radium Ra 223 dichloride (Xofigo)

Radium Ra 223 (Xofigo) is a radioactive medicine (radiotherapeutic drug) that is used to treat male patients with symptoms of advanced prostate cancer that has spread to the bones, but not to other parts of the body. The radioactive particles emitted by radium Ra 223 helps kill cancer cells in the bone by damaging their DNA. Radium Ra 223 causes minimal damage to the nearby healthy cells. Radium Ra 223 can help some patients live longer. Compared to placebo, radium Ra 223 extended life by 14.9 months vs. 11.3 months for the placebo group. The FDA approved Radium Ra 223 in May 2013.

What brand names are available for radium Ra 223 dichloride Xofigo?

Xofigo

Is radium Xofigo available as a generic drug?

No

Do I need a prescription for radium Xofigo?

Yes

The most common side effects of radium Ra 223 are:

• nausea,
• vomiting,
• diarrhea,
• swelling of the arms or legs (peripheral edema), and
• low blood cell counts.

To avoid dehydration caused by diarrhea, nausea, or vomiting, patients are advised to drink plenty of water and report any signs of dehydration such as dry mouth or increased thirst.

Radium Ra 223 can cause bone marrow suppression, a potentially serious condition in which blood cell counts decrease. In clinical studies, use of radium Ra 223 caused a drop in red blood cells, white blood cells, and platelets in some patients. Because of serious bone marrow problems, some patients had to permanently discontinue treatment, required blood transfusions, and some deaths were reported.

Radium Ra 223 dosing is based on body weight. The recommended dosage of radium Ra 223 is 50 kBq or 1.35 microcurie per kg body weight, administered intravenously every 4 weeks for a total of 6 injections. Radium Ra 223 should only be administered by slow intravenous injection over 1 minute and the line should be flushed with isotonic saline (salt water) before and after injection.

Information on potential drug-drug interactions with radium Ra 223 is not available as no formal drug interaction studies have been performed.

Radium Ra 223 can cause harm to the unborn baby and should not be used in women who are or may become pregnant. Women who are pregnant or who may become pregnant should not handle radium Ra 223 without wearing gloves or proper protection. Radium Ra 223 is classified as FDA pregnancy risk category X. Male patients who are sexually active should use condoms and their female partners should use a highly effective method of birth control (for example, birth control pills) during treatment and for 6 months after stopping treatment.

Radium Ra 223 should not be used by women. It is not known if radium Ra 223 is excreted in breast milk.

What preparations of radium Xofigo are available?

Solution for intravenous (IV) injection: 1000 kBq/ml (27 microcurie/ml).

How should I keep Xofigo stored?

Radium Ra 223 should be stored at room temperature, below 40 C (104 F).