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What is Xofigo? What is Xofigo used for?
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?
Is radium Xofigo available as a generic drug?
Do I need a prescription for radium Xofigo?
What are the side effects of Xofigo?
The most common side effects of radium Ra 223 are:
- swelling of the arms or legs (peripheral edema), and
- low blood cell counts.
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.
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What is the dosage for Xofigo?
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.
Which drugs or supplements interact with Xofigo?
Information on potential drug-drug interactions with radium Ra 223 is not available as no formal drug interaction studies have been performed.
Is radium Xofigo safe to take if I'm pregnant or breastfeeding?
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 else should I know about Xofigo?
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).
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Radium Ra 223 (Xofigo) is a drug used to kill cancer cells which have spread (metastatized) to the bones of men from their cancerous prostates. The drug emits radiation that helps kill the cells by destroying their DNA. Side effects, drug interactions, and pregnancy safety should be reviewed prior to taking this medication.
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Bone cancer is a rare type of cancer that occurs in cells that make up the bones. Primary bone cancer that arises in bone cells is different than metastatic bone cancer, which is cancer that arises in another part of the body and then spreads to the bones. Hereditary and environmental factors likely contribute to the risk of bone cancer. Signs and symptoms of bone cancer may include pain, the presence of a mass or lump, and bone fractures. There are different types of bone cancer (osteosarcoma, chondrosarcoma, Ewing's sarcoma, pleomorphic sarcoma, fibrosarcoma). Treatment for bone cancer may include surgical removal of the tumor, chemotherapy, radiation, and/or a stem cell transplant. The prognosis for bone cancer depends on the type of cancer and the extent of spread.
Prostate cancer is the most common cancer in men after skin cancer. Risk factors include age, family history, ethnicity, and diet. Prostate cancer is diagnosed by a digital rectal exam, prostate-specific antigen (PSA) test, and prostate biopsy. Symptoms may include frequent need to urinate, incontinence, pain, blood in the urine, fatigue, and more. Prognosis and treatment depend on cancer staging. Watchful waiting, surgery, radiation, cryotherapy, and other management strategies are available. Research and clinical trials strive to find new and better treatments for prostate cancer.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.