 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.

See also: Side effects (in more detail)

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